Government Takes Firm Action Against Drug Manufacturers

During a meeting with representatives from MSME Pharma Companies, Health Minister Mansukh Mandaviya stressed the importance of maintaining drug quality and urged the MSME sector to adopt Good Manufacturing Processes (GMP) through self-regulation. Emphasizing the significance of self-regulation in preserving India's global position in the pharmaceutical sector, Mandaviya highlighted the need to strengthen value and quality.

As a step towards quality assurance, it was decided during the meeting that Schedule M would be made compulsory for the MSME pharma sector in a phased manner, aiming to reduce compliance burdens while ensuring quality standards.

The Drugs Controller General of India (DCGI) has been instructed by Mr. Mansukh Mandaviya to take serious measures against pharmaceutical companies involved in the production of counterfeit drugs. Special inspection squads have been formed to crack down on these illicit practices, asserting a zero-tolerance policy towards manufacturers compromising on quality compliance.

Regulatory authorities have commenced risk-based inspections and audits of manufacturing factories. A total of 137 firms have undergone inspections to ensure the highest quality of pharma products, leading to actions taken against 105 firms. Production has been halted at 31 firms, and licenses have been canceled or suspended for 50 firms. Additionally, 73 firms have received show cause notices, and warning letters have been issued to 21 firms.


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