New Delhi: The Drugs Controller General of India (DCGI) is planning to list the qualification criteria for medical device testing officers.
At present, no qualification is needed, with mostly drugs inspectors deputed to do the job.
This follows increasing complaints by the medical device industry – a market that is estimated to be around $11 billion, and expected to grow to $50 billion by 2030.
The matter was discussed in the Drugs Technical Advisory Board (DTAB) last month, which agreed to amend the Drugs Rules.
At present, the Central or state government, by notification, appoints any person it thinks fit to be Medical Devices Testing Officer who picks samples, tests and evaluates such medical devices.
The medical devices testing officer has the power to propose restricting or allowing the import, manufacture or sale of medical devices – “in public interest”.
“The samples of medical devices cannot be picked up the way drugs are picked up. Devices like MRI or CT Scan machines have to be verified on the site itself for safety features. Therefore, it is very important to depute highly skilled technical officers for the purpose,” said an official aware of the matter.
“There’s an acute shortage of competent medical devices officers at Central Drugs Standard Control Organisation (CDSCO) and State Licensing Authorities from an engineering and science background to adequately regulate medical devices that have recently come under regulations,” Rajiv Nath, forum coordinator, AiMeD (Association of Indian Medical Devices Industry).
Due to these shortages pharmacists and drug inspectors have been redesignated as Medical Devices Officers and in many cases these are not experts at the diverse range of engineered medical devices they are supposed to regulate,” he said.
“This becomes a huge challenge to manufacturers as they struggle to communicate with these regulators who see products like defibrillators and ventilators from the eye of medicine. It’s like an Air Force officer telling a naval officer what’s expected by the Air Force. The government needs to address this staffing and competence urgently if we are aiming India to be the leading manufacturing hub for medical devices globally as stated in the National Medical Devices Policy 2023.”
The government has approached various institutions for designating medical device testing laboratories so that medical devices and in-vitro diagnostic devices available in the market can be tested for safety and performance.
In India, medical devices are a category of almost 5,000 products. Different categories of medical devices may require different kinds of testing infrastructure.
