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 ignoredâ€. 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 Actâ€). 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.
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