Regulations in the pharmaceutical sector are dynamic, evolving to keep pace with new products and technologies. The Central Drugs Standard Control Organization (CDSCO), Government of India, continually updates its rules to ensure drug quality, safety, and efficacy. A significant development in this regard is the mandatory establishment of a pharmacovigilance system at every manufacturing site, introduced via Gazette Notification No. GSR 922(E) on 28th December 2023.

This regulation, part of the Revised Schedule M, becomes effective on 1st February 2025. Clause 6.11 of the Revised Schedule M states:

“The licensee shall have a pharmacovigilance system in place for collecting, processing, and forwarding reports to the licensing authorities regarding adverse drug reactions arising from drugs manufactured or marketed by the licensee.”

 

This update has raised several questions among manufacturers, such as:

  • What is pharmacovigilance?
  • How should it be implemented?
  • Who is responsible?
  • Does it apply to all products or only new drugs?
  • Is a separate team required for pharmacovigilance activities?
  • Are there guidelines for setting up the system?

To address these concerns, we at Vaayath Consulting Services Private Limited have compiled this blog to provide clarity and guidance.

Understanding Pharmacovigilance

Pharmacovigilance, as defined by the World Health Organization (WHO), involves the science and activities related to detecting, assessing, understanding, and preventing adverse effects or any other medicine-related problems. It aims to enhance drug safety and effectiveness while minimizing risks to patients.

Mandatory Compliance for All Manufacturers

Yes, the implementation of a pharmacovigilance system is mandatory for all manufacturers, regardless of size. Clause 6.11 of Revised Schedule M explicitly requires all licensees to establish this system.

Implementation for Small Manufacturers

The law does not differentiate between small and large manufacturers. However, small manufacturers can achieve compliance through systematic planning, allocating resources, and understanding the guidelines. Partnering with experts can streamline this process.

Government Guidelines for Pharmacovigilance

The Government of India has issued the following guidelines to assist manufacturers:

  1. Pharmacovigilance Guidance Document for Marketing Authorization Holders of Pharmaceutical Products
  2. Guidance for Industry on Pharmacovigilance Requirements for Biological Products
  3. Guidance for Industry on Pharmacovigilance Requirements for Human Vaccines

Basic Requirements for a Pharmacovigilance System

Manufacturers must fulfill the following to establish a compliant pharmacovigilance system:

  • Preparation and Maintenance of Pharmacovigilance System Master File (PSMF): A document detailing all pharmacovigilance activities within the organization.
  • Collecting, Processing, and Reporting Individual Case Safety Reports (ICSRs): Systematic handling of safety data.
  • Periodic Safety Update Reports (PSURs): Regular submission of updated safety information.
  • Implementation of a Quality Management System (QMS): Ensuring adherence to standards and practices.
  • Audits and Inspections: Routine checks to ensure compliance.
  • Risk Management Plans (RMPs): Proactive identification and mitigation of risks.

Consequences of Non-Compliance

Failure to implement a pharmacovigilance system constitutes a violation of Clause 6.11 of Revised Schedule M, punishable under Section 18 read with Section 27 of the Drugs and Cosmetics Act, 1940. Non-compliance risks regulatory action, product recalls, and reputational damage.

How Vaayath Consulting Can Help

Vaayath Consulting Services specializes in regulatory compliance. Our team of pharmacovigilance experts offers:

  • Customized solutions for pharmacovigilance system setup
  • Training programs tailored to your team’s needs
  • Assistance in preparing PSMFs, ICSRs, PSURs, and RMPs
  • Conducting audits and inspections
  • Comprehensive guidance aligned with regulatory requirements

Benefits of Compliance

Implementing a robust pharmacovigilance system:

  • Enhances patient safety
  • Builds trust with regulatory authorities and consumers
  • Minimizes the risk of legal and financial penalties
  • Strengthens the manufacturer’s market reputation

Next Steps for Manufacturers

To ensure compliance by 1st February 2025, manufacturers should:

  1. Assess current systems and identify gaps.
  2. Develop an action plan for implementing pharmacovigilance processes.
  3. Train personnel and allocate resources.
  4. Partner with experts for seamless execution.

Contact Us

Need help with pharmacovigilance compliance? Vaayath Consulting is here to support you. Contact us at:

  • Website: www.vaayath.com
  • Email: vaayath@gmail.com
  • Phone: (+91) 6280051677

 

Let us guide you toward regulatory compliance and the success of your products.