DCGI to hire specialist engineers to inspect medical devices, factories

A separate cadre of drug inspectors (medical devices) possessing a specialised qualification in engineering is being raised by the Drugs Controller General of India (DCGI) for better regulation of medical devices.

A medical device is an apparatus that is either implanted in a patient’s body or used outside of it to diagnose or treat a condition. These could be thermometers, hip implants, cardiac stents, contraceptive devices etc.

Up to 17 such inspectors with a degree in bio-medicine, chemistry, bio-technology and mechanical, electrical, electronics, instrumentation or polymer engineering will be recruited in the Central Drugs Standard Control Organisation (CDSCO), said Mr. S. Eswara Reddy, DCGI. The candidates will ideally possess a Master’s degree in aforementioned engineering courses, and if they possess a bachelor’s degree, they should have two years of experience in manufacturing, testing, regulation of medical devices or in research and design.

“The Union Public Service Commission (UPSC) is through with the entrance examinations. After the interviews are completed, these officials with knowledge of engineering will be ready to join the CDSCO by next month,” he added.

The drug inspectors (medical devices) will inspect manufacturing sites licensed by the Central or State authorities and draw samples of medical devices that are domestically manufactured or imported. They can also launch prosecutions, seize stocks and investigate complaints.

Currently, the 275-strong drug inspectors’ team of DCGI, with a qualification in pharmacy, also inspects medical devices, Mr. Reddy said. “However, we need specialised people to do the job,” he added.