Medical device draft rules fall short of expectation, industry experts

Industry experts feel that medical device draft rules 2016 fall short of the expectations of the medical devices sector and draft regulations needs changes

The government must consider industry recommendations on Draft Medical Device Rule, 2016 as it lacks harmonisation with international norms of medical device regulation. This was stated by a group of industry experts representing Medical Technology Association of India (MTaI) in New Delhi.

The recently formed MTaI, which represents both domestic and foreign medical device makers like Johnson & Johnson, Bausch & Lomb, Smith & Nephew, CR Bard, Terumo, Boston Scientific and Vygon, informed that the draft rules were initially prepared with industry consultation, but the elements agreed between the industry and Union Health Ministry were not incorporated in the draft that was published on October 17, 2016.

“The health ministry’s medical devices draft rules in the current form does not ease the access of medical devices for patients instead makes it difficult for them,” commented Pavan Choudary, Director General, MTaI.

“In their current form, the Medical Device Rules could severely jeopardise the continued supply of critical care medical devices to India. They will also endanger huge investments made to manufacture the devices in the country by global companies and will dent the FDI which has been growing multifold since it was sagaciously brought on the automatic route by the current government. Having said that, we are engaged with the health ministry as well as CDSCO on the rules. Choudhary added.

The association also pointed that the new medical device draft rules are more applicable to drugs instead of medical devices. They also specified that it lacked harmonisation with international norms of medical device regulation.

Probir Das, MD, Terumo India said, “The Draft Medical Device Rule, 2016, at this stage, needs more clarity and alignment with global best practices.”

The association members uniformly voiced that labelling requirements is not aligned with international regulatory requirement. MTaI recommenced that the labelling requirements should be printed, stickered in the shelf pack and in every other outer packaging in line with GSR 690E.

The association also noted that the shelf life of a medical device shall not exceed five years from the date it was manufactured. The members opined that medical devices unlike drugs are more stable and hence restricting the shelf life of devices to five years will not be suitable for medical devices especially since the devices are made of stable metals. The restriction of shelf life will lead to devices specially manufactured for India, which will increase cost as well as affect availability of the product in India.

Susohobhan Dasgupta, MD, Johnson & Johnson Medical India, said, “We welcome the incorporation of UDI barcodes on the product, however, it should be aligned with global implementation timelines. The European Union implementation time lines will be completed in 2027 and hence MTaI recommends that it will be implemented in stages.”

Overall MTaI informed that medical device rules which has been drafted in the current form is not suitable for medical devices. They urged the health ministry to consider the suggestions made by the industry experts particularly the globally accepted shelf-life and uphold the provisions of GSR 690E with respect to the labelling requirements for import of medical devices in India.