India’s Central Drugs Standard Control Organization (CDSCO), the nation's top drug regulator, faces renewed criticism from a parliamentary committee regarding delays, inconsistent timelines, and a persistent lack of transparency in its drug and medical device approval processes. This scrutiny comes as the regulator attempts to implement reforms aimed at boosting efficiency and accountability.
Calls for Faster, Clearer Approvals
The Department-Related Parliamentary Standing Committee on Health and Family Welfare presented its 163rd report in March 2025, highlighting serious concerns about the CDSCO’s operations. The committee stated that inefficiencies and frequent queries from the CDSCO hinder the growth of India's pharmaceutical and medical device industries. These issues have even prompted some Indian manufacturers to move their operations to countries like Vietnam and Malaysia.
The parliamentary panel called for urgent reforms. It recommended a "Single Query" policy, meaning the CDSCO should ask all necessary questions at once instead of in multiple rounds. The committee also pushed for a fully digitized, time-bound, and trackable licensing system. This new system would include clear timelines for each approval stage, automatic notifications for applicants, and a public database showing all applications, queries, and approvals.[medicaldialogues+3]
Opacity in Enforcement Actions
Beyond approval delays, the CDSCO faces criticism for its lack of disclosure regarding enforcement actions. As of January 2026, the agency has not publicly revealed details on investigations into alleged counterfeit anti-rabies vaccines or other quality-related actions against drug makers.
Experts and industry executives point to a pattern of regulatory opacity. Information about a counterfeited rabies vaccine batch, for instance, first emerged from foreign governments, not from the CDSCO itself. Prashant Reddy, a lawyer and co-author of "The Truth Pill: The Myth of Drug Regulation in India," told India Today that if a fake medicine batch is found, the government should directly inform the public.[telegraphindia+2]
Recent Reforms and Ongoing Challenges
The CDSCO has been working on various reforms to address long-standing issues. In August 2025, India released its first formal guidelines for expert panels to review and approve new drugs, medical devices, and biologics. This move aims to make approvals more consistent, faster, and transparent, following recommendations from the World Health Organization (WHO).
Union Minister for Health and Family Welfare, JP Nadda, stressed the need for "transparency of procedures" at CDSCO in July 2024. He emphasized this as crucial for India to maintain its global reputation as the "Pharmacy of the World" and meet international standards.[caalley+1]
In2025, the CDSCO also proposed a new rule requiring medicine labels to show the name of the authorized person responsible for each batch. This aims to improve accountability and traceability after incidents where contaminated cough syrups made in India were linked to child deaths in other countries.[health+1]
Despite these efforts, challenges remain. A December 2025 parliamentary report, chaired by MP Prof. Ram Gopal Yadav, noted that companies, especially startups, still face delays and uncertainty. The report recommended using artificial intelligence (AI) to identify bottlenecks and reduce manual intervention in the approval process.[indiannexus+1]
Historical Context and Data Integrity
Concerns about India's drug approval system are not new. A parliamentary committee report in 2012 highlighted issues like drugs approved without proper clinical trials or expert opinions. It also pointed out the misuse of public interest waivers to fast-track approvals. Theregulatory system has also struggled with understaffing and inadequate drug testing facilities.[biospectrumasia+2]
Recent CDSCO audits in December 2025 revealed data integrity problems in Indian pharmaceutical plants. These issues include a lack of proper processes for managing electronic records and signatures, missing or poorly maintained audit trails, and insufficient employee training on data entry.[pulitzercenter]
The quality of drugs also remains a concern. In 2024-25, out of 116,323 drug samples tested, over 3,000 were found to be not of standard quality. In 2023-24, 2,988 out of 106,150 samples failed quality standards, with 282 declared spurious.[pharmaregulatory]
Looking Ahead
The government continues to push for improvements. In 2023, the Drugs Rules were amended to mandate barcoding and QR codes for the top 300 drug brands. Since December 2022, CDSCO and state regulators have inspected over 960 drug manufacturing units, taking more than 860 actions against those violating rules.
However, the parliamentary committee's latest findings underscore the ongoing need for greater transparency and efficiency. Addressing these issues is crucial for India to strengthen its position as a global pharmaceutical leader and ensure public health both domestically and internationally.[newindianexpress]
