n April 2018, the India Ministry of Health and Family Welfare launched the National Patient Safety Implementation Framework 2018-2025 (NPSIF), a comprehensive guideline and roadmap toward strengthening the safety of patients in India that also aligns with India’s goal of universal health coverage by 2030.

Prepared after extensive research by experts, the NPSIF outlines the gaps, scope, and way forward for strengthening patient safety in India through a seven-year plan that outlines strategic objectives and a communication strategy to implement the framework at all levels of healthcare in India. Six strategic objectives, clearly defined with 21 priorities and 81 interventions, address implementation of this framework.

“Patient safety is everyone’s responsibility.” This statement in the introduction to the framework underscores the importance of every stakeholder’s contribution to patient safety: central and state governments, patient and consumer rights groups, professional associations, medical education institutions, agencies for quality and accreditation, healthcare providers at public and private healthcare facilities of all sizes and functions, millions of patients and their families, and the surrounding community.

Careful analysis of the current patient safety situation in India provided in section 1 proves helpful in understanding current gaps and potential paths forward. One of these key gaps is that the “laws, regulations, policies and strategies on the quality of care do exist in the country, however they are largely fragmented.” NPSIF is an effort to address this issue by bringing all patient safety initiatives under one umbrella and working to ensure that quality-assured and safe healthcare is delivered to patients across all modalities of provision (prevention, diagnosis, treatment, and follow-up).

Progress on NPSIF implementation has been steady, albeit slowed by the priority focus on responding to the COVID-19 pandemic during the past two years. Although the overall framework is too broad to fully address here, several initiatives taken toward its implementation deserve mention.

The strategic objectives in NPSIF include establishing institutional frameworks/mechanisms for patient safety, assessing scale of adverse events and establishing reporting and learning systems, building a competent healthcare workforce, preventing and controlling healthcare-associated infections, implementing patient safety campaigns to strengthen patient safety across all clinical programs, and promoting patient safety research.

NPSIF enumerates concrete action plans to further strengthen each patient safety key priority area: safe surgical care, safe injections, medication safety, safe childbirth, blood safety, medical device safety, and safe organ, tissue, and cell transplantation and donation. This seven-year plan (2018-2025) includes detailed timelines for implementing the framework for all these priority areas.

An overarching national framework under which states are given flexibility to design their own institutional mechanisms and modalities for quality and safety in the public and private sectors has been recommended to establish the institutional framework. State and union territories have been directed to constitute patient safety committees at state and district hospitals, subsuming existing committees on infection prevention and control and biomedical waste management. States have also been directed to develop a State Patient Safety Action Plan and to include patient safety components in state program implementation plans (PIP) under Quality Assurance. States must also develop mechanisms to redress patient safety grievances and to report patient harm incidents under the National Health Mission.

Antimicrobial resistance (AMR) is a major public health challenge and is recognized as a high-priority area by the government of India. To support the creation of Antimicrobial Stewardship Program (AMSP) structures and processes in healthcare institutions across the country, the Indian Council of Medical Research (ICMR) released Antimicrobial Stewardship Program (AMSP) guidelines in November 2018 and initiated various activities including development of an AMSP curriculum, research projects, and awareness workshops for healthcare institutions.

To strengthen the quality assurance and accreditation mechanism for public and private healthcare facilities, efforts are underway to expand the applicability/coverage of quality certification/accreditation and to strengthen existing quality standards by more adequately incorporating patient safety requirements in their assessment criteria. Minimum patient safety indicators and standards are being defined and incorporated by accreditation agencies (National Health Systems Resource Center [NHSRC], National Accreditation Board for Hospitals & Healthcare Providers [NABH] and for Testing & Calibration Laboratories [NABL]) in their respective assessment criteria for quality accreditation.

The fifth edition of NABH accreditation standards for hospitals released in April 2020 replaced the chapter on continuous quality improvement with a chapter on Patient Safety and Quality Improvement to increase the focus on the critical aspect of patient safety in healthcare and ensure that national and international patient safety goals and solutions are being implemented in healthcare facilities. One important recommendation is to implement a robust incident reporting and learning system with well-defined sentinel events in every accredited hospital.

