It has been 13 years since Indian health authorities were directed to create a framework for medical device regulation, but only 23 of 5,000 product categories are currently regulated, according to a report from the Hindu BusinessLine.
In 2005, a Chief Justice at the Bombay High Court overhearing a case involving drug-eluting stents was shocked to find out that there was no framework to regulate medical devices, and directed the Central and State regulatory bodies to create a an entity to regulate the devices, according to the report.
On January 1 this year, the Indian gov’t implemented Medical Device Rules, but the implementation fell short of a 2015 promise from the then Minister of Chemicals and Fertilizers Ananth Kumar, which oversaw medicines and devices, according to the Hindu BusinessLine.
“Devices are not medicines made from a homogeneous chemical batch with very long lifecycles but usually an assembly of precision-engineered components with an ever-evolving, innovative, short-term product lifecycle,” the Association for Indian Medical Device Industry’s Rajiv Nath said, according to the report.
Patient safety is more complicated with devices than with pharmaceuticals, Nath added, saying that it is “a shared responsibility of the manufacturer, medical practitioners, product user and the regulator,” the Hindu BusinessLine reports.
AdvaMed’s Abby Pratt echoed the need to separate medical devices from pharmaceuticals, adding that “there is no need to reinvent the wheel here,” as global benchmarks and groups exist that could help organize such a regulatory framework, according to the report.
Money may be a key factor in the lack of regulation in India, according to former Maharashtra FDA Commissioner Mahesh Zagade, the Hindu BusinessLine reports. He alleges that money prevents the system from acting in patient interest or in holding companies accountable, alongside a “lack of willingness” at the administrative and political levels.
In May, a report emerged suggesting that India has no plans to roll back it price caps on stents and in fact plans to cap the prices on a trio of other cardiac devices and intraocular lenses.