The Central Drug Authority of India (CDAI) is the principle for the licensing for drugs and cosmetics.
The
Drugs and Cosmetics (Amendment) Bill, 2007 seeks to replace the Drugs
Technical Advisory Boards for allopathic and Indian systems of medicine
with the Central Drugs Authority (CDA). Drug consultative committees may
be established to advise the CDA and central and state governments.
The
CDA shall be the licensing authority for the manufacturing,
distribution, sale, import and export of drugs and cosmetics. It shall
also recommend to the central government standards for drugs and
cosmetics, measures to regulate clinical trials, etc.
The
2007 Bill expands the definition of “drugs” to include medical devices.
It also defines “clinical trial”, states that all clinical trials
require the approval of the CDA, and prescribes penalties for any person
violating this provision.
The
Standing Committee has submitted its recommendations on the 2005 Bill.
It recommended enhanced penalties for spurious and adulterated drugs
that lead to prolonged illness. It also suggested separate courts for
trying offences under the Act.
The
CDA shall be the licensing authority for the manufacture, sale or
stocking of drugs and cosmetics. Currently, these functions are
delegated to state governments.
The
2007 Bill does not mandate medical and scientific experts in the CDA. A
member can be any person with special knowledge of and a minimum of 15
years professional experience in the pharmaceutical industry, public
administration, finance or law.
Based
on the above Amendment, Recently on the RajSabha T.V had called for the
panel discussion of the expert committee. Dr.Sunil Kumar Jain, Chief
Pharmacist, AIIMS, Vice-President IPA, New Delhi and R.Narayaswamy,
Former Deputy Drug Controller of India, President of IPA, Tamil Nadu.
