CDSCO to Increase Audits of Medical-Device Makers Amid Workforce Expansion

The Central Drugs Standard Control Organisation (CDSCO) plans to significantly increase audits and inspections of medical-device manufacturers as the regulatory body receives additional manpower. The announcement was made by Drug Controller General of India (DCGI) Rajeev Raghuvanshi at the CII Global MedTech Summit.

Raghuvanshi explained that over the past two years, since medical devices came under a comprehensive regulatory framework, CDSCO's primary focus was issuing permissions and licences due to resource constraints. During this period, the agency issued around 40,000 product licences, while manufacturer audits and inspections received less attention.

With incoming resources, audits in the medical-device industry will increase significantly. Raghuvanshi noted that the industry has had sufficient time to understand regulations and prepare for compliance, meaning upcoming regulatory actions should not come as a surprise.

The regulator is expanding its workforce. The Union Public Service Commission recently provided a list of 20 additional medical-device officers expected to join in the coming months, which will double the existing strength of the regulatory team. Additionally, the government has given in-principle approval for around 1,500 new positions within CDSCO, including specialised scientific personnel to review applications across drug and medical-device sectors.

CDSCO has also established a separate functional vertical for medical-device regulation, with plans for greater operational independence. A new senior-level position has been created to strengthen this vertical, and recruitment rules have been amended to include engineering qualifications for medical-device regulators.

Addressing industry trends, Raghuvanshi stated that domestic manufacturing has grown while imports have largely stagnated. However, he emphasized that the industry needs to transition from manufacturing larger volumes of lower-risk products towards more sophisticated and innovative devices. He highlighted that Class A and B devices have grown faster than Class C and D devices, a trend India needs to reverse. He also noted that only about one in seven approved medical devices are investigational devices developed without a predicate device.

Regarding regulatory timelines, Raghuvanshi addressed concerns by stating that the average time for medical-device import licences is approximately 145 to 147 days, which is within the nine-month commitment under the regulator's charter. In-vitro diagnostic licences take about 105 days, while Class C and D manufacturing licence approvals take around 108 days. The regulator is also pursuing further reforms, including greater digitisation and the use of artificial intelligence in regulatory processes.

Finally, Raghuvanshi urged manufacturers to focus on adopting medical technologies in rural India, emphasizing that industry responsibilities should extend to ensuring point-of-care diagnostics and teleconsultation reach underserved areas.

"The ramp-up in CDSCO audits marks a critical maturation phase for India's medical-device sector. Startups and manufacturers that previously navigated an onboarding-heavy regulatory environment must now institutionalize rigorous compliance frameworks as enforcement tightens. While increased oversight and specialized engineering roles within the regulator point to a more structured ecosystem, companies building innovative Class C and D devices need to align their compliance roadmaps early. Founders must view this regulatory shift not as a hurdle, but as a baseline requirement to scale safely and build trust within the domestic healthcare market." — Dr. Shishir Gupta, Founder & CEO, StartupLanes