Drugs Body To Set Up Panel To Review Efficacy Of FDCs

New Delhi, 16 Jan 2018: India’s chief advisory body on drugs is set to decide on the fate of more than 300 banned drugs in a meeting later this month following complaints from the drug industry.

The Drugs Technical Advisory Board (DTAB) is expected to set up expert committees, which will review the safety, efficacy and therapeutic justification of these drugs—called fixed dose combinations (FDCs)—before recommending any action in its 22 January meeting.

Drug makers claim the government did not consult statutory bodies before banning these drugs—an FDC drug contains two or more active ingredients in a fixed dosage ratio—in 2016-17.

“Many of these drugs should not have been banned in the first place. We will constitute expert committees comprising clinical experts to review their safety before we decide on the final action,” DTAB chairman Jagdish Prasad said in an interview.

The Supreme Court in December referred the matter of FDCs to DTAB for a fresh review on whether these drugs should continue to be marketed. The court also set aside the ban on 15 drugs that were banned and which were manufactured before 21 September 1988 as these cases were never meant to be referred to the Kokate Committee.

For the remaining 344 FDCs, the court suggested that DTAB decide whether the manufacture and sale of these drugs should be regulated, restricted or banned outright, and submit its report and recommendations to the government within six months.

“We will constitute committees, which will consult all the stakeholders concerned, before taking a final call and submit the report to the government for action within six months. Patients’ safety is paramount to us and we will do our best to make sure that the safety is not compromised. Simultaneously, we have to ensure industry should not get severely impacted,” said Prasad.

In January 2017, the government 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.

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 government-appointed committee headed by Chandrakant Kokate, vice-chancellor of KLE University, Karnataka.

The Kokate panel, which had submitted its report on 20 January 2015, had termed 344 FDCs “irrational”, saying they posed health risks.

On 1 December 2016, Justice Rajiv Sahai Endlaw of the Delhi high court quashed the notification, holding that the government had failed to consult statutory authorities like DTAB and the Drugs Consultative Committee before enforcing the ban.

These drugs are used to treat cough, cold, anti allergies. Some of the medicines on which the ban on sale was lifted by the high court included Pfizer’s Corex cough syrup; Glaxo’s Piriton expectorant and Crocin Cold; P&G’s Vicks Action 500 Extra; Reckitt’s D’Cold; Piramal’s Saridon; Glenmark’s Ascoril and Alex cough syrups; Abbott’s Phensedyl cough syrup, and Alembic’s Glycodin cough syrup.

Welcoming the action of the court, industry experts said 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 out other irrational FDCs in the interest of patient safety. They should implement the order and get it done within six months,” said S. Srinivasan, co-convenor of All India Drugs Action Network, a non-profit patient advocacy group. Livemint