DRUG CONTROLLER GENERAL OF INDIA (Syllabus: GS Paper 2 – Governance)

Context: Recently, the Drug Controller General of India (DCGI) has instructed the manufacturers of well-known anti-flu and anti-cold combination drugs to include a warning on these formulations, cautioning against their use in infants and children under four years of age.

Drugs Controller General of India (DCGI)

• About: DCGI is the head of department of the Central Drugs Standard Control Organization of the Government of India. It is responsible for approval of licences of specified categories of drugs such as blood and blood products, IV fluids, vaccines, and sera in India.
• Ministry: Ministry of Health & Family Welfare

Functions

• Preparation and maintenance of national reference standard.
• To bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.
• Training of Drug Analysts deputed by State Drug Control Laboratories and other Institutions
• Analysis of Cosmetics received as survey samples from CDSCO.

Drugs Related Regulations in India

• The Drugs and Cosmetics Act: The primary purpose of these regulations is to oversee and regulate drugs and cosmetics within the country.
• Scope: These guidelines pertain to the issuance of licenses for the production of Ayurvedic, Siddha, and Unani medicines.
• Mandatory Compliance: Manufacturers are obligated to conform to specified criteria for both licensing manufacturing units and medicines. This includes providing evidence of safety and efficacy and adhering to Good Manufacturing Practices (GMP).