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GMP standards made mandatory for Pharma MSMEs

Updated: Jul 12, 2023 12:55:47pm

GMP standards made mandatory for Pharma MSMEs

New Delhi, July 12 (KNN) Micro, Small and Medium Enterprises (MSMEs) in the pharmaceutical industry will have to mandatorily follow good manufacturing practices detailed in the Schedule M of the Drugs and Cosmetics Act for better quality assurance.

Union Health Minister Mansukh Mandaviya announced this on Tuesday adding, “This will help in quality assurance and also reduce compliance burden.”


“It is important for MSME pharma companies to be alert to quality of drugs and expeditiously move towards good manufacturing processes through self-regulation,” said the Minister.

The adherence by pharma firms in the MSME sector to Schedule M, which details out practices related to shop floors, quality control system, quality check labs, production, cleaning of equipment and housekeeping, among others, will be implemented in a phased manner, the minister said after an interaction with industry representatives.

It is important for India to maintain its reputation as the pharmacy of the world, the minister stressed. The health ministry has been taking measures to ensure that the quality of medicines made in India is not compromised, especially after a few incidents of deaths globally, allegedly due to consumption of drugs made in the country.

In February, Tamil Nadu-based Global Pharma Healthcare recalled an entire lot of eye drops. Last year, cough syrups exported from India were linked to deaths of 66 and 18 children in Gambia and Uzbekistan, respectively.

“Our global position in the pharmaceutical sector is created through the quality of our products. We must undertake all possible steps to ensure that we strengthen this position in terms of value and quality. Hence, the role of self-regulation becomes critical,” said the Minister.

He has also directed the Drugs Controller General of India to take stringent action against those pharmaceutical manufacturing companies that are making spurious drugs. (KNN Bureau)


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