Small drug firms hustle near deadline with 1,000 GMP compliance applications

With the application submission deadline ending on 11 May, there was a flurry of applications, given that failure to meet the criteria would result in measures, including show-cause notices, production-halt orders, suspension and even licence cancellation.

In 2023, the government notified the revised Schedule M of the Drugs and Cosmetics Act, 1945, to implement GMPs at par with the World Health Organization’s (WHO) standards for drug-making companies.

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In the first phase, drugmakers with an annual turnover of ₹250 crore and above were to compulsorily follow the GMPs within six months, while the smaller firms were given a year.

MSME manufacturers must fully implement the GMPs by 31 December. However, they were supposed to submit a proposal to the Central Licensing Authority by 11 May explaining their upgradation plan.

Queries sent to the health ministry spokesperson were not answered till press time.

Notably, India is tightening scrutiny in the wake of domestically manufactured medicines failing quality tests overseas due to alleged contamination. For instance, cough syrups manufactured by Indian firms were allegedly linked to the deaths of children in developing countries, including Gambia and Uzbekistan, in 2022 and 2023.

The GMP compliance will ensure that drugs manufactured at the domestic plants have safety, quality and efficacy.

Global player

This assumes importance as the Indian pharmaceutical industry is a significant global player and the largest supplier of generic drugs, accounting for about 20% of the global supply. It manufactures about 60,000 generic brands across 60 therapeutic categories. India’s pharmaceutical exports stood at $30.47 billion in FY24-25, as per Pharmexcil, a body set up by the government to promote the export of pharma products.

The Central Drugs Standard Control Organisation (CDSCO) has developed an online system, the Online National Drugs Licensing System (ONDLS), a portal for drug makers to submit applications.

“The government is mandatorily asking all the pharmaceutical companies to improve their quality. CDSCO has received approximately. 1,000 applications from the firms submitting their upgradation plans. The government is examining the applications now,” said the first official.

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A few days before the 11 May deadline, Union health secretary Punya Salila Srivastava also raised a concern in a review meeting, highlighting that very few firms have submitted their applications to the DCGI.

“However, as per the data available, very few firms have submitted their applications requesting extension of timelines of implementation of revised schedule M,” said the health secretary in a letter to the state and Union territory governments.

The health secretary directed all the state drug regulators and pharmaceutical manufacturers to take up the issue on priority to comply with GMP within the stipulated time and submit the application for extension on the ONDLS portal.

“We have issued an advisory to companies within our jurisdictions following the directions of the health secretary, ” said a drug controller requesting anonymity.

Deadline extension

“All the major associations have requested an extension for submitting the application. The deadline of 11 May is over, and those who have given their application will be given an extension to implement GMP by 31 December 2025, and those who did not apply means they have complied with the rules and regulations. Strict actions will be taken against those who are not following the compliance,” said the second official.

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Last year, the Union government introduced the Revamped Pharmaceuticals Technology Upgradation Assistance Scheme (RPTUAS) to help drug makers upgrade their manufacturing units. Under this scheme, the government provides financial aid to firms to upgrade their plants to conform to global standards.

Harish Jain, Federation of Pharmaceutical Entrepreneurs, said, “There are two circumstances: first, a lot of the companies are following GMP compliance, and second, some may not be able to raise the funds and may close down. Multiple reminders have been issued by the governments related to GMP. We also sensitised our member companies to follow GMP.”

Key takeaways 

1. The Drugs Controller General of India received 1,000 applications from MSME medicine manufacturers detailing their plans to comply with Good Manufacturing Practices before the 31 December deadline.
2. Companies failing to meet GMP standards could face production halts, licence suspensions, or cancellations. 
3. India revised the Act governing drug manufacturing to implement WHO-standard GMP practices. 
4. The Central Drugs Standard Control Organisation developed the Online National Drugs Licensing System to streamline GMP applications. 
5. The health secretary raised concerns that many firms failed to submit their applications, while pharmaceutical associations requested deadline extensions.