Pharma Firms with more than Rs 250 crores Turnover to be Given 6 months to Adopt Good Manufacturing Practices says Official Sources

According to official sources, pharma companies with a turnover of more than Rs 250 crore will have six months to implement Good Manufacturing Practises, while companies with a turnover of less than Rs 250 crore will have twelve months. Good Manufacturing Practises (GMP) are a mandatory standard that builds and brings quality into a product by controlling materials, methods, machines, processes, personnel, facilities, and the environment, among other things.

"In order to ensure a smooth transition from the current Schedule M to the revised Schedule M," official sources said, "it has been decided to provide a transition period of 6 months and 12 months for large manufacturers (more than 250 crore turnover) and MSME (less than 250 crore turnover)." According to official sources, pharma companies with more than Rs 250 crore in revenue will have six months to implement Good Manufacturing Practises, while companies with less than Rs 250 crore will have twelve months. Good Manufacturing Practises (GMP) are a mandatory standard that controls, among other things, materials, methods, machines, processes, personnel, facilities, and the environment in order to build and bring quality into a product.

"In order to ensure a smooth transition from the current Schedule M to the revised Schedule M," according to official sources, "it has been decided to provide a transition period of 6 months and 12 months for large manufacturers (more than 250 crore turnover) and MSME (less than 250 crore turnover)." "Pharmaceutical manufacturing and quality domain has developed significantly in last 15-20 yrs. Our understanding of the domain has increased because of development in Pharmaceutical and Manufacturing Sciences. The linkage between manufacturing and product quality and interdependence between the two has been established," sources added. Now, considering the importance of upgraded and revised GMP in ensuring the quality of drugs, Government has decided to finalise the draft rules.

This will address most of the deficiencies related to documentation, failure investigation and technically qualified personnel with the right person doing the right job. It will support the development of a robust quality management system in the company thereby enabling the production of globally acceptable quality medicine. Better quality management will help manufacturers grow their business nationally and internationally which is a huge opportunity for the Indian pharmaceutical business.