Decision on banned FDC drugs in July
NEWDELHI: The fate of 349 banned fixed dose combination (FDC) drugs will become clearer in the first week of July, when an expert panel studying the issue presents its report. The panel conveyed the likely date of submitting its report at a recent meeting with India’s drug advisory authority, minutes of the meeting show.
The committee is reviewing the safety, efficacy and therapeutic justification of these drugs, which were banned in 2015, along with those that were banned before 1988.
At a meeting on May 16, committee chairman Nilima Kshirsagar informed the Drug Technical Advisory Board (DTAB) that the committee has so far reviewed more than 150 FDCs. Citing that the time given till May is not sufficient to complete the report on all 349 FDCs, Kshirsagar sought time till the first week of July.
“The chairman agreed to the extension of time,” said the minutes of DTAB.
The committee has received representations from the All India Drugs Action Network (AIDAN), Federation of Pharma Entrepreneurs (FOPE), Indian Drugs’ Manufacturers Association (IDMA), Indian Association of Dermatologists Venereologists and Leprologists (IADVL) and Abbott Healthcare Pvt. Ltd.
AIDAN and Abbott Health Care Pvt. Ltd have raised concerns over the appointment of a few members of DTAB’s subcommittee to examine the banned FDCs, citing conflict of interest. Abbott has also asked the-sub committee to consider excluding 15 FDCs approved prior to 1988 and 17 that were approved by the Drug Controller General of India (DCGI).