- (1.) LEAVE granted.
(2.) FIRST respondent is a pharmaceutical company and is engaged in the manufacture, inter alia, of the bulk drug Pentazocine in the formulation of Pentazocine injection with the brand name 'fortwin'. Sale and marketing of the said drug is controlled by the Drugs (Price Control) Order, 1995 (1995 Order ). The said order has been made by the central Government in exercise of its powers under Section 3 of the Essential Commodities act, 1955 (1955 Act ). We may notice some interpretation clauses in the 1955 Act, which are as under :- "2. (a) "bulk drug" means any pharmaceutical, chemical, biological or plant product including its salts, esters, stereo-isomers and derivatives, conforming to pharmacopoeial or other standards specified in the second Schedule to the Drugs and cosmetics Act, 1940 (23 of 1940), and which is used as such or as an ingredient in any formulation; 2. (c) "ceiling price" means a price fixed by the Government for scheduled formulation in accordance with the provisions of para. 9. 2 (f) "drug" includes- (i ). . . . . . . . (ii ). . . . . . . . (iii) bulk drugs and formulations; 2 (1) "manufacture" in relation to any drug, includes any process or part of a process for making, altering, finishing, packing, labelling, breaking or otherwise treating or adapting any drugs with a view to its sale and distribution, but does not include the compounding or dispensing of any drug or the packing of any drug in the ordinary course of retail business, and "to manufacture" shall be construed accordingly; 2 (r) "price list" means a price list referred to in paragraphs 14 and 15 and includes a supplementary price list; 2 (s) "retail price" means the retail price of a drug arrived at or fixed in accordance with the provisions of this order and includes a ceiling price;" The drug in question is one of the scheduled bulk drugs being at SI. No. 43 in the First Schedule. The Central Government in exercise of its powers conferred upon it by paragraph 23 of the 1995 Order issued guidelines for the purpose of grant of exemption in terms of paragraph 25 specifying that a manufacturer who had been given a price exemption for bulk drug should submit an application in prescribed forms for fixation of price of such bulk drug and formulation four months before the expiry of the period of the exemption. It was furthermore stipulated:- "however, if there is an existing notified price for bulk drug or ceiling price for formulations, the manufacturer shall follow the same on the expiry of the exemption and obtain price approval for non-ceiling packs of formulation (s)based on that bulk drug. "
(3.) A similar provision has been made for grant of exemptions in respect of New delivery System, in terms whereof a manufacturer is required, where there is an existing notified price, to follow the same on the expiry of the exemption. The exemption granted in favour of the first respondent had expired on 31st October, 1999.;