All medical devices currently being sold in the country will come under the purview of Drugs and Cosmetics Act, from April 1, an official communiqué has stated.
The act will regulate all medical devices and medical technology equipment used for diagnosis, monitoring, treatment, investigations and for supporting or sustaining life. The move is aimed to regulate devices in order to improve overall quality and safety.
A notification released from the ministry of health and family welfare stated all medical devices, including implants and contraceptives, will be brought under the lens of the Central Drugs and Standard Control Organization (CDSCO) in a phased manner starting 1 April.
At present, over 30 devices including syringes, cardiac stents and orthopaedic implants fall into the category of drugs, which leaves many medical companies out of the purview of the act.
With the new rule in place, effectively all medical devices would be under scrutiny. As per existing medical devices rules, private notified bodies inspect low risk-devices while licenses are given by CDSCO. But in case of high-risk devices, both tasks are performed by CDSCO alone.
Currently, all medical devices have been classified into four categories–Class A, B, C and D.
Low-risk devices like surgical dressing, alcohol swabs, thermometers belong to class A & B category while high risk devices like implants and hemodialysis catheters falls into C & D category.
The move to include all devices under drug stem from Johnson & Johnson’s faulty hip implant case where the need to have stringent regulatory body was felt.