To ensure the safety and quality of cough syrups manufactured in India, the Indian government has made it mandatory for companies to conduct testing before exporting their products.
Effective 1 June, all cough syrup makers must obtain a certificate of analysis from a government-approved laboratory.
This new rule comes in response to recent incidents where Indian-made cough syrups were linked to fatalities in The Gambia and Uzbekistan, leading to concerns and scrutiny of India’s pharmaceutical industry.
India is known for producing one-third of the world’s medicines, and these controversies have overshadowed the industry’s reputation.
The Director General of Foreign Trade announced the mandatory testing requirement through a notification, stating that cough syrups could only be exported if the export sample had undergone testing.
The notification also provided a list of government-approved laboratories at the country’s central and state levels where samples can be tested.
The decision to enforce stricter testing measures follows Reuters’ reports, highlighting the connection between domestically manufactured cough syrups and child deaths in foreign countries.
In addition, several Indian pharmaceutical companies have faced scrutiny over the quality of their drugs, raising concerns about their manufacturing practices.
In March, Marion Biotech, an Indian pharmaceutical company, had its manufacturing license revoked by India’s drug regulator after its cough syrups were linked to 18 child deaths in Uzbekistan.
Furthermore, the World Health Organization issued an alert in October, identifying four Indian-made cough syrups associated with child deaths in The Gambia.
India initially stated that the medicines met the required specifications when tested domestically.
However, the World Health Organization maintained its stance and supported the actions in response to the incidents.
By implementing mandatory testing for cough syrup exports, India aims to restore confidence in its pharmaceutical industry and ensure the safety of its products on the global market.
The government’s focus on stringent quality control measures reflects its commitment to maintaining high standards in producing and exporting medicines.
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