Supreme Court refers fixed dose combination drugs issue to govt expert body


New Delhi: The Supreme Court on Thursday referred the issue of fixed dose combination (FDC) drugs to the government’s expert body, Drugs Technical Advisory Board (DTAB), for a fresh review of their safety, efficacy and therapeutic justification before recommending action.

After the examination by the DTAB or a sub-committee constituted by it and hearing all stakeholders concerned, the expert body will be required to forward its report to the government for action within six months, held a bench headed by justice Rohinton F. Nariman.

The court, however, kept out of the purview of its order the 15 FDCs that were licensed prior to 1988.

It also held that status quo be maintained in the case of the 329 FDCs being referred to DTAB for review.

Welcoming the order, the All India Drugs Action Network said that the court’s directive clears the way for the government to take steps to weed out large numbers of irrational, unscientific and hazardous FDCs prevalent in India.

“The 344 FDCs account for only about 5% of the value of total FDCs in India, approximately half of which are considered to be irrational. The government should proactively take advantage of the space afforded by this order to weed other irrational FDCs in the interest of patient safety,” said S. Srinivasan, co-convenor of the network.

Pfizer Ltd, the Indian unit of US-based drug maker, whose Corex cough syrup was part of the FDC drugs banned by the centre, said it “fully supports the government in its goal of eradicating irrational combinations and medicines not duly approved by state and central regulators through a consultative process”.

In January, the centre had filed an appeal against a December 2016 ruling of the Delhi high court quashing its 10 March, 2016 notification banning 344 FDC drugs citing health risks and lack of therapeutic justification.

On 31 March, the apex court had stayed proceedings in all high courts against the ban on 344 FDC drugs.

An FDC drug contains two or more active ingredients in a fixed dosage ratio.

The ban covered about 6,000 brands from major pharma houses including Pfizer Ltd, Wockhardt Ltd, Alkem Laboratories Ltd, Cipla Ltd, Sanofi India Ltd, and Sun Pharmaceutical Industries Ltd. It was enforced following a report by a six-member committee headed by Chandrakant Kokate, vice-chancellor of KLE University, Karnataka.

The Kokate panel, which submitted its report on 20 January 2015, had termed 963 FDCs “irrational”, posing health threats.

Justice Rajiv Sahai Endlaw of the Delhi high court had quashed the notification, holding that the government had failed to consult statutory authorities like DTAB and the Drugs Consultative Committee before the ban.