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Last Updated : May 30, 2019 06:25 PM IST | Source:

Expert panel to examine 324 FDC drugs categorised 'irrational'

Sale of the 324 FDCs under review may not be more than Rs 500 crore, as most drug companies stopped production after anticipating the ban.

The Drugs Technical Advisory Board (DTAB), will examine 324 fixed-dose combination drugs (FDC), which are classified as irrational but not banned as further deliberation is warranted before action.

FDCs are a cocktail or combination of two or more drugs into a single pill.

"A meeting of the sub-committee of DTAB will give the manufacturers and concerned stakeholders an opportunity to present precise data with respect to these FDCs," Sanjeev Kumar, Convener, Sub-Committee of DTAB said in a notification dated May 29.


The sub-committee will be headed by Dr Nilima Kshirsagar, the Chair in Clinical Pharmacology of Indian Council of Medical Research (ICMR). Ksirsagar had in July 2018 reviewed safety and efficacy data of 343 FDCs, based on Supreme Court direction. Her earlier report found no therapeutic justification, providing ground for the government to go ahead with the ban of 328 FDCs in September 2018.

Sale of the 324 FDCs under review may not be more than Rs 500 crore, as most drug companies stopped production after anticipating the ban.

India was flooded with FDCs for a period, with one in two medications sold being one. Many were launched for commercial reasons without any scientific justification. The government thus appointed a 10-member committee headed by Prof. CK Kokate in September 2014 to ascertain the rationality of FDCs.

The Kokate Committee reviewed around 6,220 FDCs, of which it found 15 percent irrational and banned 344 of them in March 2016. The rest were kept on hold for further want of deliberation with subject experts.

Analysts say the decision to form the Kshirsagar Committee is to negate any attempts to block the ban by pharmaceutical companies.

Following the ban in 2016, the concerned drug companies approached various courts and got a stay on the ban, citing the government’s action as arbitrary and without natural justice. This lead to the Supreme Court direction asking the government to form an expert body to review banned FDC drugs before taking further action.

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First Published on May 30, 2019 06:25 pm
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