whether, within the parameters required for reversal of an order of acquittal, the needful is met in the present case. The reason to treat the same with some caution has already been set out by us hereinbefore. The testimony of PW-6, that he saw the gun being fired, but could not make out whether a bullet hit the deceased or not has been taken into account, but, in the context of the overall testimony of the eyewitnesses, the story set forth by the prosecution and the witnesses was found to be believable by the High Court. However, this story does not deal with the aforesaid aspects noted by the trial court, i.e., no bullet injury, the weapon not being recovered, no bullets or bullet marks being found at the place of occurrence and the inconsistencies in the testimonies of the witnesses. The trial court rightly observed that it was accused No.1 who was the main accused, who was subsequently murdered. We may, however, note that insofar as the statement of accused No.2, under Section 313 of the Cr.P.C. is concerned, the testimonies of PW-3, PW-4 and PW-6 all have been put to him but the said accused claimed absence from the place of the occurrence. As far as accused No.3 is concerned, once again, the testimonies of all the three eyewitnesses have been put to him, but the role sought to be assigned to him is stated to be a hit with the dagger, and not the role of firing at the accused as set out in the FIR.The subsequent testimonies, however, sought to assign a different role than the one assigned in the FIR, bringing about an inconsistency. The view taken by the trial court is, at least, a plausible view though that may not be the only plausible view or if one may say even the less probable one. We are, thus, of the considered opinion that the prosecution has not been able to prove the case beyond reasonable doubt against these two accused, and they must get the benefit of doubt and consequently have to be acquitted.

 whether, within the parameters required for reversal of an order of acquittal, the needful is met in the present case.

 The reason to treat the same with some caution has already been set out by us hereinbefore. 
The testimony of PW-6, that he saw the gun being fired, but could not make out whether a bullet hit the deceased or not has been taken into account, but, in the context of the overall testimony of the eyewitnesses, the story set forth by the prosecution and the witnesses was found to be believable by the High Court. However, this story does not deal with the aforesaid aspects noted by the trial court, i.e., no bullet injury, the weapon not being recovered, no bullets or bullet marks being found at the place of occurrence and the inconsistencies in the testimonies of the witnesses. The trial court rightly observed that it was accused No.1 who was the main accused, who was subsequently murdered. We may, however, note that insofar as the statement of accused No.2, under Section 313 of the Cr.P.C. is concerned, the testimonies of PW-3, PW-4 and PW-6 all have been put to him but the said accused claimed absence from the place of the occurrence. As far as accused No.3 is concerned, once again, the testimonies of all the three eyewitnesses have been put to him, but the role sought to be assigned to him is stated to be a hit with the dagger, and not the role of firing at the accused as set out in the FIR.The subsequent testimonies, however, sought to assign a different role than the one assigned in the FIR, bringing about an inconsistency. The view taken by the trial court is, at least, a plausible view though that may not be the only plausible view or if one may say even the less probable one. We are, thus, of the considered opinion that the prosecution has not been able to prove the case beyond reasonable doubt against these two accused, and they must get the benefit of doubt and consequently have to be acquitted.

REPORTABLE
IN THE SUPREME COURT OF INDIA
CRIMINAL APPELLATE JURISDICTION
CRIMINAL APPEAL NO.1905 OF 2009
SAMSUL HAQUE ….Appellant
VERSUS
THE STATE OF ASSAM ….Respondent
WITH
CRIMINAL APPEAL NO. 246 OF 2011
J U D G M E N T
SANJAY KISHAN KAUL, J.
1. The incident is of 17.3.1997 at 7:00 a.m. in the morning. Keramat
Ali Maral (the deceased) was having tea at the tea stall known as Kalia
Hotel. It is alleged that Abdul Hai, Abdul Rashid, Imdadul Islam, Rahul
Amin, Mofizuddin Islam and Abdul Rahim Faruki, being the first six
accused entered the stall and all of a sudden accused Nos.2 & 3 fired at
1
Keramat Ali with a pistol, while the other accused injured him by
stabbing and hacking with daggers, swords, etc. Keramat Ali is stated to
have died on the spot. The son of Keramat Ali, Nazrul Islam (PW-3)
lodged the FIR, stating that he was present at the site along with other
witnesses, but when they offered resistance, they were threatened with
pistols. To save their life, they ran away from the site. Insofar as accused
Nos.7, 8 & 9 are concerned, it is stated that “further it may be mentioned
that the incident took place at the instance and instigation of accused
Nos.7, 8 and 9.”
2. On the investigation being completed, a charge-sheet was filed and
charges were framed by the Sessions Judge under Sections 147, 148,
302/149 and 302 of the IPC against all. Accused Nos.7 to 9 faced
charges under Sections 302/109 of the IPC. In the course of trial,
accused No.4, Rahul Amin, absconded. Accused No.1, Abdul Hai, died/
was allegedly murdered during the course of trial. On completion of trial
the Sessions Judge, Morigaon found that accused No.1 was the main
culprit who had killed the deceased, Keramat Ali. The trial court also
found that the guilt of accused Nos.5 & 6 was also established beyond
reasonable doubt.
2
3. The convicted accused filed an appeal before the Gauhati High
Court and so did the State of Assam qua the accused who had been
acquitted. The appeal of the convicted accused was dismissed by the
High Court and the Special Leave Petition (‘SLP’) filed against the same
was also dismissed and, thus, that matter attained finality.
4. The impugned judgment dated 12.2.2009 deals with the appeal of
the State and has reversed the judgment of the trial court convicting the
five accused.
5. Accused No.9, Samsul Haque has filed Crl. Appeal No.1905/2009,
while Abdul Rashid (accused No.2) and Imdadul Islam (accused No.3)
filed Crl. Appeal No.246/2011. It is these three accused who are before
us.
6. We have heard Mr. R.K. Dash, learned Senior Counsel for accused
No.9, Mr. Bijan Ghosh, learned counsel for accused Nos.2 & 3 and
learned counsel for the State, Mr. Debojit Borkakati who took us through
the record before us. We have also perused the trial court record.
3
7. We would first deal with the witnesses produced by the
prosecution to prove their case. Four witnesses were projected as eyewitnesses to the occurrence, viz., Taher Ali (PW-1); Nazrul Islam (PW-3),
who is the son of the deceased and the informant; Sorhab Ali (PW-4),
brother of the deceased; Mozammil Hussain (PW-6), son of the elder
brother of the deceased. While three of the witnesses are relatives, PW-1
is an independent witness. It may be noted that Mr. Dilip Modak, owner
of the hotel, or any other independent witness present at the place of
occurrence was not examined. Mr. Somnath Bora, the IO was produced
as PW-7. It may also be noted that the defence examined only one
witness, i.e. Siraj Ali (DW-1), who was at the place of the occurrence as
recognised by the prosecution.
8. Learned Senior Counsel for accused No.9 contended that the
complainant in the complaint itself made a very vague statement that “the
incident took place at the instance and instigation of” the said accused
and two others. Nothing more was said as to how it was at the instance
and instigation of these three accused.
4
9. The second limb of his submission was that three of the witnesses,
PW-3, PW-4 and PW-6 were interested and inimical witnesses inasmuch
as PW-3, the son of PW-4 and PW-6 were accused in the murder case of
the main accused, accused No.1, Abdul Hai. The testimony of these three
witnesses was stated to be full of exaggerations, embellishments and
inconsistencies. An important aspect emphasised in this behalf is that the
version given by PW-3 in the complaint, as recorded in the FIR, is at
variance with the narration of the incident when the said witness entered
the witness box. Thus, while on the one hand in the complaint it was
alleged that the incident happened at the instance and instigation of the
appellant and two other accused, in the testimony before the court it has
been stated that these three persons ordered the other accused to catch
hold of his father, the deceased, whereafter accused Abdul Rashid, who is
accused No.2 shot at the deceased with a pistol while accused No.1 hit
him in the chest, hands and legs with a sword. The testimony of PW-4
and PW-6 states that accused No.9 and two others asked other
accomplices to hit and kill the deceased.
5
10. The aforesaid testimony, it was submitted before us, has to be read
in the context of the testimony of the only independent witness, i.e., PW1, who did not implicate the appellant in the crime. In fact, in his
testimony he has specifically stated that he did not see accused No.8 and
accused No.9 either inside or outside the hotel. Learned Senior Counsel
also submitted that a reading of the complaint, resulting in the FIR would
show that the appellant had not come to the place of occurrence along
with the others. DW-1, who was present at the place of occurrence,
according to the prosecution, stated that accused No.1 and two others
committed the crime, but he had not seen any one of the family members
of the deceased at the place of the occurrence. In fact, the suggestion in
the cross-examination of the said witness by the prosecution was that
accused No.7 had given orders to assault the deceased, but that
suggestion had been denied by the witness.
11. The third limb of the submission of the learned Senior Counsel is
based on the statement of accused No.9, recorded under Section 313 of
the Cr.P.C. It was argued that the questions asked did not really put the
case of the prosecution to the accused as was mandatory. Only two
6
questions were put in the said statement, which are as under:
“Question: PW4 Sohrab Ali has averred in evidence that at about
7 a.m. 17.3.97, you said, “Kill Keramat Ali.” What is your reply?
Ans: I was not there in the place of occurrence. My house
is at a distance of 4 or 5 kilometers from there.
Question: PW6 has stated that you asked the other accused to
kill Keramat. What do you say?
Ans: No I was not present at the place of occurrence. A
civil suit is pending over the complainant’s purchasing a plot of
land. I was one witness to (the execution of) the sale deed. Out of
that grudge they filed a false case against me.”
12. The case of PW-3 was, thus, not even put to the accused.
13. In the aforesaid context learned Senior Counsel has referred to the
judgment of this Court in Sharad Birdichand Sarda v. State of
Maharashtra1
 to contend that if the circumstances are not put to the
accused in his statement under Section 313 of the Cr.P.C., they must be
completely excluded from consideration because the accused did not
have any chance to explain them. This is stated to be the consistent view
of this Court starting from 1953 in the case of Hate Singh Bhagat Singh
1 (1984) 4 SCC 116
7
v. State of Madhya Bharat2
. Learned Senior Counsel also referred to the
judgment in Sujit Biswas v. State of Assam3
 for the proposition that the
very purpose of examining the accused persons under Section 313 of the
Cr.P.C. is to meet the requirement of the principles of natural justice, i.e.,
audi alteram partem. The accused, thus, must be given an opportunity to
explain the incriminating material that has surfaced against him and the
circumstances which are not put to the accused in his examination under
Section 313 of the Cr.P.C. cannot be used against him and must be
excluded from consideration.
14. The fourth limb of the submission of the learned Senior Counsel
arose from the acquittal of accused No.9 by the trial court and the
conviction on reversal of acquittal in appeal. Thus, the plea was that the
principles of such reversal require that the view of the trial court should
be respected unless and until the views are such as were perverse or
otherwise unsustainable. Ordinarily, the judgment of acquittal, where
two views are possible, should not be set aside even if the view formed
2AIR 1953 SC 468
3 (2013) 12 SCC 406
8
by the appellate court may be a more probable one.4
15. The last submission of the learned Senior Counsel, possibly
because it is the weakest one, was that the ingredients of common
intention under Section 34 of the IPC and abetment under Section 107 of
the IPC are distinct and separate. The principle of constructive liability,
enunciated in Section 34 of the IPC does not create a substantive offence,
unlike Section 107 of the IPC, which is an independent offence. It was,
thus, submitted that a person charged with Section 109 of the IPC (the
punishment provision for Section 107 of the IPC) cannot be convicted for
the main offence under Section 34 of the IPC. To advance this plea,
reliance was placed on Babu v. State of Tamil Nadu5
. However, in the
factual matrix of that case the person was charged under Section 34 of the
IPC and not under Section 109 of the IPC. The observations made in that
judgment, thus, have to be read in that context since substantive offence
as per Section 107 with punishment under Section 109 of the IPC was not
an aspect which the accused was charged with. The factual matrix in the
4 Sunil Kumar Sambhudayal Gupta (Dr.) v. State of Maharashtra (2010) 13
SCC 657
5 (2013) 8 SCC 60
9
present case is the opposite where the plea is that there is no charge under
Section 34 of the IPC but charge of abetment has been laid under Section
109.
16. The aforesaid last plea can be dealt with at this stage itself as the
issue is no more res integra in view of the judgment of this Court in
State of Orissa v. Arjun Das Agarwal & Anr.6
 opining that the settled
position of law is that Section 34 of the IPC does not create a distinct
offence and it is with the participation of the accused that the intention of
committing the crime is established when Section 34 of the IPC is
attracted. To rope in a person with the aid of Section 34 of the IPC, the
prosecution has to prove that the criminal act was done by the actual
participation of more than one person and that act was done in
furtherance of a common intention of all engaged in prior concert.
17. In view of the aforesaid, the last plea of the learned counsel is only
stated to be rejected.
18. On examination of the earlier pleas advanced by learned Senior
6 AIR 1999 SC 3229
10
Counsel on behalf of accused No.9, we find merit in the same.
19. PW-3 in his complaint did state that the incident took place at the
instance and instigation of accused No.9 along with accused Nos.7 & 8.
20. However, in his deposition it has been stated that these persons
asked the other accused to catch hold of the deceased. This by itself, in
our view, would not be fatal for the case of the prosecution. Similarly,
there is some variation between what exactly these three persons stated,
as available from the testimonies of even PW-4 and PW-6. However, the
crucial aspect is that PW-1, the only independent witness, does not even
implicate accused No.9, much less assign any role to him. He has stated
that he had not even seen accused No.9, even though he was the person
who was at the place of occurrence. DW-1, who was not produced as a
witness by the prosecution, though was stated to be present at the place of
occurrence, was examined by the defence and deposed against the main
accused (accused No.1) and others, while not assigning even the factum
of presence to accused No.9. Interestingly, even when the prosecution
sought to cross-examine the said witness, the case of the prosecution was
put as if only accused No.7 ordered the other accused persons to assault
11
the deceased. Had accused No.9 played a role, that would logically have
been put to DW-1 by the prosecution.
21. The most vital aspect, in our view, and what drives the nail in the
coffin in the case of the prosecution is the manner in which the court put
the case to accused No.9, and the statement recorded under Section 313
of the Cr.P.C. To say the least it is perfunctory.
22. It is trite to say that, in view of the judgments referred to by the
learned Senior Counsel, aforesaid, the incriminating material is to be put
to the accused so that the accused gets a fair chance to defend himself.
This is in recognition of the principles of audi alteram partem. Apart
from the judgments referred to aforesaid by the learned Senior Counsel,
we may usefully refer to the judgment of this Court in Asraf Ali v. State
of Assam7
. The relevant observations are in the following paragraphs:
“21. Section 313 of the Code casts a duty on the Court to put in an
enquiry or trial questions to the accused for the purpose of
enabling him to explain any of the circumstances appearing in the
evidence against him. It follows as necessary corollary therefrom
7 (2008) 16 SCC 328
12
that each material circumstance appearing in the evidence against
the accused is required to be put to him specifically, distinctly and
separately and failure to do so amounts to a serious irregularity
vitiating trial, if it is shown that the accused was prejudiced.
22. The object of Section 313 of the Code is to establish a direct
dialogue between the Court and the accused. If a point in the
evidence is important against the accused, and the conviction is
intended to be based upon it, it is right and proper that the accused
should be questioned about the matter and be given an opportunity
of explaining it. Where no specific question has been put by the
trial Court on an inculpatory material in the prosecution evidence,
it would vitiate the trial. Of course, all these are subject to rider
whether they have caused miscarriage of justice or prejudice. This
Court also expressed similar view in S. Harnam Singh v. The State
(AIR 1976 SC 2140), while dealing with Section 342 of the
Criminal Procedure Code, 1898 (corresponding to Section 313 of
the Code). Non- indication of inculpatory material in its relevant
facets by the trial Court to the accused adds to vulnerability of the
prosecution case. Recording of a statement of the accused under
Section 313 is not a purposeless exercise.”
23. While making the aforesaid observations, this Court also referred
to its earlier judgment of the three Judge Bench in Shivaji Sahabrao
Bobade v. State of Maharashtra8
, which considered the fall out of the
omission to put to the accused a question on a vital circumstance
appearing against him in the prosecution evidence, and the requirement
8 (1973) 2 SCC 793
13
that the accused’s attention should be drawn to every inculpatory material
so as to enable him to explain it. Ordinarily, in such a situation, such
material as not put to the accused must be eschewed. No doubt, it is
recognised, that where there is a perfunctory examination under Section
313 of the Cr.P.C., the matter is capable of being remitted to the trial
court, with the direction to retry from the stage at which the prosecution
was closed9
.
24. We are, however, not inclined to follow that course in the given
circumstances of this case as the inconsistencies in the testimonies also
create a doubt in the case of the prosecution qua any role of accused
No.9. The aforesaid being the factual matrix, the appellate court could
hardly have overturned the acquittal of the trial court into one of
conviction. The trial court took note of the close relationship of PW-3,
PW-4 & PW-6 to the deceased, as also the array of the accused and the
murder of accused No.1, to come to the conclusion that the abetment of
accused No.9, as alleged, had not been proved beyond reasonable doubt.
In fact, it is opined that there is no evidence that the said accused was
inside or outside Kalia Hotel at the time of the occurrence. Given the
9 Shivaji Sahabrao Bobade v. State of Maharashtra (supra)
14
circumstances, while not disagreeing with the legal proposition stated in
the impugned judgment, that there is no law that the evidence of relatives
cannot be acted upon, but, with extra care and caution, the presence of
disinterested witnesses as PW-1 and DW-1 relate another story. The
finding in the impugned order, that in the FIR filed by PW-3 as the
complainant, on the very date of the occurrence, setting out the
involvement of all the accused as clearly stated, again cannot be
sustained for the reason of the improvements and embellishments
between what was stated in the FIR and what came from the mouth of
PW-3 as his testimony in the court.
25. We are, thus, of the view that the prosecution has not been able to
establish a case against accused No.9, much less beyond reasonable
doubt.
26. Now, turning to the case of accused Nos.2 & 3, who are still in
custody, unlike accused No.9, who has since been enlarged on bail by this
Court.
27. Learned counsel sought to adopt the arguments advanced on behalf
15
of accused No.9, but then the same would not be of much use as the case
of accused No.9 is quite different from the case against accused Nos.2 &
3.
28. A perusal of the order of the trial court would show that what has
weighed in acquitting these two accused was the fact that in the
testimony of the Doctor (PW-5), who performed the post-mortem
examination on the body of the deceased, a number of injuries were
found, caused by sharp pointed objects. In the cross-examination PW-5
has specifically stated that none of the injuries is a gun-shot injury. Thus,
the medical evidence suggests the use of daggers and a sword. The plea
of the Public Prosecutor was that the gun used by these two accused (as
according to the role assigned to them) may have been used only to scare
away the persons. However, there has been no seizure of arms. Accused
No.1, the main culprit, was subsequently murdered, and the related
witnesses in the present case are the accused. PW-6 also did not see the
firing of the gun, though he claims to have heard the gun-shots though
PW-3 and PW-4 state that they saw the firing. The anomaly is that all the
accused were standing together.
16
29. On a question put by the court, whether any bullets or bullet marks
were found at the site, learned counsel for the State fairly stated in the
negative.
30. The question, which, thus, arises is that whether, within the
parameters required for reversal of an order of acquittal, the needful is
met in the present case.
31. The impugned judgment is, once again, predicated on a reasoning
placing reliance on the testimony of the related witnesses. The reason to
treat the same with some caution has already been set out by us
hereinbefore. The testimony of PW-6, that he saw the gun being fired,
but could not make out whether a bullet hit the deceased or not has been
taken into account, but, in the context of the overall testimony of the eyewitnesses, the story set forth by the prosecution and the witnesses was
found to be believable by the High Court. However, this story does not
deal with the aforesaid aspects noted by the trial court, i.e., no bullet
injury, the weapon not being recovered, no bullets or bullet marks being
found at the place of occurrence and the inconsistencies in the
17
testimonies of the witnesses. The trial court rightly observed that it was
accused No.1 who was the main accused, who was subsequently
murdered.
32. We may, however, note that insofar as the statement of accused
No.2, under Section 313 of the Cr.P.C. is concerned, the testimonies of
PW-3, PW-4 and PW-6 all have been put to him but the said accused
claimed absence from the place of the occurrence. As far as accused
No.3 is concerned, once again, the testimonies of all the three eyewitnesses have been put to him, but the role sought to be assigned to him
is stated to be a hit with the dagger, and not the role of firing at the
accused as set out in the FIR.
33. The subsequent testimonies, however, sought to assign a different
role than the one assigned in the FIR, bringing about an inconsistency.
The view taken by the trial court is, at least, a plausible view though that
may not be the only plausible view or if one may say even the less
probable one.
18
34. We are, thus, of the considered opinion that the prosecution has not
been able to prove the case beyond reasonable doubt against these two
accused, and they must get the benefit of doubt and consequently have to
be acquitted.
35. The result of the aforesaid findings is that Samsul Haque, accused
No.9 is entitled to a clean acquittal. He is already on bail and thus, the
bail bonds stand discharged. Abdul Rashid & Imdadul Islam, accused
Nos.2 & 3 respectively, are entitled to the benefit of doubt and are
consequently acquitted. The said accused may be released forthwith.
36. The appeals are accordingly allowed, leaving the parties to bear
their own costs.
...……………………………J.
[Sanjay Kishan Kaul]
...……………………………J.
[K.M. Joseph]
New Delhi.
August 26, 2019.

