(MENAFN- Live Mint)

Drug regulators in various states have issued warning notices to manufacturers to close operations for not complying with good manufacturing practices, three officials familiar with the matter said.

Delhi, Himachal Pradesh and Uttarakhand are among the states that have already initiated action, the people said. The development follows the Drugs Controller General of India (DCGI) directing regulators in all states and Union territories to conduct urgent inspections and take action.

“The DCGI has issued strict and final directions to all state authorities because every pharmaceutical company must ensure full compliance with the updated GMP. Failure to meet the upgrade deadline means they have to shut down operations by 31 December, 2025," one of the three officials cited above said on the condition of anonymity.

Key Takeaways

• All Indian pharmaceutical companies must fully comply with updated Good Manufacturing Practices by 31 December, or face closure.
• DCGI has issued a "strict and final direction" to all state and UT drug regulators to conduct urgent inspections and enforce compliance rigorously.
• States like Delhi and Himachal Pradesh have already begun issuing warning closure notices to non-compliant firms.
• The regulatory heat is particularly high on MSMEs, who received an extension but have been linked to recent quality lapses in exported products.
• The move is driven by a need to align India's standards with WHO GMP, protect domestic consumers, and reinforce India's global reputation for high-quality pharmaceuticals, following international quality concerns.

Beginning 1 January, all pharmaceutical companies must adhere to the new GMP guidelines. Adherence to GMP ensures that drugs are made following quality standards, safeguarding public health by preventing cross-contamination, mix-ups, and the manufacture of sub-potent or toxic drugs.

“Following directives from the DCGI, we have already initiated inspections of companies in Delhi. Firms that are not GMP-compliant have been issued a warning closure notice, requiring them to upgrade their facilities by 31 December 2025," said Dr. K.R. Chawala, Delhi's drug regulator.

Extending cutoff date

Dr. Manish Kapoor, state drugs controller Himachal Pradesh, said,“We have been proactive in ensuring that all drug manufacturing units in Himachal Pradesh strictly adhere to the provisions of the Drugs and Cosmetics Act and Rules. Inspections to verify compliance with the revised Schedule M norms have been planned well in advance, even before the issuance of the DCGI's letter on the subject. Independent audits have already been initiated, and the DCGI office has been duly informed about our action plan. Issuing closure warning notices forms part of our ongoing efforts to uphold stringent quality standards across the state."

He further added that last year, the Union government extended an opportunity to MSME units to apply for an extension in the implementation of the revised Schedule M, however, only a limited number of firms availed of this provision.

“We have now scheduled verification inspections of all firms that did not apply for such an extension. The purpose of these independent audits is to assess whether these firms are in compliance with the revised norms. It should not be presumed that those who did not apply are necessarily non-compliant; their compliance status will be determined during the verification process, which has already commenced and will continue over the next 2 to 3 months," Kapoor said. Himachal Pradesh has around 664 drug manufacturing units, and a comprehensive inspection of each unit is a time-intensive exercise, but it is essential to ensure quality and compliance, he added.

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Tabjer Singh, state drugs regulator for Uttarakhand, said,“We have conducted joint inspections at 152 units. Out of these, 40 firms have been issued 'stop production' notices until they significantly improve and upgrade their manufacturing facilities. We are being very active on this initiative. We have also explicitly warned these companies that their licenses will be cancelled if they continue to be non-compliant with Good Manufacturing Practices." 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 inspecting every single one to ensure they comply with the revised Schedule M Good Manufacturing Practices. Notices are being issued to those firms not adhering to these new mandatory rules," stated Ajay Patak, state drugs regulator for Rajasthan.

Queries sent to a health ministry spokesperson and DCGI on Sunday remained unanswered.

Global standards

In December 2023, the health ministry upgraded standards to align India's regulatory framework with global benchmarks like the World Health Organization (WHO) GMP. This came after drugs from India were linked to the deaths of children in Gambia and Uzbekistan. While larger pharmaceutical companies had to comply early, Micro, Small, and Medium Enterprises (MSMEs)-defined as those with a turnover of ₹250 crore or less-were allowed to comply by 31 December 2025, provided they submitted an upgrade plan. MSME drug firms represent approximately 80% of the over 10,000 pharmaceutical manufacturers in India.

“These MSME drug firms are on the radar because recent quality lapses, especially in certain exported products, have often been traced back to smaller units with limited financial resources to invest in costly infrastructure and quality management system upgrades required by the new Schedule M. Companies have to follow GMP. There is no other way for them. This is being done to ensure quality over volume, to protect both domestic consumers and the industry's global standing," the second official said.

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India holds a dominant position as the world's largest provider of generic medicines by volume, commanding approximately 20% of the total global supply.

According to the Department of Pharmaceuticals, the Indian pharmaceutical industry is worth an estimated $50 billion and is projected to reach $130 billion by 2030. This growth is critical to the national economy, with India's pharmaceutical exports standing at $30.47 billion in FY 2024-25.

Arushi Jain, director of Akums Drugs and Pharmaceuticals, said that strengthening GMP adherence across the industry will not only enhance patient safety but also reinforce India's reputation as a trusted global hub for high-quality pharmaceuticals. It's a measure to ensure that every medicine reaching a patient is safe, effective, and consistent in quality, Jain added.

"When a doctor prescribes a medicine, both doctor and patient assume it will be of good quality. But this isn't always true in India, as the same drug is made by several companies with varying standards. Those following GMP are more likely to produce better quality products," said Dr Rajeev Jayadevan, a public health expert.

"The unsuspecting public has little idea what GMP means. Not all companies follow GMP at present. But when GMP becomes necessary, more companies will start following it-just as hospitals that initially resisted obtaining NABH accreditation eventually adopted it. This happened partly because their competitors got NABH and also because patients and insurance companies began asking for it. Likewise, once GMP becomes unavoidable, patients will start demanding it. In the long run, it will raise the overall quality and global credibility of Indian pharmaceutical products," he said.

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