An experts committee, examining the safety of fixed dose combinations (FDCs), has found that 324 FDCs were “irrational" and should not be manufactured or marketed in India.
The committee evaluated 418 FDCs, out of which 324 FDCs were found to be irrational, 28 FDCs were rational. The panel also said that more data needs to be evaluated for two FDCs, while it has to further deliberate on four others. Out of the remaining 60, 48 have been prohibited, 11 have been declared rational and one case is sub judice, shows the minutes of the DTAB meeting. A copy of the document was reviewed by Mint.
The committee under the chairmanship of C.K. Kokate, former vice chancellor, KLE University, Belgaum, Karnataka, examined the safety and efficacy of unapproved FDCs, which were licensed by state authorities without the approval of the Drug Controller General of India. It submitted its report to the Drugs Technical Advisory Board (DTAB), the highest decision-making body on technical matters related to drugs, on 2 April.
The Kokate panel said the “FDCs, which have been declared as irrational, needs to be prohibited under the Drugs and Cosmetics Act, 1940, as other safer alternatives to those combinations are available".
The DTAB has also constituted a sub-committee under the chairmanship of Dr Nilima Kshirsagar, chair of clinical pharmacology at the Indian Council of Medical Research, to evaluate the report.
If accepted by the government, the report could deal another blow to domestic drug makers. The centre had launched a crackdown on “irrational" drugs following reports that some were suspected to pose health risks.
The 418 FDCs were part of the second batch of combination drugs that were examined by the Kokate panel. An FDC drug contains two or more active ingredients in a fixed dosage ratio.
The government had banned 344 such combination drugs in 2016 as well, following a report submitted by another panel led by Kokate. Subsequently, some companies had challenged the government’s ban on such drugs before the Delhi high court.
In December 2017, the Supreme Court (SC) referred the matter to DTAB for a fresh review. The SC said that the DTAB should decide whether the manufacturing and sale of these drugs should be regulated, restricted or banned outright. It also asked the sub-committee to submit its recommendations to the government within six months.