The move aims to ensure that medical devices that are implanted in the human body are tested for safety before they reach consumers. Photo: Reuters
New Delhi: The government plans to regulate the sale, manufacture and import of implantable medical devices, following a series of controversies that include hip implants by Johnson and Johnson (J&J) which led to adverse reaction in several patients.
The move aims to ensure that medical devices that are implanted in the human body are tested for safety before they reach consumers.
The Drug Advisory Technical Board (DTAB) will take up the proposal of putting these devices under the purview of the Drugs and Cosmetics Act at its 16 May meeting, according to two people aware of the matter.
In India, most implantable devices are unregulated, including pacemakers, implantable cardioverter defibrillators used to perform cardioversion, defibrillation, and pacing of the heart, neurostimulator systems, implantable gastric stimulators, glucose monitors, and infusion pumps for insulin.
“Devices implanted into the human body, or used for life support or sustenance, and may pose potential risk must be strictly controlled. The government plans to improve its system for overseeing medical devices, so that the devices that are implanted in the body are not rushed into the market, bypassing critical testing that would protect consumers,” said one of the two people cited above.
The medical device industry is ripe with loopholes and hence regulation is extremely important, this person added.
Once regulated, the Central Drugs Standard Control Organisation (CDSCO), the national regulatory body for Indian pharmaceuticals and medical devices, will become the approving authority for import, manufacture and sale of ultrasound machines. The companies will also have to apply for permission to the Drug Controller General of India, who is responsible for approval of licences, before the implantable devices are sold in India.
Both import and export of medical devices grew at more than 10% during the period 2011-12 to 2014-15, according to a report by the department of pharmaceuticals under the ministry of chemicals and fertilisers. It has grown in size, from $2.02 billion in 2009 to $3.9 billion in 2015, at a CAGR of 15.8%.
The existing Drugs and Cosmetics Act is not adequate to regulate medical devices and hence there is an urgent need to usher in a “medical devices regulatory Act” to protect patients and ensure their safety, said Rajiv Nath, forum coordinator, Association of Indian Medical Device Industry (AiMeD).
“The current Drugs and Cosmetics Act is not adequate to regulate medical devices implants like pacemakers, neurostimulator systems, implantable infusion pumps and monitors for insulin and even non implants like dialysis machines, heart lung machines as these are high precision high technology engineering items and not chemical based medicines,” said Nath.
As an interim step, the association has recommended that the government consider making IS/ISO 13485 Quality Management System mandatory for manufacturers, Indian and overseas suppliers via the BIS Act and Rules and ensure compliance by third party certification bodies accredited by the National Accreditation Board for Certification Bodies (NABCB).
Significantly, the government recently notified new rules for the medical devices industry, which became effective from 1 January 2018. These rules provide for a risk-based classification of medical devices, whereby low-risk medical devices are classified as ‘Class A’; the devices having low to moderate risk are classified as ‘Class B’; the devices having moderate risk are classified as ‘Class C’; and devices having high risk are classified as ‘Class D’.