Antidote To Drugs, Pg6

Key Highlights:

• A counterfeit medicine racket was recently busted in Bengaluru, Karnataka.
• Fake drugs, including cancer medications and injections used in ICUs, were supplied to over 90 hospitals and clinics across the state.
• An unlicensed farmhouse near Bidadi was found repacking expired and fake drugs, altering expiry dates, and selling them as expensive branded products.
• The seized consignment of illicit drugs was valued at ₹5 crore.
• A Special Investigation Team (SIT) has been formed to investigate the wider network involved in the scam.

Detailed Insights:

• The illicit operation involved selling relabelled drugs at massive discounts, indicating a thriving network before the bust.
• The scam highlights critical patient safety concerns, especially for life-saving and time-sensitive medications.
• The incident underscores India's challenges in maintaining stringent monitoring and quality control, impacting its aspiration to be the "pharmacy of the world."
• The Drugs and Cosmetics Act, 1940, governs the import, manufacture, distribution, and sale of drugs in India, aiming to ensure their safety, efficacy, and quality.
• The Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health & Family Welfare, serves as the national regulatory authority for drugs and medical devices.
• Recent government initiatives include risk-based inspections of drug manufacturing units and the revision of Schedule M for Good Manufacturing Practices (GMP).
• Mandatory QR codes for tracking and tracing top drug brands and Active Pharmaceutical Ingredients (APIs) have also been introduced to enhance supply chain integrity.
• Persistent issues include inadequate drug testing infrastructure, a shortage of drug inspectors, and gaps in enforcement, which contribute to the prevalence of counterfeit medicines.

Key Concepts Involved:

• Counterfeit Drugs: Medicines deliberately mislabelled or falsely presented, encompassing spurious, adulterated, or misbranded products.
• Drugs and Cosmetics Act, 1940: The foundational Indian legislation regulating the import, manufacture, distribution, and sale of drugs and cosmetics.
• Central Drugs Standard Control Organization (CDSCO): India's national regulatory body responsible for ensuring the safety, efficacy, and quality of drugs, cosmetics, and medical devices.
• Good Manufacturing Practices (GMP): A system ensuring that products are consistently produced and controlled according to established quality standards.