19

rejecting the challenge to their prosecution for lack of sanction under Section 197 of the Code of Criminal Procedure, 1973 = It is therefore, held that the question of sanction under Section 197, Cr.P.C. with regard to appellants nos.3 and 4 treating them to be ‘public servant’ simply does not arise because of their absorption in the Corporation. With regard to appellant no.2, considering his status as on deputation to the appellant Corporation at the relevant point of time and in absence of necessary evidence with regard to his status in the appellant Corporation throughout the litigation being ambiguous, we leave that question open for consideration in the trial after necessary evidence is available.

NON­REPORTABLE
IN THE SUPREME COURT OF INDIA
CRIMINAL APPELLATE JURISDICTION
CRIMINAL APPEAL NO. 503 OF 2010
BHARAT SANCHAR NIGAM LIMITED
AND OTHERS ..........APPELLANT(S)
VERSUS
PRAMOD V. SAWANT
AND ANOTHER ......RESPONDENT(S)
JUDGMENT
NAVIN SINHA, J.
The   appellants  are  aggrieved   by   the  dismissal   of
their   writ   application,   rejecting   the   challenge   to   their
prosecution for lack of sanction under Section 197 of the Code
of Criminal Procedure, 1973 (hereinafter called as “Cr.P.C.”).
2. A criminal complaint case no.14/S/2003 was filed by
respondent   no.1   before   the   Additional   Chief   Metropolitan
Magistrate under clauses 26(2)(3) and 39 read with clause 27
1
of the Private Security Guards (Regulation of Employment and
Welfare) Scheme, 1981 read with Section 3(3) of Maharashtra
Private   Security   Guards   (Regulation   of   Employment   and
Welfare)   Act,   1981   (hereinafter   called   as   “the   Act”).     The
complaint   stated   that   the   appellant   –   Corporation   was
registered with the respondent ­ Security Guards Board. The
Corporation was under obligation to engage security guards
registered with respondent no.1 only.  An inspection revealed
engagement  of  unregistered  guards.   The  Magistrate issued
process against the appellants in 2003.  The appellants prayed
for recall of the process, which was rejected on 06.04.2004. A
criminal revision preferred against the rejection was allowed on
07.09.2004.   The matter was remanded for reconsideration,
which was again rejected by the Magistrate on 07.06.2005. The
writ petition preferred by the appellants against the issuance of
process was also rejected on 22.12.2006.   The fresh revision
against order dated 07.06.2005 assailed the prosecution on
grounds of being barred by limitation, that the Act was not
applicable   to   the   appellants’   establishment,   and   that   the
2
issuance of process was bad in absence of sanction under
Section   197,   Cr.P.C.,   appellants   nos.2   to   4   being   ‘public
servants’.   The revision application was again dismissed on
05.09.2007   leading   to   the   impugned   order   assailed   in   the
present appeal.   In the writ petition, the appellants gave up
their challenge on grounds of limitation and inapplicability of
the Act which has therefore attained finality. The challenge in
the writ petition is confined to the question of sanction only.
3. The High Court relying on Mohd. Hadi Raja vs. State of
Bihar and another, (1998) 5 SCC 91, held that the protection
of sanction under Section 197, Cr.P.C. was not available to
officers of Government companies or public undertakings even
if it fell within the definition of ‘State’ under Article 12 of the
Constitution.
4. Shri R.D. Agarwal, learned senior counsel appearing on
behalf of the appellants, submitted that appellants nos.2 to 4
fell   within   the   definition   of   ‘public   servant’   as   they   were
discharging   public   duty   in   pursuance   of   the   policy   of   the
Central Government.   Appellants nos.2 to 4, belonged to the
3
Central   Civil   Service   –   Class­I,   having   been   appointed   by
Hon’ble the President of India to the Indian Telecommunication
Service, were removable by orders of the President only. The
fact   that   they   may   have   been   sent   on   deputation   to   the
appellant Corporation is inconsequential mandating sanction
under Section 197, Cr.P.C. before their prosecution.  The High
Court   erred   in   distinguishing  Dr.   Lakshmansingh
Himatsingh  Vaghela   vs.  Naresh  Kumar  Chandrashanker
Jah   and   another, (1990) 4 SCC 169, considering that the
appellants nos.2 to 4 were removable by orders of the President
of India only.
5. Learned counsel for the respondents acknowledged the
original appointment of appellants nos.2 to 4 in Central Civil
Services Class­1. It was however submitted that the appellant
Corporation was established on 01.10.2000.   The appellants
nos.2 to 4 were sent on deputation initially.  Option was given
for absorption in the appellant Corporation. Appellants nos.3
and 4 opted for absorption and thus became employees of the
appellant Corporation with effect from 01.10.2000 and ceased
4
to be government employees in the Central Civil Services Class1.  Appellant no.2 appears to have retired from the appellant
Corporation while on deputation, but his status is not clear.
6. The appeal raises a short and pure question of law for
consideration with regard to the protection under Section 197,
Cr.P.C.   available   to   employees   of   public   sector   corporation
claiming the status of a ‘public servant’.  The relevant extract of
Section 197, Cr.P.C., reads as follows:
“197.   Prosecution   of   Judges   and   public
servants.
(1) When any person who is or was a Judge or
Magistrate or a public servant not removable
from his office save by or with the sanction of
the   Government   is   accused   of   any   offence
alleged to have been committed by him while
acting or purporting to act in the discharge of
his official duty, no Court shall take cognizance
of   such   offence   except   with   the   previous
sanction­
(a) in the case of a person who is employed or,
as   the   case   may   be,   was   at   the   time   of
commission of the alleged offence employed, in
connection with the affairs of the Union, of the
Central Government;
(b) in the case of a person who is employed or,
as   the   case   may   be,   was   at   the   time   of
commission of the alleged offence employed, in
connection with the affairs of a State, of the
State Government.”
                               
