Pharma firms to explain medical rationale for combination drugs

NEW DELHI: Pharma firms need to explain the medical rationale for combination drugs while seeking marketing approval for them, an expert panel set up by the government has recommended.


This move is intended to get rid of irrational combination drugs which have flooded the domestic market today. Combination drugs comprise over 46% of the 70,000-crore domestic drug market.

Drugmakers would have to show why an ingredient needs to be combined with another while seeking clearance to sell the drug. "If the actives (main raw materials) in an FDC (fixed dose combination drug) are intended to relieve different symptoms of a disease state, it is a prerequisite that these symptoms commonly occur simultaneously," said the expert panel headed by Professor CK Kokate.

Pharma firms must be able to prove that two drugs when combined increase efficacy of the treatment vis-a-vis taking the drugs separately. To gain marketing approval for a combination drug, the expert panel suggests, the drug firm has to prove that the proposed combination medicine is either reducing side-effects, or reducing the dose or cutting price or improving compliance on part of patient or reducing incidence of resistance development, compared to existing therapies or would help in easy distribution, the panel has recommended.

Besides, the drugmaker may have to furnish possible risks and disadvantages a combination drug may pose.

The committee, constituted early this year, recommended that combination drugs be classified into four categories and different clearance norms be specified for each. Those in which one or more ingredient has not been approved for use in India, those which have not been marketed in India but its constituents have been approved and marketed individually in the country form the first two categories, and stricter marketing clearance routes have been proposed for them.

Relatively easier norms are recommended for other categories of combination drugs, such as when the drug in question is already being marketed in India but a pharma company proposes a minor tweak (changing the ratio of ingredients, for example) and in case of drugs which are already being marketed in the country.

The government came under pressure to streamline the approval of fixed dose combination drugs after a Parliamentary Standing Committee pointed out last year that many 'unauthorised' combination drugs, which have been not tested for safety and efficacy, are being openly sold in the market. The panel also said that many of these drugs do not even have mandatory clearance from the Drug Controller General of India's office, and have launched in the market by getting approval from various state drug regulators.