How India is failing to protect affordable medicine access | UK FTA

In recent years, the Indian government has shifted its focus from the local manufacturing of life-saving drugs at a low cost to facilitate multinationals sell patented medications at higher prices. The primacy given to voluntary licensing over compulsory licensing in India’s recently signed free trade agreement (FTA) with the UK marks the continuation of a move that began much earlier.

The relevant entry in the FTA reads: “The Parties recognise the preferable and optimal route to promote and ensure access to medicines is through voluntary mechanisms, such as voluntary licensing which may include technology transfer on mutually agreed terms.”

Commerce Ministry's stance

The Ministry of Commerce and Industry denied allegations that it amounts to any dilution in its sovereign right to give compulsory licenses and insisted that the safeguards continue for citizens and generic drug-makers.

Also read: Why India-UK FTA may push medicines out of ordinary Indians’ reach

It presented two arguments to make its point.

First, India didn’t allow patent extension (beyond 20 years) or data exclusivity — the two tools for evergreening patents that the UK sought.

Second, the reference to voluntary licensing is a mere acknowledgment of global best practices that encourage collaborative solutions and don’t limit India's right under the Patents Act of 1970.

Where it falls short

However, these are, at best, superficial arguments. Here is why.

1) The FTA doesn’t mention compulsory licensing or the Patents Act of 1970.

2) The FTA retains four elements that diluted procedural safeguards against evergreening that were included in the FTA with the four-nation EFTA (European Free Trade Association) in March 2024 and later incorporated into the Patents (Amendment) Rules of 2024. The recent FTA with the UK also carries them forward. These are:

a) Giving prima facie power to patents controller to decide if a challenge to patent application (PGO or pre-grant opposition) is valid

b) Imposing a fee for such challenges

c) Disclosure on the working of a patent is extended to once every three years, non-disclosure of a patented drug being “imported” or manufactured in India is done away

d) The onus of providing information on a patent is shifted to the patent controller, from the patent applicant.

These provisions let patents go unchallenged and violations of the 1970 act invisible.

Also read: Should homeopathy, ayurveda specialists be called ‘doctors’? The great medical divide

As for patent extension and data exclusivity, these elements came to notice when a draft of the negotiated text was leaked in 2022, provoking strong protests from civil rights activists, which forced India’s hands. If the primacy of voluntary licensing went unchallenged, it was because the negotiations were opaque.

What are these licences?

The Patents Act of 1970 empowers India to give compulsory licences to generic drugmakers to supply cheaper versions of patented drugs – without the consent of the patent owner. Such a licence can be given suo motu (Section 100) or if an application is made if the patented drug is priced unreasonably high, not easily available, or violates the Patents Act of 1970 by not setting up a manufacturing facility in three years (Sections 84 and 92).

The World Trade Organization’s (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which India signed in 1995, gives such a right in certain conditions to balance the need for protecting intellectual property with public health.

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Voluntary licensing, on the other hand, is a private commercial contract between the original patent-holder and a generic drug manufacturer. It comes with many restrictions, including high royalties, a lack of transparency, varying terms across multiple licences, broad scope of patents, limitations in geographic coverage, etc., undermining accessibility and affordability.

When compulsory licence came in

India took to compulsory licensing in 1995 after signing the TRIPS, with a 10-year transition period (up to 2005). When India granted the first and only compulsory licence to a small startup called Natco Pharma in 2012 to manufacture cancer drug Sorafenib, a cheaper version of costly Bayers’ Nexavar, it was a revolutionary moment. It brought the drug price down from Rs 2.84 lakh per month to Rs 8,800, saving thousands of poor patients.

The Indian government had then played a critical role in supporting Natco Pharma. The then health and commerce ministers openly supported it, and senior officials of health, commerce and industry and chemicals and fertilisers ministries worked together with the then controller general of patents PH Kurien, giving the go-ahead.

But such has been the pressures from drug lobbies and the likes of the US that India has not had another compulsory license since then.

