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`New guidelines to hit medical devices sector'

Our Bureau

Kochi , April 28

The Indian medical devices manufacturing sector will be adversely affected by the new guidelines for import and manufacture of medical devices as notified by the Ministry of Health and Family Welfare, according to Mr Alok Mishra, Chairman, CII - Medical Equipment Division.

In a press release issued here, he said that the Ministry has recently notified the sterile devices such as cardiac stents, drug eluting stents, catheters, intra ocular lenses, I.V. Cannulae, bone cements, heart valves, scalp vein set, orthopaedic implants and internal prosthetic replacements to be considered as drugs that require central clearance prior to import, manufacture or marketing in the country with effect from March 1, 2006.

Import guidelines

The new guidelines concerning the import of medical devices makes it mandatory to make application for import and registration for the importers for which a period of 60 days would be provided from the date of publication of these guidelines. The guidelines also said that in case of devices, which have not been imported in the country before the date of notification, no import would be permitted without the approval of the competent authority. Further, in case of stents or drug eluting stents the import will not be permitted if the applicant has not sold less than one thousand stents of the particular specification prior to the date of issue of these guidelines. Such stipulations restrict the entry of new players into the devices sector.

High registration fee

The proposed registration fees of $1,000 per device is rather high and could become a burden for smaller manufacturers and also affect the available range of products in India as the sales per device are usually quite small. Also the requirement for imported devices to conform to local labelling requirements would create a logistical bottleneck for supplies while increasing the cost of surgical products. The domestic medical equipment industry and the multinational players mainly import the devices.

Mr Mishra said that the Government should consult with the industry on the pros and cons of the guidelines. The medical devices market, which is showing a double-digit growth of around 10 to 15 per cent is essential for supporting the rapidly growing healthcare and medical tourism industry; and it needs Government support for higher penetration levels in the country. This could be done through increasing the affordability of healthcare, increased awareness on healthcare and improved hospital infrastructure.

Product testing

Though there is a need for regulation in India as globally all medical devices undergo stringent quality norms, he said that the Government should first establish required infrastructure to undertake product testing in India, certification and quality standard evaluation to ensure quality of products imported.

The industry too needs time and funds to recruit and train competent personnel for the task of collating the required data and creating files for submission.

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