UNICHEM LABORATORIES LIMITED Vs. UNION OF INDIA

JUDGEMENT

(1.) 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 :---

(3.) Respondent has filed an affidavit-in-reply through the Deputy Drugs Controller. The return refers to the decision of the Committee of experts of the Indian Council of Medical Research recommending a total ban on Anabolic Steroid with combination with other drugs. It is contended that there was no substance in the plea of the petitioners that addition of Vitamins to the Steroid was extremely useful or it had therapeutic justification. In fact mere combination of Vitamins to the Steroids did not contribute to the effect of Steroids, unless the patient had access to adequate quantities of proteins, carbohydrates and fat. The problem of malnutrition in India was well known and in the case of such a malnutritious population, addition of Vitamins to Steroids was of no assistance to the patient. In case a supplement of Vitamins was necessary the patients who had to be given Anabolic Steroid this could always done by giving the Vitamins Separately. Formulations containing Steroids and other drugs were being use indiscriminately and this was creating dangerous side effects. For that purpose it was considered necessary impose a total ban in keeping with the advise of the Board. The Government had acted in consultation with the Committee of experts and upon an approval rendered by this statutory Board. Its decision was justified under section 26-A of the Act and was non justiciable.