E MERCK INDIA LIMITED Vs. UNION OF INDIA

JUDGEMENT

(1.) By impugned Notification dated 14/10/1999 the Central Government has in exercise of powers contained under Section 26-A of the Drugs and Cosmetics Act, 1940 (as amended 68 of 1982) (hereinafter referred to as the Act, for short) prohibited manufacture, sale or distribution of Fixed Dose Combination (hereinafter referred to as FDC, for short) of Vitamins B1, B6 and B12 for human use w.e.f. 1/01/2001.

(2.) Petitioner is a pharmaceutical Company. Apart from manufacturing other medicines, it is the manufacturer of FDC of Vitamins B1, B6 and B12 which is marketed by it in the name of 'Neurobion' in tablet and injectible forms. Petitioners claim to have largest market share of this drug, with total sale of Rs. 35.43 crores per year which is equivalent to approximately 23.6% of the total pharmaceutical products. It was, therefore, but natural for the petitioners to feel aggrieved against this Notification and by means of present Writ Petition the petitioners had challenged the validity of this Notification. Challenge is also to the vires of Section 26-A of the Act under which the aforesaid Notification is issued.

(3.) The exercise undertaken by the Central Government which culminated in the issuances of impugned Notification dated 14/10/1999 has its origin in a Writ Petition filed in the Supreme Court under Article 32 of the Constitution of India being Civil Writ Petition No. 698 of 1993. This Writ Petition entitled Drug Action Forum v. Union of India and others was filed by the Drug Action Forum (hereinafter referred to as the Forum, for short) and is in the nature of Public 11. crest Litigation. In the said Writ Petition the Forum has averred that there are many drugs in the market which are hazardous or have no therapeutic value and sought direction to ban these drugs. Since the proceedings in the Supreme Court in the aforesaid Writ Petition have bearing on the present case, it would be necessary to take stock of such proceedings.