The recent global investigation- Implant Files- by International Consortium of Investigative Journalists (ICIJ) shows that the Centre is reluctant to regulate the medical device industry.

The Central Drug Standards Control Organization (CDSCO) is India's main regulatory body for pharmaceuticals and medical devices. ... In India, the manufacturing, import, sale, and distribution of medical devices are regulated under India's Drugs & Cosmetic Act and Rules (DCA).

The Bill had been drafted in 2006 by the then UPA government. Following that, under the current NDA government, a Group of Ministers (GoM) was constituted under the Union Finance Minister Arun Jaitley. However, the GoM had postponed the legislation, and had introduced the Medical Device Rules and Regulations. The new set of rules was released in 2017, and notified on January 1, 2018.

The recent global investigation – Implant Files – by International Consortium of Investigative Journalists (ICIJ), which portrayed the sorry picture of India’s medical devices industry, points to the need to have a strong legislation in this sector. Though India’s medical devices market has become the hub of global majors like Medtronic, Stryker, Abbott, Bayer and Johnson & Johnson, a legislation for the comprehensive regulation of the sector, the Medical Device Regulation Bill, was brought only in 2018.

The Bill had been drafted in 2006 by the then UPA government. Following that, under the current NDA government, a Group of Ministers (GoM) was constituted under the Union Finance Minister Arun Jaitley. However, the GoM had postponed the legislation, and had introduced the Medical Device Rules and Regulations. The new set of rules was released in 2017, and notified on January 1, 2018.

The delay of over 12 years in the enactment of a proposed legislation explains how the successive governments have treated the medical device sector.

In India, which is the fourth largest medical devices market in Asia after Japan, China and South Korea, “the need to recognise implants as separate vertical with its own regulatory framework has been ignored”. The fact is that regulation and management is done under the Drugs and Cosmetics Act of 1940.

Currently, only 23 categories of medical devices are regulated as ‘drugs’ under the Drugs and Cosmetics Act, 1940 (“D&C Act”). The notified medical devices include disposable hypodermic syringes, disposable hypodermic needles, disposable perfusion sets, in-vitro diagnostic devices for HIV, HBsAg and HCV, cardiac stents, drug eluting stents, catheters, intra ocular lenses, I.V. cannulae, bone cements, heart valves, scalp vein set, orthopaedic implants, internal prosthetic replacements, and ablation devices.

Blood grouping sera, skin ligatures, sutures and staplers, intra-uterine devices (Cu-T), condoms, tubal rings, surgical dressings, umbilical tapes and blood/ blood component bags are also regulated as ‘Drugs’ under Drugs & Cosmetics Act, 1940 & Rules, 1945.