The COVID-19 pandemic underscored the importance of anticipating potential disruptions in the supply chain for essential medicines and other health technologies, prompting a focus on bolstering local production capabilities. In World Health Assembly resolution WHA74.6 (May 2021), World Health Organization (WHO) Member States committed to “Strengthening local production of medicines and other health technologies to improve access.” India, dubbed the "pharmacy of the world," is the origin of 60% of medicines prequalified by WHO for global use.[1] As a cornerstone of India’s economy and a major player in the global pharmaceutical supply chain, the Government of India and WHO are collaborating to strengthen the quality and sustainable local production of medicines and other health technologies. This collaboration aims to enhance the capacity of micro, small, and medium-scale pharmaceutical enterprises in India for current Good Manufacturing Practices (cGMP) to ensure quality assurance, regulatory approval and WHO prequalification. WHO designed and conducted training workshops, benefiting a total of 1,115 participants from 323 pharmaceutical enterprises. Ten enterprises were selected to also take part in a mentorship programme coordinated and led by WHO India, which aimed to provide support in preparing and submitting dossiers, as well as implementing WHO prequalification standards. To date, five of ten participating enterprises obtained approval for exporting medicinal products from regulatory bodies such as the European Medicines Agency (EMA), the Brazilian Health Regulatory Agency (Anvisa), and several African regulatory authorities. In a bid to expand upon these achievements, WHO and the Government of India have launched a South-South development cooperation capacity-building programme in the South-East Asia Region.

How did India, with the support of WHO, achieve this?

The COVID-19 pandemic prompted a shift to online workshops and mentorship, offering innovative alternatives for pharmaceutical enterprise personnel to engage from their workplaces. Six comprehensive online workshops held in 2020 and 2021 focused on current Good Manufacturing Practices (cGMP) for micro, small, and medium-scale pharmaceutical enterprises in India.[2] Selection of participants was based on statistical analysis of the Indian Annual Survey of Industries 2018-19, ensuring broad geographical representation across the country. The selection methodology for enterprises was in line with a prior survey conducted jointly by WHO India and the Regional Office for South-East Asia, focusing on small and medium-scale pharmaceutical enterprises in India. WHO designed, facilitated, and monitored the training sessions, exploring key areas such as formulations, active pharmaceutical ingredients, medical devices, and diagnostics. These sessions benefited 1,115 individuals from 323 pharmaceutical enterprises, enhancing understanding of cGMP within a risk-based and quality system-based framework, and preparing them to meet WHO prequalification and other international quality standards.

^{Dr Mandeep Bhandari, Joint Secretary of the Ministry of Health and Family Welfare, Government of India, delivers remarks during the inaugural session of the 2021 current Good Manufacturing Practices (cGMP) Capacity Building Virtual Initiative.}
Photo credit: WHO India

“The initiative of establishing a robust learning and training platform meets the critical need of enabling further upgradation of pharmaceutical sector for global standards of quality. It reiterates our commitment to quality medical products and reinforces our position of being the vaccine hub and pharmacy of the world.”

- Dr Mandeep Bhandari, Joint Secretary, Ministry of Health and Family Welfare, Government of India

Workshops contributed to a WHO India-coordinated mentorship programme aiding select participants in dossier submission and adoption of WHO prequalification standards. Ten enterprises specializing in active pharmaceutical ingredients (APIs), formulations, and medical devices were selected based on predefined criteria. Mentors provided guidance on effective implementation of WHO cGMP, WHO prequalification procedures, and other internationally recognized quality standards. Ongoing mentorship activities provide guidance on dossier submission via case studies, assess audit readiness, and offer real-time experiences through virtual audits. Gap analyses employing an inspection readiness checklist and on-site/virtual regulatory readiness audits assist enterprises in upgrading facility systems and gaining valuable regulatory inspection experience, fostering increased confidence among manufacturing enterprises.

Participants acquired invaluable knowledge and skills, empowering them to elevate their practices within the pharmaceutical industry. The programme yielded notable results: five out of ten participating enterprises obtained approval for medicinal product exports from regulatory bodies such as EMA, Anvisa, and various African authorities. These approvals highlight the programme's success in enhancing awareness of global regulatory requirements and facilitating the identification of pertinent regulatory approvals for their products. These successes underscore the vital importance of the capacity-building mentorship programme in facilitating regulatory compliance and enabling pharmaceutical enterprises to thrive in the global market.

“At the heart of these workshops is the underlying philosophy behind cGMP, which is ensuring that products are consistently produced and controlled according to quality standards. WHO is fully committed to supporting such endeavors. This will have a far-reaching positive impact. Given the encouraging response to the earlier workshops, we hope to expand the outreach of this initiative.”

Dr Roderico H. Ofrin, WHO Representative in India

Initially launched in India, this initiative is poised for expansion to other Member States across the South-East Asia Region, with a pilot set to commence in Nepal in 2024, showcasing India's dedication to improving access to quality, safe, effective and affordable medicines and other health technologies. The South-South cooperation model driving this initiative can encompass various sectors and operate on bilateral, multilateral, subregional, regional, or interregional levels. As this collaborative effort gains momentum, it holds the potential to catalyze transformative change globally, fostering sustainable development and equitable access to medicines and other health technologies worldwide.

India's remarkable journey towards bolstering local production capacities for medicines and other health technologies, with support from WHO, stands as a testament to resilience and innovation amidst the challenges posed by the COVID-19 pandemic. With unwavering commitment and collaborative spirit, India's journey towards strengthening local production capacities serves as an inspiring beacon of hope for global health and sustainable development.