India’s Central Drugs Standard Control Organization (CDSCO), the national regulatory authority for drugs and medical devices, is now acting on a report submitted by the Drugs Technical Advisory Board (DTAB) — the country’s highest statutory decision-making body on technical matters related to medicines and medical devices.
According to the proposal by DTAB, a new division under the CDSCO, will be formed, and its officers will work exclusively for the medical device industry, especially critical ones such as coronary stents, pacemakers, orthopedic knee and hip implants, structural heart devices, peripheral devices, endoscopes, in vitro diagnostic devices, among others. Over 700 officers will be hired for the new division.
The proposed structure of the new division as proposed by DTAB is shown below:
However, industry experts feel that the new division might take between five to ten years to create the infrastructure and have the required resources working in it. The DTAB also has suggested the hire of physicians/surgeons across therapeutic segments such as orthopedics, dermatology, surgery, biomedical engineering/medical imaging, cardiology, and bio-compatibility experts.
If the proposal to notify medical devices as drugs under the Drugs and Cosmetics Act comes in force then imports, manufacturing, and sale of all medical devices will need certification by the Central Drugs Standard Control Organization. Apart from this, companies will also need licenses from the Drug Controller General of India.
