Regulator receives 1,000 applications from MSME drugmakers on good manufacturing practice compliance

New Delhi: The country's top drug regulator, the Drugs Controller General of India (DCGI), has received 1,000 applications from micro, small and medium enterprise (MSME) medicine manufacturers detailing their plans to comply with good manufacturing practices (GMPs), according to two officials in the know.
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.
Also read | ICMR gets a breakthrough in attempts to develop first indigenous Nipah virus medicine
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.
Also read | India tightens export rules for medicines to check wide misuse as narcotics in overseas markets
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.
Also read | Govt directs all airports, seaports and land ports to take vector-borne diseases surveillance measures
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

Try Our AI Features

Explore what Daily8 AI can do for you:

Learn with AIFact CheckingText to SpeechAI Summary

Related Articles

Business Standard

33 minutes ago

• Business Standard

Decision on merger with Biocon Biologics soon, says Siddharth Mittal

We are talking about the GLP-1 opportunity and our strong franchise in insulins. There is a huge demand in the global diabetes-obesity segment, said Siddharth Mittal Sohini Das Mumbai Listen to This Article Biocon successfully raised ₹4,500 crore through a qualified institutional placement (QIP) last week that saw strong interest from both Indian and global investors. It is also considering a merger of Biocon Biologics with Biocon to tap into business and scientific synergies rather than listing Biocon Biologics. In a virtual interaction with Sohini Das, Siddharth Mittal, chief executive officer (CEO) and managing director (MD) of Biocon outlined his plans. Edited excerpts: Your QIP was successful. What do you plan to do with the proceeds? There was very strong investor demand. The Board had approved raising up to ₹4,500 crore in one,

News18

40 minutes ago

• News18

Stock Market Updates: Sensex Tanks Over 700 Points, Nifty Below 24,950 Mark In Pre-Open

Last Updated: Indian benchmark indices Sensex and Nifty are expected to open on a cautious note today Sensex Today: Indian benchmark indices Sensex and Nifty are expected to open on a cautious note today, as a sharp rise in crude oil prices and escalating geopolitical tensions weigh on investor sentiment. The situation intensified after the United States directly entered the Israel-Iran conflict with strikes on Iranian nuclear facilities, sparking fears of a broader regional war and unsettling global markets. Adding to the pressure, mixed global cues and institutional fund flows are likely to influence market direction in today's session. As of 8:20 AM, GIFT Nifty futures were trading 112 points lower at 25,111, indicating a gap-down start for domestic equities. Global Cues Asia-Pacific markets tumbled on Monday following the US airstrikes on three Iranian nuclear sites, which raised the spectre of a wider conflict in the Middle East and drove oil prices higher. Brent crude rose 2.62% to $79.06 per barrel, while West Texas Intermediate (WTI) gained 2.75% to $75.89 per barrel. Oil prices have been on an upward trend in recent weeks due to rising geopolitical instability in the region. Gold also surged amid the uncertainty, jumping 2.95% to $3,379.60 per ounce as investors flocked to safe-haven assets. In equities, Japan's Nikkei dropped 0.74%, while the broader Topix fell 0.64%. South Korea's Kospi lost 1.22%, and Australia's ASX 200 declined 0.76%. US stock futures retreated during early Asian trading hours. Dow Jones futures were down 0.3%, while S&P 500 and Nasdaq 100 futures slipped 0.3% and 0.4%, respectively. On Wall Street last Friday, two of the three major indices closed in the red. The S&P 500 shed 0.22%, marking its third consecutive loss, and the Nasdaq Composite dropped 0.51%. The Dow Jones Industrial Average, however, inched up by 0.08%. About the Author Aparna Deb Stay updated with all the latest news on the Stock Market, including market trends, Sensex and Nifty updates, top gainers and losers, and expert analysis. Get real-time insights, financial reports, and investment strategies—only on News18. First Published: News business » markets Stock Market Updates: Sensex Tanks Over 700 Points, Nifty Below 24,950 Mark In Pre-Open

Time of India

42 minutes ago

• Time of India

Zen Technologies shares in focus after board approves acquisition of TISA Aerospace

Shares of Zen Technologies are likely to be in focus on Monday, June 23, following the company's announcement of a proposed acquisition of a majority stake in TISA Aerospace, an emerging defence technology firm specialising in loitering munitions and unmanned aerial vehicles (UAVs). In an exchange filing, Zen Technologies disclosed that its Board of Directors, at a meeting held on Saturday, approved an investment of up to Rs 6.56 crore towards the proposed acquisition. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Costco Shoppers Say This Wrinkle Cream Is "Actually Worth It" The Skincare Magazine Undo The investment will be executed through two components: The acquisition of 2,06,518 equity shares of Rs 10 each from an existing shareholder of TISA Aerospace, representing 54.67% of the total equity paid-up share capital of the company. The acquisition of 4,00,000 units of 6% Compulsory Convertible Debentures (CCDs) of Rs 100 face value each, from an existing CCD holder, also issued by TISA. The Board of Directors has unanimously approved the investment, which involves acquiring shares from current stakeholders of TISA as well as CCDs previously issued by TISA. The company stated that the transaction represents an investment in a domain of strategic relevance, comprising indigenously developed defence technologies. Live Events TISA Aerospace is positioned as a domestic player within the high-technology defence ecosystem. The company is engaged in the development of loitering munitions and UAVs—both of which are key segments within the evolving landscape of modern precision-guided weapon systems. Zen Technologies, through this acquisition, is entering a segment associated with advanced defence applications. 'This acquisition is a decisive step towards strengthening Zen's position in the rapidly evolving defence drone sector. TISA's expertise in loitering munitions provides us with immediate access to advanced technologies and platforms that align with the emerging operational requirements of the Armed Forces. TISA has achieved significant R&D milestones, including the successful execution of a project for DRDO with critical design assistance from IIT Madras. By integrating these capabilities with our existing strengths in anti-drone systems and propulsion technologies, we are building a broader and more future-ready defence portfolio,' said Ashok Atluri, Chairman and Managing Director of ZenTechnologies. Also read: How will US strikes on Iran affect Indian markets this week? Shares of Zen Technologies closed flat at Rs 1,900.30 on the BSE on Friday. ( Disclaimer : Recommendations, suggestions, views and opinions given by the experts are their own. These do not represent the views of The Economic Times)