Apr 7, 2025 07:46 IST
First published on: Apr 7, 2025 at 07:46 IST
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Three decades have passed since the Supreme Court held that the right to health and medical care is a fundamental right under Article 21 of the Constitution. The Directive Principle of State Policy enshrined in Article 41 mandates public assistance in cases of sickness and disablement. However, the Union Ministry of Health and Family Welfare (MoHFW), in its approach to the treatment of rare diseases, falls short of ensuring this basic right.
According to a reply in Parliament, 13,479 patients have registered in the National Registry for Rare and Other Inherited Disorders. The Delhi High Court observed while deciding on a petition filed by patients of rare diseases that in “a country like India, where thousands, if not lakhs, of patients suffer from rare diseases, cannot adopt a helpless approach. Courts also cannot be mute spectators. There are several registered patients, but there may be many more unregistered individuals suffering from rare diseases.” The small number of cases should help the government take focused action. The experience of the patients shows that the government has not taken its responsibility seriously. It required the intervention of the Delhi High Court for the MoHFW to approve the National Policy for Rare Diseases 2021 (NPRD) on March 30, 2021. In May 2023, the Delhi HC directed the formation of a five-member committee to oversee the implementation of the policy.
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The challenge that the patients face is the high cost of treatment. Take Spinal Muscular Atrophy (SMA). The annual cost of treatment using risdiplam is upward of Rs 72 lakh. The financial support offered under the NPRD has a limit of Rs 50 lakh per patient. This gets exhausted soon, and as a result, many patients cannot continue the treatment. The ministry told the Supreme Court that it could not extend assistance beyond Rs 50 lakh per patient due to a lack of funds.
A patient who had exhausted the funds approached the Kerala HC for a direction to the Union government to continue treatment. The High Court issued the direction, but the ministry went to the Supreme Court and obtained an interim stay. The Supreme Court had left it open to the ministry to take appropriate policy measures to address the patient’s request, which it has not done. And instead of examining the range of policy options suggested by the Delhi High Court, the ministry also obtained a stay from the Supreme Court on this order.
Paragraph 11 of the NPRD implementation strategy directs the MoHFW to approach the Department of Pharmaceuticals or the Department of Promotion of Industry and Internal Trade to facilitate the local production of medicines for rare diseases. Many such medicines, particularly small molecules like risdiplam and trikafta for the treatment of SMA and cystic fibrosis respectively, can be manufactured locally. The first generic version of a drug is launched at a price 90-95 per cent lower than the originator’s price.
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Given India’s manufacturing capabilities, these drugs can be produced at a fraction of current prices if patent encumbrances are addressed. Patent monopolies are a significant barrier to local production. After securing patents, their holders often exploit the monopoly by refusing to market life-saving medicines in India. The government need not be a mute spectator in the face of such strategies.
Despite the NPRD’s intention to support rare disease patients, delays and funding restrictions are leaving hundreds — including children — without access to life-saving treatment. The ministry’s refusal to provide additional funds, and its reluctance to invoke legal and policy measures mentioned in the NPRD or suggested by the Delhi High Court to ensure affordable access to life-saving therapies, raise legal and ethical concerns. As a member of the consultative committee of the health ministry, I have raised these issues and I hope they will be addressed with alacrity. No family should endure the heartbreak of watching their child suffer from a treatable disease simply because life-saving medicines remain inaccessible due to high costs.
The writer is a Rajya Sabha MP, the Indian Union Muslim League