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Part III – Rational Use of Drugs

3.1 Registration of new formulations, rationalization of existing formulations and creation of a National Drug Authority.
New formulations based on drugs already approved for use in the country would not be allowed to be manufactured unless their therapeutic efficacy and rationality are adequately tested and proved. A machinery to be called the National Drug & Pharmaceutical Authority would be established at the Central level, with a permanent secretariat.

3.2 Registration of new drugs
With a view to exercise closer scrutiny over the introduction of new drugs in the country, the Drugs and Cosmetic Rules will be amended to define clearly a new drug and to give statutory basis to the detailed guidelines which would be drawn up for the scrutiny and approval of new drugs.

3.3 Standardisation of packaging
With a view to ensuring the proper dispensing and use of drugs, statutory guidelines for packaging instructions would be laid down. Colour coding of packs would be insisted upon to differentiate products according to the degree of hazard. Packs would also be standardised.

3.4 Monitoring of adverse reaction
During the VII Five Year Plan, Central and peripheral units would be set up to monitor adverse drug reactions. It is also proposed to develop a Central Information Bank on the safety, efficacy, prescription and use of all drugs.

3.5 Use of generic name
Pending a final decision by the Supreme Court, permission is being granted for marketing single ingredient formulations of new drugs subject to the following conditions that the generic (Proper) name should be displayed in double the size of the trade (brand) name both in equally bold letters. Generic names will be progressively adopted in the case of all drugs included in the list of essential drugs.

3.6 Apart from the allopathic system of medicine, it is also proposed to encourage and improve upon the traditional system of medicine with a view to widening the coverage of health care schemes of the government. It is a recognized fact that large portions of our population, specially those in the rural areas, prefer to use the traditional Indian system of medicine, both for reasons of faith as also lack of access to the modern medicines; Ayurveda, Unani and Siddha systems of medicines have been practised in this country for several centuries. However, there is no uniformity in the methods of preparation of the Compound drugs in use in these systems, identification of ingredients and their composition. In order to bring about some uniformity and standardisation, Ayurvedic, Siddha and Unani Pharmacopoeial Committee constituted by the Government of India are bringing out “National Formularies”. The Formularies indicate the ingredients with their scientific names, the proportions in which these drugs are used and the method of preparation. This is the first phase for the standardisation work before finalising pharmacopoeial standards. The Pharmacopoeial Committees have now simultaneously taken up the work of evolving of standards in respect of single ingredient drugs used in these systems.

3.7 It is proposed to speedily evolve pharmacopoeial standards in respect of the drugs in these systems and also to enlarge and reactivate drugs testing facilities in each State in order to ensure quality control. It is also proposed to take steps for ensuring steady and regular availability of raw material for the growing pharmaceutical industry in the Indian systems of medicine both to meet internal as well as export demands.