India Recommendation To Ban Irrational Drugs – Science Prevails But Calls To Go The Whole Hog
An Indian expert panel has recommended prohibiting over 300 "irrational" fixed dose combinations, reinforcing a previous ban on such products. Some stakeholders want such weeding out to be an ongoing exercise alongside fool-proofing the regulatory system.
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Novartis’s plans for triple drug diabetes combination which includes vildagliptin have been turned down in India at least for now, with an expert panel questioning the rationale of such therapy.
An Indian court has struck down a controversial government order aimed at weeding out over 300 irrational fixed dose combinations, bringing some relief to the pharma industry, although the case seems far from over. The jury appears to be still out on the therapeutic rationale of some of the combinations, raising questions around patient interests.
India's health ministry is clamping down on the country's burgeoning and increasingly confusing market for fixed dose combination drugs, limiting the tendency for manufacturers to formulate approved drugs in seemingly irrational combinations. The ministry is making it clear that the Drugs Controller General of India must have approved as 'new drugs' not only the components of combinations but also the combinations themselves.