. Health ministry constitutes DTAB sub-committee to re-examine banned 344 FDC drugs

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Health ministry constitutes DTAB sub-committee to re-examine banned 344 FDC drugs

Under the Government of India’s Union Health Ministry, a sub-committee is formed to examine the banned 344 FDCs + 5 FDCs as per the directions of the Supreme Court of India. The sub-committee will be headed by Dr NilimaKshirsagar The sub-committee will not only hear the petitioners/appellants before but they also hear submissions from All India Drugs Action Network (AIDAN), an NGO working in the health sector. The DTAB sub-committee set up for the purpose will deliberate on the parameters set out in section 26A of the Drugs & Cosmetics Act.

Earlier, a Supreme Court bench headed by justice Rohinton F. Narimanin a landmark verdict on December 14, 2017, had referred the issue of fixed dose combination (FDC) drugs to DTAB, the Union health ministry's expert body on technical matters, for a review of their safety, efficacy and therapeutic justification before recommending action. Following the examination by the DTAB or a sub-committee constituted by it and hearing all stakeholders concerned, the expert body would be required to forward its report to the government for action within 6-months.

AIDAN had filed a petition in Supreme Court challenging an order of the Delhi High Court that quashed the ban of 344 FDCs in December 2016 on the grounds that the DTAB had not been consulted by the government. The 344 FDCs in question were banned by the DCGI on March 10, 2016 on the recommendation of the government-appointment Kokate Committee, which was set up to look into safety and efficacy of FDCs that lacked regulatory approval from the Central government. The Kokate Committee had found these FDCs irrational and accordingly the government notified a ban on them.

Meanwhile, the Supreme Court said that the DTAB need not be mandatorily consulted by the Government in order to be convinced of reasons for banning a medicine. The Court reiterated the fact that the Government could be justified in declaring a ban even if it finds that the drug has been banned in other countries.