The Hindu Business Line : Medical device makers get a breather

From heart-valves to cardiac-stents and orthopaedic implants to internal prosthetic replacements, makers of medical devices in the country have got a two-month reprieve to apply for import and registration of their products.

The earlier deadline for medical device makers to submit their applications to the Drug Controller General of India (DCGI) was May 1. The Centre has now extended this by another 60 days (to June 29), following industry representations seeking more time to complete the documentation required to make the application.

Although regulation was waiting to happen on the largely unorganised domestic medical devices market, it was only last year that the segment came in for stringent scrutiny over the use of drug-coated stents in Maharashtra. Subsequently, the Centre brought select `high-risk' medical-devices under the scope of the Drugs and Cosmetics Act through a notification amending the rules.

More time to complete the documentation is just one of the appeals made by industry to DCGI, the regulatory authority for drugs and medical devices. There are infrastructure bottlenecks, from the regulator point of view and in terms of the industry's preparedness to submit the documentation, said Mr Alok Mishra, Managing Director of Johnson & Johnson Medical India, speaking in his capacity as the Confederation of Indian Industry's Chairman - Medical Equipment Division.

The other cause of disagreement is the fee of $1,000 or its equivalent for registration of single medical device and an additional fee of $1,000 for each additional device when the material or method of use is changed.

"India is a market where medical devices can be innovated to suit local needs and keep costs in control. A high registration fee can create a barrier to innovation for local and smaller manufacturers," said Mr Mishra.

Echoing similar concerns on infrastructure bottleneck, Mr Swaminathan Jayaraman, Managing Director of Vascular Concepts Private Ltd, also underlined the need for a quick review of product applications. A high registration fee can be paid, provided the money went towards creating infrastructure that facilitated a speedy review of applications, said the MD of the Bangalore-based medical-devices company.

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