DCGI wants qualified medical device testing officers
Subscribe to enjoy similar stories. 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 pick samples, test and evaluate 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 drug are picked up. Devices like MRI or CT Scan machine have to be verified on the site itself for safety features.
Therefore, it is very important to depute highly skilled technical officer 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
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