Context

• India's apex drug regulator, the Central Drugs Standard Control Organisation (CDSCO), has flagged over 50 commonly used drugs, including household names such as paracetamol and the antacid Pan D, for failing to meet safety and quality standards.
• Several pharmaceutical companies have denied responsibility for producing the drugs flagged under CDSCO quality tests.

Central Drugs Standard Control Organisation (CDSCO)

• The Central Drugs Standard Control Organization (CDSCO) is a major regulatory body for drugs, cosmetics and medical devices in India. This organization ensures that all drugs and medical devices sold in India are safe and effective.
• Nodal Ministry: National Regulatory Authority (NRA) of Ministry of Health and Family Welfare.
• Establishment: Under the Drugs & Cosmetics Act,1940 and rules 1945
• Objective: To protect and promote public health in India
• Headquarters: New Delhi

Main Functions:

• Registration of drugs: CDSCO evaluates new drugs before they are released to the market and ensures they are safe and effective.
• Quality control: CDSCO conducts regular inspections to ensure quality in the production and distribution of drugs.
• Monitoring safety of drugs: CDSCO monitors the safety of drugs after they are released to the market and has a system for reporting any side effects.
• Regulation of cosmetics: CDSCO ensures the quality and safety of cosmetics.
• Regulation of medical devices: CDSCO ensures the safety and effectiveness of medical devices.

Powers:

• Registration of new drugs: CDSCO evaluates the quality and safety of any new drug before bringing it to the market. No drug can come into the market without the approval of CDSCO.
• Testing of quality of drugs: CDSCO collects samples of drugs and tests them. This ensures that the drugs are in accordance with the prescribed standards.
• Determination of drug prices: In some cases, CDSCO plays a role in determining the prices of drugs, especially essential drugs.
• Restrictions on advertising of drugs: CDSCO can ban misleading advertising of drugs.
• License suspension or cancellation: If a pharmaceutical company violates the rules, CDSCO can suspend or cancel its license.
• Regulation of cosmetics and medical devices: CDSCO also regulates the production and sale of cosmetics and medical devices.