CDSCO Directives to Ensure Pharmacovigilance

CDSCO issued a nationwide directive to enhance transparency and strengthen India’s pharmacovigilance ecosystem.

Key Directives of CDSCO

• All retail and wholesale pharmacies must display a designated Quick Response (QR) code and a toll-free number 1800-180-3024 to enable the reporting of adverse drug reactions.
• State and UT drug licensing authorities must ensure compliance and disseminate instructions to all licence holders.
• Directive follows recommendations of the 16th Working Group Meeting of the Pharmacovigilance Programme of India.

Significance of the directives

• Enables the public and healthcare professionals to easily report adverse drug reactions (ADRs).
• Integrates with India’s PvPI Adverse Drug Reaction Monitoring System for faster detection of drug-related risks.
• Promotes patient safety through timely monitoring and regulatory response.

About Pharmacovigilance Programme of India (PvPI)

• Introduction: PvPI, launched in 2010, is a national initiative under the Ministry of Health & Family Welfare to ensure systematic monitoring of medicine safety, coordinated by the Indian Pharmacopoeia Commission (IPC).
• Objective: Its core aim is to safeguard public health by assessing risks of medicines and ensuring their benefits outweigh potential harm.
• Operation: PvPI runs a nationwide network of ADR Monitoring Centres that collect reports and provide regulatory recommendations to CDSCO.

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About CDSCO

• Introduction: The Central Drugs Standard Control Organisation (CDSCO) is India’s National Regulatory Authority (NRA) for drugs and medical devices.
• Establishment: Functions under the Directorate General of Health Services, Ministry of Health & Family Welfare.
• Headquarters: Located in New Delhi, with zonal and sub-zonal offices across India.
• Key Responsibilities
• • Ensures safety, quality, and efficacy of drugs and medical products with transparency and accountability.
  • Approves new drugs and regulates clinical trials conducted in India.
  • Sets standards for drugs and monitors the quality of imported medicines.
  • Collaborates with State Drug Regulators to grant licences for critical products such as vaccines, blood products, IV fluids, and sera.
  • Provides expert guidance to ensure uniform enforcement of the Drugs and Cosmetics Act nationwide.

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