The Department of Pharmaceuticals is looking to announce some subsidies towards upgradation and quality compliance for pharmaceutical units, said Deputy Drugs Controller General of India, Chandrashekhar Ranga, in a recent conference by the Indian Drug Manufacturers' Association.
This comes after the government, on Dec. 28, announced a revised Schedule M of the Drugs and Cosmetics Rules 1940, which deals with 'Good Manufacturing Practices' to be followed by pharmaceutical manufacturing units in the country, in a bid to combat complaints regarding sub-standard Indian drugs exported from the country.
The aim of the revised Schedule M is to upgrade MSMEs at par with global standards, especially those of the World Health Organisation, and this would require upgrading manufacturing processes and systems and, in turn, investment.
Ranga said that currently 42%, or around 2,400 manufacturing units, are compliant with revised Schedule M and, thereby, WHO GMP compliant. However, compliance for around 3,000 units is not known, and "they may need to be upgraded".
The government, he said, has recently been undertaking risk-based inspections, and around 70% of the units that were under inspection have upgraded themselves post-inspection.
The manufacturing facilities that are compliant under risk-based inspections will now be automatically compliant with WHO GMP standards, he said.
The DOP is planning subsidies to ensure quality compliance, and official announcements will be made soon, he said.
Challenges In Adoption
As per the December announcement, companies were allowed a transition period of six and 12 months depending on whether they were large manufacturers (over Rs 250 crore turnover) or MSMEs (less than Rs 250 crore turnover), respectively.
However, Ranga did acknowledge that there were challenges to adoption.
He said that manufacturers are not clear about the path to adopting the revised Schedule M. While they have conducted multiple workshops across the country, he said that industry associations will also play an important role.
Once the transition and adoption are made, Ranga said that "new vistas internationally can then be achieved" by the drug manufacturing industry.
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