Recently, health groups and rare disease patients in the country have sought the intervention of the Central government to invoke powers to make high cost patented drugs for rare diseases available in the Indian market at affordable prices. The health groups and patient representatives highlighted that the government, courts and lawmakers need to take urgent action to address the abuse of patent monopolies in rare diseases. They also called upon the government to incentivise generic manufacturing of the patented drugs for rare diseases 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. The health groups’ 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 drug Risdiplam, citing patent infringement. Patent for Risdiplam is effective until May 2035, and this patented drug costs a whopping Rs. 6 lakh per bottle and a spinal muscular atrophy patient has to spend roughly around Rs. 70 lakh annually for the treatment. The health groups argue that if the generic manufacturing of the drug is allowed, the drug could be made available for as low as Rs. 3,000 per bottle. Quoting expert cost analysis, the health groups argue that the cost of production of the drug is Rs. 2,418 per bottle and cost-based estimated generic price could be around Rs. 3,024. It is true that like the spinal muscular atrophy patients, there are also patients with other rare diseases such as cystic fibrosis who are facing similar crisis due to patent barriers.
Indeed, availability of drugs for rare diseases at reasonably affordable prices has been a major issue the country has been facing for a long time now. There are over 7,000 rare diseases globally and about 450 of them have been reported in India. There are an estimated 300 million rare disease patients worldwide of which 70 million are in India. But, for most of these patients, no treatment or very limited treatment options are available. As the cost of treatment of rare diseases is prohibitively expensive, the rare disease patients depend on government’s financial assistance for treatment. Though the Union Health Ministry had notified the National Rare Disease Policy (NRDP) way back in 2021 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. Even though around 450 rare diseases have been reported in India, only 63 rare diseases are currently included under the NRDP and financial support of up to Rs. 50 lakhs per patient is provided for treatment. Certainly, availability of affordable medicines is crucial to the lives of thousands of rare disease patients in the country. At present, very few companies are manufacturing drugs for rare diseases. As the number of persons suffering from particular rare disease is small, they do not constitute a significant market for drug manufacturers to develop and bring to market these drugs for them. For the drug manufacturers, such investments cannot be financially viable. So, when they manufacture such drugs, they sell them at prohibitively high costs, arguably to recover the research and development cost. In such a background, government intervention is crucial for the survival of rare disease patients. The government should not be found wanting in availing all options to make the prices of rare disease drugs within the reach of most of the people affected with the rare diseases.
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