A notification issued by the Indian government, on Saturday, stated that pharmaceutical companies in the country must set new manufacturing standards this year.
The notice, dated December 28, stated: “The manufacturer must bear responsibility for the quality of the products to ensure that they are suitable for their intended use, comply with licensing requirements and do not expose patients to risk.”
The notification added that companies should market the final product after achieving “satisfactory results” in ingredient testing.
India's health ministry said in August that inspections at 162 pharmaceutical factories since December 2022 revealed a “lack of testing of incoming raw materials.”
The ministry added that less than a quarter of small pharmaceutical factories in India, a total of 8,500 factories, comply with international standards for drug manufacturing set by the World Health Organization.
The notification stated that these concerns must be addressed by major pharmaceutical companies within six months and by small manufacturers within 12 months.
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