3 more drug combinations under govt’s lens
A fixed dose combination (FDC) is the combination of two or more drugs in certain fixed doses
After banning 14 fixed dose combination drugs out of a list of 19 as they served no therapeutic purpose, three more of these are under the government’s lens, according to people familiar with the matter. More safety and efficacy data will be required on these drugs before a decision is taken whether to allow them to continue, they said, seeking anonymity.
The three combinations under the scanner are paracetamol + phenylephrine + caffeine; caffeine + paracetamol, phenylephrine + chlorpheniramine; and paracetamol + propyphenazone + caffeine.
A mushrooming of fixed doses combinations in the market over the years has led to the recent government crackdown.
Fixed dose combinations
A fixed dose combination (FDC) is the combination of two or more drugs in certain fixed doses. If it is combined for the first time, it would fall under the definition of a new drug.
All new drugs require prior clearance or permission from the central licensing authority before issuance of manufacturing license from the state licensing authority.
The issue
The parliamentary standing committee of the ministry of health and family welfare in its 59th report in 2012 on the functioning of the Central Drugs Standard Control Organisation (CDSCO) observed that some of the state licensing authorities issued manufacturing licences for a large number of FDCs without prior clearance from CDSCO. This resulted in the availability of several FDCs that were not tested for efficacy and safety, and would put patients at risk. Before 1988, combinations of old drugs were not legally deemed to be new drugs, but under the new law, the combination is a new drug and needs to follow the approval process.
CDSCO warning
The drugs regulatory body requested state drugs controllers to ask manufacturers to prove safety and efficacy of such drugs before the CDSCO within 18 months, failing which manufacture, sale and marketing of such drugs would have been prohibited in the country.
Kokate Committee
In 2014, the ministry constituted an expert committee under the chairmanship of C K Kokate to examine the huge number of applications. The committee submitted several reports to the health ministry from time to time. Four broad categories were created—a) irrational FDCs, b) which require further expert deliberation, c) rational and d) rational but also require further data generation. In March 2016, at least 300 FDCs came under the government scanner, of which 19 have been claimed to be pre-1988. The matter was taken to court by manufacturers and the government order was set aside for these 19 FDCs for separate deliberation. The judgments were passed in 2017 and 2019.
Bhatia Committee
In 2021, to examine the matter of 19 pre-1988 FDCs, another expert committee was constituted under the chairmanship of M S Bhatia, head of psychiatry, University College of Medical Sciences. According to the central government, a report was submitted in April last year. Out of the 19 FDCs scrutinized, 14 were labelled as irrational as they may be of risk to human beings, and have, therefore, been banned by the government, and two are rational formulations, and for the remaining three, there needs to be further safety and efficacy data. “They have been told to generate market surveillance data and, after some time, the data will be reviewed by experts and a decision taken in that regard,” said a government functionary, requesting anonymity.
