The Committee criticised CDSCO’s excessive centralization, leading to arbitrary decision-making and overregulation. It warned that India’s shift from promoting medical innovation to turning licensing into a business could hinder its global manufacturing ambitions
Published Mar 16, 2025 | 6:00 PM ⚊ Updated Mar 16, 2025 | 6:00 PM
License Raj 2.0? Parliamentary Panel slams drug regulatory for bureaucratic hurdles
Synopsis: The Parliamentary Standing Committee on Health and Family Welfare criticised India’s medical regulatory framework, accusing the CDSCO of stalling the medical device industry’s growth through slow, opaque licensing processes. The report highlighted excessive centralisation, arbitrary decision-making, and delays, warning that this approach is driving manufacturers to other countries like Vietnam and Malaysia. It recommended an independent Industry Advisory Board to improve collaboration with the sector
In a scathing indictment of India’s medical regulatory framework, the Parliamentary Standing Committee on Health and Family Welfare has raised serious concerns about the Central Drugs Standard Control Organisation (CDSCO), accusing it of functioning as a “license raj” and actively stalling the growth of the medical device industry.
The report criticises the slow, opaque, and highly discretionary licensing process, warning that it is driving manufacturers out of India and discouraging startups from entering the sector.
The Committee flagged excessive centralisation of authority within CDSCO, which it believes has led to arbitrary decision-making and overregulation. It noted that over the last two years, India appears to have shifted from facilitating medical innovation to turning licensing into a business itself, a move that could undermine the country’s ambitions of becoming a global manufacturing powerhouse for medical devices.
“The Committee would like to express that the perception of CDSCO as a “license raj” highlights a critical need for improved communication and collaboration with the medical device industry. The Committee, therefore, recommends the establishment of an independent Industry Advisory Board, comprising representatives from manufacturers (including startups), importers, healthcare providers, and experts,” said the report.
“The Committee, on examination of the submissions made by the Department, expresses concerns that the CDSCO’s current licensing process is plagued by delays, inconsistent timelines, and a lack of transparency, hindering the growth of the medical device industry. The Committee expresses serious concern that due to rigid process and inordinate delays by CDSCO, a large number of manufacturing units have gone to Vietnam and Malaysia,” said the report.
It noted that rather, several medical devices manufacturers are scared to set up a unit in India due to delaying tactics of the CDSCO.
To counter the prevailing inefficiencies, the Committee has called for a complete overhaul of CDSCO’s approval process, recommending the establishment of a fully digitised, time-bound, and trackable licensing system. Key measures proposed include:
The Committee believes that these measures will not only eliminate bureaucratic delays but also restore trust between the industry and regulators, ensuring that India moves from being a roadblock to a true facilitator of medical innovation.
One of the most damning findings of the report is the frequent and prolonged queries raised by CDSCO officials, which the Committee believes act as a deliberate strategy to stall approvals. Startups and entrepreneurs, in particular, have suffered from multiple rounds of unnecessary clarifications, leading to financial losses and missed market opportunities.
The report recommends a “single query” policy, where all required clarifications are consolidated and raised at once, rather than trapping applicants in an endless back-and-forth process. It also suggests introducing a conditional approval system within 45 days, especially for products that already hold international certifications like CE and US FDA.
Additionally, the Committee urged CDSCO to provide clear guidelines and FAQs, establish a dedicated support team, and streamline approvals for startups and innovative medical devices.
The Committee noted that CDSCO’s inefficiency is partly due to a lack of qualified personnel in key regulatory roles. Many drug inspector and medical device vertical positions remain vacant, leading to delays, inconsistencies, and arbitrary decision-making.
To address this, the panel recommended:
The Committee strongly believes that India has the potential to become a global hub for medical device manufacturing, generating an industry worth over $1 trillion. However, for this to happen, CDSCO must shed its bureaucratic mindset and embrace a transparent, efficient, and industry-friendly regulatory framework.
It called for the creation of an independent Industry Advisory Board comprising representatives from manufacturers, importers, healthcare providers, and experts to serve as a bridge between the government and the medical device sector. The panel also recommended regular stakeholder consultations, open forums, and digital feedback platforms to ensure that CDSCO operates as a facilitator rather than an obstructionist body.
Beyond the licensing mess, the Committee also raised serious concerns over the quality of medicines dispensed at Central Government Health Scheme (CGHS) dispensaries and pharmacy counters. There have been repeated complaints regarding the effectiveness of drugs procured through MSO and JAP, highlighting the urgent need for stronger quality control mechanisms.
To address this, the Committee recommended:
The Committee warned that failure to address these quality concerns would erode public trust in the healthcare system and undermine India’s efforts to provide accessible and reliable medical care.
(Edited by Ananya Rao)
