Topic– mechanisms, laws, institutions and Bodies constituted for the protection and betterment of these vulnerable sections.
2) Discuss the role of CDSCO in protecting the interests of Indian patients? Examine how can we ensure that such gross negligence that happened in Johnson and Johnson’s case is not repeated in the future?(250 words)
Why this question
The recent findings of the expert committee constituted by Ministry of health has highlighted the case of JnJ’s faulty prosthetic devices which means there is a need to review the regulatory architecture and our response to such incidents to ensure that such incidents of gross negligence does not take place in future.
Key demand of the question
The question expects us to first explain the role of CDSCO. Thereafter, we need to explain the case to highlight where CDSCO was found wanting. We need to bring out the lacunae in India’s regulatory architecture for such approval, quality control. Finally, we need to give suggestions to ensure that such incidents do not take place again.
Discuss – Here you need to bring out the role of CDSCO and explain their linkage to this case
Examine – When you are asked to examine, you have to probe deeper into the topic, get into details, and find out the causes or implications if any .
Structure of the answer
Introduction – Explain the case due to which this issue is in news.
- Explain about the role of CDSCO – Under the Drug and Cosmetics Act, the regulation of manufacture, sale and distribution of Drugs is primarily the concern of the State authorities while the Central Authorities are responsible for approval of New Drugs, Clinical Trials in the country, laying down the standards for Drugs, control over the quality of imported Drugs, coordination of the activities of State Drug Control Organisations and providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.
- Explain the case of JnJ, where faulty prosthetics were approved, with little action being taken in the aftermath. Discuss the report of the expert committee.
- Highlight the findings of the committee which suggests ways through which such incidents can be avoided in future
Conclusion – Emphasize on the need of improving the regulatory architecture and suggest way forward.