Government must consider industry recommendations for Medical Device Rules to circumvent severe jeopardy to critical healthcare in India and it falls short of the expectations of the medical devices sector, feels the industry.

In a statement, the industry experts say that the Medical Device Rules were initially prepared with industry consultation, however the comments of the industry as well as certain elements where agreement was obtained between industry and Health Ministry officials were not incorporated in the draft that was published on October 17th, 2016 for stakeholder’s comments (within 30 days).

“In their current form the Medical Device Rules could severely jeopardize the continued supply of critical care medical devices to India. They will also endanger the huge investments made in Manufacturing in the country by global companies & 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 the CDSCO on the Rules, and if the past is anything to go by, their inclusive approach and nuanced understanding of the issues will help us once again reach solutions so that the supply of critical care devices will continue uninterrupted to the Indian patient,” commented Pavan Choudary, director general, Medical Technology Association of India (MTaI) in a statement.

Also, the Advanced Medical Technology Association (AdvaMed) – a trade association expressed that the rules in its current form lack harmonization with international norms of medical device regulation, which is necessary to provide the necessary fillip to the sector that provides extraordinary growth opportunity for the country through creation of high paying jobs, economic value and better patient outcomes. In addition to the device rules, the Association also, strongly, recommends inclusion of the globally harmonized definition of medical devices into the current Act, which is not part of the drug definition, it says in a statement.

Varun Khanna, chairman, AdvaMed India Working Group, and Executive Committee Managing Director, BD India & South Asia said, “All policy decisions need to be based on scientific due diligence. The Medical device draft rules 2016, at this stage, need more clarity and alignment with global best practices to fully meet the sector specific requirements in order to ensure predictability in the Indian market, which is a critical factor when it comes to investment decisions. The current rules address some but not all of the issues that were deliberated upon during several industry consultations while working on this draft. AdvaMed and its members appreciate the efforts made by the Indian government to improve the overall landscape for medical devices. We request the Government to continue consultations with the innovative industry and build on their experience to come up with a methodology that will address reasonable concerns around access and affordability while promoting research and med-tech innovation.”

He also said, “The government needs to be mindful of the fact that without sufficient capacity it will be challenging for them to implement these rules. Therefore, a critical step for the successful implementation of the medical device rules would be to take measures for building capacity of the relevant ministries and ensure greater understanding of the sector dynamics and criticalities among the regulators.”

The association members have urged the regulators to make necessary revision in provisions that hinder operational ease of doing business for the device companies. For instance, the additional requirement for clinical investigation of medical devices already approved in GHTF countries shall cause unnecessary delay in the availability and access of innovative medical devices to the HCPs and the patient population. Moreover, the provisions with respect to labeling of medical devices should be aligned with the Draft rules published in July 2016, and the clause with respect to the shelf life of medical devices should be amended to be in line with global requirements.

The members said that while the implementation of UDI is a positive step, it is imperative for the government to have realistic timelines. For example, as per the US and EU implementation timeline, the complete implementation including direct part labeling will be over only by 2022. Hence, it is premature to incorporate this in the current rules, as manufacturers are not ready for implementation of UDI.

The association said that encouraging measures for medical device regulation would enhance penetration of essential medical devices, and it is hopeful that its perspective would be reflected in the final version.