India has stood strong as the pharmacy of the world by producing affordable and quality assured generic medications which make healthcare and treatment accessible for the global population.
Yet, over the years, multiple powerful countries have consistently put pressure on India to curtail its generic medicine industry through “data exclusivity”.
Data exclusivity grants the first applicants, which are usually major multinational pharmaceutical corporations, exclusive protection over clinical trial data submitted by them for an extended period.
Generic manufacturers, which would have otherwise received a greenlight from regulatory bodies to make affordable drugs, are forced to wait out long exclusivity periods or conduct expensive and ethically questionable clinical trials.
India has stood firm on its intent to protect its generic medicine manufacturing sector, which benefits a massive segment of patients suffering from diseases like tuberculosis, HIV-AIDS, cancer and more. As the pharmacy of the world, India has played a pivotal role in treating patients and preventing the spread of diseases, especially in countries most underserved. But recent developments indicate that India’s stance on data exclusivity is wavering.
For us at Médecins Sans Frontières, and several other humanitarian organisations who understand India’s critical role in fighting infectious diseases, this is a moment to reemphasise the role of accessible medical care to prevent societal collapse.
Pharmacy of the world
On October 8, the Central Drugs Standard Control Organisation released a notice that indicated it was considering introducing data exclusivity provisions into India’s drug regulatory laws, a move which will undermine the production of affordable medicines.
In 2025, Commerce and Industry Minister Piyush Goyal indicated that India could attract additional investments from the European Free Trade Association, if it introduced data exclusivity provisions in Indian law. Such demands, also long pushed by pharmaceutical corporations in wealthy nations, could weaken India’s pro-public health provisions.
India accounts for the supply of 20% of the global generic medicines and 60% of global vaccines, according to data from the India Brand Equity Foundation.
Indian generic medicines have been revolutionary in tackling AIDS by drastically reducing the cost of treatment in the Global South. Today, generic manufacturers supply over 80% of the antiretroviral drugs used globally to combat the disease. India also supplies an estimated 60% of the world’s vaccines. A majority of the vaccines for the immunisation programs run by the World Health Organization and UN children’s fund, Unicef, are supplied by India.
When it comes to Médecins Sans Frontières, globally, 95% of HIV medicines, 90% of Hepatitis C antivirals, 36% of tuberculosis treatments and 30% of vaccines are procured from Indian manufacturers.
Why generics matter
Data exclusivity could potentially extend the monopoly period on medicines beyond the 20 years of patent protection, forcing further delays on generic manufacturing. Without any new generics entering the market, the prices of medicines will remain high for longer periods, delaying access to much of the population.
This also raises the ethical concern of human experimentation without new scientific justification, since generic manufacturers may have to conduct fresh clinical trials for a medicine that already exists. Data exclusivity serves the purpose of monetary gains by rich pharmaceutical corporations at the expense of patients in India and beyond.
As a world leader in accessible and affordable healthcare, India must look at the larger costs of diluting its stance on data exclusivity. When affordable medicines do not reach the most affected, diseases cannot be contained, which devastates families, destabilises communities and increases the economic burden of diseases.
For example, a patient suffering from tuberculosis must follow a regimented treatment plan, reinforced by adequate nutrition and mental health support. Apart from the physical implications of TB, the patient and their families also face social stigma and ostracisation. Interruptions in treatment to patients can not only disrupt their lives but also allow the bacteria to mutate and become untreatable. This could lead to compounded complications, which increases the pressure on communities and health systems, incomes and economies.
In the United States, data exclusivity granted for a long-established treatment for gout called Colchicine, increased the price of the medicine by 50 times, from nine cents to $ 4.85 per tablet. The restrictions reinforce a vicious cycle of monopolies and high prices, making it harder for countries to eradicate diseases, even decades after treatments enter the market.
In the face of increased armed violence, climate disasters and other economic disruptions, countries should actively work on building resilience of its citizens. Resilience cannot be built without a robust healthcare system that can access and administer medications to the most affected populations.
For decades now, India has been a world leader in helping build this resilience. The price of life saving drugs, that run to hundreds and sometimes thousands of dollars, are reduced by as much as 90%-95% due to generic varieties. Science is a commons, and inventions are built on a pool of knowledge that have been funded by public and private entities over the decades and centuries. Denying access to lifesaving medicines only so a few multinational companies can rake in billions of dollars is logically flawed and morally corrupt.
Data exclusivity offers no real public-interest benefit. India has resisted the dilution of data exclusivity in the past, and we hope to see it continue to do so. The world depends on it.
[Parthesarathy Rajendran is Executive Director, South Asia, Médecins Sans Frontières (MSF/Doctors Without Borders). Courtesy: Scroll.in, an Indian digital news publication, whose English edition is edited by Naresh Fernandes.]
