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Union Health Minister Mansukh Mandaviya has said pharmaceutical companies having an annual turnover of over Rs 250 crore will have to mandatorily adopt Good Manufacturing Practices (GMP) within six months. The minister said while those with a turnover of less than Rs 250 crore will have to do so in a 12-month time. He added those who fail to follow the timelines may be penalised as per the provisions of the law.

Further, he said that the draft of Schedule M of the Drugs and Cosmetics Act prepared in 2018 has been approved and implemented. Existing schedule M under the Drugs Rules, 1945 prescribes details of requirements of facilities and their maintenance, personnel, manufacture, control and safety testing, storage and transport of material, written procedures, written records, traceability, etc. The GMP was first incorporated in Schedule M in 1988 and the last amendment was done in 2018. The Schedule M (of the Drugs and Cosmetics Act) has not been implemented properly by the majority of the drugmakers.  

Moreover, he said there are around 10,500 manufacturing units in the country out of which around 8,500 units fall under the MSME (Micro, Small and Medium Enterprises) category. India is a major exporter of medicines to LMIC (Low and Middle-Income Countries) which require WHO GMP certification. There are around 2,000 units in the MSME category in the country having WHO GMP certification.

Besides, he stated ‘Pharmaceutical manufacturing and quality domain has developed significantly in last 15-20 years. Our understanding of the domain has increased because of development in Pharmaceutical and Manufacturing Sciences. Linkage between manufacturing and product quality and interdependence between the two has been established.’