Central Drugs Standard Control Organization (CDSCO)

• The Central Drugs Standard Control Organization (CDSCO) is India’s primary regulatory body for pharmaceuticals and medical devices.

• Operating under the Ministry of Health & Family Welfare, it ensures drug quality, safety, and efficacy in India and aligns with global standards to support India’s international competitiveness in pharmaceuticals.

Key Functions

1. New Drug Approval: Approves new drugs, both domestically produced and imported, for sale in India.

2. Clinical Trials: Regulates clinical trial approvals and oversight for drug safety and efficacy.

3. Standards & Quality: Sets standards for drugs, cosmetics, and medical devices, ensuring all products meet established benchmarks.

4. Import Control: Oversees drug imports to ensure compliance with quality standards.

5. Licensing: Issues licenses, including import and clinical trial approvals.

6. Pharmacovigilance: Runs the Pharmacovigilance Programme of India (PvPI) to monitor adverse drug reactions.

Organizational Structure of CDSCO

1.Head of Organization:

• Drug Controller General of India (DCGI) oversees CDSCO operations, ensuring drug safety, efficacy, and alignment with public health goals.

2.Main Divisions:

• New Drugs: Approves new drugs, evaluating safety and quality.

  • Biological: Regulates vaccines, biosimilars, and biotechnological products.

  • Medical Devices: Manages medical device regulation, licensing, and quality assurance.

• Import & Registration: Handles registration of pharmaceuticals and medical devices for import, ensuring compliance.

  • Pharmacovigilance: Monitors and addresses adverse drug reactions.

  • Standards: Sets and enforces standards for drugs, cosmetics, and medical devices.

3.Zonal and Sub-Zonal Offices:

• Zones: North, South, East, West, and Northeast.

• Sub-Zonal and Port Offices: Manage region-specific regulatory compliance and oversee imports/exports.

4.Laboratories:

• Central Drugs Laboratory, Kolkata: Main lab for quality control.

• Central Drugs Testing Laboratories: Support regional testing and quality control functions.

5.Coordination Units:

• Enhance communication with government bodies, industry, and international partners to ensure cohesive regulatory functions.

6.Administrative & Support Units:

• Handle HR, IT, and other operational support functions, ensuring efficient organization.

Responsibilities

• Regulation & Supervision: Oversees drug manufacturing, sales, and quality.

• Approval & Licensing: Grants new drug and clinical trial approvals, issues licenses.

• Standard Setting: Sets and enforces pharmaceutical standards.

• Safety Monitoring: Evaluates drug safety through programs like PvPI.

• Coordination: Liaises with state drug control agencies and the central government.

• Regulatory Oversight: Ensures compliance for drug imports/exports.

• Law Formulation & Amendment: Advises the government on drug-related laws.

CDSCO plays a crucial role in ensuring public health by maintaining stringent regulatory standards for pharmaceuticals and medical devices in India.