India is often referred to as the ‘pharmacy of the world’ and is undeniably the leading manufacturing hub for many of the world’s most essential medicines. Supplying medicines to over 200 countries, India's prominence in the medicine supply chain is unmatched, with projections indicating that its pharmaceutical market could exceed 130 billion (1) by the end of this decade.
My recent visit to India allowed me to engage with USP’s team of scientific experts and leaders committed to advancing the supply of quality medicines manufactured in both India and worldwide. This visit coincided with the fourth USP South Asia Regional Chapter Meeting held in New Delhi. The meeting was a strategic convergence of minds and ideas from various stakeholders across the South Asia region, including India, Bangladesh, Sri Lanka, and Nepal. The event brought together government officials, industry leaders, non-governmental organizations, health care practitioners, and academic experts to forge a unified path towards enhancing medicine quality. Three USP Board members joined me at the meeting which added a special dimension to the dialogues.
Government and industry leaders from the region emphasized how various initiatives and measures can fast-track crucial policy developments, ensure capacity building and promote stakeholder awareness to continue to prioritize medicine quality. My experience tells me that the region is witnessing some great changes. Here are key highlights from my time on the ground:
Elevating medicine quality through regulatory convergence: DCGI and U.S. FDA Perspectives
Discussions focused on elevating awareness of quality challenges among stakeholders and advocating for increased collaboration to advance medicine quality.
Dr. Rajeev Singh Raghuvanshi, the Drug Controller General in India (DCGI), offered valuable insight into the regulatory environment, stating “the whole ecosystem of pharma manufacturing here is now sensitized towards the quality issues. And that is actually giving lots of advantages to us now as a regulator that things are getting aligned.” Dr. Raghuvanshi highlighted the relentless efforts the government has undertaken, such as the introduction of risk-based inspections to ensure quality assurance and good manufacturing practices for a resilient global medicines supply chain. He emphasized that "it's the time for fixing accountability about the regulatory ends," highlighting his focus on strengthening accountability within regulatory agencies as well as across the pharmaceutical industry - an area that will continue to be a priority moving forward.
In her address, Dr. Sarah McMullen, Director, U.S. FDA India Office, spotlighted the growing collaboration between India and the U.S. in the pharmaceutical sector. "The U.S. FDA has a presence here in India because it is very important to the U.S. In fact, it's one of the most significant contributors to our medical product industry and one of the largest exporters of food and drug products to the U.S.," Dr. McMullen remarked. India is home to the largest number of FDA-registered plants abroad. In describing the U.S. FDA's multi-dimensional engagement focus, Dr. McMullen explained, "We've really focused on engaging at the state level in the states that have these high concentrations of regulated products" by embracing localized collaboration that prioritizes outreach and relationship building in Indian states containing dense clusters of regulated exporters rather than relying solely on central coordination. As India's pharmaceutical industry witnesses further expansion, maintaining collaborative relationships between central and state authorities remains crucial for ensuring effective oversight.
Dr. McMullen also shed light on the robust collaboration between USP and the U.S. FDA. This goes beyond establishing quality standards, reinforcing capability building and promoting best practices among stakeholders. From collaborating on the joint review of proposed standards, regular leadership meetings, or convening regularly on pressing industry topics, the U.S. FDA-USP partnership aims to foster quality and cultivate excellence not only for the U.S. market but also for the global medicines supply chain.
Navigating Change: Standards, Policy, and Investments
A major focus of the conversations involved potential avenues for USP and India to further ally to address challenges, navigate India’s pivotal role in global healthcare and safeguard a global supply of quality medicines.
As reinforced by Dr. McMullen, USP quality standards help ensure quality throughout the product lifecycle. Adopting the USP test methods and acceptance criteria bolsters efficiency for both regulators and industry. They provide valuable guidance during development on aspects like impurities, procedures, and specifications. Staying current also streamlines method suitability assessments.
India's Evolving Leadership: The IPC's Entry into the PDG
The recent inclusion of the Indian Pharmacopeia Commission (IPC) into the Pharmacopeial Discussion Group (PDG) further underscores India's pivotal role in global healthcare. Upcoming policy efforts, such as the revised Schedule M under the Drug and Cosmetics Act and the National Pharma Policy, outline key amendments to existing regulations. These include harmonizing standards, capacity building, and digitalization aiming to transform India into a prominent global research and development hub and leading a shift from volume-based to value-based leadership.
Shared commitment to strengthen India's pharma industry
What was abundantly clear is that India stands at the epicenter of global healthcare and is embracing their role as a major hub of pharmaceutical manufacturing. USP is honored to collaborate with stakeholders throughout the transformative journey. Significant investments have been made in USP's Hyderabad Hub including its state-of-the-art laboratory, expanding staff expertise and overall capabilities. This capacity building directly supports India's growing industry from both standards development and training perspectives.
As we support India and the region in achieving their aims, USP maintains a dedication to enabling cooperation, innovation, and a steadfast commitment to excellence within the pharmaceutical industry.
Scientific expertise and advancement are at the core of what we do at USP to help ensure the quality and safety of medicines around the world.
1. Government of India, Ministry of Finance. Economic Survey of India 2022-23. Available at: https://www.indiabudget.gov.in/economicsurvey/.