This discussion theme is in continuance to our first discussion titled ‘Health System in India: Bridging the Gap between Potential and Performance’. To review what others have commented on this subject earlier in the first discussion, visit our Blog.

How can we maximize health returns through strengthening Regulation of Drugs, Food and Medical Practice?

1. Issues

1.1. Irrational prescription practices for drugs and diagnostics leads to overuse and wastage, as well as drug resistance.

1.2. Aggressive marketing and promotion activities of pharmaceutical companies augment irrational use of drugs.

1.3. There is concurrent jurisdiction of the Centre and States over drug regulation leading to dilution of accountability.

1.4. There are no regulations to control the sale and consumption of unhealthy foods in the population, particularly among children.

1.5. There is a lack of regulation to address the deficit of doctors in rural areas.

1.6. Irrational practices in clinical care continue because of non-adoption of standards of care and limited adoption by States of the Clinical Establishments Act (CEA).

2. Suggestions

2.1. The Standard treatment guidelines should be completed, widely disseminated, mandated and followed to promote rational prescription practices.

2.2. There should be effective enforcement of the guidelines on sale and prescription of drugs, especially antibiotics.

2.3. A mandatory code for identifying and penalizing unethical promotion by pharmaceutical companies is required to be developed.1 This includes legislation requiring drug companies to disclose payments made to doctors for research, lectures, consulting, travel and entertainment that may lead to conflicts of interest.

2.4. Systems of drug regulation need to be reformed since it is under the overlapping jurisdiction of Centre and States.

2.5. Suitable regulation to prevent the sale and consumption of unhealthy foods, particularly among school going children, must be in place.

2.6. There should be an appropriate regulatory mechanism to ensure compulsory rural service by medical graduates.

2.7. The conflict of interest arising due to private practice by Government doctors must be addressed through appropriate regulation.

2.8. The adoption and implementation of the Clinical Establishments Act which includes registration, standards of care, patient rights and grievance redressal mechanisms must be encouraged. Provisions to ensure these regulatory measures may be suitably incorporated into the MoU signed by States with the Centre.

2.9. Prescription audits may be undertaken by professional councils and faculty in medical colleges to ensure clinical decision making complies to evidence based protocols for care, thereby protecting patients from irrational practices.