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Health groups and patients have sought the government to invoke powers to make high cost patented drugs for rare diseases available in the Indian market at affordable cost. The demand comes in the wake of Swiss drug major Roche's legal move seeking permanent injunction against Indian generic manufacturer Natco Pharma to prevent generic versions of spinal muscular atrophy (SMA) drug Risdiplam, citing patent infringement.
Patient representatives and health groups in a press meet, highlighted that the government, courts, and lawmakers need to take urgent action to address the abuse of patent monopolies in rare diseases. They sought the government to incentivise generic manufacturing to play its crucial role as the pharmacy of the developing world by producing and supplying drugs to rare disease patients in India and other low and middle income countries, they said.
Roche's patent for Risdiplam is effective until May 2035, allowing them to charge approximately Rs. 6 lakh per bottle, while production costs suggest the drug could be made available for as low as Rs. 3,000 annually, said Chitali Rao, senior legal and policy analyst, Third World Network.
Saifullah Khalidi, a patient with SMA, said that the rare disease has affected his day to day life and Risdiplam is a drug that could be a life saver not only to him, but also to several patients in the country. However, the medicine costs at Rs. 6 lakh per bottle and he may have to spend around Rs. 70 lakh annually for his treatment.
The health groups said that expert cost analysis for the drug shows that the cost of production is Rs. 2,418 per bottle and cost-based estimated generic price could be around Rs 3,024. Production cost per unit of powder for oral solution of 60 mg/80mL vial (0.75 mg/mL) is estimated at around Rs. 80 and cost-based generic price at Rs. 99, they added quoting expert cost analysis. The infringement suit filed by Roche is currently pending with the Delhi High Court.
Responding to the press meet by the health groups, Roche said that it is committed to deliver healthcare innovations that significantly improves patient lives in the country while ensuring that as many patients as possible have access to its products.
"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," said a Roche spokesperson.
Leena Menghaney, lawyer, pharmaceuticals law and policy, and global IP advisor at Médecins Sans Frontières (MSF), highlighted that there are also patients with other diseases such as cystic fibrosis, which are facing similar issues due to patent barriers. India should use the options available under the trade related agreements to support the patients in the country, she added.
The drug for CF (CFTR modulators), while under monopoly, continues to be unavailable in the country due to a lack of registration by the patent owner with the Indian drug regulator and is priced at over Rs. 1 crore annually for those patients importing the drug under a personal use license.
CFTR modulators' production costs could be 90% lower than current prices if the government addressed patent barriers to open up supply, argues patient groups.
Pratibha Tekwani, mother of a child with cystic fibrosis, said that availability of affordable medicines are crucial to the lives of hundreds of children in the country.
While the government has notified the National Rare Disease Policy (NRDP) to support the patients with rare disease in the country, the price of the drugs (ranging from rupees 10 lakhs to rupees 1 crore annually) limits the ability of the government to provide treatment lifelong.
The 2021 policy also recommended that the Department of Pharmaceuticals, Department for Promotion of Industry and Internal Trade (DPIIT) promote local development and manufacture of drugs for rare diseases by public and private sector pharmaceutical companies at affordable prices. It also recommended that these departments take legal/legislative measures to create a conducive environment for indigenous manufacturing of drugs for rare diseases at affordable prices, said the health groups.
Courts have directed the governments to look into the affordability of rare disease drugs at reasonable prices or plans for local production to make the products affordable, in recent years.
The Government of India in August, this year, stated that 63 rare diseases are currently included under the National Policy for Rare Diseases on the recommendation of the Central Technical Committee for Rare Diseases (CTCRD). Financial support of up to Rs. 50 lakhs per patient is provided for treatment at the 12 notified Centres of Excellence (CoEs) for rare diseases.
In October 2024, the Delhi High Court directed the government to establish a National Fund for Rare Diseases and allocate Rs. 974 crore for 2024-25 and 2025-26.
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