Madras High Court refuses stay on FDC ban

The decision comes in the back of a petition filed by South Indian Pharmaceutical manufacturers' federation

The Madras High Court has refused to give a stay on Union Health Ministry's decision to ban 344 fixed-dose combination (FDC) drugs. The Court has allowed three weeks' time to the Centre to file affidavit and asked it not to take a coercive step against the manufacturers and stockists.

The developments comes in the back of a writ petition filed by the Federation of South Indian Pharmaceutical Manufacturers Association (FOSIPMA), a federation of pharmaceutical manufacturers of all the southern states.

The federation argued that the centre has taken action without sending show cause notice to the pharmaceutical manufacturers and no communication happened in this regard until the drugs were banned. This is against principles of natural justice, they alleged.

The federation also argued that the Section 26A of the Drugs and Cosmetics Act, 1940 which gives powers to the central government to prohibit manufacturing of drugs and cosmetics in public interest, should be read along with other sections that constitutes the Drug Technical Advisory Board (DTAB) and Drug Consultative Committee (DCC), when such powers are used.

The bench comprising of Chief Justice Sanjay Kishan Kaul and Justice M M Sundresh, observed that the safety standards are an issue to be decided by the experts and it is a matter of health. The Court refused to give an interin stay on the government's order.

Considering today's order, the traders' association Tamil Nadu Chemists and Druggists Association (TNCDA), which claims a strength of over 30,000 members in the State, said that it would not be approaching the court now and would try to work within the three weeks' time given by the Court to sort out the stocks and return those which are of banned combinations. It would also seek the drug control officials to provide them enough time to return these stocks to the manufacturers.