According to a notification from the Indian government on Saturday, pharmaceutical companies in the country must establish new manufacturing standards this year. However, small firms have requested a delay due to the burden of debt.
Indian Prime Minister Narendra Modi has intensified inspections of pharmaceutical factories to salvage the reputation of the industry, valued at $50 billion, following a spate of deaths outside India linked to drugs manufactured in India since 2022.
The notification read, "The manufacturer must bear responsibility for the quality of products, to ensure they are suitable for the intended use, comply with licensing requirements, and do not endanger patients."
It was added in the notification that companies must market the final product after achieving "satisfactory results" in component testing.
In August, the Ministry of Health stated that inspections of 162 drug factories since December 2022 revealed "a lack of testing for incoming raw materials."
The Ministry further noted that less than a quarter of India's small drug factories, totaling 8500, meet international standards for drug manufacturing set by the World Health Organization.
The notification pointed out that these issues must be addressed by major pharmaceutical companies within six months and by smaller manufacturers within 12 months.
Small companies have requested an extension of the deadline, warning that the investments required to meet the standards would lead to the closure of almost half the factories since they are already mired in debt.
The World Health Organization and other health bodies have linked an Indian cough syrup to the deaths of at least 141 children in Gambia, Uzbekistan, and Cameroon.
