After repeated representations from the industry, the government is finally contemplating to change Schedule M-III to be aligned with IS/ISO 13485 by delinking it from Schedule M for pharma industry. The government has already issued a draft copy to the stakeholders for getting their comments on the same.

Expressing huge relief over this move to delink Schedule M III from pharmaceutical sector, which has been a long standing demand of medical device industry, experts stressed that the government has taken initial but firm steps towards this finality.

Rajiv Nath, forum coordinator of AIMED, pointed out that this move will pave way for greater investment and R&D in the sector while helping India emerge as a world class manufacturing centre for medical devices.

This decision was taken recently following a high profile meeting between the industry experts and top government officials from the Centre regarding delinking medical devices from pharmaceutical sector. It is understood that the ministry will shortly issue a notification for change in drug rules through the law ministry for enabling this delinkage.

Nath informed that the irrational traditional linking of medical device sector with pharmaceutical through common statute and regulatory regime has been a big stumbling block in unlocking the full potential of this critical sector and had contributed to India’s humungous import dependency, while scaring away investment. Nowhere in the world are pharmaceutical and medical device sector governed by the same set of legislations as has been historically happening in India.

"By strange quirk of wisdom, the Indian medical device sector which has very different R&D, technologies, investment, production and taxation requirements from that of phrama sector, has continued to be governed by Drugs and Cosmetics Act, 1940. While this led to significant growth of Indian pharma sector, it has had exactly opposite and detrimental impact on medical device sector. This paradoxical situation also contributed to making India overwhelmingly import dependent and scaring away domestic and foreign investment. To rectify the situation, AIMED has been seeking changes in drug rules covering regulatory quality management framework and infrastructure requirements on the lines of the BIS and International ISO 13485 standard for regulatory purposes,” Nath said.

He further added that the Indian medical devices have for long been incorrectly and incompletely regulated. This has been confusing overseas and Indian investors who were scared to invest with a pharmaceutical type GMP demands being imposed by regulators in an arbitrary and prescriptive manner by unsure inspectors on an engineering industry. The government has taken the first correct strategic steps in the appropriate direction to address the ambiguity.

“Make in India of medical devices is now a possibility if government also makes it viable and profitable to invest by also simultaneously addressing the adverse inverted duty structure. The next steps to realize the dream of robust domestic medical device industry is by adopting a risk proportionate regulatory framework whereby medical devices of low patient safety risk like wheel chairs have a lower regulatory requirement and moderately risky devices like needles have a higher regulatory requirements and high risk devices like orthopaedic implants and cardiac stents have even higher regulatory compliance requirements," he pointed out.

Experts further stressed that this should be followed by unbundling of regulations and regulatory controls whereby the regulators need to delegate the task of compliance audit of manufacturers to third party competent and accredited conformity assessment and certification bodies.