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Further extension for revised Schedule M will jeopardize India's standing as 'Pharmacy of the World': Expert
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Peethaambaran Kunnathoor, Chennai
September 05 , 2025
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While pharma MSMEs across the country are pleading for more time to meet the new, stringent standards of revised Schedule M, the joint director of the Drugs Control Department in Jharkhand, Sumant Kumar Tiwari, says that any further extension of the deadline would jeopardize India's standing as the 'Pharmacy of the World'.
He argues that a further extension would be a dangerous step for a sector that has become a global leader. This stance puts him at the heart of a significant conflict, where the economic realities of thousands of small businesses clash with the regulatory imperative to uphold national and international credibility. For Tiwari, this is not just a matter of policy, but a question of integrity and the reputation of "Brand India Pharma" on the world stage.
In a telephonic talk with Pharmabiz, he said that granting another extension would not only undermine ‘Brand India Pharma’ but also risk eroding the global trust painstakingly built over years. As a regulator, his view is unyielding, the sector's long-term health depends on consistent enforcement, not perpetual leniency. He sees the past extension as political concessions that have diluted the global credibility of Indian medicines, and he is advocating for strict enforcement.
On the other side of this debate are the pharmaceutical MSMEs, a vast network of manufacturers who argue their very survival depends on more time. The Revised Schedule M, which aims to align Indian practices with global Good Manufacturing Practices (GMP) standards, requires significant investment in infrastructure, new equipment, and quality systems. For many small companies with an annual turnover below Rs. 250 crore, the financial and technical burden of these upgrades is immense. They feel that without a lifeline, they will be forced to shut down, leading to job losses and a disruption in the supply chain for affordable medicines.
Tiwari’s critique is rooted in a historical pattern of what he calls ‘political pendulums’. He points to a decade of policy discussions and a succession of health ministers who have repeatedly extended deadlines without ensuring meaningful implementation. This cycle of political appeasement, he suggests, has fostered a culture of regulatory inertia. While such relaxations may appear to support MSMEs, in reality, they have compromised the quality-driven reputation of Indian pharmaceuticals and damaged their standing with international regulators and buyers.
India's pharmaceutical sector is a global powerhouse, with approximately 60 per cent of its production exported to over 200 countries. This export-driven strength, contributing almost Rs.2.5 lakh crore annually, rests on stringent quality standards. A sustained extension of the revised Schedule M would send a message to the world that India is not serious about quality control. It could jeopardize international confidence and future exports, undermining the very foundation of India's position as the ‘pharmacy of the world’, he told Pharmabiz from Ranchi.
From his perspective as a regulator, the JDC is not advocating for an indifferent approach. Instead, he outlines a clear path forward that protects both the industry's integrity and its smaller players. He believes the sector needs consistent enforcement, technical handholding for MSMEs, and strict adherence to quality and compliance. For him, the solution is not perpetual leniency but rather a robust, quality-driven framework. He sees this as the only way to protect national health and secure India's international standing for the long run.
He said, ultimately, the government's decision on a further extension will determine the future trajectory of the Indian pharmaceutical industry. If extension is granted, it will undermine the integrity of the Indian pharma industry in the international sector. The government has already granted a conditional extension until December 31, 2025.
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