( 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