IPC, NCC-PvPI as WHO Collaborating Centre

Launch of IPC, NCC-PvPI as WHO Collaborating Centre for Pharmacovigilance on October 30, 2017
                                                                   at
                National Coordination Centre- Pharmacovigilance Programme of India,

Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Government of India

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.