MSME pharma companies get one year extra time to upgrade
NEW DELHI New Delhi: The Health Ministry on Saturday gave an additional 12 months to small and medium pharma companies with turnover less than Rs 250 crore to implement revised good manufacturing practices under Schedule M of the Drugs and Cosmetics Act. They must now comply with the good manufacturing practices by December 31, 2025. The extension has been given following requests from manufacturing units to upgrade their facilities, the ministry said in a statement. Good manufacturing practice (GMP) is being implemented in the country to bring quality in products through controls on materials, methods, machines, processes, personnel and facility/environment etc, the ministry said. There are around 10,500 manufacturing units in the country, of which around 8,500 fall in the MSME category.
India is a major exporter of drugs to low and middle-income countries (LMICs) that require WHO GMP certification. Currently, there are around 2000 units in the MSME category in the country that have WHO GMP certification. The statement said that the drug manufacturing and quality sector has seen significant development in the last 15-20 years. “Developments in pharmaceutical and manufacturing science have led to an increase in our understanding of this sector. The relationship between manufacturing and product quality and the interdependence between the two have been established,” the statement said. To keep pace with the rapidly changing drug manufacturing and quality sector, the government has revised the GMPs mentioned in the current Schedule ‘M’ of the Drugs and Cosmetics Act.