The Central Drugs Standard Control Organisation (CDSCO) is falling short in effectively regulating the medical devices industry, observed the Department-related Parliamentary Standing Committee on Health, headed by Prof. Ram Gopal Yadav, M.P., Rajya Sabha stating that the organisation in its existing structure and expertise is more pharma centric.
He presented 138th Report on the subject “Medical Devices: Regulations and Control” to Rajya Sabha earlier this week.
It has recommended for more certified medical devices testing laboratories, robust IT enabled feedback driven post-market surveillance system and medical device registry, particularly for implants to ensure traceability of patient who has received the implant in order allowing assess the performance of the implant.