India says drug-makers must clean up act as overseas deaths threaten reputation of ‘pharmacy of the world’

Companies told they can only market products after getting ‘satisfactory results’ in safety tests

India has ordered its pharmaceutical companies to meet new manufacturing standards this year after a string of deaths reported overseas linked to Indian-made drugs since 2022.

Following deaths linked to India-made cough syrups in countries including Gambia and Uzbekistan, prime minister Narendra Modi’s government increased scrutiny of drug-making factories to restore trust in the country’s image as the “pharmacy of the world”.

“The manufacturer must assume responsibility for the quality of the pharmaceutical products to ensure that they are fit for their intended use, comply with the requirements of the licence and do not place patients at risk due to inadequate safety, quality or efficacy,” a notification dated 28 December said, Reuters reported.

The new standards require large drug-makers to address concerns within six months and small manufacturers in 12 months. Small companies had asked for more time to meet the new standards, citing their debt loads.

In 2022, more than 60 children, most under five years of age, died as a result of acute kidney injuries which were linked to cough syrups made in India.

In the same year, 19 children in Uzbekistan who consumed cough syrups made in India died.

Then last year, the manufacturer of over two dozen varieties of eyedrops was subject to a US safety warning officially recalling the products.

The US’s FDA had warned consumers not to use the products due to the risk of vision loss or blindness.

The WHO also flagged a batch of a “contaminated” cough syrup made in India and found in the Marhsall Islands and Micronesia in 2023.

Overall, health authorities have linked Indian cough syrups to the death of at least 141 children in Gambia, Uzbekistan and Cameroon.

The Indian health ministry’s inspections of 162 drug factories since December 2022 found an “absence of testing of incoming raw materials”.

To ensure safety of pharma products made in the country, India has ordered its drug-makers to follow new standards.

It has ordered companies to market a finished product only after getting “satisfactory results” on tests of the ingredients.

Drug manufacturers must also retain a sufficient quantity of the samples of intermediate and final products to allow repeated testing or verification of a batch, the Indian government said.

Health experts say the government order is unlikely to see immediate changes, given manufacturers with a turnover of less than Rs 2.5bn ($30M) turnover have an entire year to implement the new rules.