The Union health ministry has released the draft Drugs and Cosmetics (Amendment) Bill, 2015 to amend the Drugs and Cosmetics Act, 1940 for upgradation and introduction of provisions for clinical trials and regulation of medical devices.
The Department of Health and Family Welfare proposes to introduce this Bill in the Budget Session of Parliament which is expected to commence in the last week of February. The Bill is placed in public domain with a view to elicit the comments/views of the stakeholders including the general public. The comments/views can be forwarded to Dr Shailendra Kumar, Director (Drugs), Department of Health and Family Welfare, latest by January 12, 2015.
The Bill proposes to expand the scope of the Act to cover new areas and 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 proposes to insert a separate chapter on clinical trial, Chapter 4A, according to which “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, “The Central Government shall, by notification, constitute a Board to be called the Medical Devices Technical Advisory Board to advise the Central Government and State Governments on technical matters pertaining to medical devices, arising out of administration of this Act and to carry out other functions assigned to it by or under this Act”.
The Bill also proposes to insert a separate Chapter on medical device, Chapter IIA, on import, manufacture, sale and distribution of notified category of medical device.
As per this chapter, “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”.