Panel on combination drugs to deliberate with pharma firms

The government has once again begun the process of analysing the rationality of fixed-dose combinations (FDCs) or combination drugs. The committee set up by the Drug Technical Advisory Board (DTAB) has asked pharma companies to prove the rationality of FDCs that have been categorised as irrational.

“We need to deliberate with pharma companies to understand why any particular FDC is rational or irrational,” says a senior committee member. “The committee will look into the evidence drug firms have provided us and make a decision on a case-to-case basis.”

After deliberations with stakeholders, the committee will submit its report on which FDCs should be banned.

The government had already asked companies to submit evidence of rationality of any cocktail drug that the Kokate committee considered irrational or the ones that require more deliberation before being given the green signal.

The government’s drug standards controller - Central Drug Standard Control organisation (CDSCO) will then act on the recommendations of the committee.

The government has fundamentally been feeling that combination drugs do not have any added advantage and extra efficacy which is why they should be banned.

In 2016, a committee headed by Professor C K Kokate had studied over 6,000 cocktail drugs out of which, many had been categorised as irrational and over 1,000 had been categorised as those that need more investigation before being banned categorically.

In fact, when the government banned 344 combination drugs in 2016, pharma companies had approached various high courts and finally the Supreme Court. The matter was referred to the DTAB, which then formed a sub-committee that now looks into the matter.

Meanwhile, at the authority meeting of the National Pharmaceutical Pricing Authority (NPPA), it was noted that a major part of the new drug price applications from companies has been for combination drugs like calcium and aspirin put together. The authority noted in the minutes of the meeting that prescription audits should be undertaken by the NPPA to understand the use and efficacy of these drugs before determining their price.

“It was discussed and felt that undertaking a ‘prescription audit’ may throw light on the prescription patterns of various drugs & their usage,” read the minutes of the meeting. “The Authority was of the view that NPPA may undertake ‘prescription audit’ as the findings can be of help for decision making."

The NPPA fixes the prices of drugs to ensure consumers are not overcharged on medicines.