DR. G.N. SINGH
Indian Pharmacopoeia Commission, Ghaziabad
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 NCC-PvPI, which also work in collaboration with the global ADR monitoring centre (WHO-UMC), Sweden to contribute in the global ADRs data base. NCC-PvPI monitors the ADRs among Indian population and helps the regulatory authority of India (CDSCO) in taking decision for safe use of medicines. I invite all the health care professionals and patients/consumers to join us in our mission to promote patient safety.
From the Desk of Secretary-cum- Scientific Director
Since its initiation in 2010, the Pharmacovigilance Programme of India (PvPI) has been enriching the quality of performance and expanding its fields activity. The quality parameters in respect of signal detection, quality review, training programmes and other activities have been maintained at higher than the expected levels.
With in a span of five years PvPI has become a formidable force at international level the best pharmacovigilance practices including Adverse Drug Reactions (ADRs) reporting and providing skill development. The Individual Case Safety Reports (ICSRs) are collected/collated in a scientific way and analysed to facilitate appropriate decisions at CDSCO.
A significant scope in extension of PvPI activities exists for moving ahead, connecting a network of ADR reporter over the country and earning trustworthiness of the masses. NCC-PvPI is fast extending its activities within the country and abroad for ensuring the safety of drugs.
I take this opportunity to appreciate the zeal with which the staff under PvPI work and wish them to take guard of public health within the country and bring laurels to the Nation.
The National Coordination Centre- Pharmacovigilance Programme of India, Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Government of India was launched as a WHO Collaborating Centre for Pharmacovigilance in Public Health Programmes and Regulatory Services on 30 October 2017.
The event also witnessed the launch of “National Strategic Plan for Scale up of Pharmacovigilance in India”; and “Pharmacovigilance Guidelines for Stakeholders”. As part of the event, a technical session on “WHO Global Patient Safety Challenge - Medication without Harm” was also organized.
Access to Medicines is a critical factor for achieving our public health goals and for success in the 2030 Sustainable Development Agenda. The issue of safe-guarding public health in India fully aligns with one of the three pillars of Universal Health Coverage; ensuring access to safe and quality medicines and vaccines in the country.
The Pharmacovigilance Programme of India (PvPI) has progressed considerably in the last few years. The Pharmacovigilance Programme of India (PvPI) was approved by the Ministry of Health and Family Welfare (MOHFW), Government of India (GOI) in July 2010 with the primary objective of the programme to create a nation-wide system for patient safety reporting. There are 250 functioning Adverse Drug Monitoring centres in the country (in medical colleges and corporate hospitals) as part of the Pharmacovigilance Programme of India.
In his inaugural address, Dr. R. K. Vats, Additional Secretary, MoHFW said that “Integrating pharmacovigilance as an essential component of public health programmes (PHPs) is crucial for patient safety.” Reflecting the government’s strong commitment, he added “The Honourable Prime Minister of India, Shri Narendra Modi has a vision focusing on the universal health care agenda so as to provide all Indian citizens, regardless of their economic, social or cultural backgrounds the right to affordable, and quality medical products.” On behalf of MoHFW, he assured to extend all kind of support to PvPI.
The pharmaceutical sector is one of the key 25 sectors identified by the Government of India under the ambitious ‘Make in India’ initiative, which is likely to provide the necessary impetus to the sector in order to achieve its true potential. At present, the Indian pharmaceuticals industry is third largest in volume and the tenth largest in value, globally.
Dr Clive Ondari, Coordinator, Safety & Vigilance, WHO “India’s concerted efforts in the area of pharmacovigilance have been recognized by WHO. It has also been highlighted that the country needs to play a bigger role in the global landscape of adverse drug reaction (ADR) monitoring, thus making India a hub for pharmacovigilance in Public Health Programmes and Regulatory Services. This would be the first WHO CC on this theme globally and the first in the entire WHO South East Asia Region”.
The National Regulatory Authority of India (NRA) competencies were reiterated with the WHO Global Benchmarking Tool during a comprehensive review by WHO led team of international experts from 13-17 February 2017. The Indian NRA was declared functional with Pharmacovigilance as one of the core functions with a maturity level of 4 in the WHO global NRA benchmarking undertaken in February 2017.
Dr G.N. Singh, Secretary-Cum-Scientific Director, IPC; and Drugs Controller General (India) during inaugural said, “Pharmacovigilance and drug safety monitoring is of pivotal importance, for improving treatment support and adherence. The Pharmacovigilance Programme of India and its integration with public health programmes has been noteworthy. It is vital to ensure that adequate systems and practices for reporting of the Adverse Drug Reactions are in place to ensure that the benefit of use of medicine outweighs the risks associated with its use.”