How India backtracked

The first sign of Indian government’s backtracking came in March 2016, when international and national media went to town with headlines screaming “US industry body says India agreed to not issue 'compulsory' drug licences”, “India gave ‘private reassurance’, says US business council”, “India ‘privately’ against patent-overriding drug permits: USIBC”.

These reports said, the US-India Business Council (USIBC) had told the United States Trade Representative (USTR) that the Indian government had “privately assured” that it would not use compulsory licences for commercial purposes and that “Government of India has denied several compulsory license applications”.

Also read: Dr Reddy's recalls 3.3 lakh bottles of generic medicine in US

The commerce and industry ministry dismissed the reports as “factually incorrect” and assured that it had TRIPS compliant legislative, administrative and judicial framework as safeguards.

USTR's priority watch

The USTR had, by then, put India on “priority watch” list for two consecutive years for unfairly favouring local drug-makers. Its annual “2013 Special 301 Report” called the Natco-Bayer case a “troubling precedent”; its “2014 Special 301 Report” expressed alarm “over a dozen patented medicines” being considered by India for compulsory licenses and urged India to “allow opportunities for input by rights holders”.

Its “2025 Special 301 Report” of April 2025 has a stern message to India and others: “…actions by trading partners to unfairly issue, threaten to issue, or encourage others to issue compulsory licenses raise serious concerns”.

If the US didn’t impose trade sanctions on India, which its pharma lobby demanded, it was because of a brave fightback from the Indian health activists.

Pandemic event

Then came a critical turn.

Amid the pandemic in 2021, the Indian government refused to allow the manufacturing of low-cost versions of COVID-19 medicines such as Remdesivir and Tocilizumab in its affidavit to the Supreme Court, while saying that it was open to any application for it by a generic drugmaker. The affidavit was in response to the court’s observation that it should consider compulsory licenses.

The affidavit’s argument was that during the pandemic, when the demand for these drugs was urging world over “any exercise of statutory powers…can only prove to be counter-productive at this stage” and that it was trying to find a solution at “diplomatic level”.

Any wonder the 2012 miracle hasn’t happened again?

Patients in protest

The fight for compulsory licensing has continued, however.

KM Gopakumar, a health activist and co-convenor of the Working Group on Access to Medicine and Treatment, says currently, patients have filed three petitions in the Kerala and Karnataka high courts (during 2022-24) seeking compulsory licenses for four lifesaving drugs.

These are: breast cancer drugs Ribociclib (Rs 64,000 a month) and Abemaciclib (Rs 48,000-95,000 a month depending on doses), spinal muscular atrophy drug Risdiplam (Rs 6.2 lakh a bottle and 18.6 lakh for three bottles a month for adults) and cystic fibrosis drug Trikafta ($320,000 a year).

“This is an apparent failure of both the Indian government and Big Pharma”, he said.

About the Indian government’s stand, he added that it opposed compulsory licensing for breast-cancer drugs (but silent on others) by arguing that it was not needed because the generic medicine of Palbociclib was available. Gopakumar, however, pointed out that while Palbociclib is for late-stage treatment, the applications are for earlier stages.

Voluntary licences not the answer

A global study on voluntary licences by the Médecins Sans Frontières in 2022 concluded that these being private commercial contracts, they “cannot be expected to achieve the optimal level of public health benefit and access to affordable medicines” and governments should intervene through compulsory licenses.

It further said the COVID-19 pandemic highlighted the urgent need for non-exclusive and worldwide licensing norms to scale up and supply affordable medicines, vaccines and diagnostics globally.

Voluntary licences are not unknown in India, but no study exists about their efficacy. For example, Indian manufacturers have voluntary licences to make HIV drugs such as Dolutegravir, Cabotegravir and Lenacapavir.

According to Gopakumar, drug prices can be lower in such cases but not to the extent that generic version brings; conditions such as sourcing active pharmaceutical ingredients from the original manufacturer jack up prices and in some in cases, the Indian manufacturers are not allowed to sell in India but export to underdeveloped countries (geographical restrictions).

The onus now lies on the Indian government to take a fresh call on its position.