Panel reviewing efficacy of 349 FDCs may reinforce ban
Committee set to give its report to drug advisory body DTAB at a meeting on Wednesday
New Delhi: Pharmaceutical companies awaiting report on the safety of those fixed dose combinations (FDCs) that were earlier banned by the ministry of health and family welfare are unlikely to get a breather.
The expert panel probing the efficacy of 349 (344+5) banned FDCs is likely to reinforce the ban. According to the people with knowledge of the development, out of 349 drugs under scrutiny, only three are likely to get relief.
The panel will give its report to India’s top drug advisory body, the Drug Technical Advisory Board (DTAB), in a meeting slated to happen on 25 July, thereby settling the dust on the fate of “irrational” FDCs in India.
As per the same people quoted above, the panel after considering these drugs “irrational”, citing safety issues and lack of therapeutic justification, has recommended continuing the ban.
However, three drugs are likely to come out of the list as they are already banned and should not have been there in the list.
The panel will submit the report to DTAB , which will be then forwarded to the health ministry.
In its report submitted on 20 January 2015, the committee led by Chandrakant Kokate, vice-chancellor of KLE University, Karnataka, had deemed these FDCs irrational, saying they posed health risks and, hence, banned them, pushing some of the companies and the pharma groups to challenge the government’s notification banning FDCs in the court.
Last December, the apex court referred the matter to DTAB for a fresh review on whether these drugs should continue to be marketed. The Supreme 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.
An expert panel was then formed under the chairmanship of Nilima Kshirsagar, professor head clinical pharmacology, G.S. Medical College KEM hospital, Mumbai, to review the safety, efficacy and therapeutic justification of these drugs.
An FDC drug contains two or more active ingredients in a fixed dosage ratio.
The Union health ministry’s ban on FDCs included painkillers, anti-diabetic, respiratory and gastro-intestinal medicines.
The ban covered about 6,000 brands from major pharma companies, including Pfizer Ltd, Wockhardt Ltd, Alkem Laboratories Ltd, Cipla Ltd, Sanofi India Ltd and Sun Pharmaceutical Industries Ltd.
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. “We expect that the expert committee reinforces and stays with the ban,” said S. Srinivasan, co-convenor of the All India Drugs Action Network, a non-profit patient advocacy group.
After examination by DTAB or a sub-committee constituted by it and hearing all concerned stakeholders, the expert body was required to forward its report to the government for action within six months, a bench headed by justice Rohinton F. Nariman had held.
During the course of review, the committee had received representations from the All India Drugs Action Network, the Federation of Pharma Entrepreneurs, the Indian Drugs’ Manufacturers Association, the Indian Association of Dermatologists Venereologists and Leprologists and Abbott Healthcare Pvt. Ltd.
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