As a component of NPSIF, the syllabus for undergraduate- and postgraduate-level medical, nursing, and pharmaceutical courses is being revised to incorporate adequate learning objectives for patient safety based on the WHO Patient Safety Curriculum Guide. A mixed-methods study published in 2020 identified patient safety gaps in graduate curricula and training needs, and the curricula are currently being revised to address these gaps. India also joined the WHO Global Patient Safety Collaborative (GPSC) at the direct/bespoke level. Through direct/bespoke cooperation, countries have the opportunity to implement additional country-level activities based on their country-specific priorities and needs, and as part of this collaboration will receive technical support from GPSC partners to strengthen India’s leadership, training capacity, and research to accelerate improvements in patient safety.

The Pharmacovigilance Programme of India (PvPI) has laid a strong foundation for assessing and reporting adverse events by establishing adverse event monitoring centers throughout the country. Standardizing adverse event definitions and reporting formats and establishing a web-based reporting system across public and private healthcare facilities are planned to further strengthen this adverse event system.

Under-reporting has been one of the major impediments for adverse drug reaction (ADR) surveillance in India. “To improve reporting, we intend to increase patient engagement and public awareness about the pharmacovigilance program whereby patients and their family members start regularly reporting the adverse events on their own, independent of the practitioners,” explains Dr. Rajeev Raghuvanshi, secretary-cum-scientific director of the Indian Pharmacopoeia Commission (IPC), Ministry of Health and Family Welfare.

Public patient safety campaigns have been aligned with Global Patient Safety Day, and various organizations have encouraged participation and awareness of this cause. For example, PvPI celebrated National Pharmacovigilance Week in 2021 (September 17-23), and active participation from ADR monitoring centers throughout the country was instrumental in creating awareness of pharmacovigilance across many different stakeholders.

Efforts to encourage and consolidate patient safety research at the state and national level is another key area highlighted in the NPSIF. Numerous research hospitals and institutions are conducting multiple studies on such topics as medication errors, prescription audits, and ADR surveillance to gather data on the overall burden of unsafe care and the ways forward to alleviate it.

The NPSIF also values the contributions of non-profit healthcare organizations, patient rights groups, and patient safety organizations as important stakeholders in implementing patient safety principles in India. Patient safety initiatives directed by some of these organizations include:

1. In 2019, the Consortium of Accredited Healthcare Organisations (CAHO) launched an initiative to improve patient safety and quality healthcare in India by bringing all stakeholders across the healthcare spectrum together on a common platform to spearhead patient safety discussions and initiatives.
2. The Association of Healthcare Providers India (APHI) has designed a national patient safety framework training module to help implement essentials of the framework at different healthcare facilities.
3. The Indian Medical Association (IMA) leads various patient safety initiatives covering key priority areas of the NPSIF.
4. The Patient Safety and Access Initiative of India Foundation collaborates with different stakeholders to raise awareness about various patient safety issues such as spurious drugs and medication safety and ways to mitigate them.
5. The Delhi Society for Promotion of Rational Use of Drugs (DSPRUD) conducts various programs to raise awareness about antimicrobial resistance and safe use of medications.
6. The Patient Academy for Innovation and Research (PAIR) and DakshamA Health are working to empower patients and caregivers with the proper knowledge, tools, and forums to find and access healthcare options that meet their needs. They are also bringing patients together to inform policy makers about and advocate for policy changes that reflect the needs of patients in India’s rural areas.
7. PAIR Academy has collaborated with the International Alliance of Patients’ Organizations (IAPO) on a freely accessible patient safety course designed to build capacity around the recently launched WHO Global Patient Safety Action Plan 2021-2030 by providing an overview of each strategic pillar and thematic area and ideas on how patients can engage in these processes at local and national levels.

“Our aim is to create a network of patient safety champions who advocate for patient centricity, create awareness, and collaborate with different stakeholders at various levels to bring about positive policy changes for patient safety in the country,” explained Dr. Ratna Devi, vice president of IAPO Patient for Patient Safety Observatory, to this author.

Other independent organizations have worked on awareness and advocacy initiatives by sharing expert knowledge through webinars and publications. It is essential to consolidate the efforts of all these organizations and develop a rich central resource repository for capacity building for patients and healthcare professionals.

It is essential to accelerate our efforts to implement NPSIF in India with the Ministry of Health and Family Welfare leading this initiative at the national level in collaboration with many stakeholders. COVID-19 not only slowed down NPSIF implementation but brought to light further global-level lacunae in healthcare systems, patient safety, and medication safety processes, and the urgency to fill them.

Allocating appropriate budgets for patient safety activities and capacity building will significantly speed up implementation of this framework. With concerted efforts from all directions, we look forward to moving toward a patient-centric healthcare system and universal healthcare coverage in India.