The Indian Pharmacopoeia Commission (IPC), an autonomous institution under the Ministry of Health and Family Welfare, Government of India, has been instrumental in addressing the issues related to the quality of medicines since its establishment in 2009.The year 2019 was memorable for IPC as it marked one glorious decade of its foundation with a forward looking approach. With an overall objective of contributing towards public health, IPC along with its team is committed to promote the quality of drugs and pharmaceuticals through standards setting in Indian Pharmacopoeia (IP), providing Indian Pharmacopoeia Reference Substances (IPRS) to the stakeholders, rational use of medicines by bringing out National Formulary of India (NFI), to ensure safety of medicines and medical devices through Pharmacovigilance Programme of India (PvPI). The National Coordination Centres for PvPI and Materiovigilance Programme of India (MvPI) are located at IPC.
The publication of IP addendum 2019 to IP 2018 and other resource materials by the IPC in continued pursuit of its mission is a testimonial. The IPC team ensures adherence to the Quality Management Systems at IP Laboratory, IPC. IP has been formally recognized by the National Department of Regulation of Medicines and Health Products of the Ministry of Public Health of Islamic Republic of Afghanistan. As a part of capacity building, IPC has entered into collaboration with Research and Pharmacopoeial Institutions at National and International level. IPC having “Observer” Status at the EDQM has provided the opportunity to the IPC scientists to understand and harmonise IP standards with International standards. National Coordination Centre-PvPI functioning as a WHO Collaborating Centre for Pharmacovigilance in Public Health Programmes and Regulatory Services is committed to strengthen the Pharmacovigilance systems.
IPC regularly conducts Skill Development Programmes in the area of Pharmacopoeial Standards and Pharmacovigilance for creating qualified and skilled human resources to cater to the future need of the country. In addition, IPC resolves the queries of stakeholders on Pharmacopoeial and other related matters on continuous basis to leverage the standard setting process. The accreditations and recognitions of labs and services of IPC from various National and International organizations make us confident that we can be one of the best institutions in the world. IPC is grateful to the scientific experts along with IPC team for their dedicated services to IPC and we look forward for their continuous support in future also. I am confident that with the active cooperation of all stakeholders, experts, scientific staff, collaborators, and public at large, we will be able to fulfil the mission, objectives and vision of IPC.
Dr Jai Prakash
Indian Pharmacopoeia Commission
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: