India's Medical Device Bill Raises Concerns For Manufacturers

Medical device companies are lobbying Indian officials against creating harsher punishments for breaches by tech manufacturers than those imposed by international standards.

The Advanced Medical Technology Association (AdvaMed) told the Parliament of India in a recent filing that all the regulations for medical devices should align with widespread best practices, such as those set by the International Organisation for Standardization (ISO) and International Medical Device Regulators Forum (IMDRF), according to a write-up by PharmaBiz.

The legislation in question is the Drugs & Cosmetic Bill of 2013, also known as the medical devices bill. It includes strong enforcement measures aimed at medical device companies — a major sore point for technology makers. 

"The bill contains severe penal provisions for its violations that include imprisonment of maximum 10 years and penalty of up to Rupees 30 lakh," the Times of India reported. 

The legislation would create a medical regulatory body for India similar to the FDA, Medical Design Asia reported. Medical product regulations in India are way behind the times, critics say.

The nation is "crying out for a new overarching authority to manage the affairs of the pharmaceutical industry in a country which was estimated to be worth $19.2 billion in 2012," India.com Health reported. "Currently, the nation’s apex body behaves in an extremely disorganized way."

The bill aims to differentiate medical devices from drugs, but critics say it needs to draw clearer lines. "The distinction needs to be carried to the last mile," the PharmaBiz piece said. 

Abby Pratt, an executive at AdvaMed, noted some positive aspects of the bill in an IANS article, even as the lobby seeks major changes: "The medical device industry is encouraged by the bill for recognizing medical devices as a separate and critical element of the Indian healthcare delivery system, and believes that the bill will improve the industry's ability to serve India's growing healthcare needs in a safe, effective, and timely manner."

AdvaMed is not the only group concerned about the legislation. All India Drug Control Officers’ Confederation (AIDCOC) has vocal objections, as well.

"Secretary general of the AIDCOC Ravi Uday Bhaskar stated that the move will encroach on the powers of state drug authorities as it seeks to centralize licensing powers of 17 critical category products with Central government," the New India Express reported. 

A version if the bill published in September is available here.