Indian pharmaceutical companies must meet new manufacturing standards this year, according to a government notification released on Saturday, although small companies have asked for a delay, citing their debt load.
Jolted by a string of overseas deaths linked to Indian-made drugs since 2022, Prime Minister Narendra Modi’s government has stepped up scrutiny of pharmaceutical factories to clean up the image of the $50 billion industry.
Companies must market a finished product only after getting “satisfactory results” on tests of the ingredients and retain a sufficient quantity of the samples of intermediate and final products to allow repeated testing or verification of a batch, it says.
The notification said those concerns must be addressed by large drugmakers within six months and small manufacturers in 12 months. Small companies had asked for the deadline to be extended, warning that investments required to meet the standards would shut down nearly half of them because they are already heavily indebted.