The Government of India has published a draft of its Drugs and Cosmetics (Amendment) Bill, 2015, a revised and updated version of the Drugs and Cosmetics Act, 1940.
The Bill proposes to expand the scope of the 1940 Act. Its documentation outlines that it will, “regulate the import, manufacture, distribution and sale of drugs, cosmetics, medical devices and conduct of clinical trials and for matters connected therewith or incidental thereto”.
The Bill has been published on the Government’s website, placing it in public domain to invite comments and views from stakeholders and the general public. Once this stage comes to an end on January 12, the Department of Health and Family Welfare proposes to introduce the Bill in the Budget Session of Parliament, which is expected to commence in the last week of February.
The Bill proposes stringent controls regarding medical trials for drugs, cosmetics and medical devices. It states, “No person, sponsor, clinical research organisation or any other organisation or investigator, shall conduct any clinical trial in respect of a new drug, investigational new drug, notified category of new medical device and investigational new medical device, new cosmetic, bioavailability or bioequivalence study of any new drug, in human participants except under, and in accordance with, the permission granted by the Central Licencing Authority in such form and manner as may be prescribed”.
In another major amendment in the medical devices sector, the Bill proposes to introduce a Medical Devices Technical Advisory Board, which will provide guidance to the government on technical matters pertaining to new medical devices.
The Bill also aims to introduce new regulations for the import, manufacture, sale and distribution of medical devices and cosmetics.
It states, “The classification, standards, manufacturing, testing, distribution, labeling, packaging, essential requirements for quality, safety and performance, adverse events, post marketing surveillance, conformity assessment bodies, exemptions, procedure to regulate notified category of medical device, manner and conditions of licence shall be such as may be prescribed”.