Even as a comprehensive bill to regulate the medical devices bill is stuck up without any progress, the Health Ministry is planning to amend the Drugs and Cosmetics Rules to introduce certain provisions relating to medical devices and diagnostic reagents.

The Ministry will frame draft rules in respect of labelling, manufacturing, shelf life and other matters relating to medical devices and publish them for seeking feedbacks from the stakeholders, before putting them into effect, sources said.

The medical devices were notified under the Drugs and Cosmetics Rules in 2005 for regulating their quality in the country under the D&C Rules. However, many specifics like the manner of labelling, qualifications of competent person to manufacture and test these devices, shelf life etc. are missing.

Apart from these, provisions for the standards on quality management systems and exemptions for custom made devices for their import are also being proposed to be incorporated under the D&C Rules for having proper quality control over medical devices.

“These issues were deliberated by a committee having experts from the medical device industry, regulatory authorities and clinicians who use such devices. The committee had made recommendations in respect of amendments that are required to be made under the D&C Rules, so as to have an effective control over the quality of medical devices,” sources said.

The DTAB recently gave a go-ahead to the proposal for amending the D & C Rules, taking into consideration the pressing requirements on the subject and also based on the recommendations of the expert panel. The highest technical advisory panel however suggested that these draft rules should be published in the public domain for comments.

A bill seeking to lay down separate provisions for medical devices and formation of a regulatory authority has been pending for many years now. The bill was expected to provide a separate definition of medical devices, their risk based classification for regulatory control, clinical trials, conformity assessment procedures, penal provisions, etc. Though the Centre circulated the bill, many states expressed reservation on the same.