A notification issued by the Indian government today stated that pharmaceutical companies in the country must establish new manufacturing standards this year, but small companies asked to postpone this due to the burden of debt.
Indian Prime Minister Narendra Modi intensified inspection of pharmaceutical factories to save the reputation of the sector, which is worth $50 billion, after a wave of deaths outside India linked to medicines manufactured in India since 2022.
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 must market the final product after achieving “satisfactory results” in testing the ingredients.
The Ministry of Health 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. Small businesses asked for the deadline to be extended, warning that the investments needed to meet the standards would cause nearly half of the factories to close because they were already mired in debt.
The World Health Organization and other health bodies have linked an Indian cough medicine to the deaths of at least 141 children in Gambia, Uzbekistan and Cameroon.
2024-01-06 14:14:00
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