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Central Drugs Standard Control Organization (CDSCO)

S-7-INDUSTRIAL PHARMACY-II
2 min read

  • 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

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.


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