5
The term ‘public servant’ has been defined in Section 21
of the Indian Penal Code, the relevant portion for the present
case reads as follows:
“21.   “Public   servant”.—The   words   “public
servant” denote a person falling under any of
the descriptions hereinafter following; namely:
—
xxxxxxx
Twelfth —Every person—
(a) in the service or pay of the Government or
remunerated   by   fees   or   commission   for   the
performance   of   any   public   duty   by   the
Government;
(b) in the service or pay of a local authority, a
corporation established by or under a Central,
Provincial   or   State   Act   or   a   Government
company   as   defined   in   section   617   of   the
Companies Act, 1956 (1 of 1956).”
7. At the very outset, we are of the opinion that the question for
grant of sanction for prosecution under Section 197, Cr.P.C. on the
ground of being a ‘public servant’ is not available to appellants
nos.3 and 4 on account of their ceasing to be employees of the
Indian   Telecommunication   Service   after   their   absorption   in   the
appellant Corporation on 01.10.2000, prior to the complaint.  The
fact that their past service may count for purposes of pension in
6
case   of   removal   or   dismissal   by   the   Corporation   or   that
administrative approval of the concerned ministry may be formally
required before any punitive action will not confer on them the
status of ‘public servant’ under the Cr.P.C.
8. The necessary facts with regard to status of appellant no.2 are
not very clear from the pleadings.  It appears that at the relevant
point of time before superannuation he was on deputation to the
Corporation. The allegations related to discharge of his duties in the
appellant   Corporation.   We   are   therefore   required   to   consider   if
sanction under Section 197, Cr.P.C. was a prerequisite with regard
to him in a status as a ‘public servant’.  The question is no more
res   integra  and   stands   authoritatively  settled   that   employees   of
public sector corporations are not entitled to the protection under
Section 197 Cr.P.C. as ‘public servant’.
9. In  Mohd.  Hadi  Raja  (supra), the court was considering the
need   for   sanction   for   prosecuting   officers   of   public   sector
undertakings or government companies falling within the definition
of   ‘State’   under   Article   12   of   the   Constitution   and   who   were
removable from office save by sanction of the Government.  Holding
7
that protection under Section 197, Cr.P.C. was not available to
such persons, it was held as follows:
“27.  Therefore,  in   our   considered  opinion,   the
protection by way of sanction under Section 197
of   the   Code   of   Criminal   Procedure   is   not
applicable   to   the   officers   of   government
companies or the public undertakings even when
such public undertakings are “State” within the
meaning   of   Article   12   of   the   Constitution   on
account   of   deep   and   pervasive   control   of   the
Government….”
10. In  N.K.   Sharma   vs.   Abhimanyu,   (2005)   13   SCC   213,
rejecting the challenge for requirement of sanction under Section
197, Cr.P.C., it was observed as follows:
“13. Admittedly the salary of the appellant is not
paid by the Government. He at the relevant time
was not in the service of the State. Prosecution
against an officer of a government company or a
public   undertaking   would   not   require   any
sanction under Section 197 CrPC.”
11.  The question again fell for consideration in Chandan Kumar
Basu vs. State of Bihar, (2014) 13 SCC 70, involving an officer of
an   Indian   Administrative   Service   serving   on   deputation   as
Administrator­cum­Managing   Director   of   Bihar   State   Housing
8
Cooperative Federation Ltd.   Elucidating the requirements to be
fulfilled for the applicability of the protection under Section 197,
Cr.P.C., it was observed as follows:
“8. A reading of the provisions of Section 197(1) of
the Code reveals that there are three mandatory
requirements   under   Section   197(1)   of   the   Code,
namely:
(a) that the accused is a public servant;
(b) that the public servant can be removed from
the post by or with the sanction either of the
Central or the State Government, as the case
may be;
(c) the act(s) giving rise to the alleged offence had
been committed by the public servant in the
actual or purported discharge of his official
duties.”
12. We are of the opinion that sufficient evidence is not available
on record at this stage with regard to the status of appellant no.2 in
all aspects for us to unhesitatingly hold that the protection under
Section 197 Cr.P.C shall be available to him. These are matters to
be considered by the Magistrate on basis of the evidence that may
be placed before him during the course of trial.
9
13. Mohd. Hadi Raja  (supra) has been noticed more recently in
Punjab State Warehousing  Corporation vs. Bhushan Chander
and another, (2016) 13 SCC 44, holding that the High Court erred
in   providing   the   protection   under   Section   197,   Cr.P.C.   to   an
employee of the appellant Corporation which was fully government
owned   and   financed   by   the   State   Government,   and   therefore,
respondent fell within the definition of a ‘public servant’.   Setting
aside the orders of the High Court, this Court observed as follows:
“23.  In  Mohd.   Hadi   Raja  v.  State   of   Bihar  the
question   arose   whether   Section   197   CrPC   was
applicable   for   prosecuting   officers   of   the   public
sector undertakings or the government companies
which can be treated as State within the meaning of
Article 12 of the Constitution of India. The Court
referred   to   Section   197   CrPC,   noted   the
submissions   and   eventually   held   that   the
protection by way of sanction under Section 197
CrPC is not applicable to the officers of government
companies or the public undertakings even when
such   public   undertakings   are   “State”   within   the
meaning   of   Article   12   of   the   Constitution   on
account   of   deep   and   pervasive   control   of   the
Government.
24.  The   High   Court   has   not   accepted   the
submission of the Corporation in this regard. We
are constrained to note that the decision in Mohd.
Hadi Raja  has been referred to in the grounds in
this appeal. There is nothing on record to suggest
10
that the said decision was cited before the High
Court…”
14. Dr. Lakshmansingh Himatsingh Vaghela (supra), on which
the appellants have placed reliance, is completely distinguishable
on its own facts. The appellant was employed in the Municipal
Corporation as a Laboratory Officer.   He was only entrusted with
discharge of duties as a public analyst. His remuneration was not
paid by the Government, but by the Corporation.  The observations
in Paragraph 5 have to be understood in that context:
“5. Section 197, CrPC clearly intends to draw a
line between public servants and to provide that
only in the case of the higher ranks should the
sanction of the government to their prosecution
be necessary. While a public servant holding an
office of the kind mentioned in the section is as
such public servant appointed to another office,
his   official   acts   in   connection   with   the   latter
office will also relate to the former office. The
words   “removable   from   office”   occurring   in
Section 197 signify removal from the office he is
holding. The authority mentioned in the section
is the authority under which the officer is serving
and competent to terminate his services. If the
accused is under the service and pay of the local
authority,   the   appointment   to   an   office   for
exercising functions under a particular statute
will not alter his status as an employee of the
local authority.”
11
15. It   is   therefore,   held   that   the   question   of   sanction   under
Section 197, Cr.P.C. with regard to appellants nos.3 and 4 treating
them to be ‘public servant’ simply does not arise because of their
absorption   in   the   Corporation.   With   regard   to   appellant   no.2,
considering   his   status   as   on   deputation   to   the   appellant
Corporation   at   the   relevant   point   of   time   and   in   absence   of
necessary   evidence   with   regard   to   his   status   in   the   appellant
Corporation throughout the litigation being ambiguous, we leave
that question open for consideration in the trial after necessary
evidence is available.
16. The trial has turned out to be stillborn since 2003, with the
appellants   filing   one   application   after   another.     We   are   of   the
considered   opinion   that   the   trial   needs   to   be   expedited   and
concluded at an early date. It is ordered accordingly. The Magistrate
shall endeavour to conclude the trial within a period of one year.
The parties are directed to cooperate for its early disposal.
12
17.  The appeal is dismissed.
………………………………….J.
(NAVIN SINHA)
……….………………………..J.
     (A.S. BOPANNA) 
New Delhi,
August 19, 2019.
13

No doubt, that nonexplanation or false explanation by appellant cannot be taken as a circumstance to complete the chain of circumstances to establish the guilt of the appellant. However, the false explanation can always be taken into consideration to fortify the finding of guilt already recorded on the basis of other circumstances.

 No doubt, that nonexplanation or false explanation by appellant cannot be taken as a circumstance to complete the chain of circumstances to establish the guilt of the appellant. However, the false explanation can always be taken into consideration to fortify the finding of guilt already recorded on the basis of other circumstances. 

1
NON-REPORTABLE
IN THE SUPREME COURT OF INDIA
CRIMINAL APPELLATE JURISDICTION
CRIMINAL APPEAL NO. 751 OF 2010
SUDRU .... APPELLANT

