1993 (9) TMI 369 - SC - Indian Laws

Summary

Issues Involved:
1. Validity of the notification dated November 3, 1988, prohibiting the manufacture and sale of fixed dose combinations (FDCs) of corticosteroids with other drugs for internal use.
2. Proper consideration of scientific data and studies submitted by manufacturers.
3. Reasonableness of the prohibition under Article 19(1)(g) of the Constitution.
4. Opportunity for manufacturers to present fresh material to the Drugs Technical Advisory Board (DTAB).

Issue-wise Detailed Analysis:

1. Validity of the Notification Dated November 3, 1988:
The notification dated November 3, 1988, issued by the Government of India, amended the earlier notification dated July 23, 1983, to prohibit the manufacture and sale of FDCs of corticosteroids with other drugs for internal use. This notification was issued under Section 26-A of the Drugs & Cosmetics Act, 1940. The Central Government was satisfied that long-term use of these FDCs for asthma treatment posed risks to human beings and lacked therapeutic justification, making it necessary and expedient in the public interest to prohibit their manufacture and sale.

2. Proper Consideration of Scientific Data and Studies Submitted by Manufacturers:
Manufacturers challenged the notification, arguing that the scientific data and studies they submitted were not properly considered by the experts, the Drugs Consultative Committee (DCC), and the DTAB. The court reviewed the minutes of the meetings of these bodies and found that the material submitted by the manufacturers was examined. The court noted that medical experts in clinical medicine were indeed part of the evaluation process, including Dr. O.D. Gulati, Dr. J.P. Wali, and Dr. M. Durairaj. The court concluded that there was proper consideration of the material submitted by the manufacturers.

3. Reasonableness of the Prohibition Under Article 19(1)(g) of the Constitution:
The petitioners argued that the prohibition unreasonably restricted their right to carry on trade guaranteed under Article 19(1)(g) of the Constitution. They suggested that a less drastic measure, such as permitting the manufacture and sale of the drugs with a warning about their use, could have been adopted. The court referred to the criteria for examining the reasonableness of restrictions under Article 19, as laid down in previous judgments. The court found that the Central Government had acted cautiously and provided manufacturers with adequate opportunities to present their case. The prohibition was deemed reasonable, given the harmful potentialities of the drugs and the conditions prevalent in the country.

4. Opportunity for Manufacturers to Present Fresh Material to the DTAB:
The court noted that, following its order dated January 6, 1992, the matter was being reconsidered by the Technical Advisory Board in light of fresh material. The court allowed the petitioners and other manufacturers to approach the Board and submit any fresh material in support of their claim for revocation of the ban within one month. The Board was directed to consider this material along with other representations within three months.

Conclusion:
The appeals, special leave petitions, transferred cases, and writ petition were dismissed. The judgment of the Punjab and Haryana High Court was affirmed, subject to the direction that manufacturers could submit fresh material to the Board within one month, and the Board would consider these submissions within three months. No order as to costs was made.