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It may not be rare for consumers to have taken a combination drug at some point to treat an illness. But the National Pharmaceutical Pricing Policy (NPPP), to be notified by the Government any day now, is set to take a cautious view on new combination drugs – that combine two or more medicines into a single pill.
The NPPP is believed to have mandated that any new combination involving medicines mentioned in the list of essential medicines – either with each other or with medicines outside the list – will need price approvals from the National Pharmaceutical Pricing Authority, a source close to the development told Business Line .
The development comes, even as the final version of the NPPP is to be notified and placed before the Supreme Court this week.
Price approvals for combination drugs is an addition to the present regulatory practice and could be the Government’s attempt to bridge concerns between pro-health groups and the pharmaceutical industry. Questions have often been raised on the industry’s motive behind developing a combination drug. Is it good science or commercial interest?
Even as the Government cobbled together a consensus on the formula for price control on drugs, as part of the new drug policy – pro-health groups were concerned that drug companies would circumvent price-control by developing combination drugs.
Good combination
Industry-watchers, though, differentiate between good combination drugs, as seen in the HIV/AIDS segment, for instance, and irrational combinations that sometimes include seven medicines in a single pill.
In a good combination, patients are spared taking six pills a day, for instance, by taking instead two 3-in-1 medicines. Besides the convenience and ease, it also helps a patient comply with the regimen prescribed by her doctor. Industry analysts observe, much of the local new drug launches are combination medicines.
Pro-health groups, though, reserve comment on this development, till more details were publicly available.
The policy
Besides the mention on combination drugs, the final avatar of the NPPP is as cleared by the Cabinet recently.
The proposal is to cap ceiling prices on all 348 drugs mentioned in the National List of Essential Medicines (NLEM) at the average of medicines with one per cent market-share in a said category. All imported drugs under the NLEM will also be under price control.
Industry representatives, though happy that the Government is going with the market-based formula, point out that the price-control yardstick will affect the average industry profitability by 25 per cent.
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