LAW FOR ALL

Drugs (Prices Control) Order, 1995= there are about 250 large units and about 8000 small scale units in operation. These units produce about 350 bulk drugs, and as we have mentioned above more than 2000 formulations. The Drug Policy, 1994 also mentions that the production of bulk drugs in 1993-94 is in the region of Rs.1320 crores and for the same period the production of formulations is in the region of Rs. 6900 crores. In other words, not only is the drug industry in the country extremely large with heavy financial stakes but there is lot at stake in it not only for the industry but also for the consumers. For this reason, the Courts have to extremely cautious in interfering in any manner whatsoever with the working of the drug industry. Any interference by the Courts would have wide ranging repercussions not only in commercial terms but also for the people of the country.- Whether the notification dated 13th July, 1999 issued by the Central Government under Paragraph 7 of the Drugs (Prices Control) Order, 1995 prescribing the norms for conversion cost, packing charges and process loss of raw materials (other than packing materials in conversion) and packing and process loss of packing materials in packaging was issued mechanically and without any application of mind or is it valid in law? Our answer to this is that the notification is valid and that the notification was not issued mechanically or without any application of mind. Whether the notifications dated 12th July, 2000, 12th July, 2001, 12th July, 2002 and 11th July, 2003 issued by the Central Government under Paragraph 7 of the Drugs (Prices Control) Order, 1995 re-notifying the norms prescribed on 13th July, 1999 were issued mechanically, without any application of mind and without re-determining the norms every year as required by the Drugs (Prices Control) Order, 1995 and are they valid in law? Our answer is that the notifications are valid and were not issued mechanically or without any application of mind and that it was not necessary to re-determine the norms every year. Whether various notifications issued by the Central Government fixing the retail price or ceiling price of formulations under Paragraphs 8 and 9 (as the case may be) of the Drugs (Prices Control) Order, 1995 without determining the norm for cost of packing material as required by Paragraph 7 of the Drugs (Prices Control) Order, 1995 are valid in law? Our answer is in the affirmative. Whether fixing the retail price of a formulation under Paragraph 8 of the Drugs (Prices Control) Order, 1995 without first fixing the sale price of a bulk drug under Paragraph 3 of the Drugs (Prices Control) Order, 1995 utilized in the manufacture of a formulation is valid in law? Our answer is in the affirmative. - 2016 Oct. http://judis.nic.in/supremecourt/imgst.aspx?filename=44262