Patient representatives and treatment activists have urged the Government to encourage domestic drugmakers to make generic versions of drugs to treat rare diseases, including spinal muscular atrophy (SMA) and cystic fibrosis.

Pointing to Risdiplam used to treat SMA, they said, Roche was seeking a permanent injunction to prevent Hyderabad’s Natco Pharma from making a generic version of Risdiplam, on the grounds that it was a patent infringement. This would affect access to affordable versions of the drug, activists said, as it blocks generic supplies.

SMA-related petitions

The Delhi High Court has been addressing SMA-related petitions since early 2021, highlighting the need for a coordinated treatment framework, given the challenges from high drug costs and limited access, they said.

“Roche’s patent for Risdiplam is effective until May 2035, allowing them to charge approximately ₹6 lakh per bottle, while production costs suggest the drug could be made available for as low as ₹3,024 annually,” the activists said. The monopoly on the drug could hinder the Union Health Ministry’s efforts “to benefit from domestic production and competitive pricing through pooled procurement (tendering) strategies,” they added.

What Roche said

In its response on the development involving Risdiplam, Roche told businessline, “Our focus remains on discovering and developing innovative medicines and diagnostics that will change standards of care in the future. At the same time, we are also committed to protect our innovations within the scope of applicable laws in the countries we operate and believe that laws provide sufficient safeguards for protection of innovation.”

“At Roche, drug innovation and its access to patients is foremost,” it said, adding that they were committed to deliver healthcare innovations that improves patient lives “while ensuring that as many patients as possible have access to our products.” 

“Overwhelming” barriers

Meanwhile on cystic fibrosis, health advocates pointed out, there were no options for patients in India, as the patent barriers were “overwhelming”.

The drug for CF continues to be unavailable in India since Vertex (the patentee) has not registered it with the Indian regulatory authorities, they said, adding that it was priced at about ₹1 crore annually for those importing the drug under a personal use licence.

Last year, a patient-driven campaign had been mounted across South Africa, Ukraine, Brazil and India, for access to the CF therapy, Trikafta, from the American biotech company Vertex Pharmaceuticals. The company had then told this correspondent, that it was exploring initiatives to make their drug accessible in India.

A company spokesperson had said., “In some low-to-middle-income countries such as India where access challenges are significant and where we do not currently have a presence, we are actively evaluating options that may facilitate access to our medicines including a product donation programme, which we began piloting last year.”

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