India's 'Haphazard' Ban On 344 Combos Struck Down But Will Science Prevail?

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

The Delhi High Court has quashed orders by India's Ministry of Health and Family Welfare banning 344 fixed dose combinations (FDCs) that were deemed likely to involve "risk to human beings" and where safer alternatives are available, citing, among other factors, procedural nonconformities and a "haphazard" approach by the government.

The order brings some reprieve for industry although the government is sticking to its guns - it has been pursuing efforts to transfer all petitions pertaining to the FDC issue (of which more than 400 have been filed) to India's Supreme Court

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