D&C Rules On Labeling Norms, Shelf Life Of Medical Devices

The Centre is expected to further streamline the medical devices sector by suitably amending the norms on labeling, qualification for supervision of manufacturing of devices, quality standards and shelf life under the Drugs and Cosmetic Rules.

Though a Bill to amend the Drugs & Cosmetics Act by including a whole chapter on the medical devices sector is under the scrutiny of the Parliamentary panel after tabling it in the Rajya Sabha, the government has already drafted some amendments to the D &C Rules regarding labeling and quality standards.

Provisions of Rule 76 will be changed to specify the qualification of those supervising the manufacturing of medical devices. A graduate in pharmacy or engineering in appropriate branch with 18 months experience in manufacturing or testing of devices, a graduate in physics, chemistry or microbiology with three years experience, and a diploma holder in pharmacy/engineering with four years service will need to supervise the manufacturing of devices.

According to the draft rules, the shelf life of the medical devices shall not exceed 60 months from the date of manufacturing.

According to the draft under Schedule R-1, “The medical devices shall conform to the Indian standards laid down from time to time by the Bureau of Indian Standards (BIS). If there are no BIS standards then, it shall conform to the international standards like International Organisation for Standardisation (ISO), or other International Pharmacopoeia Standards and such other standards as may be prescribed. In case national or international standards are not available, the device shall conform to the manufacturer’s validated standards”.