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Source: The post is based on an article “Lessons from Maiden: Gambia deaths raise several questions” published in The Business Standard on 14th October 2022.
Syllabus: GS 3 – Industrial Policy
Relevance: issues associated with the pharma companies in India.
News: 66 children have died in the Gambia after drinking cough syrup manufactured by Maiden Pharmaceuticals.
The centre has decided to set up a four-member committee to investigate allegations against Maiden Pharmaceuticals.
It has raised questions about the regulatory systems that govern India’s pharmaceutical industry.
What are the findings of the probe made by different organization?
Maiden Pharmaceuticals company had not been following the Good Manufacturing Practices (GMP) prescribed under the Drugs and Cosmetic Rules.
According to the WHO, two toxic contaminants, diethylene glycol and ethylene glycol were found in cough syrups manufactured by the company. They may have caused acute kidney failure in the Gambian children.
The Central Drugs Standard Control Organisation (CDSCO) probe found that the date of manufacture printed on the drug product predated the batch of manufacturing date.
What are other concerns?
The drugs manufactured by other big companies have also failed multiple US Food and Drug Administration inspections in the past. This raises threat not only for the overseas buyers but it is also threat for the domestic markets.
A study shows that fake drugs are a booming business in India accounting for a 25 per cent of the domestic medicine market. The study also says the Delhi-National Capital Region is the epicentre of this fake business.
Further, India is the world’s fourth-largest producer of pharma products and one of the biggest exporters of generic drugs. These kinds of issues may damage the image of India worldwide.
Therefore, there is a need that proper inspection and regulatory mechanism should be carried out by the government in the pharma companies in India.