DCGI to Intensify Medical Device Audits & Ease R&D Rules
DCGI to Step Up Medical Device Facility Audits
India’s apex regulatory body is preparing to expand oversight across domestic manufacturing hubs. Consequently, the Central Drugs Standard Control Organisation (CDSCO) plans to conduct rigorous medical device facility audits nationwide. Dr. Rajeev Raghuvanshi, the Drugs Controller General of India (DCGI), spoke at the 18th Global MedTech Summit. He highlighted that authorities granted over 30,000 product licences during the last two years. Furthermore, the regulatory focus is now transitioning toward thorough physical inspections. He stated that manufacturers have received sufficient time to adapt to current quality standards. Therefore, upcoming compliance inspections should not surprise industry stakeholders.
Surging Domestic Production and Market Expansion
India's medical technology sector currently stands at approximately $16 billion. In addition, the market is projected to reach $50 billion over the next five years. This rapid growth follows the launch of the National Medical Devices Policy, 2023. Domestic manufacturing contribution surged by 43 percent between 2022 and 2025, rising to $7 billion. Meanwhile, import values remained steady at $9 billion. The country currently houses around 800 manufacturing facilities, mostly producing Class A and B devices. Consequently, stricter oversight ensures that expanding production upholds patient safety.
Proposed Test-Licence Waiver for Novel Devices
Of the 30,000 medical devices licensed recently, only 117 represented novel technologies. Consequently, CDSCO is preparing to eliminate mandatory test licences for devices undergoing R&D. The Drugs Technical Advisory Board (DTAB) will evaluate this deregulation proposal this month. Previously, regulatory authorities extended similar R&D waivers to pharmaceutical manufacturers. Therefore, removing early licensing hurdles will significantly lower barriers for indigenous innovators. Clinicians can thus expect faster clinical evaluation of emerging medical technologies.
Streamlined Timelines and Regulatory Capacity Building
Alongside expanded surveillance, the regulator has significantly shortened administrative timelines. Specifically, the median processing timeline for import licences decreased to 145 days. This duration falls well below the statutory charter commitment of nine months. Furthermore, review times for in-vitro diagnostics and high-risk devices dropped to approximately 105 days. To manage this workload, CDSCO established a dedicated Joint DCGI-level leadership post. Additionally, the central authority promoted 21 inspectors and recruited 20 new medical device officers.
Frequently Asked Questions
Q1: Why is the DCGI increasing medical device facility audits now?
The regulator previously focused on facilitating rapid market entry by issuing 30,000 licences. However, with expanded manpower, CDSCO is now intensifying inspections to enforce quality standards and protect patient safety.
Q2: How will the proposed test-licence waiver benefit medical innovation?
Currently, innovators must obtain test licences during early prototype testing and laboratory evaluations. Therefore, waiving test licences during early development removes bureaucratic delays and lowers R&D costs.
Q3: What changes have occurred in import and high-risk device approval timelines?
CDSCO has dramatically reduced regulatory review durations across categories. Specifically, import licence processing dropped to 145 days, while high-risk device approvals now average 106 days.
References
- Medical device makers to soon face Facility audits; Test-Licence waiver oncards: DCGI - ETHealthworld
- Central Drugs Standard Control Organisation (CDSCO). Medical Devices Rules, 2017. Ministry of Health and Family Welfare, Government of India.
- Department of Pharmaceuticals. National Medical Devices Policy, 2023. Ministry of Chemicals and Fertilizers, Government of India.
