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Revised Schedule M norms is a transformative milestone in the industry’s quest for quality supremacy. These regulations would serve as a catalyst for nurturing a culture of meticulous compliance and continuous improvement, thereby fortifying India’s position as a reliable provider of quality medicines to over 200 countries worldwide, opine experts.
The confluence of stringent regulation, relentless pursuit of quality, and resilient supply chain dynamics underscores India’s unwavering commitment to global healthcare excellence. As India’s pharmaceutical exports continue to scale new heights, propelled by adherence to rigorous quality norms and market-driven innovations, the nation reaffirms its pivotal role as a beacon of pharmaceutical prowess on the global stage.
India’s stringent regulation in the form of Revised Schedule M norms is poised to cultivate a culture of excellence within the pharmaceutical industry adding heft to the growth of pharma exports from India. This landmark development underscores India’s unwavering commitment to ensuring the highest standards of safety and efficacy in pharmaceutical manufacturing, paving the way for sustained growth and global credibility, said Uday Bhaskar, former director general (DG) of the Pharmaceuticals Export Promotion Council of India (Pharmexcil).
Reflecting on past incidents, Bhaskar underscored the industry’s steadfast commitment to stringent quality standards, stressing their pivotal role in ensuring patient safety and preserving the credibility of Indian pharmaceuticals on the global stage.
Contaminated cough syrups exported from India to Gambia and Uzbekistan were pointers to critical lapses in quality control, igniting apprehensions over the safety of pharmaceutical products emanating from the Indian market. The emergence of tainted batches has thrust the spotlight on India’s pharmaceutical industry, prompting urgent calls for heightened vigilance and robust regulatory measures to safeguard global health.
Bhaskar articulated the necessity for industry stakeholders to remain abreast of regulatory dynamics, particularly those pertinent to the Indian market. He advocated for a culture of unwavering quality consciousness, asserting that only through diligent adherence to evolving regulations could the industry sustain its integrity and competitiveness.
Bhaskar emphasized the need for industry players to stay updated with regulatory amendments, particularly those pertaining to the Indian market. He urged pharmaceutical companies to cultivate a culture of quality consciousness, which would facilitate compliance with evolving regulations and standards.
Need for pragmatism
At the same time according to Manoj Palrecha, president, Karnataka Drugs and Pharmaceutical Manufacturers Association and managing director, Lake Chemicals, Union government should adopt a phased and pragmatic approach for the pharma industry to implement the extension of revised Schedule M compliance on similar lines of the practices followed by regulatory bodies like the US FDA.
The industry now needs the government to allow manufacturers to continue producing existing products without immediate facility upgrades to ensure operational stability and prevent disruptions in supply chains. This approach allows companies to transition gradually to the updated regulations, he added.
In fact, this would be a practical approach just like US FDA which, after an inspection, issues warning letters for violations of current Good Manufacturing Practice (cGMP) regulations across Indian pharma plants. Yet, the companies are allowed to export their existing products registered for global exports. But the global regulatory authority stalls manufacture of any new product from the facility which is found to be not conforming to cGMP. This balances the need for regulatory improvements. No new product registrations are approved until such time the company gets compliant, but production of existing products to be exported is permitted, Palrecha said
Even though the extension to December 2025 of revised Schedule M averts immediate risks, its compliance is not easy. Here we recommend the introduction of a provision where facilities producing existing products can continue under the current standards, with phased upgrades over a defined timeline, said Palrecha.
Hence a phased approach with a two-year period for compliance, would allow companies to integrate documentation systems. This would avoid rushed implementation, which could lead to errors or disruptions. Also, MSMEs get sufficient time to adapt without financial or operational stress. If the government looks into this, it can foster a more cooperative environment, ensuring successful compliance with the revised Schedule M, Palrecha pointed out.
The reality is MSMEs manufacture 40 per cent of medicines in India but lack the financial cushion to endure downtime or invest heavily in immediate upgrades. The facilities upgrade to manufacture existing products would require significant civil and structural changes, leading to temporary shutdowns and loss of market share for companies, he noted.
Moreover, Indian pharma is a major global player. Abrupt regulatory changes could weaken its ability to meet domestic and international demand. A measured transition ensures the sector remains competitive without compromising on quality, he said.
There is also need for soft loans to help MSMEs meet compliance requirements. With MSMEs accounting for 50 per cent of the pharma industry manpower, it will need to implement training initiatives to build the workforce skills needed for compliance, especially for the documentation and infrastructure aspects of the revised Schedule M. It is here the government will need to constantly engage with the industry bodies, to co-create a roadmap for compliance that aligns with the sector’s realities, said Palrecha.
A step in right direction
The extension of deadline for revised Schedule M compliance for the MSMEs will be a key step to avoid closure of facilities and align with global quality standards. It underscores the government’s understanding of the challenges faced by MSMEs, opined some of the industry consultants.
Kaushik Desai, a pharma consultant, pointed out, “CDSCO has taken the right step in issuing the notification on Schedule M compliance by MSMEs. The industry shall take this extension of the revised Schedule M notification in a positive spirit and make their sincere efforts to comply with the requirements specified in the given timelines. There is also a provision given of seven days to comment on the recent extension of the revised Schedule M notification which every stakeholder including national pharma associations should have a relook at and take this opportunity of submitting their comments for kind consideration of the CDSCO.”
Now the companies who are in various stages of upgrading their systems and facility will now need to provide their gap analysis in the prescribed format and request for extension which is fixed for December 31, 2025. It would have been better from the governance point of view to ask for submission of periodic updates from the industry during the extension period, added Desai, who helps in the audits of several pharma companies in the country.
Also, the Indian pharma machinery industry is well equipped to supply machines for upgradation. The revised Schedule M has been framed on the lines of WHO GMP guidance document and will surely benefit the patients in getting the medicines of assured quality, Desai noted.
According to Harish K Jain, president, Federation of Pharmaceutical Enterprises (FOPE), which played a pivotal role in convincing the government for an extension of the revised Schedule M implementation said, “We will ensure that India will also be pharma innovation hub of the world. Therefore, we see this extension till December 31, 2025 as a welcome step as it is a positive direction and in the national interest. We are committed to upgrade our facilities and systems to global standards.”
Jatish Sheth, honorary secretary, Confederation of Indian Pharmaceutical Industries, the largest pharma association in the country and co-chairman, KDPMA, noted that rescheduling the revised Schedule M to the year-end was a good initiative but with a rider. A gap analysis by way of self-declaration by the company will serve two purposes. One is that the industry will now pace up to identify and address disparities between their current and desired performance. Second is that the industry will now make a commitment to upgrade by 2026.
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