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The recent amendments in Drugs (Prices Control) Order signals a pragmatic shift towards sustainable pharmaceutical pricing by seeking to balance the twin objectives of ensuring affordable access to essential medicines and fostering a predictable, innovation-friendly business environment., said the Indian pharma industry.
The proposed framework introduces a more transparent and rational approach to price regulation, reduces regulatory uncertainty, and acknowledges the need for commercially viable pricing that supports continued investment in research, manufacturing, and supply chain resilience. By aligning public health priorities with industry sustainability, the 2026 framework represents a constructive evolution in India's drug pricing regime, they added.
Harish K Jain, president, Federation of Pharmaceutical Entrepreneurs (FOPE) and director, Embiotic Labs, viewed it as a pragmatic, industry-friendly amendment. Restricting overcharging liability to the specific distributor or retailer at fault, rather than the entire company, corrects a long-standing disproportionate burden on our members, many of whom are SME (small medium enterprises) manufacturers. Easing entry for follow-on manufacturers and allowing pack-based price flexibility will further support ease of doing business.
He also noted that the extended seven-year record-retention requirement under Paragraph 29 will need stronger compliance systems, and the Federation will engage with the Department for implementation clarity. “We reaffirm our commitment to working with the Government and NPPA (National Pharmaceutical Pricing Authority) to balance patient affordability with a sustainable domestic pharma industry,” said Jain.
Jatish Sheth, president, KDPMA and CIPI (Confederation of Indian Pharmaceutical Industry) and Director, Srushti Pharmaceuticals said that the Department of Pharmaceuticals has introduced a crucial change in Paragraph 14(2) of the Drugs (Prices Control) Order, 2013.
Earlier, manufacturers were held liable for all overcharged stock in circulation if formulations were sold above the notified ceiling price. Now, liability is restricted only to the actual quantity traded by distributors/retailers found guilty of overcharging, provided manufacturers demonstrate compliance with Paragraph 24 on price dissemination obligations, added Sheth.
The benefits for the industry are reduced financial burden on manufacturers, greater transparency and trust in price control mechanisms, smoother implementation of regulatory changes and balanced enforcement that recognizes real-world supply chain complexities. Therefore, the amendment is a progressive step in aligning regulatory enforcement with industry realities, safeguarding consumer interests while ensuring manufacturers aren’t unfairly penalized. Pharma manufacturing industry had been asking for this change in the regulations, for quite some time, said Sheth.
Dr. Premnath Shenoy, former director, Regulatory Affairs, Quality Assurance & Patient Safety, AstraZeneca, sees the amendment as a progressive step that balances patient affordability with regulatory oversight. By linking compliance to documented dissemination of revised prices, it ensures fairness while discouraging exploitative practices.
The amendment strengthens transparency and accountability in pharmaceutical pricing. It introduces provisions for separate price fixation based on pack size, dosage form, and therapeutic rationale, while tightening rules on overcharging and mandating seven-year record retention, said Dr Shenoy adding that DPCO 2026 underscores the focus on patient safety and equitable access.
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