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

Ramesh Shankar, Mumbai
Thursday, February 22, 2018, 08:00 Hrs  [IST]

The Union health ministry has constituted a sub-committee under the chairmanship of Dr. Nilima Kshirsagar, The Chair in Clinical Pharmacology, ICMR, Mumbai, to examine the banned 344 FDCs + 5 FDCs as per the directions of the Supreme Court. A decision to this effect was taken at a meeting of the Drugs Technical Advisory Board (DTAB) of the ministry held on February 12, 2018 under the chairmanship of the Director General of Health Services.

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, in a landmark verdict on December 14, 2017, a Supreme Court bench headed by justice Rohinton F. Nariman had referred the issue of fixed dose combination (FDC) drugs to DTAB, the Union health ministry's expert body on technical matters, for a fresh review of their safety, efficacy and therapeutic justification before recommending action.  After 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 six months.

AIDAN had earlier filed a Special Leave Petition in Supreme Court, alongside the government’s own petition, 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.

The Supreme Court in its verdict stated that for the exercise of powers under Section 26 (A) of the Drugs and Cosmetics Act, the DTAB need not be mandatorily consulted by the Government in order to be convinced of reasons for banning a medicine. The Court remarked that the Government could be justified in declaring a ban even if it finds that the drug has been banned in other countries.

In its meeting on February 12, the DTAB) deliberated on the directions of the Supreme Court of India dated 15.12.2017 in regard to the notifications issued by the DCGI prohibiting 344 FDCs +05 FDCs vide S.O. No. 705(E) to 1048 (E) dated 10.03.2016 and S.O. No. 1851(E) to 1855(E) dated 08.06.2017 respectively.


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