GLAXO SMITHKLINE PHARMACEUTICALS LTD. & ANR. versus UNION OF INDIA & ORS.
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(2017] 7 S.C.R. 894 A GLAXO SMITHKLINE PHARMACEUTICALS LTD. & ANR. B v. UNION OF INDIA & ORS. (Civil Appeal No. 6178 of 2009) JULYl8,2017 [R. F. NARIMAN AND SANJAY KISHAN KAUL, JJ.) Drugs (Prices Control) Order, 1987: Para 28 r/w Exemption Notification dated 28'" Febntary, 1992 C - Exemption Notification issued to appellant (manufacturer of a bulk drug) for the period upto 31.12.1994 - Demand notice by revenue to the appellant finding that there was differential in the price charged for the goods manufactured during exemption period - Writ petition challenging the demand, dismissed by High Court - D On appeal, held: The exemption only relates to manufacture and has no reference to sale - Therefore, demand is not justified. E F Allowing the appeal, the Court HELD: 1. In view of paragraph 28 of the Drugs (Price Control) Order, 1987 (DPCO), the exemption relates to drug manufacturing units or classes of such units. The very exemption order refers only to bulk drugs and formulations based thereupon which are "manufactured" by the company. Further, a reading of the Central Government Guidelines of 1989 also makes it clear that the exemption only relates to manufacture and has no reference to sale whatsoever. [Para 8) (899-C-D) 2. It is not correct that in view of sub-clause (viii) of the 1989 Guidelines, after the expiry of the period of exemption, the manufacturer has to submit an application for fixation of the price of a bulk drug under the provisions of the DPCO. Sub-clause (viii) cannot be read in isolation, but must be read as a part of the G entire scheme of the Guidelines. All that sub-clause (viii) says is that after the period of exemption, which is after the period which has reference to manufacture and not sale of goods, such goods as are manufactured after the exemption will be subject to the drill of sub-clause (viii). [Paras 9, 10] (901-C-E] H 894 GLAXO SMITHKLTNE PHARMACEUTICALS LTD. & ANR. v. 895 UNION OF INDIA & ORS. 3. It is not correct to say that the period of 15 days is A mentioned in paragraph 16(3) of the DPCO to give effect to the price of bulk drug or formulation, so that one price may be fixed by the Government for each bulk drug and formulation from time to time, as there cannot be two prices for the same bulk drugs or formulation. There will only be one price that is fixed for all goods that are manufactured by the appellant upto 31'' December, 1994, and that price will be a price unilaterally determined by the appellant and will not be fixed under the DPCO. [Para 14) [904- D-E] Union of India v. Ranbaxy Laboratories Limited and Ors. (2008) 7 SCC 502 : [2008) 8 SCR 315 - relied on. Glaxosmithkline Pharmaceuticals Ltd. v. Union of India and Ors. (2014) 2 SCC 753 : (2013] 12 SCR 1120 - distinguished. Case Law Reference (2008) 8 SCR 315 relied on [2013) 12 SCR 1120 distinguished Para6 Para 7 B . c D CIVIL APPELLATE JURISDICTION: Civil Appeal No. 6178 E of 2009. From the Judgment and Order dated 16.02.2004 of the High Court of Bombay in Writ Petition No. 1266of1999. S. Ganesh, Sr. Adv., U. A. Rana, Himanshu Mehta (for Gagrat and Co.), Advs. for the Appellants. F Rana Mukherjee, Sr. Adv., Merusagar Samantary, Prateek Jalan, Lhingneirah, Ms. Viddusshi, Ms. Anu Singh, B. Krishna Prasad, Advs. for the Respondents. The Judgment of the Court was delivered by R. F. NARIMAN, J. I. The present appeal arises on the true construction of paragraph 28 of the Drugs (Prices Control) Order, 1987, read with exemption notification dated 28'h February, 1992. Paragraph 28 of the DPCO, 1987, reads as under: G "28. Power to exempt- (I) The Government may, having regard H 896 A B c SUPREME COURT REPORTS [2017] 7 S.C.R. to the factors mentioned in sub-paragraph (2) and subject to such conditions, if any, as it may specify, by order in the Official Gazette, exempt any drug manufacturing unit or a class of such units from the operation of all or any of the provisions of this order and may, as often as may be, revoke or modify such order. (2) While granting exemption under sub-paragraph (1), the Government shall have regard to all or any of the following factors relating to the drug manufacturing unit or a class of such units, namely; a) Number of workers employed; b) Amount of ca pi ta! invested; c) Range and type of products manufactured; d) Sales turnover; e) Production of bulk drug basic stage by process develope
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