‘Need to harmonise the rules with the Drugs & Cosmetics Act’

The draft Medical Devices Rules, 2016 have been framed under the existing Drugs and Cosmetics Act, 1940, although the government appears to have intended the passage of a separate Act. In their current form, these rules rely on the regulatory structure under the existing 1940 Act. However, the government has also declared its intention to overhaul the 1940 Act in a muchneeded move to strengthen drug regulatory processes. Legislative efficiency demands that these two processes work in harmony. For instance, the draft Medical Devices Rules, in their current form, confer important regulatory functions on the existing Central Licensing Authority and State Drugs Controllers under the 1940 Act. However, the functioning of these authorities has been sharply criticised and any attempt to revamp the 1940 Act ought to make significant changes to their structure.

If such changes are made, the Medical Devices Rules will also have to be updated, which seems an unnecessary duplication of legislative work. Notifying the Medical Devices Rules without having in place a new and stronger Drugs and Cosmetics Act is a bit like putting the cart before the horse.

The provisions on clinical investigation and clinical performance evaluation under the draft Medical Devices Rules must also be harmonised with the provisions on clinical trials under the Drugs and Cosmetics Rules, 1945. Currently, there are differences in both sets of rules regarding important provisions, such as the definitions of ‘serious adverse event’ and ‘academic clinical trials’ and the provision of medical management and compensation for an injury or death during such investigations/trials.

In any case, the provisions on clinical trials under the Drugs and Cosmetics Rules themselves need to be streamlined and amended. This process ought not to take place independently of the framing of equivalent provisions in the draft Medical Devices Rules. The same standards of safety must be guaranteed for clinical trial participants and users of drugs as well as medical devices.

Frequent amendments to the Drugs and Cosmetics Act and rules have already made for a very confusing regulatory framework, making a dampening effect on clinical research in India. The move to overhaul this framework is welcome, but must take place transparently and in consultation with all stakeholders so that the same mistakes are not repeated.

DHVANI MEHTA