Now, in India all medical devices—diagnosis, monitoring, treatment, investigations and for supporting or sustaining life—to be brought into the ambit of ‘drugs’ an would be under the acumen of the Drugs and Cosmetics Act 1940 from April, this year, reveals the government on Tuesday.

Presently, above 30 apparatus that include syringes, cardiac stents and orthopaedic implants are grouped as drugs (under Medical Device Rules), leaving a large section of med technology companies “largely unregulated”. This development is expected fetch important changes for the sector in the next few years — firstly, their prices will be governed (as per the Act), and secondly, in case of a violation, they could be susceptible to a penalty in a court of law.

The over $15-billion industry is highly import-dependent with 70-80%, which also include imaging equipment like CT and MRI scanners, cardiac stents, orthopaedic implants, syringes, surgical gloves, glucometers, and critical care equipment.With this, quality, certification and pricing of devices will through government scanners. The Act will ensure that they are safe and conform to quality standards, and will be subject to an annual price increase of 10%. There would be a specific timeline for the regulation—30 months in respect of devices which are of low and moderate risk, while 42 months for moderate-high and high-risk devices from April 1.

Since the 1980s, the government has been notifying a few devices like drugs, but in a phased manner. While over a few months, the industry and health ministry have been in talks over the modalities of bringing in a separate Medical Device Act, this development was unexpected.The decision was taken after consultation with the Drugs Technical planning board, the notification added.