Indian Pharmacopoeia Commission through National Coordination Centre, Pharmacovigilance Programme of India is one of the active member countries in WHO-Programme of International Drug Monitoring and is also leading the thematic area of Vigilance as part of the South East Asia Regulatory Network (SEARN).
Speaking at the inaugural ceremony of the meeting, Ms Prakin Suchaxaya, Coordinator, Health Programmes, WHO Country Office for India said “WHO has been playing a pivotal role in supporting countries in strengthening the pharmacovigilance systems for medical products and in promoting equitable access to quality, safe, efficacious, and affordable medical products. WHO also provides technical and operational assistance towards strengthening of India’s National Regulatory Authority (NRA). The endeavour is to scale-up the support to public health programmes and develop a strong regulatory network for India and South East Asian Countries”.
Other prominent dignitaries at the inaugural were: Padamshree Dr Nitya Anand, Dr KK Aggarwal, Dr Shanthi Pal, WHO headquarters, Dr Raj Long, Bill and Melinda Gates Foundation, Dr Manisha Shridhar, WHO SEARO, Dr Hilde De Greave, and Dr Madhur Gupta, WHO India Country Office.
An international team of experts from WHO headquarters, South East Asia Regional Office, WHO Country Office, senior officials from the MoHFW, officials from CDSCO and its affiliated institutions, various public health programme stakeholders such as Adverse Event Following Immunization (AEFI), Revised National Tuberculosis Control Programme (RNTCP), National AIDS Control Organization (NACO), National Vector-Borne Disease Control Programme (NVBDCP), Indian Medical Association (IMA), Indian Council of Medical Research (ICMR), National Accreditation Board for Hospitals (NABH), Adverse Drug Reaction Monitoring Centre (AMC) Coordinators, Industry representatives, relevant stakeholders, and Pharmacovigilance Programme of India officials were present at the occasion.
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, with the All India Institute of Medical Sciences (AIIMS), New Delhi as the National Coordinating Centre (NCC) for monitoring Adverse Drug Reactions (ADR) in the country to safe-guard Public Health. In year 2010, 22 ADR monitoring centres (AMCs) including AIIMS, New Delhi had been set up under this Programme. To ensure implementation of this programme in a more effective way, the National Coordinating Centre was then shifted from the All India Institute of Medical Sciences (AIIMS), New Delhi to the Indian Pharmacopoeia Commission (IPC), Ghaziabad, (U.P.) in April, 2011.
The mission of PvPI is to safeguard the health of the Indian population by ensuring that the benefit of use of medicine outweighs the risks associated with its use. Since there exist considerable social and economic consequences of adverse drug reactions and the positive benefit/cost ratio of implementing appropriate risk management - there is a need to engage healthcare professionals and the public at large, in a well structured programme to build synergies for monitoring adverse drug reactions in the country.
The purpose of the PvPI is to collate data, analyze it and use the inferences to recommend informed regulatory interventions, besides communicating risks to healthcare professionals and the public. The broadened patient safety scope of pharmacovigilance includes the detection of medicines of substandard quality as well as prescribing, dispensing and administration errors. Counterfeiting, antimicrobial resistance, and the need for real time surveillance in mass vaccinations are other pharmacovigilance challenges which need to be addressed.
The vision of PvPI is to improve patient safety and welfare in Indian population by monitoring drug safety and thereby reducing the risk associated with use of medicines.The ultimate safety decisions on medicines may need considerations of comparative benefit/risk evaluations between products for similar indications, so the complexity is great.
Pharmacovigilance activities may be undertaken by several organizations, individuals and agencies. The Pharmacovigilance Programme of India fulfills the minimum requirements that should be present in any functional national pharmacovigilance system, as per WHO, which include the following:
Once the Medical institute is enrolled as an AMC under PvPI, the AMC starts reporting ICSRs to NCC via a VigiFlow. These ICSRs are then assessed at NCC for quality of data and if found valid, they are further committed to the global drug monitoring centre “Uppsala Monitoring Centre” in Sweden. But if the data is not complete or valid, then the ICSRs are reverted back to their concerned AMC with the query or necessary comments, so that the respective ICSR can be corrected or completed and sent to NCC again for evaluation. The data from NCC is also sent to CDSCO, as and when required.
Following chart explains the flow of data at regional, national and international level:
The quality of the ICSR is assessed for completeness of information and is reviewed for:
Data collected in Pharmacovigilance can be used in a variety of ways: