Delhi, Himachal Pradesh and Uttarakhand are among the states that have already launched the drive, the people said. The development follows the Drugs Controller General of India (DCGI) ordering regulatory authorities in all states and Union Territories to conduct urgent inspections and take action.
“The DCGI has issued strict and final instructions to all state departments as every pharmaceutical company must ensure full compliance with the updated GMP. Failure to meet the upgrade deadline means they must cease operations by December 31, 2025,” said one of the three officials cited on condition of anonymity.
Key things
- All Indian pharmaceutical companies must fully comply with the updated GMP by December 31 or face closure.
- The DCGI has issued a “strict and final direction” to all state and UT drug regulators to conduct urgent inspections and strictly enforce compliance.
- States like Delhi and Himachal Pradesh have already started issuing closure notices to non-compliant firms.
- Regulatory pressure is particularly high on SMEs, which have received extensions but have been linked to recent quality declines in exported products.
- The move is driven by the need to align Indian standards with WHO GMPs, protect domestic consumers and strengthen India’s global reputation for high-quality pharmaceuticals in the wake of international quality concerns.
From January 1, all pharmaceutical companies must comply with the new GMP guidelines. GMP compliance ensures that medicines are manufactured in accordance with quality standards, protecting public health by preventing cross-contamination, mix-ups and the production of sub-potent or toxic medicines.
“As per the DCGI guidelines, we have already started inspections of companies in Delhi. The non-GMP compliant firms have been issued a closure notice asking them to upgrade their facilities by December 31, 2025,” said Dr. KR Chawala, Drug Regulator, Delhi.
Extension of the deadline
Dr. Manish Kapoor, State Drug Controller, Himachal Pradesh said, “We have been proactive in ensuring that all drug manufacturing units in Himachal Pradesh strictly comply with the provisions of the Drugs and Cosmetics Act and Rules. Inspections to verify compliance with the revised Schedule M norms were planned well in advance, even before the DCGI letter was issued on the subject and the DCGI audit initiated. We are properly informed about our action plan. Issuing closure warning notices is part of our ongoing efforts to maintain strict quality standards across the state.”
He further added that last year, the Union government had given an option to MSMEs to apply for an extension in the implementation of the revised Plan M, however, only a limited number of firms had availed of this provision.
“We have now scheduled verification inspections of all firms that have not applied for such an extension. The purpose of these independent audits is to assess whether these firms are complying with the revised standards. Those that have not applied should not necessarily be assumed to be non-compliant, their compliance status will be determined during the verification process that has already begun and will continue over the next 2-3 months,” Kapoor said. Himachal Pradesh has around 664 drug manufacturing units and comprehensive inspection of each unit is a time-consuming exercise but necessary to ensure quality and compliance, he added.
Tabjer Singh, state drug regulator for Uttarakhand, said: “We have conducted joint inspections of 152 units. Out of these, 40 companies have been issued stop production notices until they significantly improve and modernize their manufacturing facilities. We are very active in this initiative. We have also explicitly warned these companies that their licenses will be revoked if they continue to be Good Manufacturing Non-compliant.” The state has around 260 drug manufacturing plants.
Rajasthan has also cracked down on pharmaceutical units in the state. “We have 65 pharmaceutical units in our jurisdiction and we are actively monitoring each one to ensure that they are in compliance with the revised Schedule M GMPs. Notices are being issued to companies that do not comply with these new mandatory rules,” said Ajay Patak, state drug regulator for Rajasthan.
Queries sent to the spokesperson of the health department and the DCGI remained unanswered on Sunday.
Global standards
In December 2023, the Ministry of Health updated the standards to align India’s regulatory framework with global benchmarks such as World Health Organization (WHO) GMP. This comes after drugs from India were linked to the deaths of children in Gambia and Uzbekistan. While larger pharmaceutical companies had to comply in time, micro, small and medium enterprises (MSMEs) – defined as businesses with turnover ₹250 crore or less – they were allowed to comply by December 31, 2025, provided they submitted an upgrade plan. MSME pharmaceutical firms account for approximately 80% of the more than 10,000 pharmaceutical manufacturers in India.
“These MSME pharma firms are on the radar because recent declines in quality, particularly for some exported products, have often been traced back to smaller units with limited financial resources to invest in the costly infrastructure and quality management system upgrades required by the new Plan M. Companies must follow GMP. There is no other way for them. This is done to ensure quality over volume, to protect both official domestic consumers and global second-tier status industry.”
India occupies a dominant position as the world’s largest provider of generic drugs by volume, accounting for approximately 20% of the total global supply.
According to the Ministry of Pharmacy, India’s pharmaceutical industry is worth an estimated US$50 billion and is projected to reach US$130 billion by 2030. This growth is critical to the national economy, with India’s pharmaceutical exports reaching $30.47 billion in FY 2024-25.
Arushi Jain, Director, Akums Drugs and Pharmaceuticals, said strengthening GMP compliance across the industry will not only enhance patient safety but also strengthen India’s reputation as a trusted global hub for high-quality pharmaceuticals. It is a measure to ensure that every drug that reaches a patient is safe, effective and of consistent quality, Jain added.
“When a doctor prescribes a drug, both the doctor and the patient assume that it will be of good quality. But in India, this is not always true as the same drug is produced by several companies with different standards. Those who follow GMP are more likely to produce better quality products,” said Dr. Rajeev Jayadevan, a public health expert.
“The unsuspecting public has little idea of what GMP means. Not all companies currently comply with GMP. But when GMP becomes necessary, more companies will follow it – just as hospitals that initially resisted obtaining NABH accreditation have finally adopted it. This is partly because their competitors have obtained NABH and also because patients and insurers have started asking for it. Likewise, once GMP becomes generally unavoidable and patients will require it overall quality. credibility of Indian pharmaceutical products,” he said.
