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Regulation Of Medical Devices

Neesha Patel

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In 2004, Dr Narendra Bansal’s use of unapproved and untested stents, marketed by a Netherland-based company Occam, on 60 patients at JJ Hospital provoked an intense inquiry into the nature of devices used on patients and the nominal jurisdiction of the medical device industry in India. Alarmed by the large-scale use of illegal and unapproved medical devices in the country, the Department of Medical Education and Research (DMER) banned use of unapproved stents and stated that all medical devices required approval in the country of manufacture or US Food and Drug Administration (FDA)/CE certification. In 2004, Mashelkar Committee called for the creation of a specific medical devices division within the Central Drugs Standard Control Organisation (CDSCO) to address the management, approval, certification and quality assurance of all medical devices. This involved changing the status of sterile medical devices intended for internal or external use to medical drugs and consequently making suitable provisions and amendments in the Drugs and Cosmetics Act, 1940. This was approved by the Drugs and Consultative Committee (DCC) in July 2005 and henceforth, all devices were licensed for manufacture, distributed and sold by the CDSCO with special evaluation committees constituted to ensure manufacturing units were GMP?? compliant.

In a gazette notification, the Ministry of Health and Family Welfare (MOHFW) stated that 10 devices; namely cardiac and drug eluting stents, catheters, bone cement, heart valves, scalp vein sets, orthopedic implants, internal prosthetic replacements, IV cannulae and intraocular lenses; would be considered as drugs and consequently regulated.

Current Regulation & Its Implications

The Drug Controller General of India (DCGI) formulated guidelines for the import and manufacture of medical devices in the country to be effective from March 1, 2006; a date that was later changed to June 29, 2006. Says Pavan Choudhary, MD, Vygon India and Chairman of the European Business Healthcare Group, “The change of deadline will definitely make a difference, as new guidelines are expected shortly. This will give companies adequate time to prepare and file the papers for registration well before the next deadline.”

As Per The Guidelines

Ten categories of sterile devices declared as drugs under the Drugs and Cosmetics Act will be imported to India under the procedure for registration and import license as prescribed by the same. The DCGI has set up separate committees for evaluation and formulation of standards for conformation, for specific categories of devices. An importer will be permitted to submit the US FDA clearance, the European Union medical device directive and similar approvals from other countries for proof of quality. For granting of licences to locally manufactured devices with no benchmark certification, the DCGI will set up expert committees for evaluation. The State Licensing Authority (SLA) and the Central License Approving Authority will verify the recommendation of the committees. DCGI has also specified that all importers, stockists and retailers of medical devices will have to obtain sale licences from the SLAs within a period of three months. Devices that are not imported into the country by the date of notification are not permitted without the approval of competent authority. In the case of stents (specifically drug eluting stents) imports are permitted only if the applicant has sold more than 1,000 stents of the particular specification prior to the date of issue of these guidelines.

Such stipulations consequently restrict the entry of new players into the sector and have caused severe speculation in the industry. Experts predict that these guidelines will adversely hit patients, as medical device players might have to stop importing devices into the country to comply with the legal situation that demands the registration of each medical device within 60 days since March 1, 2006. Since 80-90 per cent of all medical devices are imported, non-import may lead to scarcity of crucial life-saving devices. According to Philips Medical Systems CEO and Immediate Past Chairman of CII, Medical Equipment Division, Anjan Bose, “It is a catch 22 from a patient’s perspective – we need to give patients high quality and regulated devices. However, in the effort to attain this goal, patients should not be denied the availability of life- saving devices.”

An issue predominantly associated with smaller medical device companies is the lack of awareness regarding medical device regulations and the extended deadline. According to Alok Mishra, CII Chairman, Medical Equipment Division, “There are still a lot of problems as many device companies are simply not aware of the deadline. Regulations with such vast implications should be widely communicated.”

The writer is Mumbai-based research analyst.

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