FRANKLIN LABORATORIES INDIA PRIVATE LIMITED PHARMACEUTICALS MANUFACTURERS Vs. DRUGS CONTROLLER INDIA SHOWING HIS OFFICE AT DIRECTOR GENERAL OF HEALTH SERVICES NEW DELHI

JUDGEMENT

(1.) This bunch of 17 petitions viz. C.W.Ps. Nos. 7749, 8393, 9409, 9418, 12222 to 12224, 12328, 12329, 12298, 12299, 13076, 13212, 13933, 14613, 18350 and 18887 of 1991 raise a challenge to the validity of the notification (s) issued by the Central Government banning the manufacture etc. of various fixed dose combinations of drugs. Learned counsel for the parties are agreed that these petitions can be disposed of by one common order. The facts as stated in C.W.P. No. 7749 of 1991 may be briefly noticed.

(2.) The petitioner herein is a Company engaged in production, sale and distribution of various drugs and pharmaceutical products. It is producing various sedative, anxiolytic, hypnotic, analgesic and antipyretic drugs in different combinations. It claims to have been granted the permission to manufacture various products included in Schedule 'X' to the Act. It is claimed that these products are of great utility and therapeutic value to the patients. It is further claimed that the petitioner-Company has been licenced under the provisions of the Drugs and Cosmetics Act, 1940, (hereinafter referred to as 'the Act'). It has been further mentioned that the Government of India had constituted a Drugs Consultative Committee which after thorough examination of the matter made its recommendations. The Central Government on examination of the proceedings of the Committee, issued a notification in the year 1983, by which the manufacture and sale of various drugs was banned. However, the medicines prepared by the petitioner were not mentioned in this notification.

(3.) On 26/12/1990, the Government has issued a notification by which the manufacture of fixed dose combination of various drugs has been banned. The validity of this notification has been challenged on the ground that it is wholly arbitrary and violative of the principles of natural justice.