QUALITY SAFETY AND EFFICACY OF DRUGS

There is considerable variations in the capacity to ensure the quality, safety and efficacy of drugs in the local market. Inadequacies are there in

1. The drug legislation and regulation

2. Inspection and enforcement

3. Standards for quality, safety and efficacy

4. Use of a standard certification scheme

5. Information management and exchange

6. Training

7. Consumer involvement

Emphasis should be given to:

* Fundamental role of drug registration, inspection and enforcement.

* The need for adequate human, financial and organisational resources.

* Training in areas such as standards for quality, safety and efficacy.

* Good manufacturing practice

* Drug evaluation

* Standards of drug information

* Effective communication among various agencies.

ACCESS TO DRUGS

* Affordability should be promoted through generic drug policies, social and community schemes and creation of incentives for improving access in under-served areas.

* Ensure effective procurement systems in the public sector.

* Analyse the cost effectiveness of health care interventions, including the economic analysis of individual pharmaceutical products, where ever it is appropriate.

* Support the efforts to make affordable essential drugs available to low income and other target populations.

* Information should be exchanged on prices, pricing mechanisms and policies, performance of manufacturers and suppliers of Essential drugs and raw materials, pattern of drug use and economic analysis.