( 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.

( 4 ) PETITIONERS herein moved an application in that Writ Petition before the Supreme Court for impleadment as a party as being vitally interested in the outcome of the Petition. This application for impleadment was allowed by Order dated 17/10/1994 and petitioners have been participating in those proceedings ever since. Respondents herein filed affidavits from time to time pursuant to various Orders passed by the Supreme Court in that Writ Petition giving their views/comments as well as available material on various drugs including on FDC of Vitamin B1, B6 and B12. It may be mentioned that the Forum in the said Writ Petition had filed additional affidavit dated 5/05/1994 covering various drugs and following averments were made in respect, of FDC of Vitamins Bl, B6 and B12 :-

"probably no other combination of drugs is an completely without rationale as combinations of Vitamins B1 (Thiamine), B6 (pyridoxine) and B12 (cyanocobalamine ). Both Vit. B1 and B12 have specific indications related to their deficiencies. Why they should be combined along with Vit. B6 is anybody s guess. This combination does not find mention any standard work of Medicine and Pharmacology. Yet a large number of these combinations as injections or tablets are propagated. They are propagated as general "health Tonics" and for a large variety of obscure to common neurological problems. "

"vitamin B12 has an undeserved reputation as a health tonic and has been used for a number of diverse disease states. . . . . . "

( 5 ) THERAPY should always be as specific as possible. While a large number of multi- vitamin preparations are available, the use of "shotgun" therapy in the treatment of Vitamin B12 deficiency can be dangerous. . . " - GOODMAN and GILMAN s the Pharmacological Basis of Therapeutics, Seventh Edition (1986 ). "adverse reactions virtually do not occur, but its use as a "tonic" is an abuse of a powerful remedy for it may obscure diagnosis of pernicious anemia which is a matter of great importance in a disea