New Delhi: The government on Friday decided to regulate the sale, manufacture and import of medical implants, a move that will ensure safe and tested medical devices reach the end user.
According to an 8 February notification, the government has put implantable medical devices, CT scan equipment, MRI equipment, defibrillators, dialysis machine, PET equipment, X-Ray machines and bone marrow cell separator under purview of The Drugs and Cosmetics Act, 1940.
Once regulated, 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 implantable medical devices.n Manufacturers will also have to apply for permission to the Drug Controller General of India, responsible for approval of licences.
The matter of regulating medical implants was first discussed on 16 May 2018. It has now been decided that these devices will be regulated with effect from April 2020.
In India, most implantable medical devices are unregulated.
“Devices implanted into the human body, or used for life support or sustenance, may pose potential risk (and) must be strictly controlled. As of now there is no safety check on the devices. This will regulate and make sure that devices that are implanted in the body are not rushed into the market, bypassing critical testing that would protect consumers," said S. Eswara Reddy, the Drug Controller General of India.
According to public health experts, the medical device industry is ridden with loopholes; regulation thus is extremely important.
“The majority of medical devices are completed unregulated in india. With this move, all implantable devices and some diagnostic equipment will be brought into the regulatory framework, which is important from a patient safety perspective," said Malini Aisola, co-convenor, All India Drugs Action Network (AIDAN).
Both import and export of medical devices grew at more than 10% between 2011-12 and 2014-15, according to a report by the department of pharmaceuticals under the ministry of chemicals and fertilizers. The medical devices industry has grown from $2.02 billion in 2009 to $3.9 billion in 2015, at a compounded annual growth rate (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).
As an interim step, AiMeD has recommended that the government consider making IS/ISO 13485 Quality Management System mandatory for manufacturers, domestic and overseas suppliers via the BIS Act and Rules and ensure compliance by third party certification bodies accredited by National Accreditation Board for Certification Bodies.
Significantly, the government notified the 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’.