The Ministry of Health and Family Welfare has invited feedback on the draft Drugs and Cosmetics Bill and has inserted new chapters to expand the scope and the areas which 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”.
Further, the Centre would need to frame rules for clinical trials in consultation with the relevant drug advisory bodies.
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.
According to a separate chapter on clinical trial, Chapter 4A, bill proposes “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”.
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”.