Anti-diabetes drugs, anti-hypertensive drugs and anti-TB drugs could get cheaper as the Union health ministry is considering approving Fixed Dose Combinations (FDCs) that falls under the category of “
Anti-diabetes drugs, anti-hypertensive drugs and anti-TB drugs could get cheaper as the Union health ministry is considering approving Fixed Dose Combinations (FDCs) that falls under the category of “rational” according to the Kokate Committee.
In a meeting held on Saturday, the Union health ministry initiated the process of granting permission to the manufacturers of FDCs, irrespective of whether they are old or new, that have been given a thumbs up by the expert committee.
A fixed dose combination contains two or more drugs combined in a fixed ratio of doses, available in a single dosage form. Recently, the health ministry, had, in a notification on March 12, banned nearly 344 FDCs with immediate effect, following recommendations of an expert committee formed to examine the efficacy of these drug combinations.
The Drug Controller General of India (DCGI) had stopped granting fresh licenses to the manufacturers after a parliamentary committee in 2012 came out with a damning report, suggesting that many FDCs were arbitrarily approved without conducting trials. The report suggested that many combinations were approved by state drug authorities without the nod of the DCGI.
“The report said that licenses were issued to manufacturers without looking into the safety and efficacy of the drugs,” said a senior official.
As a result, it was decided that no fresh licenses would be issued. The Union health ministry formed a committee under C.K. Kokate to look into the matter. The report categorised certain drugs as “rational” or “irrational”.
Senior health ministry officials said that the move is expected to bring down the prices of drugs heavily.
“The process was stuck up for the last two years. No new licenses have been granted to the manufacturers of FDCs since 2014. If this happens, it will pave the way for new manufacturers, resulting in flooding the market with new drugs and will consequently bring down the prices,” said an official.
Earlier, out of the 6,200 applications that the committee received from manufacturers presenting their cases, 2,800 were found to be “rational”.
