DTAB panel on FDCs gives appellants more time to submit data; 150 drugs reviewed so far

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A sub-committee of the Drugs Technical Advisory Board (DTAB) examining the ban on 300-plus fixed dose combination (FDC) drugs has given appellants, including All India Drug Action Network (Aidan), time till June 4 to make submission of information on these products. The panel has so far reviewed more than 150 FDCs out of 349, according to the minutes of the DTAB meeting held on May 16.

The panel headed by Dr Nilima Kshirsagar, the chair in clinical pharmacology at ICMR Mumbai, is expected to submit the final report on FDCs in question by the first week of July. The representations submitted to the sub-committee from associations like Aidan, Federation of Pharma Entrepreneurs (FOPE), Indian Drugs Manufacturers Association (IDMA), Indian Association of Dermatologists Venereologists and Leprologists (IADVL) and Abbott Healthcare were also reviewed at the meeting.

Abbott Health Care, in its representation, has requested the panel to exclude 15 FDCs approved prior to 1988 and 17 products that were approved by the Drug Controller General of India from the list of drugs under the purview of the panel. “However, the DTAB members deliberated the issue and were of the view that the sub-committee shall submit the report of all 344 plus 5 FDCs again as per the directions from the Supreme Court,” the minutes of the meeting show.

Regarding demand from Aidan and Abbot for the removal of industry body representatives and professional association members from the sub-committee over conflict of interest and lack of expertise, the panel has observed that no such issue is involved as these members are from professional associations and don’t require any criteria of expertise.

An FDC drug contains two or more active pharmaceutical ingredients in a fixed dosage ratio. The health ministry last year banned 344 FDCs, estimated to affect around 6,000 brands, after an expert committee declared them unsafe. Drug makers challenged the ban in high courts across the country seeking interim relief on their specific brands. In January this year, the ministry moved the apex court challenging a Delhi high court order that quashed the ban on the grounds that the DTAB was not consulted by the government. Aidan had also filed a special leave petition in the top court against the Delhi high court order.

Healthcare professionals and advocacy groups had cheered the apex court intervention. Numerous studies show that thousands of medicines go on sale in Indian market without approval. A recent report in the British Journal of Clinical Pharmacology stated that of 118 FDC antibiotic formulations sold in India between 2007 and 2012, 64 per cent were not approved by the Central Drugs Standard Control Organisation. Only 4 per cent of the FDCs were cleared in the US or Britain.

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