The Central Drugs Standard Control Organisation (CDSCO) has issued guidelines to address minor drug violations, allowing pharmaceutical companies to pay fines and take self-corrective actions instead of appearing in court, promoting easier business compliance.

About

• CDSCO is the National Regulatory Authority (NRA) of India, under the Directorate General of Health Services, Ministry of Health & Family Welfare.
• Headquarters: FDA Bhawan, Kotla Road, New Delhi and it also has 6 zonal offices, 4 sub-zonal offices, 13 port offices, and 7 laboratories across the country.
• CDSCO operates under the Drugs & Cosmetics Act, 1940 and Rules, 1945, ensuring safety, efficacy, and quality of drugs and cosmetics.
• CDSCO jointly with state regulators grants licenses for critical drugs such as blood products, IV fluids, vaccines, and sera.

Functions of CDSCO:

• Approve drugs for manufacture, import, and marketing.
• Regulate and monitor clinical trials in India.
• Lay down and enforce standards for drugs and cosmetics.
• Control quality of imported drugs.
• Coordinate with State Drug Control Organisations for uniform enforcement.
• Grant licenses for specialised and critical drugs jointly with states.
• Ensure patient safety, public health, and ethical standards in medical products.