Industry draws govt's attention to gaps in Medical Device Rules 2016 draft

As industry associations prepare to submit a detailed representation of medical device industry to the Central Drugs Standard Control Organisation (CDSCO) and Ministry of Health & Family Welfare, it has been a winding exercise for last six months involving all stakeholders through consultations over meetings, sharing of industry inputs and waiting for the final draft which was notified on October 17, 2016.

“The Medical device draft rules 2016 though broadly well drafted and aligned with global regulatory practices still leave few critical gaps on issues which were well discussed and deliberated upon but have not been incorporated in the draft,” said Probir Das, chairman - FICCI Medical Device Forum.

Indian medical technology industry currently traversing the inflexion point of growth and value creation through Make in India, needs a scientifically well thought regulatory regime which embodies the essence of industry growth and patient safety in equal measure.

According to industry experts, measures to lift current restrictions on shelf life of medical devices are much needed to appreciate the usability of device and establish trust in manufacturers quality systems, these are imperatives to strengthen ease of doing business. On the same lines, redundant regulatory measures like requirement for having both accelerated and real time stability data and clinical investigation of medical devices already approved in GHTF countries must be waived off to facilitate use and reachability of medical devices to needy Indian population.

GHTF (Global Harmonization Task Force) was established as a voluntary international group of medical device regulatory authorities, and medical device trade associations from Europe, the US, Canada, Japan and Australia, grouped into three geographical areas, namely Europe, North America and Asia-Pacific.

“Attractiveness of a country’s industrial sector also lies in the stability of policy decisions and countries are closely watched by global investors on that aspect, India should uphold the provisions of GSR 690E with respect to the labelling requirements for import of medical devices in India,” added the FICCI press release.