Cough syrup deaths: CAG flagged shortfall in TN drug tests last year, Pg9.

Key Highlights:

• A CAG report in August 1, 2024, revealed that Tamil Nadu's drug regulator consistently missed inspection and sample collection targets between 2016-17 and 2020-21.
• Drug inspectors only conducted about 61% of scheduled drug inspections and collected approximately 49% of required samples for quality testing during this period.
• The Centre has directed "risk-based inspections" in 19 manufacturing units across six states following the death of 22 children in Madhya Pradesh due to contaminated cough syrup.
• Sresan Pharmaceuticals, manufacturer of the cough syrup, received a show-cause notice after the Madhya Pradesh drug regulator alerted its Tamil Nadu counterpart.

Detailed Insights:

• The CAG report, which was tabled in the Tamil Nadu Assembly on December 10, 2024, highlighted structural weaknesses in the state's drug regulatory ecosystem.
• Between 2016-17 and 2020-21, inspection shortfalls ranged from 34% to 40%, while sample collection deficits varied between 45% and 54%.
• The drug control department in Tamil Nadu faced a 32% manpower shortage, with only 344 personnel working against a sanctioned strength of 488.
• The incident in Madhya Pradesh led to the suspension of a doctor and three drug inspectors, prompting calls for improved regulatory oversight to prevent future tragedies.

Key Concepts Involved:

• Drug Regulator: An authority responsible for overseeing the safety, efficacy, and quality of pharmaceutical products.
• CAG (Comptroller and Auditor General of India): The constitutional body responsible for auditing the accounts of the Union and State governments.
• Risk-Based Inspections: Inspections that prioritize facilities and products based on potential risks to public health.