A committee had been set up under the chairmanship of CK Kokate, former vice-chancellor of KLE University, Belgaum, to review the safety, efficacy and therapeutic justification of these drugs. The Drugs Technical Advisory Board (DTAB), India’s top technical board on drugs, has now asked the panel for a report on their evaluation.
“The report will now go to the Directorate General of Health Services (DGHS). The health ministry will take a final decision following the recommendation of the DTAB),” one of the people cited earlier said.
Another source said, “The committee has reviewed whether they are rational, appropriate. Different mixtures of vitamins and minerals are available in the market. People pop them in as a daily requirement and it needs to be checked if they are posing a risk.”
The crackdown on FDCs in the country has been continuing since 2016. Earlier this month, the government banned 14 FDC drugs, citing that there was “no therapeutic justification” for these medicines.
The Kokate committee had declared many FDCs irrational, which were needed to be prohibited under the Drugs and Cosmetics Act, 1940, as other safer alternatives to those combinations are available.A FDC drug contains two or more active ingredients in a fixed dosage ratio. The drugs are deemed rational when claims for their benefits are supported by evidence-based data and well-designed clinical studies.In 2016, the Centre had banned 344 FDCs pursuant to the report submitted in January 2015, in which the committee led by Kokate, then vice-chancellor of KLE University, had deemed the FDCs “irrational”.
The committee had said that these FDCs posed health risks and hence should be banned, pushing some of the companies and pharma groups to challenge the government’s notification banning FDCs in court.
In December 2017, the Supreme Court referred the matter to DTAB for a fresh review on whether these drugs should continue to be marketed. The top court suggested that DTAB should decide whether the manufacture and sale of these drugs should be regulated, restricted or banned outright, and asked the committee to submit its report and recommendations to the government within six months.
An expert panel was then formed under the chairmanship of Nilima Kshirsagar to review the safety and efficacy of these drugs. The panel, after considering these drugs “irrational”, citing safety issues and lack of therapeutic justification, recommended continuing the ban. The panel also found that many FDCs were formulated without due diligence, with dosing mismatches that could result in toxicity.
A parliamentary standing committee of the ministry of health and family welfare, in its 59th report in 2012, also observed that some of the state licensing authorities issued manufacturing licences for a large number of FDCs without prior clearance from the central drug authority, resulting in the availability of several FDCs which were not tested for safety and efficacy.