 VERSUS
THE STATE OF CHATTISGARH .... RESPONDENT
J U D G M E N T
B.R. GAVAI, J.
1. The appellant has approached this court being
aggrieved by the Judgment and order passed by the High
Court of Chattisgarh at Bilaspur in Criminal Appeal
No.1072 of 2001 thereby, dismissing the appeal of
appellant and confirming the Judgment of conviction and
order of sentence as recorded by the Learned Special
Judge, Scheduled Castes & Scheduled Tribes (Prevention of
Atrocities) Act and Additional Sessions Judge, Bastar at
Jagdalpur (hereinafter referred as ‘Trial Court’) on 6th
September, 2001.
2. The prosecution story in brief is thus, Janki Bai
is the second wife of the appellant. First wife of the
appellant had died. The marriage between the appellant
2
and Janki Bai was solemnized seven years prior to the
date of incident. They were having three issues from the
wedlock. On 22.7.2000 the appellant had come home in a
drunken condition and had a quarrel with Janki Bai.
During the quarrel Janki Bai took her two children and
went to the house of her brother-in-law. The appellant
and their elder son Ajit remained in the house. On
23.7.2000 when she returned to the house, she saw that
Ajit was lying on mat and his body was covered with a
blanket. Upon removing blanket, she saw Ajit in dead
condition. Blood was oozing from his mouth. She called
her father-in-law Lakhmu. Injuries were seen on the neck
of the deceased. An FIR came to be lodged in Police
Station Dantewada by Janki Bai. Upon completion of
investigation, chargesheet came to be filed in the Court
of Chief Judicial Magistrate, Dantewada, who in turn
committed the case to the Court of Sessions Judge,
Jagdalpur. The case was received on transfer by the
Additional Sessions Judge, Jagdalpur, who conducted the
trial. The learned Trial Court passed an order of
conviction thereby, convicting the appellant for the
offence punishable under section 302 of the IPC and
sentenced him to undergo imprisonment for life and to pay
fine of Rs.500/- and in default of payment of fine to
further undergo R.I. for one year. Being aggrieved
3
thereby, appeal was filed before the High Court of
Chattisgarh at Bilaspur. The High Court dismissed the
appeal. Hence, the appellant filed the present appeal in
this Court.
3. The learned Counsel for the appellant submitted
that, the Trial Court as well as the High Court have
erred in convicting the appellant and dismissing the
appeal. It is submitted that, the case rests on
circumstantial evidence and the prosecution has utterly
failed to prove the incriminating circumstances and in
any case has failed to establish the chain of
incriminating circumstances, which leads to no other
conclusion than the guilt of the appellant. It is further
submitted that, the star witness Janki Bai has turned
hostile and as such there is no evidence to sustain order
of conviction.
4. No doubt, in the present case all the witnesses
who are related to the accused and the deceased have
turned hostile. PW-1 Janki Bai, wife of the appellant
and the mother of the deceased has also turned hostile.
However, by now it is settled principle of law, that such
part of the evidence of a hostile witness which is found
to be credible could be taken into consideration and it
is not necessary to discard the entire evidence.
Reference in this respect could be made to the judgment
4
of this Court in the case of Bhajju v. State of M.P.,
(2012) 4 SCC 327, which reads thus:
“36. It is settled law that the evidence of
hostile witnesses can also be relied upon
by the prosecution to the extent to which
it supports the prosecution version of the
incident. The evidence of such witnesses
cannot be treated as washed off the
records, it remains admissible in trial and
there is no legal bar to base the
conviction of the accused upon such
testimony, if corroborated by other
reliable evidence. Section 154 of the
Evidence Act enables the court, in its
discretion, to permit the person, who calls
a witness, to put any question to him which
might be put in cross-examination by the
adverse party.”
5. From the evidence of PW-1 Janki Bai it would
reveal, that insofar as that part of the evidence
wherein, she has stated that there was a quarrel between
her husband and her, she left the room with the other two
children and the deceased and the appellant were alone in
the room and that when she reached the house in the
morning, she saw her son Ajit covered with the blanket
and after opening the said blanket seeing Ajit to be dead
is concerned, the same has remain unshattered. It could
thus be seen that, from the evidence of PW1 Janki Bai, it
can be safely held that there was a quarrel between PW-1
Janki Bai and appellant and after the quarrel, she went
to the house of her brother-in-law with two younger
children and that the deceased was left alone in the
5
company of appellant and on the next day morning the
deceased was found to be dead.
6. In this view of the matter, after the prosecution
has established the aforesaid fact, the burden would
shift upon the appellant under Section 106 of the Indian
Evidence Act. Once the prosecution proves, that it is the
deceased and the appellant, who were alone in that room
and on the next day morning the dead body of the deceased
was found, the onus shifts on the appellant to explain,
as to what has happened in that night and as to how the
death of the deceased has occurred.
7. In this respect reference can be made to the
following observation of this Court in the case of
Trimukh Maroti Kirkan versus State of Maharashtra,
reported in (2006) 10 SCC 681:
“In a case based on circumstantial evidence
where no eye-witness account is available
there is another principle of law which
must be kept in mind. The principle is that
when an incriminating circumstance is put
to the accused and the said accused either
offers no explanation or offers an
explanation which is found to be untrue,
then the same becomes an additional link in
the chain of circumstances to make it
complete.”
8. The appellant has utterly failed to discharge
such burden. The appellant has taken defence in his
statement under Section 313 of Cr.P.C., that the deceased
6
has died due to ailment. However, this is falsified by
the medical evidence of PW-2 Dr. B.K. Tirki. In his
evidence he has stated that, there was a fracture on the
head of the deceased and the death of the deceased might
have occurred due to strangulation. There were marks of
fingers on the neck of the deceased. No doubt, that nonexplanation or false explanation by appellant cannot be
taken as a circumstance to complete the chain of
circumstances to establish the guilt of the appellant.
However, the false explanation can always be taken into
consideration to fortify the finding of guilt already
recorded on the basis of other circumstances.
9. In this respect apart from referring to the
observations of this Court in the case of Trimukh Maroti
Kirkan (supra), it will be apposite to refer to the
following observation of this Court in Sharad
Birdhichand Sarda v. State of Maharashtra, (1984) 4 SCC
116, which reads thus:
“151. It is well settled that the
prosecution must stand or fall on its own
legs and it cannot derive any strength from
the weakness of the defence. This is trite
law and no decision has taken a contrary
view. What some cases have held is only
this: where various links in a chain are in
themselves complete, then a false plea or a
false defence may be called into aid only
to lend assurance to the court.”
7
10. Taking into consideration these aspects of the
matter, we do not find that the learned Trial Court and
the High Court have erred in recording the finding of
guilt and order of conviction. The appeal is found to be
without merit and as such is dismissed.
...................J.
 [DEEPAK GUPTA]
...................J.
[B.R. GAVAI]
NEW DELHI;

AUGUST 22, 2019.

the unregulated and clandestine manufacture of the drug Oxytocin, which is reportedly misused in milch animals; and on the other hand, the continued supply of an essential life­saving drug, which is used as the first line drug for 33 prevention and treatment of post­partum haemorrhage at the time of childbirth.

the unregulated and clandestine manufacture of the drug Oxytocin, which is reportedly misused in milch animals; and on the other hand, the continued supply of an essential life­saving   drug,   which   is   used   as   the   first   line   drug   for 33 prevention and treatment of post­partum haemorrhage at the time of childbirth.                                                                                                                                      The   following   substantial   questions   of   law   arise   for consideration: (i) Whether a drug included in the National List of Essential Medicines   published   under   Schedule   1   of   the   Drugs (Prices Control) Order, 2013 notified under Section 3 of the Essential Commodities Act, 1955 would be subject to the provisions of Section 26A of the Drugs and Cosmetics Act, 1940?                                                  (ii) Whether   the   impugned   notification   has   resulted   in creating a monopoly in favour of public sector companies, to the complete exclusion of private sector companies, and if so, whether it would be protected by Article 19(6)(ii) read with Article 14 of the Constitution? (iii)Whether   the   classification   made   by   the   impugned notification   between   licensed   public   sector   and   private sector   companies,   in   the   manufacture   of   the   drug Oxytocin for domestic use, would achieve the object and purpose of preventing the unregulated and illegal use of the drug? 34 (iv)Whether   it   would   be   in   public   interest   to   restrict   the manufacture of a life­saving drug for domestic use, to a single   public   sector   undertaking,   to   the   complete exclusion of the private sector companies, particularly in view of the high maternal mortality rates in the country?                                                                      (v) Whether there was relevant and objective material before the Central Government to form the basis of satisfaction to exercise the power to prohibit the manufacture of the drug by the private sector companies for domestic use, under Section 26A of the Drugs and Cosmetics Act, 1940?                                                                  (vi)Whether   the   object   of   curbing   the   clandestine manufacture and unregulated use of the drug Oxytocin, which   is   covered   by   Section   18   of   the   Drugs   and Cosmetics Act, 1940, can be achieved by taking recourse to Section 26A by imposing a ban on the manufacture of licensed drugs by private sector companies? (vii) Whether the exercise of power by the Central Government under Section 26A of the Drugs and Cosmetics Act, 1940 is legislative or executive in nature? 35 13. We are of the considered view that this is a fit case to refer the matter to a larger Bench of three Judges to consider the aforesaid questions of law, and authoritatively pronounce upon the same. Accordingly, we direct the Registry to place the   present   group   of   appeals   before   the   Hon’ble   Chief Justice of India for necessary directions.

