Pharma upgrade drive: IPA-Mysuru backs Revised Schedule M rollout

• IPA-Mysuru and PHDCCI drive awareness and readiness for revised Schedule M and WHO-GMP compliance
• Financial and technical guidance offered to MSMEs under the RPTUAS scheme
• Experts stress education reform, infrastructure upgradation, and innovation to sustain quality standards

With the updated Schedule M guidelines representing significant compliance issues for small and medium pharmaceutical units, the Mysuru pharma industry has taken a joint initiative to try and prepare for it.

The Indian Pharmaceutical Association (IPA), Mysuru Branch, organised a significant outreach event at JSS College of Pharmacy (JSSCP) along with the PHD Chamber of Commerce and Industry (PHDCCI) to help inform everyone about the guidelines and to work towards regulatory compliance.

A prime component of the discussions was around the Revamped Pharmaceutical Technology Upgradation Assistance Scheme (RPTUAS), aimed at helping existing pharma units upgrade their facilities to comply with Schedule M and WHO-GMP standards. There was substantial participation from regulators, academia and industry in discussing challenges including financial barriers, documentation requirements and gaps in technical capabilities.

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Dr. S N Manjula, President, IPA-Mysuru, highlighted the association's efforts for awareness and readiness, and Dr. Khalid Ahmed Khan, Deputy Drug Controller, FSDA-GoK, illustrated the changes to GMP standards and an extension of the deadline for companies whose turnover is less than ?250 crore.

Experts, Dr. Amaresh Tumbagi and Dr. Girish Pai, spoke to the importance of alignment with global standards and explicitly including cGMP education in pharmacy education. Dr. H Basavanagowdappa, Vice-Chancellor of JSSAHER, indicated that we should view GMP as a quality undertaking rather than only as compliance, and that they should be empowering the industry to innovate and build capacity for long-term sustainability.