The government may soon come out with a set of Good Manufacturing Practice (GMP) norms for regulating manufacture and imports of medical devices used in the clinical as well as therapeutic areas in the country. The norms, which are recommended by the Regulatory Committee constituted last year for preparing a draft of code for approval of medical devices, would most likely replace the Schedule M (2) of the Drugs and Cosmetics Act.
The Committee report, which was submitted recently to the Union Ministry of Health through the Drug Controller General of India (DCGI), has listed out around 1800 products classifying into different groups by which the manufacturing and quality standards, the regulations, testing and analysis have been defined.
However, the informed sources said that the government has yet to resolve the issues like defining the products to fit into the framework of Drugs & Cosmetics Act, appointment of suitably qualified officers for implementing medical device norms and also recognition of testing laboratories.
The Regulatory Committee headed by B B Sharma, former Commissioner, FDA, Maharashtra, had other members like Dr. M Venkateswarlu, Deputy Drug Controller (India), West Zone, S P Adeshara, Commissioner, Food and Drug Control Administration, Gujarat, Anand Rajashekhar, former Food and Drug Controller, Karnataka, K Bhargava, Sr. Drug Inspector, CDSCO (West zone). The Committee has identified the medical devices to be put under regulatory control in the order of very critical, critical and semi-critical.
Broadly, these products 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. Though there are standards set by the Bureau of Indian Standards (BIS) for almost all these products to ensure the manufacturing quality, the sources close to the technical committee, confirmed that since these devices are used in the clinical applications, the safety and therapeutical accuracy have to be tested and approved exclusively as it is followed in case of drugs.
"A lot of other factors have also to be considered and incorporated in the regulatory framework as the engineering (mechanical, electronic) and other scientific aspects are also to be looked after before evaluating the safety and manufacturing standards for these devices to be granted licence for manufacturing and marketing," the officials said.
However, the regulatory guideline according to the report will be submitted to the Drug Consultative Committee (DCC) for further discussion soon and thereafter to the Drug Technical Advisory Committee (DTAB) for final implementation, the sources said.
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 devises, inhalers etc used for healing under regulatory mechanism.