Mansukh Mandaviya calls for mandatory adoption of Good Manufacturing Practices by all pharma companies
Observations from ongoing risk-based inspections further reiterated the need to have a re-look at the current GMP regulations and quality management systems being followed by pharmaceutical manufacturers, the health ministry said in a statement.;
New Delhi: Pharmaceutical companies having an annual turnover of over Rs 250 crore will have to mandatorily adopt Good Manufacturing Practices (GMP) within six months, Union Health Minister Mansukh Mandaviya said on Wednesday. The minister said while those with a turnover of less than Rs 250 crore will have to do so in a 12-month time.
Those who fail to follow the timelines may be penalised as per the provisions of the law, he added. Mandaviya said that the draft of Schedule M of the Drugs and Cosmetics Act prepared in 2018 has been approved and implemented.
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.
"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," Mandaviya said. 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.
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