The Government has the power to ban the manufacture and sale of drugs that are found to be harmful to human beings or animals, and that this power is not subject to the principles of natural justice.

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.

4. A written statement has been filed on behalf of the Union of India and the Drugs Controller by the Deputy Drugs Controller (India). It has been mentioned that there were lots of representations from the consumers associations questioning the rationale and safety of fixed combination drugs. Consequently, Parliament had in its collective wisdom incorporated Sec. 26-A authorising the Central Government to identify such harmful drugs and to prohibit their manufacture, sale and distribution. The Drugs Consultative Committee constituted under the Act surveyed fixed combination drugs available in this country. According to the written statement definite guidelines, as envisaged in Sec. 26-A of the Act were laid down and after thorough screening, the Consultative committee published the list of various drugs periodically. Further a Sub-Committee of the Drugs Consultative Committee consisting of Experts in Pharmacology and medicine screened the fixed dose combination drug available in this country and identified such drugs as were considered irrational and harmful. It is on the basis of the recommendations of the Sub-Committee that the Central Government finally issued the impugned notification. Reasons have also been given in the written statement to show that a combination of various drugs like diazepam or phonobarbitone with analgesic or antipyretic drugs is not more advantageous than individual drug therapy. It has been further mentioned that there is a possibility of the drug being misused and administered in combination even in a condition when it is not actually required. On these promises, the impugned notification(s) are sought to be sustained.

5. I have heard learned counsel for the parties. The primary contention raised by the learned counsel is that the impugned notification vitally affects the interests of the small scale units, like the petitioners, and they had a right to be heard before their freedom of trade as guaranteed under Article 19 of the Constitution could be curtailed. It has also been contended that the action is beyond the provision of Sec. 26-A of the Act and suffers f