Following deaths linked to India-made cough syrups in countries including Gambia and Uzbekistan, 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. Companies are told they can only market products after getting’satisfactory results’ in safety tests.
Overall, health authorities have linked Indian cough syrups to the deaths of at least 141 children in Gambia, Uzbekistan, and Cameroon.
“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 license, and do not place patients at risk due to inadequate safety, quality, or efficacy,” a notification dated December 28 said, Reuters reported.
Deadline established
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 new standards require large drugmakers to address concerns within six months and small manufacturers within 12 months. Small companies had asked for more time to meet the new standards, citing their debt loads.
As per the notification, companies are required to conduct tests on ingredients and maintain adequate samples of intermediate and final products before marketing the finished product. The objective is to enable repeated testing or verification of a batch.
In 2022, more than 60 children, most under five years of age, died as a result of acute kidney injuries 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 “contaminated” cough syrup made in India and found in the Marhsall Islands and Micronesia in 2023.
The Indian health ministry’s inspections of 162 drug factories since December 2022 found an “absence of testing of incoming raw materials. Shockingly, less than a quarter of India’s 8,500 small drug factories met international drug manufacturing standards stipulated by the World Health Organization (WHO).”.
