On April 2, US President Trump is expected to follow through on his threats to impose 25 per cent tariffs on drug imports from India. And even if the tariff announcements are deferred or lower than expected, the US Trade Representative (US TR)’s latest report gives some clues that the re-calibration indicated by President Trump will continue. On March 3, the US TR Jamieson Greer delivered President Trump’s 2025 Trade Policy Agenda and the 2024 annual report to the US Congress. Titled, A Trade Policy for the Next Great American Century, the document lays out why President Trump’s trade policy favours a “Production Economy” and how such a policy will help the President Make America Great Again. While major Indian pharma companies have a US-based manufacturing footprint, there are other non-tariff barriers in play as well. For instance, the report has once again included India in the “priority watch list” for IP violations along with China, Russia, Argentina, Chile, Indonesia and Venezuela.
On the IP front, the ongoing legal proceedings to allow the manufacture of generic risdiplam, a drug for spinal muscular atrophy (SMA) is being seen as a test case for interpreting India’s IP laws. The judgements could impact petitions from patients suffering from other rare diseases, who are dependent on medicines still under patent protection. These patients are therefore dependent on compassionate use programmes, government or NGO funding, all of which run out after a certain number of doses. A more permanent solution would be to legally challenge these patents, as Natco has done for Roche’s brand of risdiplam Evrysdi.
AN MSF statement on February 28, Rare Disease Day, highlighted that since early 2021, the High Courts have been addressing petitions related to SMA, calling for local production and generic competition to address challenges like the high cost of medications caused by patent monopolies. While effective therapies, such as risdiplam, have proven to be lifesaving, they continue to remain out of reach for many patients due to their prohibitive cost.
As mentioned above, present policies do not go the entire distance. The MSF release further indicates that despite the availability of funding under India’s National Policy for Rare Diseases, the high price of risdiplam – priced at Rs 6.2 lakh per bottle by Roche – continues to limit access. For patients weighing under 20 kg, one bottle is required each month, and those above 20 kg may need up to three bottles per month, making the treatment unaffordable.
Seba P A, an SMA patient, submitted that under Roche’s Patient Support Programme in India, patients pay Rs. 12.5 lakhs for two bottles and get three bottles free. Thus, patients get five bottles for Rs. 12.5 lakhs, and for a patient weighing 20 kgs or more, needing 30 bottles a year, will still pay over Rs.30 lakhs, pointing out that this was still unaffordable for patients like her.
Leena Meghaney, a lawyer focusing on public health, pharmaceuticals & access issues, and global IP advisor, MSF emphasises that, “Seba’s challenge of treatment interruption highlights that SMA patients cannot afford delays given the price disparity between the Roche’s price for the patented drug risdiplam and the anticipated low cost of generic versions due to Roche’s long drawn patent dispute in courts. The question before the courts is not just about patent validity, but whether a generic can be allowed in the public interest while the patent is tested – royalties can be paid if the patent is upheld. Although the Indian government has increased funding for rare disease patients under the National Policy for Rare Diseases, providing up to Rs 50 lakh per patient, this amount remains insufficient due to Roche’s exorbitant monopoly pricing – Rs 203,840 per bottle – creating significant barriers to continued therapy, as the government is unwilling to raise the funding limit.”
If the courts do not provide legal relief, this situation could continue till Roche’s patent runs out in May 2035. The Delhi High Court’s judgment decision of March 24 2025 drew comparisons between the cost of Roche’s imported drug and the potentially lower cost of Natco’s generic version, which is still under development but the company claims could eventually be 80-90 per cent cheaper than Roche’s Evrysdi. The two other alternative treatments for SMA, Zolgensma and Spinraza, are also too expensive and not registered in India.
The court also referred to statements made by senior counsel Anand Grover who represented the Cure SMA Foundation in a 2017 case, when he stated that while Roche made the drug available at Rs 72 lakhs annually for the first two years and Rs 56 lakhs annually for the third year via their patient support programme, the same medicine was available at much lower costs in countries such as China and Pakistan. He thus contended that the Union of India has a responsibility to negotiate better prices with the company to ensure that a larger number of patients can access these medicinal products at an affordable price.
But these deliberations could earn India more censure from the US. Will the courts stand by the March 24 decision to not grant any injunction to Roche, reasoning that Natco can compensate them in damages should they win the case at a later stage? Or will they back down under tariff threats?
VIVEKA ROYCHOWDHURY, Editor
viveka.r@expressindia.com
viveka.roy3@gmail.com