More medical devices may fall under the category of drug in the country as the subcommittee, formed to set up standards for 10 notified medical devices, plans to recommend the authority to notify devices including orthopaedic implants as drugs. The committee has identified three drug-testing laboratories in the country to be upgraded for testing standards of the medical devices.

The subcommittee may recommend the Union Health Ministry to notify devices including stents other than drug eluting stents, catheters and orthopaedic implants as drugs, in order to smoothen the preparation of Schedule M standards for the already notified devices. According to the revised Schedule M norms, the premises for manufacturing drug products should not be used for any other manufacturing activities unless it is not in the same category.

The subcommittee members are planning to visit various manufacturing facilities in a month's time to finalise the list of fresh devices to be added in the drug list. "The idea to add more devices into the list is in our mind and the decision may vary according to the progress of our analysis on the issue. Though we think that a number of devices have to be added, it would be finalized only after our visit to the manufacturing facilities of various medical devices," said an official from the subcommittee.

In the first meeting of the subcommittee, in early April, the Drug Controller General of India (DCGI) had identified Sree Chitra Thirunal Institute of Medical Science and Technology, Thiruvananthapuram, Kerala to upgrade to the laboratory facilities for testing medical devices. The Central Drug Testing Laboratory, Guwahati, under Central Drugs Standard Control Organisation (CDSCO) and the Drugs Control Laboratory, Maharashtra Food and Drug Administration (FDA) had also voluntarily agreed to add the testing facilities with the existing facility.

Sources said that facilities in more labs would be upgraded for testing standards of medical devices at a later stage on need basis. "We have not started inviting applications for granting license to the medical devices at present. The process of upgrading more labs will be executed in the areas where more number of license applications get filed," the official told Pharmabiz.

The second meeting of the subcommittee is scheduled in mid July mainly to analyse whether the Schedule M should be revised for setting standards for sterile devices. The subcommittee will take further steps by accepting the definition of medical implants as in the medical dictionary and at a later stage will come up with a definition for 'implants'.

As Pharmabiz reported earlier, the sub-committee was constituted with officials from Central Drugs Standard Control Organisation (CDSCO) and various state drug control offices to set standard for Good Manufacturing Practices for the notified medical devices, and to take care of setting rules for testing and qualification of technical staffs both in production and testing process.