Draft for the 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 has been released by the Union Health Ministry.
The bill is set to be proposed in the Budget Session of Parliament by the
Department of Health and Family Welfare, which is expected to commence in the
last week of February. The Bill is currently placed in public domain to
elicit comments and views of the stakeholders including the general public,
which 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 that was introduced in the
1940's 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
The Bill intends to include a separate chapter on clinical trial, Chapter 4A,
according to which "No person, sponsor, clinical research organization or any
other organization 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, bio-availability
or bio-equivalence study of any new drug, in human participants except under,
and in accordance with, the permission granted by the Central Licensing
Authority in such form and manner as may be prescribed".
The Bill also proposes another major amendment in the medical devices sector,
which states, "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 proposed 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 license
shall be such as may be prescribed."