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2008 Supreme(SC) 842

S.B.SINHA
Union of India – Appellant
Versus
Ranbaxy Laboratories Ltd. – Respondent


JUDGMENT

S.B. SINHA, J.

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(l) "manufacture" in relation to any drug, includes any process or




























































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