REPORTABLE
IN THE SUPREME COURT OF INDIA
CIVIL APPELLATE JURISDICTION
Civil Appeal Nos.6588­6591  of 2019
(Arising out of SLPs (Civil) Nos. 3296­3299 Of 2019)
UNION OF INDIA & ANR. ETC                APPELLANTS
Versus
BGP PRODUCTS OPERATIONS GMBH
AND HAGENE IMMERMATT WEG. & ANR. ETC.  RESPONDENTS 
J U D G M E N T
INDU MALHOTRA, J.
  Leave granted.
1. The issue which arises for consideration in the present appeals
is the validity of the Notification dated 27.04.2018 issued under
Section 26A of the Drugs and Cosmetics Act, 1940 (hereinafter
referred to as the “Act”) by the Ministry of Health and Family
Welfare.
The   impugned   notification   restricts   the   manufacture   of
Oxytocin formulations for domestic use, only by public sector
1
undertakings or companies, to the complete exclusion of the
private sector companies. However, the manufacture of the drug
for export purposes is open to both public and private sector
companies.
It was notified that the notification would come into force on
01.07.18.
By a subsequent notification dated 29.06.2018, the date was
extended to 01.09.18.
2. Till the issuance of the impugned notification, Oxytocin was
being manufactured by private sector companies to meet the
entire need in the country.
After the issuance of the impugned notification, Karnataka
Antibiotics   &   Pharmaceuticals   Ltd.   (“KAPL”),   a   public   sector
company has commenced the manufacture of Oxytocin in May
2018.
3. The Active Pharmaceutical Ingredient (“API”) or the bulk drug is
manufactured in India only by one private sector company in
India, viz. Hemmo Pharmaceuticals Pvt Ltd. (“Hemmo Pharma”).
4. The impugned Notification dated 27.04.2018 was challenged in
a group of Writ Petitions by various private sector companies
who are inter alia  manufacturing the drug Oxytocin in W.P.(C)
No. 6084/2018, W.P.(C) No. 8555/2018, W.P.(C) No. 8666/2018
and W.P.(C) No. 9601/2018 before the Delhi High Court on
various   grounds.   The   Delhi   High   Court   granted   stay   of   the
operation of the impugned notification vide Interim Order dated
31.08.2018.   The   order   of   stay   was   extended   by   subsequent
2
Orders, which remained in force till 15.12.2018. The Delhi High
Court  vide  a detailed Judgment and Order dated 14.12.2018
has quashed the impugned notification. As a consequence, the
impugned notification did not come into force at all.
5. The Appellant­Union of India has filed the present Special Leave
Petitions before this Court, to challenge the judgment passed by
the Delhi High Court.
6. The subject matter of the present appeals is the drug Oxytocin,
which   is   notified   as   an   essential   drug   by   the   World   Health
Organization   (WHO)   Model   List   of   Essential   Medicines   since
2002. The concept of “Essential Medicines” was first introduced
by the WHO in 1977, and has now been adopted by many
countries, NGOs and international non­profit supply agencies.
Oxytocin continues to be notified in the 21st edition of the WHO
Model List of Essential Medicines published in 2019. It is listed
under   the   head   “Medicines   For   Reproductive   Health   And
Perinatal   Care”   and   the   recommended   form   of   dosage   is
“Injection: 10 IU in 1­ mL”.
6.1. Oxytocin is an essential life­saving drug, which is included
in the National List of Essential Medicines, 2011 (“NLEM”).
It   continues   to   be   listed   at   S.No.   26.1.5   in   the   latest
notification   published   in   2015.   The   NLEM   is   published
under the 1st Schedule to the Drugs (Prices) Control Order,
2013   (“DPCO”)   under   Section   3   of   the   Essential
Commodities Act, 1955 (“EC Act”).
The   NLEM   specifies   the   recommended   dosage   and
strength of Oxytocin injection as 5IU per 1 ml and 10IU per
3
1 ml. Oxytocin injection in the form of “5 IU per ml in 1ml
ampoule pack” is included in the “Essential Drug List for
the year 2016­2018” at Serial No. 228 published by the
National Health Mission, Department of Health and Family
Welfare, Government of Himachal Pradesh.
6.2. The objective of the National List of Essential Medicines
(NLEM) is that the drugs included in it are adequate to
meet   the   contemporary   health   needs   of   the   general
population of the country.1
 It is one of the key instruments
in balanced healthcare delivery system of a country. The
first NLEM was prepared and released in 1996. This list
was subsequently revised in 2003, 2011 and 2015.
NLEM contains those essential medicines “that satisfy
the primary health needs of the country‘s population.” NLEM
medicines are required to be made available at all times in
adequate   quantities   in   the   appropriate   dosage   forms   to
serve the larger public interest. The primary purpose of the
NLEM is to promote rational use of medicines considering
three important aspects i.e cost, safety and efficacy. The
list   is   considered   to   include   the   most   cost­effective
medicines for a particular indication.
The   criteria   for   the   inclusion   of   a   medicine   in   the
NLEM  inter   alia  includes   that   the   medicine   should   be
approved/licensed   in   India;   the   medicine   should   have
1 Press Release on “Essential Drugs” dated 15.03.2013 by the Press Information Bureau,
Government of India, Ministry of Health and Family Welfare.
4
proven efficacy and safety profile based on valid scientific
evidence; the medicine should be cost effective etc.2
The NLEM is prepared by an Expert Core Committee
constituted   by   the   Director   General   of   Health   Services
(DGHS) out of the World Health Organization (WHO) Model
List   of   Essential   Medicines,   Essential   Drugs   Lists   of
various  States, and  medicines  used  in various  National
Health Programmes and Emergency Care Drugs.3
6.3. Oxytocin   is   recommended   as   the   first   line   drug   for
prevention   and   treatment   of   post­partum   haemorrhage
(excess bleeding immediately after child­birth).4
 Oxytocin is
the drug of choice used for pregnant women to induce or
augment labour at the time of delivery, to control postpartum bleeding and uterine hypo­tonicity and is placed
under   Schedule   H1   of   the   said   Act.5
  Oxytocin   is   also
included in the Indian Pharmacopoeia published in 2010,
2014, and 2018.
6.4. The misuse of Oxytocin has been the subject matter of
discussion   because   of   rampant   misuse   of   the   drug   on
milch animals. The issue was under deliberation by the
Drugs Technical Advisory Board (“DTAB”) and the Drugs
Consultative   Committee   (“DCC”),   which   are   statutory
bodies constituted under the said Act.
2 Executive Summary, Report of the Core Committee for Revision of the National List of
Essential Medicines published in 2015.
3 Paragraph 3.1(ii) of the National Pharmaceuticals  Pricing Policy, 2012 (NPPP­2012) dated
07.12.12 published by the Ministry of Chemicals and Fertilizers, Government of India
4  World Health Organisation  Recommendations For The Prevention And Treatment Of
Postpartum Haemorrhage, 2012
5  Fifty­Ninth Report Of Parliamentary Standing Committee On Health And Family Welfare
On The Functioning Of Central Drugs Standard Control Organization
5
The   DTAB   is   a   statutory   body   established   under
Section 5 of the said Act. The DTAB consists of technical
experts   to   advise   the   Central   Government   and   State
Governments on technical issues arising under the said
Act.
The DCC has been constituted under Section 7 of the
said Act, which consists of representatives of the Central
Government, and one representative of each of the State
Governments to advise the Central and State Governments,
and the DTAB, on any matter relating to secure uniformity
in the administration of the Act.
6.5. The deliberations on the issue of rampant misuse of the
drug commenced from 1997 onwards.
It is necessary to advert to the deliberations of the
meetings   of   these   statutory   bodies   to   understand   the
background   in   which   the   impugned   notification   was
passed.
6.6. The misuse of Oxytocin came up for discussion first in the
31st  meeting   of   the   DCC   held   on   21.08.1997   and
22.08.1997. The DCC noted that it had received several
complaints on the misuse/abuse of Oxytocin in veterinary
practice.   Oxytocin   injections   were   being   misused   to
artificially   extract   milk   from   cows   and   buffaloes.   The
members of the Committee were requested to collect more
information on the issue.
6.7. At the 48th meeting of the DTAB held on 08.07.1999, the
DTAB discussed the misuse of Oxytocin in milch animals
6
and the deleterious effects due to consumption of such
milk on consumers. The DTAB considered the suggestion
of imposing a general ban on the manufacture of Oxytocin.
However,   11   members   opined   that   as   the   drug   is
“essential”   in   the   medical   field,   and   is   included   in   the
“Essential Drug list”, the same could not be prohibited.
The Joint Secretary, Ministry of Food Processing, an
invitee to the meeting mooted a suggestion that “perhaps
restricting   the   manufacture   of   Oxytocin   to   PSUs,   and
thereafter   keeping   a   track   on   its   distribution”   may   be
considered.
The   representative   of   the   Department   of   Consumer
Affairs agreed that the whole issue of use and misuse of
Oxytocin injection requires an in­depth examination and
suggested that a detailed paper be prepared based on the
outcome of such study.
6.8. At   the   36st  meeting   of   the   DCC   held   on   23.07.05   and
24.07.05, the DCC advised not to ban Oxytocin injection
since it formed a part of the NLEM. The DCC noted that the
sale   of   Oxytocin   had   been   regulated   by   amending   the
package   size   of   Oxytocin   to   “single   blister   packs”,   as
against the earlier prescribed larger packaging of 50­100
ampoules.
6.9. At the 40th Meeting of the DCC held on 29.06.2009, it was
observed that the misuse of Oxytocin injection had been
reported   in   many   parts   of   the   country,   and   a   strong
vigilance was required to stop the clandestine manufacture
7
of the drug. The DCC observed that the drug has a definite
place in medical treatment, and is used by gynaecologists
universally. The DCC urged the members/representatives
of each State to ensure that the clandestine manufacture of
the   drug   under   their   jurisdiction   is   curbed   through
extensive surveys and raids.
6.10. At the 43rd  meeting of the DCC held on 14.11.2011, the
DCC observed that there was an increasing misuse of the
drug by dairy owners, because of the clandestine supply of
the drug through illegal channels, and recommended that
its   misuse   can   only   be   curbed   through   increased
surveillance.
6.11. At the 44th meeting held on 20.07.2012, the DCC noted the
importance of continuous surveillance to stop the misuse
of   the   Oxytocin.   After   deliberations,   it   was   agreed   that
diversion  of  the  bulk  drug  to  illegal  channels  could   be
curtailed to a large extent, if it was ensured that the bulk
drug is sold to licensed manufacturers only.
6.12. On   12.11.2013,   the   DCC   convened   its   46th  meeting,
wherein the misuse of oxytocin injections to milch animals
came up for further discussion.
After  deliberations,  the  DCC  recommended that  the
manufacture   and   sale   of   Oxytocin   injections   should   be
banned for veterinary use under Section 26A of the Act
coupled with the condition that the manufacturers of the
bulk   drug   Oxytocin   should   supply   the   Active
8
Pharmaceutical   Ingredient   (“API”)   only   to   licensed
manufacturers of Oxytocin formulations for human use.
6.13. At the 65th meeting of the DTAB held on 25.11.2013, the
misuse of Oxytocin by dairy owners to extract milk from
milch   animals   and   its   harmful   effects   on   animals   and
human   consumption   was   deliberated   upon.   While
acknowledging that Oxytocin had proven medical use for
inducing labour, and to control post­partum bleeding and
uterine hypotonicity, the DTAB recognized the abundant
availability and use of the drug in a clandestine manner,
which was a matter of great concern for public health. In
spite of the action taken by the authorities to place the
drug under Schedule H of the Drugs & Cosmetics Rules,
1945, which requires the drug to be dispensed only on the
prescription   of   a   Registered   Medical   Practitioner,   the
manufacture and sale of the drug in a clandestine manner
in large quantities, and its misuse by the farmers or dairy
owners was rampant.
The opinion of the Department of Animal Husbandry,
Dairying and Fisheries, Ministry of Agriculture, was sought
with   respect   to   the   proposal   for   banning   Oxytocin   for
Animal use. It was opined that ban on the production and
use   of   Oxytocin   for   veterinary   purposes,   was   not
recommended, since the drug has therapeutic application
in case of expulsion of foetus, and retention of placenta
even in animals.
9
After deliberations, the DTAB noted that since the drug
has a definite use for therapeutic purposes, it need not be
prohibited. It was, however, opined that the manufacturer
of the bulk drug should supply the API only to licensed
manufacturers of the drug and veterinary hospitals. It was
further recommended that the State Drugs Controllers be
asked to curb the misuse of the drug through increased
surveillance and raids conducted on the possible hideouts
of clandestine manufacture and sale of the drug, and take
strict action against the offenders.
6.14. Pursuant to the recommendations made by the DTAB in
the 65th meeting, the Ministry of Health and Family Welfare
issued   a   Notification   G.S.R   29(E)   dated   17.01.2014
restricting the manufacture and sale of Oxytocin as under:
“Whereas the Central Government is satisfied that the drug Oxytocin has a
definite therapeutic use in certain medical conditions;
And whereas the Central Government is satisfied that it is necessary and
expedient to regulate and restrict the manufacture, sale and distribution of
the said drug in the country to prevent its misuse in public interest.
Now, therefore, in exercise of the powers conferred by Section 26A of the
Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government
hereby directs that the drug oxytocin shall be manufactured for sale or for
distribution   or   sold   in   the   manner   specified   below,   in   addition   to   the
provisions contained in the said Act and Rules made thereunder, namely: ­
1.  The   manufacturers   of   bulk   oxytocin   drug   shall   supply   the   active
pharmaceutical drug only to the manufacturers licensed under the Drugs
and Cosmetics Rules, 1945 for manufacture of formulations of the said
drug.
2. The formulations meant for veterinary use shall be sold to the veterinary
hospitals only.” 
(emphasis supplied)
6.15. The validity of the aforesaid Notification dated 17.01.2014
was challenged before the Punjab & Haryana High Court in
Narang   Medical   Store   v.   Union   of   India  [W.P.(C)   No.
10
7135/2014],  inter alia  on the ground that it was not in
consonance with the provisions of Section 26A of the Act.
The High Court vide judgment and order dated 28.01.2016,
upheld the validity of the Notification, to avoid the misuse
of the bulk drug or Active Pharmaceutical Ingredient used
in Oxytocin injections.
6.16. At the 67th  meeting of the DTAB held on 01.04.14, the
DTAB once again recognized that the drug Oxytocin has a
definite   role   in   the   medical   field   for   both   humans   and
animals, and as such the legitimate manufacture and sale
of the drugs cannot be stopped by banning the drug. Even
if   the   domestic   manufacturers   are   prohibited   from
