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India Orders New Standards for Drug Manufacturing After Children Die Overseas

An announcement issued by the Indian government on Saturday 6 of January, said that the country's pharmaceutical companies must establish new manufacturing standards this year, but small companies requested a delay due to the debt burden.

Indian Prime Minister Narendra Modi intensified inspection of pharmaceutical factories to save the reputation of the sector, which is worth $50 billion, after a large number of deaths outside India related to medicines manufactured in India since 2022.

He added “the manufacturer must take responsibility for the quality of products to ensure that they are suitable for their intended use, comply with licensing requirements and do not expose patients to risk.”

Also states that companies should market the final product after attaining “satisfactory results” in ingredient testing.

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 announcement stated that these concerns must be addressed by all 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.

Other health organisations have linked an Indian cough medicine to the deaths of at least 141 children in Gambia, Uzbekistan, and Cameroon.

Independent News claimed that in 2022, more than 60 children, most under five years of age, died as a result of acute kidney injuries which were linked to cough syrups made in India.

In the same year, in Uzbekistan 19 children died from drinking cough syrup made in India.

Last year, the manufacturer of more than two dozen types of eye drops was subject to a US safety warning officially recalling the products.

Moreover, the WHO states that Good Manufacturing Practices (GMPs) are mandatory standards that build and impart quality to a product by controlling materials, methods, machinery, processes, personnel, facility/environment, etc.

There are about 10,500 manufacturing units in the country, of which about 8,500 fall under the Small and Medium Enterprises (MSME) category. India is a major exporter of medicines to low- and middle-income countries (LMICs) that require WHO GMP certification, an official said.

The pharmaceutical manufacturing and quality domain has developed and advanced significantly in the past 15-20 years.

“We have about 2,000 units in the MSME category in the country that are WHO GMP certified,” the official claimed.


Edited by Chloe Mansola.


Image ‘Drugs Concept’ by Marco Verch is licensed under CC BY 2.0 DEED


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