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The Central Drugs Standard Control Organization Headquarters

The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for Indian pharmaceuticals and medical devices, and serves parallel function to the European Medicines Agency of the European Union, the PMDA of Japan and the Food and Drug Administration of the United States. Within the CDSCO, the Drug Controller General of India (DCGI) regulates pharmaceutical and medical devices. The DCGI is advised by the Drug Technical Advisory Board (DTAB) and the Drug Consultative Committee (DCC). It is divided into zonal offices which do pre-licensing and post-licensing inspections, post-market surveillance, and recalls when needed. Following website provides information about CDSCO and PvPI:

Indian Pharmacopoeia Commission

Indian Pharmacopoeia Commission (IPC) is an Autonomous Institution of the Ministry of Health and Family Welfare, Govt. of India. IPC is created to set standards of drugs in the country. It’s basic function is to update regularly the standards of drugs commonly required for treatment of diseases prevailing in this region. It publishes official documents for improving Quality of Medicines by way of adding new and updating existing monographs in the form of Indian Pharmacopoeia (IP). It further promotes rational use of generic medicines by publishing National Formulary of India. IPC also acts as a National Coordination Centre for Pharmacovigilance Programme of India, thereby coordinating all the activities related to pharmacovigilance in India. Following website provides information about NCC-PvPI in IPC:

WHO Collaborating Centre for International Drug Monitoring: The Uppsala Monitoring Centre

The World Health Organization (WHO) is a specialized agency of the United Nations (UN) that is concerned with international public health. The Uppsala Monitoring Centre (UMC) is an independent foundation and a centre for international service and scientific research.

The operational responsibility for the ADR monitoring programme rests with the WHO Collaborating Centre for International Drug Monitoring, Uppsala Monitoring Centre, (UMC), in Sweden. The system started with 10 countries that had already established national systems for spontaneous adverse reaction reporting and who agreed to contribute data. For an effective international system to become operative, a common reporting form was developed, agreed guidelines for entering information formulated, common terminologies and classifications prepared and compatible systems for transmitting, storing and retrieving and disseminating data were created. The ADRs database in Uppsala currently contains over eight million reports of suspected ADRs.

Following site provides very useful information about practical pharmacovigilance including definitions and advice on pharmacovigilance policy:

WHO Country Office for India

Envisioning better health for all Indians, Mr Ghulam Nabi Azad, the Hon’ble Minister for Health & Family Welfare, Government of India launched WHO’s new Country Cooperation Strategy with India (2012-17) along with Dr Nata Menabde, WHO Representative to India on 29 June 2012.

The WHO Country Office for India is headquartered in Delhi with country-wide presence. Its areas of work are enshrined in its new Country Cooperation Strategy (CCS) 2012-2017.The key aim of this path-breaking strategy is to contribute to improving health and equity in India. It also provides the blueprint for unleashing India’s role on the global health arena alongside the continued pursuit of health improvement in the country. In this context, it distinguishes and addresses the challenges to India’s potential globally as well as impediments in solving long-standing health and health service delivery internally.

National Institute of Biologicals

National Institute of Biologicals (NIB), an autonomous Institution under the Ministry of Health & Family Welfare (MOHFW)-Government of India is a premier Scientific Organization and a Centre of Excellence to ensure quality of biologicals and vaccines in the country. The institute responsibly assures and reviews the quality of number of biological products available through domestic manufacturers or imports. The operations are carried out in the state of the art Facility of the Institute and in close coordination with Government of India regulatory authorities as Office of Drug Controller of India, Indian Pharmacopeia's Commission.

Indian Pharmacopoeia Commission in collaboration with National Institute of Biologicals has launched a Haemovigilance programme across the country under its Pharmacovigilance Programme of India (PvPI) with following Terms of References:

  1. To track Adverse Reactions/ Events and incidence associated with Biologicals, Blood transfusion and Blood product administration (Haemovigilance) as well as tissue organ and cell therapy transplantation.
  2. To help identify trends, recommend best practices and interventions required to improve patient care and safety, while reducing overall cost of the healthcare system.

Haemovigilance Programme was launched on 10th Dec 2012 in already enrolled 60 Medical College under PvPI as an integral part of Pharmacovigilance Programme of India NIB is the Coordinating Centre, for BvPI to collate & analyze data with respect to Biologicals & Haemovigilance. Please Click Here for Transfusion Reaction Reporting Form (TRRF) for blood and blood products. Detailed information on haemovigilance programme is available here.

Adverse Event Following Immunization

Adverse Event Following Immunization (AEFI) is defined as a medical event that takes place after immunization, causes concern and is believed to be caused by immunization. AEFI Surveillance System in India came a long way since its inception in 1986. AEFI surveillance and timely management will build public confidence and prevent additional clustering of cases if they occur due to a programmatic error.

AEFI surveillance monitors immunization safety, detects and responds to adverse events; corrects unsafe immunization practices, reduces the negative impact of the event on health and contributes to the quality of immunization activities. Operational Guidelines of AEFI mainly relate to vaccines included in the National Immunization Program and issues of vaccine manufacturing, safety & quality control of AEFI cases are handled by CDSCO headed by DCGI. Intensive efforts are being made by MoHFW, Government of India to strengthen surveillance and monitoring of AEFI in the country. In India, the safety of vaccine is monitored by the division of AEFI, MoHFW, Government of India and PvPI.

AEFI cases submitted to PvPI are further coordinated with national level committee AEFI for reporting & investigation. Subsequently AEFI committee will follow with local AEFI team to completely furnish First Information Report (FIR) form/ Preliminary Investigation Report (PIR) form/ Detailed Investigation Report (DIR) form to do the causality assessment (Please Click Here for AEFI Reporting forms).

National Health Programmes in India

PvPI have also extended its reach to the various National Health Programmes running in India, encouraging them to participate and contribute in the nationwide drug safety monitoring programme, leading to patient safety. Following are the various National Health Programmes initiated by the Ministry of Health & Family Welfare, details of which are available here:

Revised National Tuberculosis Control Programme

The Revised National Tuberculosis Control Programme (RNTCP), based on the Directly Observed Treatment, Short-course (DOTS) strategy for TB control, began in 1993 and was launched as a national programme in 1997 in India. By the end of 2002, 50%of the country’s population was covered under the RNTCP. By December 2005, around 97% (about 1080 million) of the population had been covered, and the entire country was covered under DOTS by 24th March 2006.

On 11 Oct 2013, PvPI collaborated with RNTCP and decided to work and move forward together towards the monitoring of ADRs from antitubercular drugs for patient safety in the nation.

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Last updated: 31/10/2018 12:30:02