manufacturing   the   drug,   the   bulk   drug   is   liable   to   be
smuggled from the neighbouring countries for illegal use.
Misuse can only be contained by enhanced surveillance by
the regulatory authorities, followed by strict action against
the violators.
After deliberations, the DTAB recommended that at the
time of sale of oxytocin by retail chemists, the name and
address of the purchaser, the name of the patient, and the
quantity supplied shall be recorded. Such records shall be
maintained for three years, and shall be kept open  for
inspection. This would help in not only maintaining the
legitimate supply of the drug, but also to curb misuse of
the drug through the legitimate sale channels.
6.17. The recommendations of DTAB came to be given statutory
effect   by   an   amendment   to   Rule   65   of   the   Drugs   and
11
Cosmetics Rules,1945  vide  Notification dated 30th  August
2013   published   by   the   Ministry   of   Health   and   Family
Welfare.
6.18. On 05.11.2014, a meeting was convened by the Minister
for   Women   and   Child   Development   Ministry   (MWCD),
which   was   attended   by   Secretaries   from   various   other
Ministries. In this meeting, a suggestion was mooted that
on account of the rampant misuse of Oxytocin, which led
to cows and animals contracting diseases, and the illegal
use   for   increasing   milk   production,   could   be   effectively
controlled if a “Government of India owned company may
be allowed for production of this drug in the country and the
private companies may be prohibited for the same.”
6.19. At the 69th  DTAB meeting held on 22.04.15, the DTAB
reiterated its earlier recommendation that Oxytocin “need
not   be   prohibited   as   it   has   definite   use   for   therapeutic
purposes. Shri A. K. Tiwari of IVRI stated that the drug
oxytocin is an essential drug in the veterinary practice. He
added that the Department of animal husbandry had also
earlier given his opinion that the ban on production and use
of oxytocin for veterinary used is not recommended.” The
DTAB   observed   that   the   misuse   of   the   drug   can   be
controlled by stricter control over the manufacture and sale
of the drug, especially through clandestine channels. The
DTAB noted that “Constant surveillance by the State Drug
Regulatory Authorities and other regulatory authorities can
only curb the misuse of the drug.”
12
6.20. In its 70th meeting dated 18.08.15, the DTAB was informed
that dairy owners were getting the drug manufactured at
dubious premises from unscrupulous suppliers. The DTAB
noted that the raw material or the bulk drug was being
clandestinely smuggled into the country from the border
States,   which   was   then   being   crudely   manufactured
clandestinely and sold to dairy owners at a very cheap rate.
The DTAB reiterated its recommendation that “the drug
legitimately manufactured is required for medical purposes
and as such cannot be prohibited. The misuse of the drug in
a   crude   form,   can   only   be   curbed   through   constant
surveillance by the Regulatory Authorities.”
6.21. On 16.10.2015, the DCC in its 49th Meeting discussed the
rampant misuse of Oxytocin through clandestine channels.
It was inter alia recommended that officials from the State
Drug   Regulatory   Authority   must   conduct   periodic   raids
with the assistance of the Police at suspected outlets; and
that the manufacture and sale of oxytocin formulations by
the   licenced   manufacturers   in   the   State,   should   be
monitored regularly.
6.22. On 12.02.2018, the DTAB in its 78th  meeting considered
the proposal to restrict the supply of Oxytocin formulations
for human use only to registered hospitals and clinics in
public and private sector to prevent misuse of the drug.
The members deliberated upon the matter and “agreed on
a draft notification for regulating, restricting the Oxytocin
13
formulations for human use to be supplied only to registered
hospitals and clinics in public and private sector.”
The DTAB accepted in principle the proposal to amend
Rule 96 of the Drugs and Cosmetics Rules, 1945 to ensure
that bar­coding system is adopted for the manufacture and
sale of Oxytocin formulations so as to ensure track and
traceability of the product, to avoid its misuse.
The DTAB had further agreed to prohibit the import of
Oxytocin formulations under Section 10A of the said Act
for human as well as animal use.
6.23. On 09.04.2018, the DCC at the 53rd meeting was informed
about the recommendations of the 78th DTAB meeting held
on   12.02.2018   to   address   the   misuse   of   Oxytocin.   The
DCC, in principle, agreed with the recommendations of the
DTAB.
6.24. On 18.04.2018, The Ministry of Health and Family Welfare,
issued   a   Notification,   containing   “Draft   Rules”  viz.  the
“Drugs and Cosmetics (Amendment) Rules, 2018, on which
objections and suggestions were invited to within 45 days.
The Draft Rules proposed to amend Rule 96 of the Drugs
and Cosmetics Rules, 1945 to ensure that a 3­tier barcoding   system   is   adopted   by   licensed   manufacturers   of
Oxytocin formulations to facilitate and trace their products.
The   relevant   extracts   of   Rule   1   and   2   are   extracted
hereinbelow for ready reference:
DRAFT RULES
“1. (1) These rules may be called the Drugs and Cosmetics ( Amendment) Rules,
2018.
14
(2) These rules shall come into effect after one hundred eighty days of the publication
of the final rules in the Gazette of India. 2. In the Drugs and Cosmetics Rules, 1945,
in rule 96, in sub-rule (1), after clause (xii) the following clause shall be inserted,
namely:-
"(xiii) (A) The manufacturers of drug formulations of oxytocin shall print the details
specified below to facilitate tracking and tracing of their products, namely:-
a. at primary level packaging of two dimensional barcode encoding unique and
universal global product identification code in the 14 digits Global Trade Item
Number format along with batch number, expiry date and a unique serial number of
the primary pack;
b. at secondary level packaging of one or two dimensional barcode encoding unique
and universal global product identification code in the 14 digits Global Trade Item
Number format along with batch number, expiry date and a unique serial number of
the secondary pack;
c. at tertiary level packaging of one dimensional barcode encoding unique and
universal global product identification code in the 14 digits Global Trade Item
Number format along with batch number, expiry date and a unique serial number of
the Tertiary pack.
(B) The manufacturer of drug formulation shall maintain the data in the parent —
child relationship for all three level of packaging and their movement in its supply
chain.
(C) The data referred to in sub-rule (2) shall be uploaded on the central portal of the
Central Government by the manufacturer or its designated agency before release of
the drugs for sale or distribution. (D) The responsibility of the correctness,
completeness and ensuring timely upload of data on the Central portal shall be that of
the manufacturer.”
The Central Government did not proceed with these
Draft Rules, since the Impugned Notification came to be
passed on 27.04.2018. As a consequence, the Draft Rules
lapsed.
6.25. On 24.04.18, the Ministry of Health and Family Welfare in
exercise of its powers under Section 10A of the Act issued a
Notification completely prohibiting the import of ‘Oxytocin
and its formulation in any name or manner’ into India.
6.26. On 27.04.18, the Ministry of Health and Family Welfare in
exercise of its powers under Section 26A of the Act issued
the   Impugned   Notification,   which   superseded   the
Notification dated 17.01.2014, and directed that the drug
Oxytocin   shall   be   manufactured   only   by   public   sector
undertakings or companies for domestic use. However, the
manufacture of Oxytocin formulations for export purposes
shall be open to both public and private sector companies.
15
The   impugned  Notification   date  27.04.2018   is   extracted
herein below for ready reference:
“G.S.R. 411(E).—Whereas the Hon’ble High Court of Himachal Pradesh,
Shimla, has, in its judgment dated 15.3.2016 in CWPIL No. 16 of 2014
titled ‘Court on its own motion’ versus State of Himachal Pradesh and
others, observed that there is large scale clandestine manufacture and
sale of the drug Oxytocin leading to its grave misuse, which is harmful to
animals and humans;
And   whereas,   the   said   Hon’ble   High   Court   also   observed   that   the
feasibility of restricting the manufacture of Oxytocin only in public sector
companies and also restricting and limiting the manufacture of Oxytocin
by companies to whom licenses have already been granted should be
considered;
And whereas, the Drugs Technical Advisory Board constituted under
section 5 of the Drugs and Cosmetics Act, 1940 (23 of 1940) considered
the   said   issue   in   its   meeting   held   on   the   12th   February   2018   and
recommended that Oxytocin formulations for human use be regulated
and restricted to be supplied only to registered hospitals and clinics in
public and private sector to prevent misuse of the said drug;
And   whereas,   the   Central   Government,   on   the   basis   of   the
recommendations of the said Board and after examination of the matter,
is satisfied that unregulated and illegal use of the drug Oxytocin is likely
to involve risk to human beings or animals and that in the public interest
it is necessary and expedient to regulate and restrict the manufacture,
sale and distribution of the drug Oxytocin in the country to prevent its
misuse by unauthorised persons or otherwise;
Now, therefore, in exercise of the powers conferred by section 26A of the
said Act, and in supersession of the notification number G.S.R. 29(E)
dated 17th January, 2014, the Central Government hereby directs that
the drug Oxytocin shall be manufactured for sale or for distribution or
sold in the manner specified below, namely:­
(i) The manufacture of Oxytocin formulations for domestic use shall
be by public sector undertakings or companies only and the label of the
product shall bear barcodes.
(ii)   The manufacture of Oxytocin formulations for export purposes
shall be open to both public and private sector companies and the packs
of such manufacture for exports shall bear barcodes. 
(iii) The   manufacturers   of   active   pharmaceutical   ingredient   of
Oxytocin shall supply the active pharmaceutical ingredient only to the
public sector manufacturers licensed under the Drugs and Cosmetics
Rules, 1945 for manufacture of formulations of the said drug for domestic
use.
(iv) The   manufacturers   of   active   pharmaceutical   ingredient   of
Oxytocin shall supply the said active pharmaceutical ingredient to the
manufacturers in public and private sector licensed under the Drugs and
Cosmetics Rules, 1945 for manufacture of formulations of the said drug
for export purpose.
(v) The   Oxytocin   formulations   manufactured   by   the   public   sector
companies   or   undertakings   licensed   under   the   Drugs   and   Cosmetics
Rules, 1945 for domestic use shall supply the formulations meant for
human and veterinary use only,­
16
(a) to the registered hospitals and clinics in public and private sector
directly; or (b) to the Pradhan Mantri Bhartiya Janaushadhi Pariyojana
(PMBJP) and Affordable Medicines and Reliable Implants for Treatment
(AMRIT) outlets or any other Government entity which may be specified
by the Central Government for this purpose in the country which shall
further supply the drug to the registered hospitals and clinics in public
and private sector.
(vi) The Oxytocin in any form or name shall not be allowed to be sold
through retail Chemist.”   
    (emphasis supplied)
6.27. On 25.07.18, the DTAB in its 80th  meeting recommended
the amendment of the Impugned Notification by deleting
Clause (v) and Clauses (vi) of the impugned Notification
dated 27.04.18, so as to ensure availability of the drug for
human use.
6.28. The Impugned Notification was subsequently amended by
Notification   dated   21.08.18.   The   Notification   dated
21.08.18 substituted clauses (v) and (vi), with the following
amended clause (v),
“(v)   The   Oxytocin   formulations   manufactured   by   the   public   sector
companies or undertakings licensed under the Drugs and Cosmetics
Rules,  1945   shall   be   distributed   or   sold   in   accordance   with   such
rules.”
As a consequence of this amendment, the effect of the
impugned   notification   was   diluted,   and   Oxytocin
formulations could be sold and distributed by the public
sector companies or undertakings in accordance with the
Drugs and Cosmetics Rules, 1945 as against the earlier
restriction  wherein  Oxytocin   formulations  could  only be
supplied to the registered hospitals and clinics in public
and private sector directly; or through the Pradhan Mantri
Bhartiya Janaushadhi Pariyojana (PMBJP) and Affordable
17
Medicines   and   Reliable   Implants   for   Treatment   (AMRIT)
outlets.
6.29. On 30.07.2018, the DCC convened the 54th meeting where
the Chairman of the DCC apprised the Committee of the
Notification dated 27.04.2018 (“Impugned Notification”) to
restrict the manufacture for sale, sale or distribution of
Oxytocin   to   only   to   public   sector   undertakings   or
companies for domestic use.
The Secretary, Ministry of Health & Family Welfare
requested   the   State   Drug   Controllers   to   ensure   the
availability of Oxytocin in their respective States by placing
purchase   orders   in   time   with   Karnataka   Antibiotics   &
Pharmaceuticals Ltd. (“KAPL”).
6.30. The Ministry of Health and Family Welfare issued another
Notification   on   the   same   date   i.e.   21.08.18,   wherein
Oxytocin,   which   was   included   under   Entry   No.   382   of
Schedule ‘H’ of the Drugs and Cosmetics Rules,1945 was
now shifted to Schedule ‘H1’ at Entry No. 47. Schedule H1
refers to Rules 65 and 97 of the Drugs and Cosmetics
Rules,1945.
As per the said Rules, Schedule H1 prescription drugs
provide   for   stricter   control   and   additional   precautions
when compared with Schedule H drugs.
The relevant extracts of the Rules are set out herein
below for ready reference:
“65. Conditions of licences. ­ Licences in Forms 20, 20­A, 20­B, 20­F,
20­G, 21 and 21­B shall be subject to the conditions stated therein and
to the following general conditions18
….
(3)(1) The supply of any drug [other than those specified in Schedule X]
on a prescription of a registered medical practitioner shall be recorded
at the time of supply in a prescription  register specially maintained for
the purpose and the serial number of entry in this regard shall be
entered on the prescription. The following particulars shall be entered in
the register:­
(a) serial number of the entry,
(b) the date of supply,
(c) the name and address of the prescriber,
[(d) the name and address of the patient, or the name and address of
the owner of the animal if the drug supplied is for veterinary use,]
(e) the name of the drug or preparation and the quantity or in the case of
a medicine made up by the licensee, the ingredients and quantities
thereof,
(f) in the case of a drug specified in Schedule C or Schedule H and
Schedule H1, the name of manufacturer of the drug, its batch number
and the date of expiry of potency, if any,
(g)   the   signature   of   the   [registered   Pharmacist]   by   or   under   whose
supervision the medicine was made up or supplied
…..
    (h)  the   supply   of   a   drug   specified   in   Schedule   H1   shall   be
recorded in a separate register at the time of the supply giving
the name and address of the prescriber, the name of the patient,
