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 which 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 and so on.

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 S Eswara Reddy, DCGI.

“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,” Reddy added.

The Drug Inspectors (Medical Devices) will inspect manufacturing sites licensed by the Central or State authorities and draw samples of medical devices being domestically manufactured or imported. They can also launch prosecutions, seize stocks and investigate complaints.

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.

Failure of medical devices

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

As far as failure of medical devices is concerned, since 2015, the Indian Pharmacopeia Commission has received close to 1,000 complaints of adverse events from patients who have used medical devices such as heart pacemakers under the Materio-Vigilance Programme of India. Though the programme was launched three years ago, no details or data related to it are available in the public domain.

Commenting on this, Reddy said, “An expert committee vets the cases to understand whether the complaints are related to the device or not, and if related, then how can they be rectified. We have yet not vetted the entire data.”