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Source: The post is based on the article “Scarred terra pharma: Gambia tragedy needs sharp regulatory response” published in The Times of India on 8th October 2022.
Syllabus: GS 3: Changes in industrial policy and their effects on industrial growth.
Relevance: About India’s pharma sector.
News: Followed the death of 66 children, the WHO issued an alert on four cough syrups manufactured and exported by Haryana-based Maiden Pharmaceuticals to Gambia.
What is the issue?
|Must Read: Cough syrups exported only to the Gambia, finds CDSCO probe|
What are the implications of the Gambia issue on the Indian pharma sector?
Earlier, Ranbaxy falsified drug data and systemically violated good manufacturing practices and laboratory practices. Indian pharma’s global reputation is once again, after Ranbaxy, at risk.
What are the issues associated with the Indian pharma sector?
State drug controllers tasked with licensing and monitoring manufacturing units and quality control are not functioning effectively. If a drug fails a quality test in one state, the obvious thing to do is suspend the manufacturing licence in the state where it is located till a clean-up.
The Haryana drugs controller certified Maiden as compliant with WHO-Good Manufacturing Practices, making it eligible for exporting drugs. But central regulator CDSCO is now answerable to WHO for the failures.
|Read more: Drug Regulations in India – Explained, pointwise|
What should be done to regulate the Indian pharma sector?
Penalties without deterrent effect will not nudge offenders to reform. So, the Centre’s new drugs and cosmetics bill to replace the colonial-era law must be reconfigured with learnings from this tragedy and embarrassment.
A rigorous regulatory regime is needed to ensure India remains the pharmacy of the world and provides affordable medicines to the poorest sections of society also.