Introduction
Pharmacovigilance, as defined by the World Health Organization (WHO), is the science and practice of detecting, assessing, understanding, and preventing adverse effects or any other drug-related problems. Pharmacovigilance in essence aims to enhance patient safety by monitoring and evaluating the risks associated with pharmaceutical products. It is interesting to note that the significance of pharmacovigilance has grown over the years, especially with the increasing global integration of pharmaceutical supply chains and concerns over drug safety. With India being commonly referred to as the ‘pharmacy of the world’ due to it being a global supplier of affordable medicines, ensuring drug safety is critical for public health at large. This blog post outlines the pharmacovigilance system in India, including the existing framework, current challenges, and the future roadmap.
Understanding Pharmacovigilance in India
As the Indian pharmaceutical industry continues to expand, both in domestic and international markets, a well-structured pharmacovigilance system is essential to ensure compliance with global safety standards. The ambit of pharmacovigilance in India spans across various pharmaceutical products including modern medicines, herbal/ traditional medicines, biological products (such as blood products and vaccines) and medical devices. Most notably, the need for pharmacovigilance has grown over the years, particularly due to the increasing concerns about drug safety and rising incidents of (a) adverse drug reactions (“ADR”) which are unintended, noxious responses to a drug given to patients at doses normally used for diagnosis or treatment; (b) adverse events (“AE”) which are any untoward medical occurrences in a patient or clinical investigation subject who has been administered a pharmaceutical product and such occurrences necessarily have a casual relationship with the treatment; (c) adverse events following immunization (“AEFI”) which are untoward medical occurrences following administration of a vaccine to an individual wherein such occurrences do not necessarily have a casual relationship with the usage of the vaccine; and (d) serious ADR or serious AE which are any untoward medical occurrences in a patient due to administering a pharmaceutical products which results in: (i) death of the patient; (ii) life-threatening conditions for the patient; (iii) patient hospitalisation or prolongation of existing hospitalisation; (iv) persistent or significant disability/ incapacity; or (v) congenial anomaly or birth defect.
The Pharmacovigilance Programme of India (PvPI)
The Pharmacovigilance Programme of India (“PvPI”) is the primary, drug safety monitoring programme in India which collects, collates and analyses drug-related adverse events received through various adverse drug reaction monitoring centres. The PvPI was operationalized in 2010 by the Ministry of Health and Family Welfare, Government of India (“MoHFW”) and the All India Institute of Medical Sciences (AIIMS), New Delhi was established as the National Coordination Centre (NCC) for PvPI. Subsequently, the MoHFW in 2011 shifted the National Coordination Centre from AIIMS, New Delhi to the Indian Pharmacopoeia Commission (IPC), Ghaziabad.
When an ADR, AE or serious ADR/AE occurs, healthcare professionals (including doctors, dentists, pharmacists, nurses etc) are expected to report such instances associated with pharmaceutical products to safeguard public health and assist in improving patient safety. The PvPI encourages reporting of all types of suspected adverse reactions in respect of all pharmaceutical products irrespective of whether such reactions are unknown, non-serious or rare.
The vision of PvPI is to improve patient safety and welfare in Indian population by monitoring drug safety and thereby sensitizing the stakeholders regarding reducing the risk associated with use of medicines. The key objectives of PvPI include:
- Creation of a nation-wide system for patient safety by ensuring drug safety;
- Identification and analysis of new signals from the reported cases;
- Analysis of the benefit-risk ratio of marketed medications;
- Generation of evidence-based information on safety of medicines;
- Supporting regulatory agencies in the decision-making process on use of medications; and;
- Communication of safety information on use of medicines to various stakeholders for preventing/minimizing the risk.
Given the increasing regulatory scrutiny for medical devices, the Materiovigilance Programme of India (“MvPI”) has also been established under the PvPI with an aim to collect data on medical device related adverse events and scientifically analyse them to aid in regulatory decisions and recommendations on safe use of medical devices. Further, the MvPI monitors medical device-associated adverse events (MDAE), creates awareness among healthcare professionals about the importance of MDAE reporting in India and evaluates the benefit-risk ratio of medical devices.
The Drugs and Cosmetics Act, 1940
The Drugs and Cosmetics Act, 1940 read with the Drugs Rules, 1945 (“Drugs Rules”) regulate inter alia the manufacture, import, sale and distribution of all drugs in India. The regulatory regime pertaining to the safety of drugs in India is also governed by these legislations. Specifically, under Schedule M of the Drugs Rules, there is a requirement on manufacturers and/ or marketers of drugs to have a pharmacovigilance system in place for collecting, processing and forwarding reports of adverse drug reactions. Furthermore, manufacturers of drugs are required to comply with ‘Guidelines on Recall and Rapid Alert System for Drugs’ issued by the Central Drugs Standard Control Organization (“CDSCO”) for undertaking recall of drugs if pharmacovigilance reports indicate that are serious safety risks associated with the drug product.
Additionally, the New Drugs and Clinical Trials Rules, 2019, emphasize the importance of post market assessment and pharmacovigilance responsibilities of pharmaceutical companies in relation to newly approved drugs. The regulatory regime pertaining to clinical trials in India makes it mandatory for entities engaged in conducting clinical trials to report serious AE within specified timelines, provide compensation for injuries, disabilities and death occuring in the course of clinical trials and maintenance of a robust pharmacovigilance system. In the case of vaccines, the CDSCO has also released the ‘Guidance for Industry on Pharmacovigilance Requirements for Human Vaccines’ dated August 7, 2024 which elaborates on the compliance and framework surrounding the extensive pharmacovigilance programme for vaccines as part of post licensure submissions (in the form of Periodic Safety Update Reports (PSURs), AEFI case reports and Individual Case Safety Reports (ICSRs)).
Conclusion and the Way Forward
India’s pharmacovigilance system, while steadily improving, still faces significant shortfalls that hinder effective drug safety monitoring. One major issue is underreporting of ADRs due to a lack of awareness and motivation to report among healthcare professionals and consumers. The existing pharmacovigilance system in India suffers from inconsistent reporting on drug safety concerns and numerous hospitals and healthcare institutions across the country lack the necessary infrastructure and skilled manpower to undertake efficient pharmacovigilance activities. The current reliance on voluntary reporting by consumers and healthcare professionals further dilutes the proactiveness required for undertaking stringent pharmacovigilance measures.
There is no doubt that the establishment of PvPI and the regulatory reporting requirements have strengthened the drug safety framework in India. Moving forward, India must focus on digital transformation, regulatory enforcement, and greater stakeholder engagement to build a robust pharmacovigilance ecosystem. Enhancing public awareness through targeted education campaigns may also encourage patient participation in drug safety monitoring. Additionally, adoption and integration new-age digital health technologies, such as AI-driven reporting tools and centralized databases will greatly assist in increasing the efficiency and time-required to streamline data collection and analysis. A proactive approach by the authorities will not only enhance public health safety but also improve India’s reputation as a trusted global pharmaceutical supplier. By fostering a culture of pharmacovigilance, the Indian healthcare ecosystem can ensure that safe, effective, and high-quality pharmaceutical products reach patients globally.
For further information, please contact:
Biplab Lenin, Partner, Cyril Amarchand Mangaldas
biplab.lenin@cyrilshroff.com
