Allow fixed drug combos for now: IPA

NEW DELHI: Domestic pharma industry representative Indian Pharmaceutical Alliance (IPA) has asked the government to allow drug companies to sell fixed dose combination (FDC) drugs till a proper assessment of the benefits and use of such medicines.

In a letter to the Drug Controller General of India (DCGI), IPA secretary-general DG Shah said there should be a criterion for weeding out irrational fixed combination drugs on the lines of the US, which is based on usage and science.

If the combinations have scientific rationale and usage, and have been approved by DCGI, the government should give an authorisation to companies to sell the drugs. At the same time, IPA has agreed that there is a need to screen FDC drugs in the country.

For other drugs, companies should be asked to establish the rationality of combinations within a specified time. However, until then, manufacturers should be allowed to manufacture and market the drugs. FDCs are drug combinations that combine two or more therapeutic molecules in a single drug.

Most licences for these drugs have been issued by respective state drug authorities. About 100 companies have FDC drugs in the market. The government is planning to centralise the licensing of FDCs. DCGI had recently asked pharma companies to withdraw about 1,100 irrational drug combinations, which are currently sold in the market.

“It may be noted that a large number of patients are currently prescribed FDCs. It is, therefore, important that the changes sought to be made are done in a manner that causes minimal disruption. The timelines for approval of FDCs are defined clearly and the guidelines and their implementation are transparent,” Mr Shah said.

However, it may be noted that some state drug authorities, under the direction of DCGI, have already asked companies to withdraw drugs from the market.