SC to consider restriction of essential drug's output

A larger bench of the Supreme Court has decided to examine if the production of a drug classified as essential and life-saving can be restricted to government companies only, in public interest and to prevent its misuse.

A bench of Justices Abhay Manohar Sapre and Indu Malhotra said issues which came up for consideration were, on the one hand, the unregulated and clandestine manufacture of the drug Oxytocin, which is reportedly misused in milch animals.

On the other hand, the question was of the continued supply of an essential life­-saving drug, which is used as the first-line drug for prevention and treatment of post­partum hemorrhage at the time of childbirth, the court said.

The court framed a series of questions, including whether the object of curbing the clandestine manufacture and unregulated use of the drug Oxytocin, which is covered by Section 18 of the Drugs and Cosmetics Act, 1940, can be achieved by taking recourse to Section 26A, by imposing a ban on the manufacture of licensed drugs by private sector companies.

Both Justice Malhotra and Sapre said a larger bench of three judges should examine the matter for authoritative pronouncement of the judgement as questions will have "far-reaching effect on the rights and health of the public at large and especially on the rights and health of the teenage girls, pregnant females and milch animals".

The central government had on April 27, 2018, taken the drastic course of prohibiting the manufacture of the drug by all private sector licensees, to prevent the ill effects of Oxytocin, which may affect human life due to prolonged consumption of milk from milch animals injected with the drug.

Statutory bodies like Drugs Technical Advisory Board and the Drugs Consultative Committee had also deliberated on the issue as Oxytocin was included as an essential life­-saving drug in the National List of Essential Medicines, 2011.