The Centre is all set to revise its good practice guidelines for medium, small, and micro enterprises (MSMEs) engaged in making drugs after an inspection of scores of manufacturing sites and labs revealed glaring lapses.
Government officials who inspected 162 units and 14 public testing labs found them riddled with poor documentation, lack of process and analytical validation, infrastructural deficiencies, unqualified employees, and faulty design of manufacturing and testing areas.
The matter of regulating quality is of considerable importance to India, which is the world’s largest exporter of generic drugs and was able to showcase its vaccine manufacturing capacities during the covid-19 epidemic.
At the same time, the government has been tightening its regulations for pharma companies, especially MSMEs, in recent months after some Indian cough syrups made by MSMEs were linked to children’s deaths in several developing countries, including 66 in Gambia.
Diese Geschichte stammt aus der August 03, 2023-Ausgabe von Mint Mumbai.
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Diese Geschichte stammt aus der August 03, 2023-Ausgabe von Mint Mumbai.
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