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Karnataka pharma’s adherence to robust quality systems indicate need for gap analysis minimal
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Nandita Vijayasimha, Bengaluru
June 06 , 2025
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Karnataka pharmaceutical industry’s adherence torobust quality system practises and efforts to regulatory compliance for operational excellence indicate the state is comparatively well-prepared for compliance with the Revised Schedule M guidelines. This is owing to its established pharmaceutical infrastructure, proactive regulatory engagement, and a higher proportion of facilities already aligned with current Good Manufacturing Practices.
According to Dr. Shenoy, quality and compliance advisor and former director of regulatory affairs & patient safety, AstraZeneca, MSME pharmaceutical companies are required to submit Form 1 to the Drug Controller General of India (DCGI) as part of their gap analysis for implementing the revised Schedule M guidelines. This process ensures compliance with Good Manufacturing Practices (GMP) and helps manufacturers upgrade their facilities to meet regulatory standards. It seems only a small percentage of companies have submitted gap analysis in Karnataka.
However, the majority of small-sized pharmaceutical companies across India, except in Gujarat, yet to submit Form 1 are facing several challenges. The primary concern is financial constraints, as upgrading facilities to meet revised GMP standards requires significant investments, which many micro, small & medium enterprises (MSMEs) struggle to afford. Additionally, issues such as lack of technical expertise and operational disruptions further hinder compliance. Many MSMEs prioritize day-to-day production over regulatory upgrades, fearing temporary shutdowns during facility improvements," noted Dr. Shenoy.
With a total turnover of around Rs. 12,500 crores and export sales of around Rs. 5,200 crore, it indicates Karnataka has a robust pharmaceutical ecosystem. This infrastructure caters to global medicine demands and cater to contract manufacturing orders.
Manoj Palrecha, president, Karnataka Drugs and Pharmaceutical Manufacturers Association (KDPMA) and managing director, Lake Chemicals said incidentally, very few manufacturers from Karnataka have approached the CDSCO with a gap analysis report, which suggests that Karnataka is relatively well-positioned in terms of compliance with the revised Schedule M guidelines.
The state appears to have an advantage, as many of its manufacturing units operate as contract manufacturers for large multinational corporations or are focused on exports in regulated market. As a result, they have systematically developed robust quality systems over time. This prior investment in quality infrastructure has enabled them to adapt more easily to the updated regulatory requirements, added Palrecha.
Jatish Sheth, secretary general, Confederation of Indian Pharmaceutical Industry (CIPI), co-chairman-nominated, KDPMA and director Srushti Pharma stated that units are getting ready for compliance to the revised Schedule M. There is lot of work both in terms of upgrading facilities and documentation is ongoing in the units based out of Karnataka. On the basis of the continuous discussion with KDPMA members gap analysis units’ deficiencies are proactively addressed through well-integrated quality assurance frameworks and internal audit mechanisms. We at KDPMA are very hopeful that all the units will be compliant by December 31, 2025.
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