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Business Standard
11 hours ago
- Business Standard
Substandard quality in 3,104 drugs, 245 found spurious in FY25: JP Nadda
Since December 2022, the Central Drugs Standard Control Organisation (CDSCO) has inspected 905 drug manufacturing and testing units, resulting in 694 regulatory actions, Nadda said Rahul Goreja New Delhi Between April 2024 and March 2025, a total of 3,104 drug samples were declared not of standard quality, while 245 were found to be spurious or adulterated, the government informed the Rajya Sabha on Tuesday. These results came from 1,16,323 drug samples tested across the country during the period. The data was shared by Union Health Minister Jagat Prakash Nadda in response to a question on the prevalence of substandard and spurious drugs in the country. Nadda also stated that between April 2023 and March 2024, a total of 1,06,150 drug samples were tested, out of which 2,988 were found to be not of standard quality and 282 were identified as spurious. Risk-based inspections and regulatory action Since December 2022, the Central Drugs Standard Control Organisation (CDSCO) has inspected 905 drug manufacturing and testing units, resulting in 694 regulatory actions, including stop production or testing orders, licence suspensions or cancellations, warning letters, and show-cause notices, Nadda said. He further added that manufacturers whose drugs fail quality checks are required to immediately recall and halt further distribution of those batches. As for whether the government plans to publish a list of compliant drug manufacturers to rebuild public trust, Nadda said that CDSCO already uploads alerts about drugs declared not of standard quality, spurious, misbranded or adulterated on its website under the 'Drug Alert' section. Funding and policy initiatives To address broader challenges in drug quality, the government is implementing the Strengthening of Pharmaceutical Industry (SPI) scheme, which includes support for common facilities, technology upgrades for small and medium enterprises, and promotion of research and knowledge-sharing. The ministry of health and family welfare is also running a centrally sponsored scheme - Strengthening of States' Drug Regulatory System (SSDRS) - with an approved outlay of ₹850 crore, Nadda said, adding that the funding has supported the construction of 17 new drug testing labs and the upgradation of 24 existing labs.


The Hindu
13 hours ago
- The Hindu
Eliminate unnecessary animal studies, establish clear conditions for comparative clinical trials, say healthcare advocates
There is an urgent need to eliminate unnecessary animal studies, and establish clear conditions for requiring comparative clinical trials for affordable biosimilars without compromising safety and efficacy, members of civil society said in a letter to the Central Drugs Standard Control Organisation (CDSCO) on the draft guidelines on biosimilars. Also read:India takes first step to remove animals from drug-testing process A biosimilar is a biological medicine like another already approved biological medicine. While it is not an exact copy, it is clinically similar in terms of safety, purity, and potency. Biosimilars are developed to be a more affordable alternative to the reference biologic, increasing access to treatment options and potentially lowering healthcare costs. 'These guidelines mark a significant step toward making affordable, lifesaving biosimilars available to Indians suffering from serious illnesses like cancer, diabetes, and auto-immune disorders like arthritis. Biosimilars offer hope to patients by providing lower-cost alternatives to expensive biologic medicines. In India, where many struggle to afford basic healthcare, these drugs can transform lives. The draft guidelines are progressive as they have simplified the approval process, but we believe additional changes can make biosimilars even more accessible, ethical, and affordable, while maintaining safety and quality,'' the group, which includes patient advocates, healthcare organisations, and concerned citizens, said in its letter. 'The proposed guidelines on seeking reduced animal testing are encouraging. However, without a complete waiver, we are looking at increased costs and delayed access to affordable biosimilars. So, by eliminating these tests, India can lower production costs, speed up the biosimilar development, and uphold ethical standards, as well as make biosimilars more affordable for patients,' K.M. Gopakumar, co-convenor of the Working Group on Access to Medicines and Treatment, a civil society network for affordable healthcare, said. There is also a global trend to make clinical efficacy studies an exception rather than a rule, Mr. Gopakumar added. 'The draft guidelines' provision to skip clinical trials when a biosimilar is proven similar through lab tests is a positive step. But the language used grants significant discretion to the licensing authority and carries the risk of regulatory arbitrariness. Moreover, it could be exploited by originator companies to initiate legal action against biosimilar manufacturers, alleging potential compromises in safety and quality,'' he warned, adding that the group is demanding a clear definition for the situation where a biosimilar developer needs to carry out comparative clinical trials. Calling on the CDSCO to ensure the finalised guidelines on biosimilars remain free from any conflict of interest, the group said that the 2025 Draft Guidelines on Similar Biologics offer an opportunity to advance India's healthcare system. 'By removing animal studies, clarifying clinical trial waivers, and prioritising affordability, India can make biosimilars more accessible, reduce ethical concerns, and reinforce India's leadership in affordable medicine. We request that you incorporate these recommendations and engage with civil society, patient groups, and healthcare advocates as you finalise the guidelines,'' the group has urged the CDSCO.


