It’s been nearly 20 years since the US Pharmacopeia (USP) established our laboratories in Hyderabad and we began growing our team of scientists and other professionals in India. In the time since, the global pharmaceutical landscape has undergone a tremendous amount of evolution. India has emerged as a major pharmaceutical manufacturing hub, producing so much of the world’s most essential medicines that it is commonly referred to as the “pharmacy of the world.” It is no exaggeration; India supplies medicines to more than 200 countries, and the value of the pharmaceutical market in India is projected to exceed USD 130 billion by the end of this decade.
International attention on medicine quality and policy reforms
This is an exciting time for India, of course, and for the potential for improving the global supply of quality medicines. India is poised to leverage the opportunities before it while also managing continued challenges to ensure the quality of both finished products and ingredients (including excipients). For example, the Central Drugs Standard Control Organization (CDSCO) recently implemented revisions to Schedule M of the Drugs and Cosmetics Act that will strengthen Good Manufacturing Practices (GMP). With this important and growing role, India is in the spotlight. But it is not alone, and it can leverage partnerships with key global collaborators, such as USP, to support it in its journey.
As the new lead for USP’s International Government and Regulatory Affairs team, I have been inspired to learn about USP’s historic involvement – as a partner, resource, and ally – in supporting India’s emergence as such an important source of medications for the world. USP's cross-disciplinary collaboration with India's government, industry, and healthcare leaders will be instrumental to India's shift from a principal medicine supplier to a true global leader.
In recent months, USP’s collaboration with India has reflected this. We are actively making significant strides towards helping to address quality challenges, helping India’s leadership navigate the country’s role in global healthcare, and collectively safeguarding the global supply of quality medicines.
IPC joining PDG underscores India’s pivotal role in global healthcare, opportunities for harmonization
A key milestone was recently reached when the Indian Pharmacopeia Commission (IPC), which is the institution under the Ministry of Health and Family Welfare that is responsible – like USP - for setting standards for drugs, gained membership to the Pharmacopeial Discussion Group (PDG). The PDG was formed for the purpose of harmonizing pharmacopeial standards. Its members consist of a group of pharmacopeias from Europe, Japan, the United States and now – as of late 2023 – the IPC.
At a gathering in India last fall, PDG members welcomed IPC as a formal member following a year-long pilot of IPC as an observer – the first-ever expansion since the PDG was formed in 1989. According to USP Chief Science Officer Jaap Venema, IPC gaining membership status marked “the latest step in the USP’s and PDG’s commitment to expand access to PDG quality standards by approximately 1.3 billion people, as well as to the Indian pharmaceutical industry as a major manufacturer of the world’s medicines.”
The inclusion in PDG is deeply meaningful to India as well. Dr. Rajeev Singh Raghuvanshi, the Drug Controller General of India (DCGI), remarked about what he characterized as an “important milestone” for IPC: “PDG membership has given us an international platform. Internally it’s a big motivating factor for IPC. We will be interacting with the best in the world. We now have the opportunity to set a global agenda for ourselves, which becomes a big driver for IPC.”
USP collaboration with CDSCO leadership to address challenges and safeguard global medicine supply
In November 2023, USP hosted its fourth meeting of the South Asia Regional Chapter, a gathering in New Delhi of USP stakeholders - government officials, industry leaders, non-governmental organizations, health care practitioners, and academic experts – based in the region. DCGI’s Dr. Raghuvanshi attended the Chapter meeting and offered valuable insight into the region’s regulatory environment.
Last month, USP’s hub in Hyderabad hosted the USP Science Conclave, an annual event that aims to provide innovative solutions for global public health and patient safety through knowledge-sharing and open discussions. The conclave was attended by 250+ participants from 53 companies, and included participation by U.S. FDA office in India, as well as by regulatory and government bodies from India, Bangladesh, Sri Lanka, and Europe, as well as industry associations. The conclave fostered knowledge exchange among professionals from diverse industries and experience levels, and it underscored an increasingly collaborative effort to enhance the quality and safety of medicines worldwide. DCGI’s Dr. Raghuvanshi also spoke as a panelist at USP’s Science Conclave, where he stressed the tremendous opportunities facing India’s pharmaceutical industry, as well as the crucial role of quality for pharmaceutical manufacturers.
Building on this series of engagements between USP and Indian regulatory entities, we recently welcomed Dr. Raghuvanshi and Rajiv Wadhawan, Joint Secretary, Ministry of Health and Family Welfare, along with other key Embassy and Indian government officials at USP’s Rockville offices. This visit served as a meaningful demonstration of the continued collaboration between the Government of India and USP. The delegation’s visit to USP headquarters included an intimate conversation with USP leaders, a tour of one of our laboratories, and an engaging fireside chat attended by USP staff and streamed live for our colleagues in India and around the world. The conversation covered topics ranging from standards-setting strategy and how a centuries-old pharmacopeia must transition to the digital world, to detailed discussion about the detection of impurities in pharmaceuticals and the broad challenges facing regulation of newly emerging therapeutics.
The visit culminated with the signing of a memorandum of understanding (MOU) between IPC and USP, indicating our ongoing commitment to collaboration in support of the production of quality pharmaceuticals and to enhancing public health and safety in India, the United States, and worldwide.
Looking to the future
As next steps, USP and IPC will build out a detailed workplan under the MOU, and we are also planning a rich dialogue on improving standards for biologics products. The Government of India will also be host to the 19th International Conference of Drug Regulatory Authorities (ICDRA) later this year, and USP looks forward to contributing to this important meeting. We are excited to be a part of India’s journey embracing its role as a major hub of pharmaceutical manufacturing and about our potential impact for creating a healthier, safer world where quality medicines are accessible to all.
