Drug Quality Control in India: The Need for a 'Zero Tolerance' Framework
UPSC Relevance
Prelims: Indian Polity and Governance (Drug Regulation in India, Central Drugs Standard Control Organisation - CDSCO); General Science (Health, Chemicals in news - Diethylene Glycol (DEG)); Indian Economy (Pharmaceutical Industry, Atmanirbhar Bharat).
Mains:
General Studies Paper 2 (Health & Governance): Issues relating to development and management of Social Sector/Services relating to Health; Government policies and interventions; Important aspects of governance, transparency and accountability.
General Studies Paper 3 (Economy): The impact of such incidents on India's 'Make in India' initiative and its pharmaceutical export industry.
Key Highlights from the News
The problem of poor quality drugs, which tarnishes India's image as the "pharmacy of the world," is once again under discussion.
The Tamil Nadu Drugs Control Department found Diethylene Glycol (DEG), a toxic substance, in cough syrup that caused the deaths of children in Madhya Pradesh and Rajasthan.
Key problems behind this crisis:
Manufacturers using non-pharmacopoeial grade raw materials.
Failure to adhere to Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) during manufacturing.
Deficiencies in drug quality control and government-level inspections.
The article demands a shift from a reactive approach (taking action only after a disaster occurs) to strong and continuous monitoring.
The government should adopt a zero threshold approach towards poor quality drugs.
For the Atmanirbhar Bharat concept to succeed, ensuring the quality of "Make in India" products is essential.
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