According to Catch News, the cabinet has decided to withdraw the bill, which came as an amendment to the original 1940 Drugs and Cosmetics Act, as the amendment has meant the country is unable to regulate the latest industry developments appropriately in such areas as “stem cells, regenerative medicines, medical devices and clinical trials under the law”.
The cabinet is now in the process of drawing up new legislation, which is set to particularly clarify regulation requirements for the medical devices market, and separate their regulation from that of cosmetics more generally.
Looking ahead, Catch News reports that the Drug Controller General of India will be the central licensing authority for cosmetics, drugs and medical devices.
It will control the issuing, licensing, suspension and cancellation of licences for the import, export and manufacture of products, and regulate the standard quality expected from them.
For those products which fall below minimum standards, the new bill is set to also specify conditions under which they will be considered misbranded, adulterated or spurious, and outlines the penalties for these breaches.
Starting from scratch
Wider consultations have been recommended for the formulation of the new legislation, and the Ministry of Health is expected to hold various sessions with interested groups and departments.
The cabinet has made clear that the incoming legislation will be in the form of a new bill rather than an amendment, in order to be able to address current industry demands fully.
"The Cabinet has, keeping in view the role of the sector in managing public health, decided that it will not be appropriate to carry out further amendments in the present Act," it confirmed in a statement.