ROUSSEL PHARMACEUTICALS INDIA LTD Vs. UNION OF INDIA

JUDGEMENT

(1.) BY this writ petition the petitioners are challenging the validity of a notification dated 3rd november, 1988 issued by the Government of India under which the Government of India, in exercise of the powers conferred on it by Section 26a of the Drugs and Cosmetics Act, 1940, hereinafter referred as "the Act", has banned the manufacture of fixed dose combination of corticosteroids with any other drug for internal use.

(2.) THE petitioners are manufacturers of a drug called "cartasmyl", which is a fixed dose of combination of corticosteroids and bronchodilators. They contend that this drug is of great benefit to asthma patients. They also contend that the ban imposed by the aforesaid notification has been done without being properly satisfied, as required under Section 26a of the Act.

(3.) FEW facts need to be mentioned. Sometime in the year 1980 the question of the rationality or otherwise of the various fixed dose combinations then available in the market began to exercise the mind of the Government. The then Drugs Controller, Dr. S. S. Gothoskar had invited the views of the manufacturer of drugs on the recommendations which had made by the sub-committee of Drugs Consultative Committee for weeding out the unnecessary and irrational combinations. The industry, presumably, expressed its opinion on the same. The Government thereafter banned the fixed dose combinations of steroids for internal use, except the combination of steroids with other drugs for the treatment of asthma. The material, which has been brought on record by the petitioners and which has not been controverted, shows that the then Drugs Controller, India, Dr. Gothoskar, had stated that there was evidence then when steroids are added to bronchodilators there is lesser dose of steroids required to allay bronchial spasm than when steroids are given alone causing thereby lesser side effects due to steroids. This amounted to saying that there was evidence of pharmacological synergism between corticosteroids and bronchodilators.