Government injunction on 328 fixed dose combinations is strongly opposed by manufacturers
On 14 September, India’s health ministry banned the sale and distribution of 328 fixed dose combination (FDC) drugs, with immediate effect. The government asserts that there is no therapeutic justification for these cocktail medicines, and that their consumption could involve risk to human health.
Days later, under petition from drug companies, India’s supreme court partially overturned the order, allowing continued sale of three specific FDCs. A group of manufacturers, including Wockardt, Lupin, Glenmark and Macleods, also won a ruling from the Delhi high court that stock already in distribution should not be subject to immediate enforcement, but that manufacturers should cease production of the banned products.