Establishment of a regulatory control and monitoring system for medical devices in the country is likely to get delayed as the government still finds it a complex procedure to identify the types of devices, to finalise appropriate standards, to identify laboratories for testing the devices and also to create a set of licensing and quality manufacturing rules.

Though the committee constituted by the Drug Controller General of India for preparing a draft rule, has submitted preliminary report to the DCGI early this year, it gives only broad direction towards achieving this objective. The comprehensive draft dealing with the basic criteria to identify the devices, standards and quality aspects, application profile and the licensing methods are yet to be prepared and submitted to the central authority.

At present, out of the thousands of medical devices already in use in India, just four types of devices, including disposable needles and syringes, infusion sets and blood bags and sets, have been notified as drug category for the licensing and quality control purposes. At the same time, in the list of Bureau of Indian Standards (BIS), there are about 1080 types of devices.

Even though, the DCGI had asked the Committee after accepting the preliminary report, to submit the draft by August this year, it is still not ready as the identification and the standardizing procedures are yet to be worked out. However, the Committee, comprising of the central and state drug officials, has so far picked up more than 1000 products available in the healthcare market to put under the proposed regulatory code and is currently categorising them in the order of their very critical, critical and semi-critical uses etc.

The Committee comprises of Dr M Venkateshwarlu, deputy drug controller, India (West), S P Adeshara, commissioner, Food and Drug Control Administration, Gujarat and Anand Rajashekhar, controller, Food and Drug Authority, Karnataka.

According to the Committee, the type of medical devices considered for bringing under the regulatory code broadly include the electronic as well as mechanical devices made of plastic as well as metals, which are used within the body and externally for medical and therapeutical application associated with medication.

Though there are standards set by the Bureau of Indian Standards (BIS) for almost all these products to ensure the manufacturing quality, since these devices are used in the clinical applications, the safety and therapeutic accuracy have to be tested and approved by authorized licensing authority as it is followed in case of drugs. However, most probably the Central licensing authority would only be authorized to the grant permission for manufacturing and marketing of these devices.

Currently, there are no regulations for the manufacture, imports and marketing of these products in the country. The proposed regulatory framework will put all the medical devices including hearing aids, patches, straps, electronic massaging devices, inhalers, etc used for healing under the regulatory mechanism.