The Secretary, Ministry of Health and Family Welfare, Government of India has released Pharmacovigilance Guidance Document for Marketing Authorization Holders of Pharmaceutical Products.

Pharmacovigilance

According to the World Health Organization, Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. WHO established its Programme for International Drug Monitoring in response to the Thalidomide disaster detected in the year 1961. Together with the WHO Collaborating Centre for International Drug Monitoring, Uppsala, WHO promotes PV at the country level. By the end of 2010, 134 countries were part of the WHO PV Programme. The aims of PV are to enhance patient care and patient safety in relation to the use of medicines; and to support public health programmes by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines6.

Pharmacovigilance Program of India

The Central Drugs Standard Control Organisation (CDSCO), New Delhi, under the aegis of Ministry of Health & Family Welfare, Government of India has initiated a nation-wide Pharmacovigilance programme in July 2010. The Pharmacovigilance Program of India (PvPI) was launched with a broad objective to safe guard the health of 1.27 billion people of India. Adverse Drug Reactions (ADRs) are reported from all over the country to National Coordination Centre (NCC)-PvPI, which also works in collaboration with the global ADR monitoring centre (WHOUMC), Sweden, to contribute in the global ADRs data base. NCC-PvPI monitors the ADRs among Indian population and helps the regulatory authorities of India (CDSCO, Indian Pharmacopeia Commission (IPC)) in taking decision for safe use of medicines.

PvPI collects and evaluates spontaneous reports of Adverse Drug Reactions (ADRs) due to use of medicines, vaccines, medical devices and herbal products from all healthcare professionals and consumers/patients. To monitor ADRs and reporting the same to NCCPvPI, ADR Monitoring Centres (AMCs) have been set up all over India. At present 250 AMCs (medical colleges, district and corporate hospitals etc) are enrolled under PvPI across the country7.

Pharmacovigilance Guidance Document for Marketing Authorization Holders (MAHs)

In order to ensure smooth functioning of Pharmacovigilance activities by Pharmaceutical industries, National Coordination Centre-Pharmacovigilance Programme of India (NCC-PvPI), in collaboration with Central Drugs Standard Control Organization (CDSCO), has developed Pharmacovigilance Guidance for Marketing Authorization Holders (MAHs) of Pharmaceutical Products.

This Pharmacovigilance guidance document is introduced for the first time by the Government of India for Pharmaceutical industries which aims to establish and ensure an effective Pharmacovigilance system at their site as per recent amendment in the Drugs & Cosmetics Rules, 1945, Schedule Y vide Gazette Notification G.S.R. 32 (E) published on March 08, 2016. This guidance document is prepared under the aegis of CDSCO by the NCC – Pharmacovigilance Programme of India (PvPI), The Indian Pharmacopoeia Commission (IPC), for guiding MAHs involved in the manufacture, sale, import, and distribution of pharmaceutical products in India.

The MAHs Pharmacovigilance Guidance Document comprises following modules:

  • MODULE 1 – Pharmacovigilance System Master File
  • MODULE 2 – Collection, Processing & Reporting of Individual Case Safety Reports
  • MODULE 3 – Preparation & Submission of Periodic Safety Update Report
  • MODULE 4 – Quality Management System at Marketing Authorization Holder organization
  • MODULE 5 – Audits & Inspections of Pharmacovigilance System at Marketing Authorization Holder organization
  • MODULE 6 – Submission of Risk Management Plan

The effective date for this guidance document has been set as January 20188. The guidance document defines the roles of CDSCO, IPC, NCC-PvPI, States(s)/UT(s) Drug Regulatory Authority and the MAHs in Individual Case Safety Reports (ICSRs) processing; submission of Periodic Safety Update Reports (PSURs); Audits and Inspections, and Risk Management Plans (RMPs) wherever applicable. The guidance document also provides assistance to MAHs on establishing and ensuring an effective pharmacovigilance system at their site.

Conclusion:

This guidance document intends to be an aid to the Marketing Authorization Holders and other stakeholders in meeting the pharmacovigilance regulations and requirements of the Indian Drug Regulator (CDSCO). The main focus of the guidance document is to ensure identification of risks associated with pharmaceutical products and establishment of an ideal pharmacovigilance system to mitigate such risks.

Footnotes

6. http://www.who.int/medicines/areas/quality_safety/safety_efficacy/pharmvigi/en/

7. http://ipc.nic.in/showfile.asp?lid=833&EncHid=

8. http://www.ipc.gov.in/PvPI/pub/Guidance Document for Marketing Authorization Holders.pdf

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