Parliamentary Panel Slams CDSCO for Slow Drug Approvals, Calls for Conditional Licensing in 45 Days
The delays and frequent queries raised by CDSCO have become a major obstacle for applicants, particularly startups and entrepreneurs.
New Delhi: The Department-Related Parliamentary Standing Committee on Health and Family Welfare has raised serious concerns about the functioning of the Central Drugs Standard Control Organization (CDSCO), highlighting inefficiencies in licensing, delays in regulatory approvals, and a lack of transparency in its processes.
The report emphasized that these issues have hindered the growth of India's medical device and pharmaceutical industry and called for urgent reforms to improve efficiency, ensure timely approvals, and enhance India’s position as a global manufacturing hub.
The CDSCO, functioning under the Directorate General of Health Services (DGHS), is the Central Drug Authority under the Drugs and Cosmetics Act, 1940. Its responsibilities include regulating drug imports, approving new medicines and clinical trials, standardizing drug quality control, and overseeing vaccines, blood products, and medical devices.
The parliamentary panel strongly criticized the delayed licensing process and inconsistent timelines, noting that these inefficiencies have driven several Indian manufacturers to shift operations to Vietnam and Malaysia. The report stated, "The delays and frequent queries raised by CDSCO have become a major obstacle for applicants, particularly startups and entrepreneurs." The committee stressed the need for a faster and more transparent regulatory system to prevent unnecessary roadblocks in the approval process.
One of the major concerns raised was the fragmented and prolonged nature of regulatory approvals. The report pointed out that applicants often face multiple rounds of queries, significantly delaying approvals. To address this, the committee recommended a “Single Query” policy, ensuring that all necessary clarifications are sought in one go instead of piecemeal questioning. It further suggested that "Conditional approvals should be granted within 45 days based on self-declaration and international certifications such as CE or US FDA." Additionally, the report proposed AI-based screening mechanisms to automate the pre-screening of applications, reducing human intervention and minimizing processing time.
The panel also criticized CDSCO’s centralized authority, arguing that it has created an over-regulated environment that discourages domestic manufacturing. The report observed that the current system "creates an impression of CDSCO being a licensing body rather than a facilitator for India’s growth as a medical device manufacturing hub." To counter this, it recommended faster documentation processes, a more transparent approval system, and incentives for medical device startups to encourage innovation.
The committee acknowledged CDSCO’s progress in global medical device classification, noting that India became an affiliate member of the International Medical Devices Regulatory Forum (IMDRF) in 2024. Under this system, medical devices are categorized into Class A (Low Risk), Class B (Moderate Risk), Class C (Moderate-High Risk), and Class D (High Risk). However, the report stressed that while India has aligned with global standards, "there is a need for structured audits and regulatory enhancements similar to WHO’s vaccine regulation system." This would strengthen India’s credibility in international markets.
To address these pressing issues, the committee proposed several key reforms aimed at modernizing CDSCO’s regulatory framework. It urged the complete digitization of the licensing system, advocating for a "time-bound, AI-assisted online licensing process to ensure faster and more efficient approvals." Additionally, the panel recommended setting up an Industry Advisory Board, including startups, manufacturers, and medical experts, to regularly consult CDSCO on policy improvements.
Recognizing the complexity of regulating cutting-edge medical technology, the committee called for mandatory professional training for CDSCO officials to keep them updated on emerging medical innovations. It emphasized that "regular training programs should be conducted to enhance regulatory expertise in rapidly evolving medical technology fields." Furthermore, the report suggested hiring industry professionals within CDSCO to "ensure a more balanced and industry-friendly regulatory framework." This would help bridge the gap between regulatory oversight and industry needs.
