After banning 344 combination drugs earlier this year, the government is once again targeting another 500 combination drugs.
A report in the Economic Times
says that the regulator has sent letters to over 300 firms, which are looking to get approvals for fixed dose combination (FDC) drugs.
FDC drugs are those that which contains combination of two or more active pharmaceutical ingredients (APIs) in a single form, which is usually manufactured and distributed in fixed dose. Earlier, these drugs used to be for a single disease, but are now available for multiple diseases.
The report adds that some companies have been asked to undergo the Phase IV trials, which is a post marketing study to prove that their drugs are safe.
But, some companies have also been granted a no-objection certificate (NOC). ET says that Pfizer has received NOC for drug. The report further adds that some companies have been sent a show-cause notice for harmful drugs as well.
In March this the government had banned 344 combination drugs leading to a series of court cases questioning the move.
According to IMS Health, the FDCs market, as of June, is valued at Rs 3,535 crore. Last month, the FDC market de-grew at 23.5 percent wherein Indian companies saw de-growth of 29.3 percent and MNCs de-grew at 13.1 percent, as per AIOCD Pharmasofttech AWACS data