New committee to examine safety, rationality of over 300 drugs banned since 2016

The committee will be headed by Dr Nilima Kshirsagar, chair of clinical pharmacology at the Indian Council of Medical Research, Mumbai, according to the notification.

ET Bureau
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NEW DELHI: Over 300 combination medicines banned by the government for being “irrational” or unsafe for consumption will now be examined by a sub-committee under the Drugs Technical Advisory Board (DTAB), according to a new notification by the government. The 300 plus contested drugs include popular brands such as Corex, Phensedyl, D’Cold Total, Vicks Action 500 Extra and Saridon.

This committee is expected to hear arguments supporting the government’s ban as well as those against it before deciding whether companies should be banned from making and selling these medicines, known as fixed dose combinations, here. It may also decide that these drugs should be regulated or restricted to some extent.

The Supreme Court in December directed the committee is required to make its decision by June 2018.

The committee will be headed by Dr Nilima Kshirsagar, chair of clinical pharmacology at the Indian Council of Medical Research, Mumbai, according to the notification.

“The DTAB/sub-committee set up for the purpose will deliberate on the parameters set out in section 26A of the Drugs and Cosmetics Act,” stated Drug Controller General of India GN Singh in a notice dated February 19.

In December 2017, the Supreme Court asked DTAB to decide on the fate of the medicines, banned between March 2016 and June 2017.

The order was a potential relief to drug makers who have argued that the government did not consult statutory bodies provided for in the country’s drug regulations before banning these drugs.

However, if it chooses to, the government could carry out further inquiry on whether these drugs should continue to be marketed in the country, the court added.

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