If 2025 was defined by US tariffs, predatory pricing + dumping of key ingredients, and quality concerns due to sub-standard exports and counterfeits, let’s hope 2026 will see firm policy measures to balance these headwinds. Thankfully we do not need to wait for the Union Budget 2026 for such policy directives. But industry too needs to step up its efforts to comply.
For instance, India’s Directorate General of Foreign Trade (DGFT), based on inputs from the Department of Pharmaceuticals (DoP), is using Minimum Import Prices (MIP) as a priority policy intervention to ensure that the early gains of the Production Linked Incentive (PLI) scheme continue to scale up, rather than be undermined by predatory pricing of key ingredients and APIs dumped by China, often at prices lower than its own production cost.
On September 18, the DGFT imposed MIP on ATS-8, a key ingredient of atorvastatin, a common cholesterol-lowering drug, at US$111 per kg, till September 30, 2026. On December 19, DGFT imposed MIP on potassium clavulanate and related ingredients, seeking to secure India’s antibiotic supply chains. Reports are that penicillin and it’s intermediates will also have MIPs, to incentivise pharma companies to continue to invest in fermentation-based manufacturing infrastructure.
As India moves to scale up towards self-sufficiency, MIPs and other measures will be required to safeguard progress and maintain a sustainable balance between local manufacturing and global sourcing, a key part of India’s long term health security.
2026 must be the year India’s pharma policy and industry align, as policy directives can only be successful if all sections of the industry step up to the challenge. For instance, consider the much delayed compliance with the revised Schedule M guidelines, which were first notified in December 2023.
Poor quality medicines due to non-compliance with Good Manufacturing Practices (GMP) have dodged India’s pharma companies over the past few years. These quality concerns spurred India’s authorities to release a revised Schedule M in December 2023, aimed at strengthening GMPs and pharma quality systems to assure patient safety and re-build global confidence in Made in India medicines.
While larger pharma companies have met the deadline to comply, MSME pharma companies have requested another extension beyond the December 31, 2025 deadline.
The Indian Drug Manufacturers’ Association (IDMA), which represents most of the MSME pharma companies, has written to Punya Salila Srivastava, Secretary (H&FW), requesting that manufacturers who have already submitted upgradation plans and can demonstrate, through documented milestones, that execution is actively in progress, be granted extension on a case-by-case basis, commensurate with the progress demonstrated and subject to continued regulatory oversight.
IDMA’s second request relates to encouraging wider MSME participation through clarificatory guidance. As per the letter, IDMA had earlier submitted specific suggestions and proposed clarifications on certain provisions.
Key concerns included whether the implementation would be adaptable guidelines or mandatory interpretation, the acceptance of alternate contamination-control approaches, the removal of earlier concessions for allied products like nutraceuticals, the introduction of separate, detailed requirements for hazardous substances, the uncertainty if manufacturers would alone remain accountable for pharmacovigilance compliance even when products are marketed by third parties, expectations regarding retail-level recalls, and ambiguity on additional labelling provisions beyond existing Drugs & Cosmetics Rules. IDMA reasoned that clarity on such interpretative aspects already raised in earlier submissions would increase MSME confidence, and encourage more manufacturers to submit upgradation plans in a structured manner.
IDMA’s letter asks for one further conditional opportunity up to December 2026. But would another extension guarantee compliance? What can policy makers do to smooth the process for manufacturers with honest intent to upgrade, but need more clarity? One easy way would be to respond faster to queries, with clarifications.
Along with GMP compliance, India’s pharma sector will also have to double down on securing their supply chain from counterfeits, as even one case can result in reputational loss, followed by a dent in revenues. In the case of vaccines, such reputational loss is even worse as it may increase vaccine hesitancy.
In the most recent example, Indian Immunologicals Limited (IIL) had to issue a clarification and refute the ‘over-cautionary and misplaced’ reference made to its Abhayrab anti rabies vaccine in a recent Australian health advisory, stressing that the advisory does not reflect the current situation.
As per the press note from IIL, in January 2025, the company identified one batch (Batch#KA24024, manufactured in 2023) with ‘packaging different to the original.’ ILL proactively notified Indian regulators and law enforcement agencies, lodged a formal complaint and worked with authorities to ensure swift action. The company had also reportedly informed health authorities in international export markets. There were no market complaints with the rest of the Abhayrab Batch#KA24024, and IIL has written to the Australian health authorities to consider revising the advisory.
The priorities for 2026 are clear: scaling up PLI-scheme production, higher compliance among MSME pharma to revised Schedule M and raising the bar against counterfeits. Or will we end 2026 with more of the same concerns?
VIVEKA ROYCHOWDHURY, Editor
viveka.r@expressindia.com
viveka.roy3@gmail.com