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Centralisation of drug licensing may not be the right path to improve quality of drugs: SPIC
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Gireesh Babu, New Delhi
March 18 , 2023
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Empowering of the Central Drugs Standard Control Organisation (CDSCO) through centralisation of drug licensing may not be the path to improve the quality of drugs manufactured in the country both for domestic and international markets, says SME Pharma Industries Confederation (SPIC), the apex organisation of small and medium pharma industries in the country.
Empowering state licensing authorities for better testing and manpower training and subsidised funding for tests with a cluster approach should be the way forward to ensure quality of drugs, it added.
In a letter to the Prime Minister Narendra Modi, SPIC alleged that corruption in CDSCO remains high despite the 59th report of the Standing Committee of Parliament in 2012 said that the CDSCO has no concern for quality and its sole interest was promotion of Multi National Corporations.
“All units accredited with WHO Certification (mainly meant for Exports) are inspected by CDSCO. Every Export consignment goes through CDSCO at the ports. How the Cough Syrup made by Maiden Pharma carried the WHO APPROVED stamp is not understood. This proves CDSCO was inept,” said the letter.
Corruption is reflected on the state inspectors too and there is no authority which the manufacturer in States can approach for redress. MSMEs do not afford such gratification, since cash for gratification ought to be generated by sale of medicines without invoicing and Good Manufacturing Practices can never be followed for such production.
“It is strange the same CDSCO is sought to be empowered with licensing all over India - which is a vast country,” said the Organisation. It referred to the recent meeting of the regulators held in Hyderabad, which was meant to find a solution to prevent death of children in Gambia and Uzbekistan allegedly due to the use of cough syrups manufactured in the country.
It seems the entire blame is being heaped on the State Governments for lax control and once again Centralization of licensing is mooted. Parliament refused to centralize licensing vide Drugs Act Amendment Bills in 2007 and 2013 earlier. Centralising Licensing would also be a Constitutional violation since Drugs is on the Concurrent List of the Constitution. Unless Drugs is shifted to the Central List, Licensing cannot be centralized.
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