Over 2,000 cough syrup brands: Can regulators ensure they’re safe?, Pg15

Key Highlights:

• India has over 2,000 manufacturers of cough syrups, with sales reaching ₹6,670 crore in May alone.
• Contaminated cough syrups have been linked to child deaths both in India and internationally.
• The Health Ministry has tightened regulations, mandating prescriptions and restricting sales to licensed chemists.
• The Central Drugs Standard Control Organisation (CDSCO) and state regulators inspected 960 companies, leading to 860 actions including production halts and license cancellations.
• A Tamil Nadu-based firm, implicated in the deaths of 22 children in Madhya Pradesh, was not on CDSCO records.

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Detailed Insights:

• The fragmented regulatory ecosystem, with 37 state/UT regulators and the CDSCO, poses a significant challenge to quality control.
• There is a lack of a consolidated database for licensing, inspection, and marketing information across central and state authorities.
• Smaller manufacturers often source propylene glycol from the open market, increasing the risk of contamination with industrial-grade solvents.
• Non-compliance with Good Manufacturing Practices (GMP) is a major concern, as companies are legally required to test raw materials.
• State drug controllers face limitations in inspecting manufacturing units located in other states, hindering effective enforcement.
• India's pharmaceutical industry is facing reputational damage globally due to recurring quality control issues in its products.

Key Concepts Involved:

• Central Drugs Standard Control Organisation (CDSCO): India's principal regulatory body responsible for ensuring the quality and safety of drugs and medical devices.
• Good Manufacturing Practices (GMP): A system ensuring that products are consistently produced and controlled according to quality standards appropriate for their intended use.
• Propylene Glycol: A common solvent used in pharmaceuticals, cosmetics, and food products, which can be a source of contamination if industrial-grade is used.
• Risk-based inspection: A regulatory approach that prioritizes inspection of manufacturing units based on their potential for non-compliance or risk to public health.