India’s production of affordable generic medicines sustains a global lifeline, but it must fortify quality assurance

INDIA’S SUCCESS IN PRODUCING AFFORDABLE GENERIC MEDICINES has been decades in the making, built on strategic policymaking since the 1970s, regardless of the political party in power. The country’s ability to develop both active pharmaceutical ingredients (APIs) and finished formulations independently—without technology transfer from multinational corporations or high-income countries—has positioned it as a vital player in global health and security. The recent exclusion of pharmaceuticals from increased import tariffs by the Trump administration, for example, highlights the critical role that affordable generic medicines play in keeping healthcare costs under control, even in high-income settings.

However, this self-reliance in production of essential medicines is not an accident. It is the result of decades of public sector investment, strong position against increasing intellectual barriers beyond the requirements of the World Trade Organisation in trade negotiations (known as ‘TRIPS plus’ provisions), and a regulatory environment that has historically prioritised competition and accessibility over monopoly control over the market and supply chain of pharmaceuticals. 

The pillar of global health

India’s role in supplying affordable medicines has been crucial in combating health emergencies such as drug-resistant tuberculosis, epidemics like HIV/AIDS, and public health crises like viral hepatitis. By cutting the costs of life-saving drugs by up to 99 percent, India has expanded treatment access in high-burden, resource-poor settings. The country has been a cornerstone in terms of providing affordable treatments for HIV/AIDS, tuberculosis, viral hepatitis, and malaria to public health programs in low- and middle-income countries. Increasingly, efforts are being made to explore the potential of India supplying medicines for non-communicable diseases and rare diseases.

National Drug Regulatory Authorities of countries like Thailand, Brazil, US, organisations like the Global Fund, and UN agencies like WHO, UNICEF and Medecins Sans Frontieres have invested in quality assurance of generic medicines from key manufacturing countries including India. They rely on Indian manufacturers to supply essential medicines to low and middle-income countries. This model of quality assurance coupled with high-volume, low-cost generic production and supply ensures that lifesaving drugs reach the world’s most vulnerable populations.

India's stance on intellectual property (‘IP’), particularly regarding pharmaceuticals, has often been framed in the context of public health and access to medicines. A key driver of generic production by India has been the manner in which its lawmakers have balanced IP laws with the need for competition in supply of life saving medicines. Both the Patents Act, 1970 and the Patents (Amendment) Act. 2005 were watershed moments for Indian lawmaking in this critical area. Even when complying with international trade rules in 2005, lawmakers ensured there was no linkage between IP and drug registration. 

Safeguards were also implemented to prevent frivolous patents from extending monopolies, thereby allowing early competition into the market, and significantly lowering drug prices for key therapeutic areas, including treatments for cancer, HIV, drug-resistant tuberculosis, hepatitis C, and diabetes.

Key challenges ahead

Today, as India speeds up free trade agreement (‘FTA’) negotiations with the US, UK and European Union—amid pressure from the Trump administration to further open its markets and avoid the threat of escalating tariffs on Indian exports—there is a growing risk that vital safeguards that protect generic competition could be eroded, with serious consequences for both national and global health security.