Medical Devices Still Governed By Old Law

Visakhapatnam, 27 April 2019: Elaborating on the regulation and classification of medical devices in India, CEO and MD Andhra Pradesh Medtech Zone (AMTZ), Jitender Sharma said that India at present is placed disproportionately with respect to other countries, with medical devices still falling under the Drugs and Cosmetics Act, 1940. During an interactive session with TOI, here on Friday at the WHO workshop on medical devices and regulation, Jitender Sharma said as the new rules follow the old Act, this has resulted in non-technological logic, leading to cherry picking of devices.

Regarding the efforts being made to undo the lopsided approach, Jitender Sharma further added, “Though India has been conducting a massive exercise to regulate medical devices over the last few years, there are many challenges that need to be overcome. The challenges are double-sided; both the safety of the device and the patient need to be taken into account. If any leniency is shown it could lead to low quality products flooding the market and if the regulations are too tight it could prevent the flow in the market.”

Elaborating on the manner in which regulation is carried out in India, Jitender Sharma said that 22 categories of medical devices are being regulated and recently, eight more products have been added. However, he noted that instead of an approach that looks at different segments, we still use a product-wise approach, which is contrary to technological logic.

Regarding the approach to vigilance, Jitender Sharma observed that India has put in place a system of tracking adverse events (reports of damage to patients), which is also known as metro vigilance tracking.The Times Of India