The statement by former President Barack Obama, "When Dr. Singh speaks, the whole world listens," highlights the global respect and recognition that former prime minister late Manmohan Singh received, particularly in the aftermath of the global financial crisis of 2008. India was one of the few economies that managed to avoid a severe recession.
Singh’s leadership and the economic reforms he spearheaded, first as finance minister (1991-1996) and later as prime minister (2004-2014), laid the foundation for India's rise as a major player in global healthcare.
The Catalyst for Change
Singh's role in the 1991 economic reforms marked a turning point for India’s pharmaceutical sector. The reforms focused on liberalising the economy and encouraging private investment and foreign trade. India’s pharmaceutical sector, which had long been shielded from global competition, suddenly gained access to international markets. His reforms allowed Indian pharmaceutical companies to adopt advanced technologies, scale up operations, and expand their reach into global markets.
Singh’s leadership was crucial when India had to align its patent laws with the TRIPS (Trade-Related Aspects of Intellectual Property Rights) agreement as part of its accession to the World Trade Organization (WTO) in 1995. The most significant regulatory change was the amendment to India's Patents Act, which was a direct response to India’s obligations under the TRIPS agreement. This reform led to the introduction of product patents for pharmaceuticals in India.
India’s generic drug industry flourished after this reform, allowing Indian companies to supply low-cost, high-quality generics to countries around the world, especially to those in Africa and Asia.
India’s capacity to reverse-engineer and manufacture generics helped reduce the cost of many life-saving drugs for HIV/AIDS, tuberculosis, malaria, and hepatitis, making essential medicines available to populations that would otherwise not have access.
Singh’s policies enabled India to become a leading supplier of affordable antiretroviral (ARV) drugs to treat HIV/AIDS, particularly in Africa and other developing countries.
India’s contribution to the global fight against HIV/AIDS is widely regarded as one of its most significant achievements in the field of global health.
Singh’s economic reforms also led to an increase in research and development within India’s pharmaceutical sector. Indian companies began focusing on the development of biosimilars (generic versions of biologic drugs), allowing them to tap into the global market for biologics. India became a leader in producing biosimilars, further solidifying its role in the global pharmaceutical market.
India is commonly referred to as the "Pharmacy of the World” due to its significant role in global pharmaceutical manufacturing and supply. India is home to over 10,000 pharmaceutical companies, which makes it one of the largest pharmaceutical markets globally. As of today, India has around 650 USFDA-approved facilities, accounting for 25 per cent of all USFDA-approved facilities located outside the United States. This positions India as the second-largest country in terms of USFDA-approved plants, after the US. This is a testament to India's strong manufacturing capabilities and compliance with stringent regulatory standards, making it a key player in the global pharmaceutical sector.
In addition, more than 700 Indian pharmaceutical companies have secured approvals from the European Medicines Agency (EMA) or national regulatory authorities within the European Union. This further demonstrates India's extensive presence in international markets, providing high-quality medicines and contributing to the global healthcare supply chain.
Today India is one of the largest exporters of generic drugs to the United States, and around 40 per cent of all generic drugs sold in the US are sourced from India. This allows Indian pharmaceutical companies to supply drugs to the US market, including critical medicines in areas like oncology, cardiovascular diseases and more.
As an "accidental pharmacist" I started my career during this transformative period, witnessing the dynamic changes in the Indian pharmaceutical industry, from technological advancements to regulatory reforms and business transformations. The mid-90s to mid-2000s was truly a pivotal time for India's pharmaceutical sector. The technological transformation in the pharmaceutical industry during the 1990s and 2000s was nothing short of revolutionary, driven by the liberalisation of the Indian economy.
My firsthand experience with pharmaceutical facilities across Europe, China, and Asia provides a valuable perspective on the remarkable progress that Indian pharmaceutical companies have made. Here are several key factors that contribute to this achievement:
Aligning Schedule M of the Drugs and Cosmetics Rules, with the global standards of regulatory bodies like the WHO, EU, USFDA, and ICH not only involved ensuring adherence to high patient safety and quality standards but also required India to modernize its legal and procedural frameworks.
India made substantial improvements to manufacturing facilities, especially in the pharmaceutical and biotechnology sectors. Standard Operating Procedures (SOPs) were upgraded to meet international regulatory norms. This included improving the documentation, operational efficiency, and compliance monitoring within manufacturing facilities. These enhancements ensured greater consistency and quality in products being exported globally.
India saw a growing importance of clinical trials in the early 2000s, with both Indian and international pharmaceutical companies conducting trials within the country. The regulatory framework for clinical trials, especially in terms of ethical standards, was also evolving during this time.
The Indian pharmaceutical companies, especially the generics sector, became a global force due to their ability to produce high-quality, cost-effective medicines, supplying affordable generics to markets in Africa, Southeast Asia, and Latin America, and increasingly to the United States and Europe.
The business landscape saw a surge in mergers and acquisitions activity as Indian pharma companies began acquiring multinational assets to expand their reach and acquire new technologies.
Rise of Contract Research and Manufacturing Services (CRAMS)
Indian firms began to offer contract manufacturing and research services to global pharmaceutical companies, further establishing India as a global hub for outsourced pharmaceutical services.
While the focus in the early years of liberalisation was on generic drug production, the industry also began to invest more heavily in innovative R&D, which led to India emerging as a significant biosimilar and generic drug developer. Companies began establishing state-of-the-art research facilities to develop new drugs, focusing on NCEs (New Chemical Entities), biologics, and vaccines.
The country produces about 20 per cent of the world's generic medicines. India’s large pharmaceutical sector serves as a backbone for countries like the US and the UK, supplying 40 per cent and 25 per cent of their generic drug needs, respectively.
India is responsible for a staggering 60 per cent of the global vaccine supply. During the Covid pandemic, India’s timely and large-scale production and export of vaccines like Covishield helped to vaccinate millions in resource-constrained nations.
India’s pharmaceutical industry not only ensures affordable access to essential medicines and vaccines but also strengthens the global healthcare system, making it truly the 'Pharmacy of the World'. Through its continuous innovation, production capabilities, commitment to affordable medicines & consistent supply, India remains a cornerstone in ensuring health equity across the globe.
(The author is a pharmaceutical professional)