the   name   of   the   drug   and   the   quantity   supplied   and   such
records   shall   be  maintained   for   three   years   and   be   open   for
inspection.
….
(6) The licensee shall produce for inspection by an Inspector appointed
under the Act on demand all registers and records maintained under
these Rules, and shall supply to the Inspector such information as he
may require for the purpose of ascertaining whether the provisions of
the Act and Rules thereunder have been observed.
(7) Except where otherwise provided in these Rules, all registers and
records maintained under these Rules shall be preserved for a period of
not less than two years from the date of the last entry therein.
(8)  Notwithstanding   anything  contained   in  this   Rule  it   shall  not   be
necessary to record particulars in a register specially maintained for the
purpose if the particulars are recorded in any other register specially
maintained under any other law for the time being in force.
9)      (a)  Substances   specified   in   Schedule  H  and   Schedule  H1  or
Schedule   X   shall   not   be   sold   by   retail   except   on   and   in
accordance   with   the   prescription   of   a   Registered   Medical
    Practitioner and in the case of substances specified in Schedule X, the
prescriptions shall be in duplicate, one copy of which shall be retained
by the licensee for a period of two years.
(b) The supply of drugs specified in Schedule H and Schedule H1
or   Schedule   X   to   Registered   Medical   Practitioners,   Hospitals,
Dispensaries and Nursing Homes shall be made only against the
signed order in writing which shall be preserved by the licensee
for a period of two years.
19
….
(11) The person dispensing a prescription containing a drug specified in
Schedule H and Schedule H1 and Schedule X shall comply with the
following requirements in addition to other requirement of these rules.
(a) the prescription must not be dispensed more than once unless the
prescriber has stated thereon that it may be dispensed more than once;
(b) if the prescription contains a direction that it may be dispensed a
stated number of times or at stated intervals it must not be dispensed
otherwise than in accordance with the directions;
(c) at the time of dispensing there must be noted on the prescription
above the signature of the prescriber the name and address of the seller
and the date on which the prescription is dispensed.
…..
(11­A)   No   person   dispensing   a   prescription   containing   substances
specified in Schedule H and Schedule H1 or X, may supply any other
preparation,  whether   containing  the   same  substance   or  not,   in  lieu
thereof.
97.  Labelling of medicines.— 1 [(1) The container of a medicine for
internal use shall—
(b) if it contains a substance specified in Schedule H, be labelled with
the symbol Rx and conspicuously displayed on the left top corner of the
label and shall also be labelled with the following words in legible black
coloured font size in completely red rectangular box:
‘Schedule H Prescription Drug­ Caution: Not to be sold by retail without
the prescription of a Registered Medical Practitioner’
(e) if it contains a drug substance specified in Schedule H1, be
labelled   with   the   symbol   Rx,   which   shall   be   in   red   and
conspicuously displayed on the left top corner of the label, and
shall also be labelled with the following words in legible black
coloured font size in completely red rectangular box:
“SCHEDULE H1 PRESCRIPTION DRUG – CAUTION. –
­ It   is   dangerous   to   take   this   preparation   except   in
accordance with the medical advice.
­ Not   to   be   sold   by   retail   without   the   prescription   of   a
Registered Medical Practitioner.
(emphasis supplied)
7. The Impugned Notification dated 27.04.18 was challenged by
the   Respondents   –   BGP   Products   Operations   GmBH,   Mylan
Pharmaceuticals Pvt. Ltd., All India Drug Action Network, Neon
Laboratories Ltd. and Ciron Drugs And Pharmaceuticals Pvt. Ltd
before the Delhi High Court in May 2018.
20
8. The   Delhi   High   Court  vide  the   Impugned   Judgment   dated
14.12.2018   quashed   the   impugned   Notification   as   being
arbitrary and unreasonable. It was held there was no scientific
basis, and insufficient data to support the conclusion that the
existing availability or manner of distribution of Oxytocin posed
a   risk   to   human   life   or   animals,   which   is   one   of   the   preconditions for exercise of power under Section 26A of the Act.
The High Court held that the trigger and catalyst to the passing
of the impugned Notification was the decision of the High Court
of Himachal Pradesh, Shimla dated 15.03.2016 in Court On Its
Own   Motion   vs   State   of   Himachal   Pradesh6
,   which   did   not
consider   that   Oxytocin   was   an   essential   drug   which   was
included in the NLEM. It was further held that the Central
Government did not adequately weigh the danger to the lives of
the users of Oxytocin i.e pregnant women and young mothers,
nor did it consider the deleterious effect to the public generally
and women particularly, of the possible restricted supply of a
life­saving drug, if the manufacture is confined to one single
public   sector   enterprise,   namely   Karnataka   Antibiotic   and
Pharmaceuticals Ltd. (“KAPL”), which admittedly has no prior
experience in manufacturing the drug. The High Court opined
that the risk of such a consequence can be drastic since the
scarcity of the drug, or even a restricted availability can lead to
increased maternal fatalities during childbirth, impairing lives of
thousands of innocent young mothers. It was held that there is
no provision in the Act, including Section 26A, which authorized
the Central Government to create a State monopoly in favour of
6 CWPIL No. 16 of 2014
21
one licensee, which did not fall within the protective ambit of
Article 19(1)(6)(ii).
9. We have heard the learned Counsel for the parties, and perused
the pleadings and written submissions filed by the parties.
10. Mr.   Tushar   Mehta,   Learned   Solicitor   General   and   Mr.
Vikramjeet   Banerjee,   Learned   Additional   Solicitor   General   of
India appeared on behalf of the Appellant­Union of India.
The   Senior   Counsel   for   the   Union   of   India   assailed   the
impugned Judgment on the ground that the High Court had
exceeded   its   jurisdiction   by   reviewing   the   sufficiency   of   the
material relied upon by the Central Government in exercise of
its legislative powers under Section 26A of the Act. The Counsel
for the Union of India­Appellants submitted as follows:
10.1. The exercise of power under Section 26A being
legislative in  nature, the grounds for judicial review are
limited. The  Court should exercise judicial restraint in
review of policy  matters and cannot sit in appeal over a
policy decision.  Since   the   impugned   notification
creates a general restriction  with respect to all licensed
manufacturers, it would not  amount   to   an   executive
action.
10.2. It   was   further   submitted   that   there   is   a
presumption in favour of constitutionality or validity of a
subordinate  legislation   and   the   burden   is   upon   the
Respondents to show  that   it   is   invalid.   Reliance   was
placed on Akadasi Pradhan  vs State of Orissa7
,  State of
7 1963 Supp (2) SCR 691 : AIR 1963 SC 1047
22
T.N. v. P. Krishnamurthy8
, UOI v.  Cynamide   India   Pvt.
Ltd9
;  E   Merck   (India)   Limited   v.   UOI10;  Macleods
Pharmaceuticals Limited v. UOI11
, Drug Controller  General
of India vs West Bengal Small Scale Manufacturers12
,  UniSan Pharmaceuticals Ltd.& Anr. v UOI13
10.3. It   was   further   argued   that   the   Court   cannot
exercise judicial  review   over   a   legislative   act   on   the
basis of sufficiency or  insufficiency   of   material.   The
Court cannot weigh and sift  through evidence or material
relied upon by the Central Government in exercise of its
powers under Section 26A.  The Court cannot substitute its
wisdom in place of the  wisdom   of   the   Central
Government, particularly, in matters  of   public   health
and public interest. Reliance was placed on  Union   of
India vs Pfizer Ltd.14, Khoday Distilleries Ltd. v State  of
Karnataka15,   Shimnit   Utsch   India   (P)   Ltd.   v   West   Bengal
Transport   Infrastructure   Development   Ltd.   &   Ors.16
,
Directorate of Film Festivals v. Gaurav Ashwin Jain & Ors.17
,
Academy   of   Nutrition   Improvement   v   Union   of   India18
,
Vincent  Panikurlangara   v   Union   of   India19
,  Systopic
Laboratories v  Dr. Prem Gupta20
.
8 (2006) 4 SCC 517
9 1987 (2) SCC 720
10 2001 (90) DLT 16
11 2012 SCC Online Mad 1735
12 AIR 2000 Cal 133
13 AIR 2002 Ker 72: (2001) 1 KLJ 822
14 (2018) 2 SCC 39
15 (1996) 10 SCC 304
16 (2010) 6 SCC 303.
17 (2007) 4 SCC 737
18 (2011) 8 SCC 274
19 (1987) 2 SCC 165
20 (1994) Suppl. 1 SCC 160
23
10.4. It was submitted that Section 26­A confers wide
powers   on   the   Central   Government   to   either   regulate,
restrict or prohibit the manufacture, sale or distribution of
a drug, if the   Central   Government   is   “satisfied”   that   the
conditions mentioned in Section 26­A exist.
Section 26­A of the Act reads as under:
26A. Powers of Central Government to prohibit manufacture, etc., of
drug and cosmetic in public interest.­­­Without prejudice to any other
provision contained in this Chapter, if the Central Government is
satisfied, that the use of any drug or cosmetic is likely to involve any
risk to human beings or animals or that any drug does not have the
therapeutic value claimed or purported to be claimed for it or contains
ingredients and in such quantity for which there is no therapeutic
justification   and   that   in   the   public   interest   it   is   necessary   or
expedient so to do, then, that Government may, by notification in the
Official Gazette, regulate, restrict or prohibit the manufacture, sale or
distribution of such drug or cosmetic.”
The   Central   Government   was   not   bound   by
recommendations of the DTAB or the DCC. The Central
Government could independently arrive at a satisfaction
with regard to the factum of misuse of the drug.
10.5. The  misuse   of   Oxytocin   was   consistently
deliberated by the DCC and DTAB since the past 21 years
from 1997 onwards, and formed the basis of the impugned
Notification. The minutes of the meetings of the DTAB and
DCC   reveal   the  factum   of   misuse  of   Oxytocin   and   its
harmful effects on  milch   animals   and   humans   through
consumption of such milk. The subjective “satisfaction” of
the Central Government was arrived at after considering
24
the factum of  misuse which was deliberated by the DTAB
and DCC. Reliance was placed on a Chart on Oxytocin Data
Compilation from April 2015 to August 2018, which showed
that licensed manufacturers were manufacturing far more
Oxytocin   than   the   legitimate   national   requirement,   and
there   was   a   considerable   amount   of   “leakage”   in   the
production. The licensed manufacturers were responsible
for this leakage as they were supplying the bulk drug or API
manufactured   by   Hemmo   Pharma   to   small   illegal   local
units   for   production   of   spurious   Oxytocin.   The   Central
Government in public interest decided to strike a balance
between   two   competing  interests  i.e  animal   and   human
health, and issued the impugned notification.
10.6.The   impugned   Notification   does   not   violate   or
extinguish the  right to carry on any trade or business or
occupation of the Respondent­Manufacturers under Article
19(1)(g). The  Impugned   Notification   does   not   create   a
State Monopoly in  favour of KAPL, since the Respondentmanufacturers still  have a right to export Oxytocin and sell
their products  overseas. They are restricted only insofar as
domestic  manufacture   and   distribution   of   Oxytocin   is
concerned. The Impugned Notification merely regulates the
manufacture of Oxytocin, and does not completely prohibit
it.
Even   otherwise,   the   High   Court   in   the   impugned
judgment has held in favour of the Appellants to the extent
that the power to restrict or prohibit under Section 26A
can be used to “partially ban the manufacture of a drug i.e
25
prohibit   its   production   by   private   manufacturers,   and
reserve it, so to speak for the public sector”.
Such a measure cannot be said to be ultra vires the
power under the statute.
10.7.The Impugned Notification is protected under Article
19(6) of the Constitution of India. It was contended that
Article 19(6)(ii) of the Constitution empowers the State to
enact laws with regard to any trade, business, industry or
service,  to the complete or partial exclusion of citizens
and private  entities.
In the alternative, even if the impugned notification
does   create   a   State   monopoly,   there   is   no   requirement
under Article 19(6) to enact legislation for the creation of
the same. Restrictions on trade can be created by way of
notification as well. Such a measure should be presumed
to be reasonable and constitutional. Reliance was placed
on  Akadasi   Pradhan   vs   State   of   Orissa21
,  Khoday
Distilleries Ltd. v State of Karnataka22, Daruka & Co v Union
of India & Ors.23, Indian Drugs & Pharmaceuticals Ltd. v.
Punjab Drugs Manufacturers Assn.24, Municipal Committee,
Amritsar v State of Punjab25
.
10.8. It   was   further   submitted   that   the   impugned
notification was  issued   in   furtherance   of   legitimate
public interest towards  protection   of   bovine   heath,
21 1963 Supp (2) SCR 691 : AIR 1963 SC 1047
22 (1995) 1 SCC 574
23 (1973) 2 SCC 617
24 (1999) 6 SCC 247
25 (1966) 1 SCC 475
26
maintenance of animal  husbandry   standards   and
protection of the environment. The impugned notification is
also aimed to prevent the ill  effects   of   Oxytocin,   which
may affect human life due to  prolonged   consumption   of
milk from milch animals injected  with   the   drug.   The
Appellants placed reliance on Articles 48,  48A   and
51A(g) of the Constitution, which form part of the Directive
Principles of State Policy.
11. Mr. Kapil Sibal, Mr. Colin Gonsalves and Mr. S. Ganesh, Senior
Advocates   appeared   on   behalf   of   the   Respondents.   Ms.
Meenakshi Arora, Senior Advocate appeared for the Federation
of   Obstetric   and   Gynaecological   Societies  of   India,   and  Mr.
Jayant   Mehta,   Advocate   appeared   on   behalf   of   the   Indian
Medical Association (Intervenors).
The Respondents submitted as follows:
11.1 The   Respondents   –   BGP   Products   Operations   GmBH,
Mylan  Pharmaceuticals  Pvt.  Ltd.,  and Ciron  Drugs And
Pharmaceuticals   Pvt.   Ltd   have   been   manufacturing
Oxytocin injections I.P. 5IU per 1 ml under a license issued
under Part VII of the Drugs and Cosmetics Rules, 1945 for
over three decades in India. They manufacture the drug
only   for   domestic   use.   It   was   submitted   that   the
Respondents have at least 50% of the market share in
terms of manufacturing the drug. It was submitted that the
Respondent­manufacturers do not sell the drug directly to
the end consumer and only sell by way of wholesale dealing
to licensed distributors and licensed retail chemists, and
use the very same chain of distribution that KAPL uses.
27
The license issued to the manufacturers under Part VII
of the Act also carries with it the license to sell by way of
wholesale dealing within the territory of India.
As a consequence of the Impugned Notification, the
license   issued   to   these   Respondents,   for   all   practical
purposes, stood cancelled and terminated.
The   impugned   Notification   impinges   and   violates
Article 19(1)(g) of the Constitution in as much as it has
