JUDGMENT - S.M. DAUD, J.:---This petition under Article 226 of the Constitution impugns the notification dated 22 November, 1985, where by the use of Anabolic Steroid with other drugs has been completely prohibited in purported exercise of the power conferred upon the Central Government by section 26-A of the Drugs and Cosmetics Act. 1940 (Act No. 23 of 1940) hereinafter referred to as 'the Drug Act'.

2. Petitioners are pharmaceutical company engaged in the manufacture of a variety of drugs and pharmaceutical products one of the products manufactured by them is a drug known as 'Trinergic'. The product is brought out in two forms, viz. capsules and injections, Trinergic is a combination of Anabolic Steroid known as Methanoienone and Vitamin B-1, B-6 and B-12, M/s. Ciba Geigy of Basle, Switzerland took a decision to withdraw their Anabolic Steroid, a preparation of Methandienone being marketed under the brand name 'Dienabol' from the world market. Their Indian subsidiary informed the Director General of Health Services of this decision and the reason indicated by them to the Drugs Controller was thus :---

"Clinical evaluation has indicated that the balance between clinical benefit on the one hand and side effects such as virilisation on the other, now appears to be less favourable, except possibly osteoporosis and in the management of certain forms of anaemia. Moreover, the drug is being abuse by athletes to improve their physical performance."

On receipt of the above intimation, the Drugs Controller wrote to Director General of Indian Council of Medical Research on May 20, 1983, ascertain the Council's response. The matter was discussed at a meeting of experts assembled for the purpose on November 24, 1983. The meeting reached certain conclusions, and, the important ones which have a relevance to this petition were worded thus :-

"1. Anabolic Steroids should not be used in combination with any other class of drugs, whatsoever.

4. The package inserts on Anabolic Steroids should incorporate the following :

(i) Anabolic Steroid should be administered only in the form of intermittant course, not exceeding 3 months, at a time.

(ii) If no beneficial effect is observed during this period, the drug should be discontinued.

(iii) The interval between two courses of treatment should not be less than 3 months.

(iv) There should be warning in bold letters or in a box that long term use of Anabolic Steroids can produce cancer, especially of prostate, liver and the breast.

(v) In female patient, the use of Anabolic Steroids can produce virilism which is reversible when an intermittant dosage schedule followed; but this effect will be irreversible when prolonged treatment is given.

5. There is documentary evidence based on controlled clinical trials which has shown that the use of Anabolic Steroids in athletes does not improve the work performance of these athletes. The Group, therefore, recommended that this fact should be brought out in their product literature by the manufacturers......

6. It should be mandatory on the part of the drug manufacturers to bring out documents such as product safeguards with respect to Anabolic Steroid compounds manufactured by them, giving information related to warning, precautions, adverse reactions and contra-indications of the product.

7. The Group was of the firm view that Anabolic Steroids should not be promoted as food substitutes under any circumstances. It is now well known that Anabolic Steroids exert their optimal effect only when adequate protein and calories intake in patient is ensure and not other wise.

8. ......The Group was of the firm view that there was no case for banning Anabolic Steroids which constitute a useful class of drugs, provided they are use rationally and judiciously with proper precautions, as detailed above."

The Drugs Technical Advisory Board, functioning under section 5 of the Drugs Act, considered the matter on 19 December, 1984 and approved the reasons which had tentatively weighed w

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