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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 functions:

  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
    • it meets real medical need,
    • it is therapeutically effective, and
    • it is acceptably 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 rational prescribing.
  6. To ensure that appropriate information about registered pharmaceuticals is made available for the guidance of consumers having regard to:
    • the adverse consequences of non-compliance by patients particularly in the case of antibiotics, steriods etc.,
    • dangers of self-medication, and
    • 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 include:

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, centralizing all manufacturing licencees 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 Laboratories.

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.

Indigenous and Other Systems of Medicines

21. Various aspects relating to development and promotion of Ayurvedic, Unani, Sidha, Homeopathic and traditional systems of medicines would be actively pursued and the machinery for carrying out these tasks would be adequately strengthened. To provide better focus to this important work it is felt that there is need to create a separate Department, to look after all matters relating to development and promotion of these systems of medicines.