National Drug Authority
16. In view of the above it is envisaged that a National Drug Authority may be set up by a separate Act of Parliament to perform the following
(1) Develop and define basic appropriate standards relating to the manufacture, import, supply, promotion and use of drugs.
(2) To approve and register pharmaceutical products for use in the country only if
(a) it meets real medical need,
(b) it is therapeutically effective, and
(c) it is acceptable safe
(3) To enforce effectively appropriate quality standards of medicines and Good
Manufacturing Practices, throughout the country, having full regard to the
needs of public health and standardize dosage strengths and pack sizes of
formulations with a view to check proliferation.
(4) To monitor standard practices in drug promotion and use and to clearly identify those
which are acceptable and prohibit those which are unethical and against
the consumers' interest.
(5) To monitor the prescribing practices and to evaluate their appropriateness for the
purpose of guiding the medical profession and for achieving the aim of
(6) To ensure that appropriate information about registered pharmaceuticals is made
available for the guidance of consumers having regard to;
(a) he adverse consequences of non-compliance by patients particularly in the case of
antibiotics, steriods etc.,
(b) dangers of self-medication, and
(c) the need to involve consumers as full partners in the health care system
(7) To prepare and publish a national formulary and formularies relevant to various
levels (like district hospital, community centre, primary health centre)
for the guidance of consumers as well as doctors.
17. The functions mentioned above involve new responsibilities which will
Special focus on examining the technology of bulk drugs; capacity validation of machinery;
assessing suitability of manpower for bulk drug production; undertaking
scientific scrutiny of master formulae for manufacture of formulations;
developing testing labs for cosmetics, diagnostics and devices; laying
down standards for veterinary drugs; examination of labels and promotional
claims and prescribing procedures for public hearing under the Drugs and
Cosmetics Act; monitoring of clinical trials for the protection of human
rights; quality control of herbal medicines; updating new drug approval
process; weeding out of irrational combination formulations; and formation
of expert committees for examination of new drugs.
18. In addition, screening promotional literature, monitoring ongoing clinical trials
through an Institutional Review Board, unearthing sub-standard and
spurious drugs with the help of Legal cum Intelligence Cells, centralising
all manufacturing licensees for inter-State commerce, updating Good
Manufacturing Practices and education to achieve judicious use of drugs,
setting up of new analytical testing labs, as well as imparting continuous
education and skills for inspection and testing and setting up of Dispute
Mechanism Cell are envisaged.
19. There is an imperative need to undertake upgradation of the drug testing facilities
under the Central and State organizations as well as augmentation of the
Drug Control and enforcement staff to enable statutory inspections to be
undertaken as provided for under the Act. Therefore, there is need for
establishing more zonal and sub-zonal offices under the Central Drug
Standards Control Organization as well as additional Regional Drug Testing
20. The implementation of the above proposals would require additional funds,
which are proposed to be mobilized by levying a cess of 1% on production
of drugs and pharmaceuticals, by a special legislation to be piloted by
the Ministry of Health and Family Welfare. The funds mobilized through the
cess would be utilized also for encouraging Research and Development in
the drug sector.