News18
16 hours ago
- News18
900 Pharma Units Inspected In 3 Years, 700 Actions Taken; Himachal Key In Drug Quality Crackdown
In Himachal alone, 2,275 drug samples from local firms have been tested in the past two years, signalling the regulatory focus on pharma hotspots. In a crackdown that exposes lapses in the pharmaceutical manufacturing sector, India's drug regulator has ramped up scrutiny, issuing almost 700 regulatory actions following risk-based inspections across India. The Central Drugs Standard Control Organisation (CDSCO), India's apex drug regulator, has inspected 905 pharmaceutical units as part of its risk-based surveillance drive — and 694 actions have been taken, leading to enforcement measures ranging from stop production orders and license suspensions to show cause notices and warning letters. 'As of now, 905 units have been inspected, resulting in 694 actions being taken." The data has been shared by the Minister of State, Health and Family Welfare, Anupriya Patel, in Rajya Sabha on Tuesday. The scale of non-compliance, where roughly 3 actions were taken for every 4 units inspected — underscores concern about quality control in the country's pharma ecosystem. The actions on these firms include 'Stop Production Orders (SPO), Stop Testing Orders (STO), licence suspensions/cancellations, warning letters, and show cause notices, depending on the severity of non-compliance," the minister replied. 'This initiative has provided valuable insights into the ground reality of manufacturing practices and has led to relevant corrective actions, resulting in noticeable improvements in the regulatory framework," Patel said. In Himachal alone, 2,275 drug samples from local firms have been tested in the past two years, signalling the regulatory focus on pharma hotspots. 'In the last two years, CDSCO has tested 2275 drug samples of pharma companies situated in Himachal Pradesh. These drugs include vitamins, antipyretics, antibiotics, antihelminthics, antihistaminics, antineoplastics, corticosteroids, anticoagulants, analgesics, antacids, antidiabetics, anti-lipidemic and antihypertensives etc," she said while responding to the question on 'the details of drugs of pharmaceutical companies tested by the Central Drugs Standard Control Organisation (CDSCO) during the last two years in Himachal Pradesh…" The inspections, along with many other moves detailed by the minister in the Rajya Sabha, claim to be one of the most aggressive regulatory exercises in recent years to clean up India's drug manufacturing practices. According to the data shared by Patel, in the latest May 2025 drug alert released by CDSCO, 186 drug samples failed quality checks and were classified as Not of Standard Quality (NSQ). Among these, 49 products were manufactured in Himachal Pradesh, one of the largest pharmaceutical manufacturing hubs in India. The flagged samples, now publicly listed on CDSCO's website, include medicines used for a wide range of conditions — from common antibiotics and antihypertensives to corticosteroids, antidiabetics, and anticoagulants. She further added that the central government is providing regular residential, regional training and workshops to officials of CDSCO and state drug regulatory authorities on good manufacturing practices. 'In the financial year 2023-24, CDSCO has trained 22854 persons while in financial year 2024-25, 20,551 persons have been trained." Disclaimer: Comments reflect users' views, not News18's. Please keep discussions respectful and constructive. Abusive, defamatory, or illegal comments will be removed. News18 may disable any comment at its discretion. By posting, you agree to our Terms of Use and Privacy Policy.