Regulator warns against careless use of antibiotics, Pg14

Key Highlights:

• The Central Drugs Standard Control Organisation (CDSCO) has issued a warning against the indiscriminate use of painkillers and antibiotics.
• The regulator highlighted the associated risk of kidney damage from such practices.
• A circular dated September 21 emphasized that these drugs should only be sold on the prescription of a registered medical practitioner.
• Painkillers and antibiotics are regulated under the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945.
• The public was advised to avoid self-medication with antibiotics, especially for conditions like uncomplicated viral infections where they are not clinically indicated.

Detailed Insights:

• The CDSCO functions as India's primary regulatory body for pharmaceuticals and medical devices, ensuring their safety and quality.
• The warning specifically targets Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), a common type of painkiller, and antibiotics.
• Indiscriminate use of antibiotics is a major contributor to Antimicrobial Resistance (AMR), a growing global health crisis.
• The Drugs and Cosmetics Act, 1940 and its subsequent Drugs Rules, 1945, govern the manufacture, sale, and distribution of drugs in India.
• The Drugs Rules, 1945 classify drugs into various schedules, with Schedule H drugs, including many antibiotics and painkillers, requiring a prescription.

Key Concepts Involved:

• Central Drugs Standard Control Organisation (CDSCO): India's national regulatory authority for drugs, medical devices, and cosmetics, ensuring their safety and quality.
• Non-Steroidal Anti-Inflammatory Drugs (NSAIDs): A class of medications used to reduce pain, fever, and inflammation.
• Antimicrobial Resistance (AMR): The ability of microorganisms to resist antimicrobial drugs, making infections harder to treat.
• Drugs and Cosmetics Act, 1940: The primary legislation regulating the import, manufacture, distribution, and sale of drugs and cosmetics in India.
• Drugs Rules, 1945: Rules framed under the 1940 Act, classifying drugs and governing their sale, storage, and prescription.