Regulator will review order if companies prove drugs are safe

NEW DELHI: The government is likely to review the list of 350-odd banned drugs.

“We are open to review and revisit the banned list. Companies can come to us with scientific proofs to back their drugs,” KL Sharma, joint secretary, ministry of health and family welfare, told

HT. “We had given a fair chance to companies to put forward their point by putting up public notices and showcause notices, but it’s our duty to re-look decisions if they are backed by evidences,” he added. The government last week decided to prohibit manufactur- ing and sale of these medicines because they were found to be “irrational” without any therapeutic efficacy and use.

The health ministry had received about 7,000 applications in 2013 from manufacturers of FDCs for proving their safety and efficacy. The ministry constituted a committee under the chairmanship of CK Kokate, which reviewed the applications under four categories — irrational, rational, those requiring further deliberation and those requiring generation of additional data. While deliberations on the last two categories are still on, in February 2016, the Kokate Committee submitted its report along with a list of approved and irrational FDCs.

According to pharmaceutical research company AIOCD, the top five companies which would be impacted most by the decision include Abbott, Pfizer, Mankind, Macleods Pharma and Alkem.