Topic: Effects of liberalization on the economy, changes in industrial policy and their effects on industrial growth.
5. Although the Indian pharmaceutical industry has emerged as the third global producer in the generic medicine manufacturing, many regulations are still archaic. Elaborate on the reforms needed in the pharmaceutical industry to meet the present-day needs. (250 words)
Difficulty level: Tough
Reference: Live Mint
Why the question:
According to the Economic Survey of 2020-21, the Indian pharmaceuticals sector is expected to expand multi fold and become a $ 130 billion industry by 2030
Key Demand of the question:
To have a good understanding of the shortfalls in the present regulatory system in the pharmaceutical industry and to suggest adequate measures to address the issues.
Directive word:
Elaborate – Give a detailed account as to how and why it occurred, or what is the context. You must be defining key terms wherever appropriate and substantiate with relevant associated facts.
Structure of the answer:
Introduction:
Begin by highlighting the great potential of pharmaceutical industry in the generic medicine category for India.
Body:
First, mention the shortfalls in the current regulatory mechanism in the pharmaceutical industry.
Next, give a point by point analysis of major areas of reforms needed such as revising the age old The New Drugs, Cosmetics and Medical Devices Act, need to bring in a regulatory structure in the context of e pharmacy and teleconsultations, better clarity in the issue of Licenses as per Drugs and Cosmetics Act (DCA) of 1940 etc.
Conclusion:
Conclude by saying that India should focus on a comprehensive, clear and concise regulatory structure meeting the needs of the new age pharmaceutical industry.