completely   prohibited   the   Respondents   from
manufacturing Oxytocin as they do not have a license to
export the drug.
11.2 It was submitted that the Act provides for a level playing
field in relation to the manufacture, distribution and sale of
drugs by any person. Reliance was placed on Section 16
read with Schedule II of the Act, to contend that the Act is
concerned   with   “what”   is   manufactured,   distributed   or
sold;   and,   not   with   “who”   is   the   manufacturer   or
distributor or seller of the drug.
11.3 It was submitted that there was no relevant material or
evidence placed before the Central Government for it to
arrive   at   a   “satisfaction”   to   completely   prohibit   the
manufacture   and   sale   of   the   drug   by   the   RespondentManufacturers. It was submitted that neither the DCC nor
DTAB   had   recommended   or   approved   the   complete
prohibition   of   manufacture   of   Oxytocin   by   private
licensees.   It   was   further   submitted   that   the   statutory
bodies had never recommended that the manufacture of
28
Oxytocin for domestic use be exclusively reserved for the
public sector.
11.4 It   was   submitted   that   the   basis   of   the   impugned
Notification was the decision of the High Court of Himachal
Pradesh, Shimla dated 15.03.2016 in  Court On Its Own
Motion   vs   State   of   Himachal   Pradesh26,   which   was
completely   irrelevant   for   forming   a   “satisfaction”   while
issuing the Impugned Notification.
11.5 The Respondent­Manufacturers had never been prosecuted
or even issued a Show­Cause Notice under the Act for any
misuse or abuse of the drug, or violation of any provisions
of the Act. There was no material or evidence to show any
illegal   or   clandestine   manufacture   of   Oxytocin   by   the
Respondent­manufacturers who are licensed in accordance
with law. The Chart on Oxytocin Data Compilation from
April   2015   to   August   2018   relied   on   by   the   Central
Government to show unutilised quantity of the bulk drug
or the API is wholly irrelevant, and was only prepared in
August 2018, much after the impugned Notification was
passed.
11.6 It was submitted that at the 78th  meeting of the DTAB
dated 12.02.18, which forms the basis of the Impugned
Notification, the DTAB did not recommend to restrict the
manufacture of Oxytocin to public sector companies only,
nor did it determine that Oxytocin is likely to pose a risk to
animals or humans.
26 CWPIL No. 16 of 2014
29
Rather, the DTAB agreed on a draft notification for
regulating   and   restricting   the   supply   of   Oxytocin
formulations only through registered hospitals and clinics
in the ‘public and private sector’.
11.7 It was submitted that the Draft Rules published by the
Ministry   of   Health   and   Family   Welfare   on   18.04.2018
suggested and recommended a 3­tier system of barcoding of
all   Oxytocin   formulations   manufactured   by   licensed
manufacturers “so as to ensure track and traceability of the
product to avoid its misuse”. The Central Government after
10 days i.e., on 27.04.2018, took the drastic course of
prohibiting   the   manufacture   of   the   drug   by   all   private
sector   licensees,   and   arbitrarily   issued   the   impugned
notification.
It was submitted that there is no material on record to
show   on   what   basis   the   Central   Government   suddenly
changed   its   stand   between   18.04.2018   and   27.04.2018
from   a   3­tier   system   of   barcoding   to   that   of   complete
prohibition on the manufacture of the drug by licensed
private sector manufacturers.
11.8 It   was   submitted   that   the   impugned   notification   is
arbitrary,   unreasonable   and   issued   with   complete   nonapplication of mind. The power under S. 26A cannot be
used   in   respect   of   a   licensed   drug,   or   in   respect   of   a
spurious,   misbranded,   adulterated   and   illegally   or
clandestinely manufactured drug. The “use of any drug” as
used in Section 26A means its use only for the intended,
30
declared   and   avowed   purpose,   and   does   not   cover   its
misuse.   Therefore,   Section   26A   could   not   have   been
invoked   to   prohibit/regulate/restrict   the   misuse   of   an
essential and licensed drug.
11.9 Section 26A cannot be invoked where the manufacture,
sale or distribution of a drug is already “prohibited” under
Section 18 of the Act. The Act and the accompanying Rules
provide   for   a   robust   mechanism   for   countering   any
contravention   of   the   Act   by   licensed   manufacturers.
Therefore,   there   was   no   public   necessity   to   completely
prohibit   all   licensed   manufacturers   from   manufacturing
the drug.
11.10 The exercise of power under Section 26A cannot be said to
be   legislative   in   nature,   since   it   is   based   on   the
“satisfaction” of the Central Government alone. The Central
Government   in   exercise   of   its   executive/administrative
powers under Section 26A, cannot create a State monopoly
in the manufacture for domestic sale of a drug, and claim
the protection of Article 19(6) of the Constitution.  Reliance
was placed on  Rai Sahab Ram Jawaya Kapur & Ors. v
State of Punjab27
.
11.11 It was further submitted that Memorandum of Delegated
Legislation   accompanying   the   Bill   No.65   of   1982
introducing insertion of Section 26A in the Act, makes no
reference to the exercise of powers under Section 26A as a
form of delegated legislation.
27 (1955) 2 SCR 225
31
11.12 It   was   submitted   that   the   Impugned   notification
discriminates   between   private   sector   licensed
manufacturers and public sector manufacturers as a State
monopoly has been created in favour of one public sector
company,  viz.  KAPL. It was submitted that the impugned
notification is hit by Article 14 of the Constitution of India
as   being   arbitrary,   unreasonable,   discriminatory   and
disproportionate.
11.13 By virtue of the Impugned Notification, only one public
sector   company  viz.  Karnataka   Antibiotic   and
Pharmaceuticals   Ltd.   (“KAPL”),   would   be   allowed   to
manufacture the drug for domestic purposes. This would
create a monopoly in favour of a public sector corporation,
which could have a disastrous effect on the supply and
availability of the drug to hospitals and patients in the
country. It was further submitted that KAPL is completely
inexperienced, since it obtained a license to manufacture
the drug as recently as in April 2018 i.e. a couple of weeks
before   the   impugned   notification   was   passed.   It   was
submitted that the manufacturing activity commenced in
May 2018, after the impugned notification was passed.
11.14 It   was   further   submitted   that   the   Drug   Control
Department,   Drug   Testing   Laboratory   Karnataka   had
found   that   several   drugs   manufactured   by   KAPL,   as
recently as in October 2018 were of Non­Standard Quality
(NSQ).
32
11.15 It was further submitted that on 01.11.2017, the Cabinet
Committee on Economic Affairs had given its in­principle
approval   for   the   strategic   disinvestment   of   the   Central
Government’s   100%   equity   stake   in   KAPL   though   an
auction sale.  Since the Central Government owns at least
51% equity stake in KAPL, this would mean that upon
such   disinvestment   KAPL   would   no   longer   be   a   public
sector company/undertaking.
11.16 It was contended that the Central Government could not
have invoked Section 26A of the Act, since Oxytocin is an
“essential drug” enlisted under the NLEM. The NLEM is
listed   in   the   1st  Schedule   to   the   DPCO   notified   by   the
Central Government in exercise of its powers under Section
3 of the Essential Commodities Act, 1955. It was submitted
that   power   under   Section   26A   cannot   be   exercised   in
respect of NLEM drugs. Section 6 of the EC Act gives the
DPCO   an   overriding   effect   over   other   statutes.   The
impugned notification issued under Section 26A is ultra
vires the said provision since it runs counter to the DPCO
and the Section 6 of the Essential Commodities Act, 1955.
12. After having heard the Senior Counsel appearing for parties
on both sides, we are of the view that the present group of
appeals raise serious issues having far reaching implications.
The twin issues which arise for consideration are on the one
hand, the unregulated and clandestine manufacture of the
drug Oxytocin, which is reportedly misused in milch animals;
and on the other hand, the continued supply of an essential
life­saving   drug,   which   is   used   as   the   first   line   drug   for
33
prevention and treatment of post­partum haemorrhage at the
time of childbirth.
The   following   substantial   questions   of   law   arise   for
consideration:
(i) Whether a drug included in the National List of Essential
Medicines   published   under   Schedule   1   of   the   Drugs
(Prices Control) Order, 2013 notified under Section 3 of
the Essential Commodities Act, 1955 would be subject to
the provisions of Section 26A of the Drugs and Cosmetics
Act, 1940?
(ii) Whether   the   impugned   notification   has   resulted   in
creating a monopoly in favour of public sector companies,
to the complete exclusion of private sector companies, and
if so, whether it would be protected by Article 19(6)(ii) read
with Article 14 of the Constitution?
(iii)Whether   the   classification   made   by   the   impugned
notification   between   licensed   public   sector   and   private
sector   companies,   in   the   manufacture   of   the   drug
Oxytocin for domestic use, would achieve the object and
purpose of preventing the unregulated and illegal use of
the drug?
34
(iv)Whether   it   would   be   in   public   interest   to   restrict   the
manufacture of a life­saving drug for domestic use, to a
single   public   sector   undertaking,   to   the   complete
exclusion of the private sector companies, particularly in
view of the high maternal mortality rates in the country?
(v) Whether there was relevant and objective material before
the Central Government to form the basis of satisfaction
to exercise the power to prohibit the manufacture of the
drug by the private sector companies for domestic use,
under Section 26A of the Drugs and Cosmetics Act, 1940?
(vi)Whether   the   object   of   curbing   the   clandestine
manufacture and unregulated use of the drug Oxytocin,
which   is   covered   by   Section   18   of   the   Drugs   and
Cosmetics Act, 1940, can be achieved by taking recourse
to Section 26A by imposing a ban on the manufacture of
licensed drugs by private sector companies?
(vii) Whether the exercise of power by the Central Government
under Section 26A of the Drugs and Cosmetics Act, 1940
is legislative or executive in nature?
35
13. We are of the considered view that this is a fit case to refer
the matter to a larger Bench of three Judges to consider the
aforesaid questions of law, and authoritatively pronounce
upon the same. Accordingly, we direct the Registry to place
the   present   group   of   appeals   before   the   Hon’ble   Chief
Justice of India for necessary directions.
.......................................J.
(ABHAY MANOHAR SAPRE)
...…...............………………J.
(INDU MALHOTRA)
New Delhi;
August 22, 2019.
36
REPORTABLE
IN THE SUPREME COURT OF INDIA
CIVIL APPELLATE JURISDICTION
CIVIL  APPEAL Nos.6588­6591 OF 2019
(Arising out of S.L.P.(C) Nos.3296­3299 of 2019)
Union of India & Anr. Etc.Etc. ….Appellant(s)
VERSUS
BGP Products Operations GMBH
& Hagene Immermatt Weg. & Anr. 
Etc.Etc.              ….Respondent(s)
J U D G M E N T
Abhay Manohar Sapre, J.
1. I have had the advantage of going through an
elaborate drafted judgment proposed by my learned
sister Justice Indu Malhotra. I entirely agree with the
reasoning and the conclusion arrived at by her.
2. I need not set out the facts and submissions of
learned counsel for the parties as the same have been
succinctly set out by my learned sister in her draft
judgment.
1
3. Indeed, having heard very learned and persuasive
arguments   of   Mr.   Tushar   Mehta,   learned   Solicitor
General for the appellants and Mr. Kapil Sibal, learned
senior counsel for the respondents at length and on
perusal   of   the   record,   I   am   also   of   the   considered
opinion that having regard to the nature of controversy
and the myriad issues, which arise in the appeals,
they have far reaching consequences on the rights of
the citizens qua State and, in particular, the abstract
legal   issues   such   as   what   is  the   nature   of   powers
exercised by the Central Government under Section
26­A of the Drugs and Cosmetics Act, whether it is
legislative or executive, because we find that there is
no decision of this Court so far on this issue. (see
observations of this Court in  Union of India  &  Anr.
vs. Pfizer Ltd. & Ors., 2018 (2) SCC 39)
4. Secondly, what are the essential ingredients for
invoking the powers under Section 26­A of the Drugs
and   Cosmetics   Act   in   relation   to   any   Drug   and
2
whether such power is in conflict with the exercise of
powers   conferred   under   the   Essential   Commodities
Act.
5. Thirdly,   whether   issuance   of   impugned
notification   has   resulted   in   creating   monopoly
(whether partial or full) in favour of the State and, if
so, whether it has satisfied the rigor of Article 14 read
with Article 19 (6)(ii) of the Constitution of India.
6. Lastly,  depending upon the answer to the nature
of exercise of powers under Section 26­A of the Drugs
and Cosmetics Act, whether material relied on by the
Central   Government   can   be   held   as   sufficient   to
sustain the impugned action.
7. In   my  opinion,   if  the   exercise  of   power  under
Section 26­A of the Drugs and Cosmetics Act  is held
as   being   legislative   in   nature,   the   parameters   to
examine   the   legality   of   the   impugned   notification
would be different whereas if it is held to be executive
in nature, the parameters to examine the legality of
3
impugned   notification   would   be   somewhat   different
than the former one.
8. In my considered opinion, the decision either way
on any of these questions will have its far reaching
effect on the rights and health of public at large and
especially on the rights and health of the teenage girls,
pregnant females and milching animals. It will also
decide   the   scope   of   the   powers   of   the   Central
Government   under   Section   26­A   of   the   Drugs   and
Cosmetics Act qua the rights of the persons, who are
engaged in business of manufacture and sale of Drugs
specified under the Drugs and Cosmetics Act read with
Essential Commodities Act.
9. In effect, in my opinion, it will not be a judgment
inter party but it will be in rem laying down the law on
the questions. 
10. It is for all these reasons, we have formulated the
questions   for   being   answered   on   their   respective
4
merits   in   paragraph   12   of   my   sister’s   drafted
judgment.
11. Let   the   matter,   therefore,   be   placed   before
Hon’ble the Chief Justice of India under Rule VI (2) of
the Supreme Court Rules for being  dealt with by the
larger bench for their authoritative pronouncement on
the   questions   framed   and   for   the   disposal   of   the
appeals accordingly.
12. Since I have also formed an opinion to refer the
matter to be dealt with by the larger bench under VI
(2) of the Supreme Court Rules, I also do not consider
it   necessary   to   give   my   opinion   in   detail   on   the
questions formulated.
         ……...................................J
                                     [ABHAY MANOHAR SAPRE]
 
                                 
New Delhi;
August 22, 2019
5