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Stricter Norms in India to Ensure Healthy Medical Devices

New standards are meant to test and verify medical devices

By: Michael Barbella

Managing Editor

Companies manufacturing medical devices are likely to face more stringent regulations for selling products in India.

The Drugs & Cosmetics Amendment Act is set to enforce stricter standards and classifications for medical devices such as catheters, stents, pace makers and bone cements. The idea is to ensure the sale of safe medical devices to avoid adverse effects in treatment of critical diseases.


India’s government has proposed inclusion of a separate chapter on medical devices in the Drugs & Cosmetics Act. A draft of the schedule for medical devices, prepared by the drug controller general of India (DCGI) and the medical technology industry last year, is already in Parliament.

Once the Bill goes through and the amendment Act is in place, both domestic and global companies would have to meet the standards and comply by the classifications defined in the Act.

“The move would ensure that only companies with a quality certification of compliance of standards defined by the Act get a licence to sell in the domestic market,” Medtronic’s managing director Milind Shah said.

According to Mr Shah, the standards are meant to test and verify the medical devices, whereas the classification will assess the risk associated with the devices.

“There would be four classes based on risks. The riskier the device, the higher the class,” an official said.

According to the official, DCGI’s office recently found there are several low quality medical devices available in the market which could have an adverse effect, proving a setback for the industry. The amendment Act would be a significant step to ensure the most up-to-date technology is used to make the best products for patients.

The Act would make it mandatory for companies to get certification from notified bodies such as ISO, which are supervised by the government.

“Certain medical devices are as important as life-saving drugs. Certain devices are implanted in the human body for critical care. Therefore, manufacture and sale of medical devices is an important issue as patients are often exploited with the sale of low quality medical devices,” a medical expert said.

India’s medical device industry is estimated at $2.17 billion, growing significantly at 15% annually. According to industry experts, it is expected to reach $4.97 billion by 2012.

SOURCE: The Economic Times

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