Center Announces 1,500 CDSCO Posts for Medical Device Regulation
In a significant enhancement to India's medical device regulatory framework, the Center has revealed plans to establish 1,500 additional positions within the Central Drugs Standard Control Organization (CDSCO), with a considerable portion of the hires aimed at reinforcing regulation of medical devices, declared Drugs Controller General of India (DCGI) Rajeev Raghuvanshi.
At the 9th edition of India Medical Device 2026, Raghuvanshi stated that a significant number of the newly approved positions would be assigned to the medical device regulatory framework, facilitating the establishment of an internal scientific team to assess applications, offer regulatory advice, and promote innovation.
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Raghuvanshi stated that the enlarged workforce would enhance scientific capabilities in CDSCO and aid India’s goal of becoming a worldwide center for cost-effective medical technologies.
The DCGI stated that the CDSCO has set up a specialized medical devices division manned by experts possessing specific qualifications and experience in the medical devices sector. He mentioned that the leadership of the vertical has been distinct from other regulatory roles, while approximately 30-35 new positions are currently being filled through the Union Public Service Commission (UPSC). Regulators focused on ophthalmic medical devices are anticipated to participate in the upcoming months.
The DCGI announced that the recruitment guidelines for the position of Drugs Controller General of India were updated to incorporate qualifications associated with medical device regulation. According to the updated regulations, individuals with engineering qualifications and experience in the medical device sector will now qualify for consideration for the nation’s leading drug regulatory role.
Raghuvanshi stated that the larger workforce would enhance scientific capabilities at CDSCO and bolster India's goal of becoming a worldwide center for cost-effective medical technologies.
The DCGI stated that CDSCO has created a specific medical devices division employing experts with specialized qualifications and expertise in medical devices. He stated that the leadership of the vertical has been distanced from other regulatory roles, while approximately 30-35 new positions are currently being filled through the Union Public Service Commission (UPSC). Experts in ophthalmic medical device regulation are also anticipated to participate in the upcoming months.
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The DCGI announced that the hiring criteria for the position of Drugs Controller General of India have been modified to incorporate qualifications related to the regulation of medical devices. According to the updated regulations, individuals with engineering qualifications and experience in the medical device sector will now qualify to be considered for the nation's leading drug regulatory role.
Emphasizing current regulatory changes, Raghuvanshi mentioned that India provides exemptions for clinical trials of innovative medical devices when suitable. He mentioned that the European Union (EU) has been included on the roster of trusted regulatory jurisdictions, together with the US, Canada, the UK, Australia, and Japan.
He also highlighted the recent publication of the medical device software guidelines, which establish the regulatory structure for the creation, assessment, and authorization of software-driven medical devices.
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A significant reform in progress is the suggested exemption from the T-licence requirement for research and development (R&D) of medical devices. A T-licence (Test Licence) for a medical device is an authorized permit granted by regulatory bodies such as the CDSCO. It enables businesses to produce or bring in limited amounts of a device solely for testing, assessment, clinical research, or training purposes, instead of for commercial distribution.
Currently, manufacturers need a T-licence to carry out R&D. Raghuvanshi mentioned that talks about eliminating this prerequisite are finished, and the Drugs Technical Advisory Board (DTAB) has approved the proposal.