New Delhi: The government has exempted all food and drugs imported for the treatment of all rare diseases from basic customs duty, a move that could potentially benefit 70-90 million people and which has been hailed by people working in the sector as well as politicians.
In a statement released Thursday, the Ministry of Finance said it had issued a notification the previous day to exempt these products from basic customs duty. Medicines generally attract a basic customs duty of 10 per cent, while some life-saving drugs are taxed at 5 per cent or are exempt, the statement said.
“While exemptions have already been provided to specified drugs for treatment of Spinal Muscular Atrophy or Duchenne Muscular Dystrophy, the government has been receiving many representations seeking customs duty relief for drugs and medicines used in treatment of other rare diseases,” the statement said.
“Drugs or special foods required for the treatment of these diseases are expensive and need to be imported.”
“In order to avail this exemption, the individual importer has to produce a certificate from central or state director health services or district medical officer/civil surgeon of the district.”
The government had in 2021 released a National Policy for Rare Diseases, which tackled aspects like how to define rare diseases, how to treat them, and how to implement the best practices in this regard seen around the world.
“It is estimated that for a child weighing 10 kg, the annual cost of treatment for some rare diseases may vary from Rs 10 lakh to more than Rs 1 crore per year with treatment being lifelong, and drug dose and cost increasing with age and weight,” the policy document said.
This estimate broadly aligns with the estimates made by the Organisation for Rare Diseases India (ORDI), a non-profit body set up to give a voice to patients afflicted by rare diseases.
“There are some conditions that require a special diet, in terms of their chemical composition,” Prasanna Shirol, co-founder and executive director of ORDI, told ThePrint. “Most of these kinds of dietary foods are not available in India; they have to be imported. The diet itself costs on average Rs 6,000 for half a kg. Suppose a person has to be given a diet of 4-5 kg of the special food per month, it works out to Rs 60,000 per month. And that’s just the food, not counting the medicine.”
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Lack of standard definition a problem
A major problem when it comes to rare diseases is their definition, with no country or organisation agreeing on a set definition.
The WHO (World Health Organisation) classifies a disease or disorder as rare if it has a prevalence of one or less per 1,000 population. In the US, it is defined as a condition that affects fewer than 200,000 patients in the country. The European Union defines a rare disease as a life-threatening or chronically debilitating condition affecting no more than five in 10,000 people.
Japan identifies rare diseases as those with fewer than 50,000 prevalent cases in the country. India has no set definition.
“India faces the limitation of lack of epidemiological data to be able to define rare diseases in terms of prevalence or prevalence rate, which has been used by other countries,” according to the National Policy for Rare Diseases.
According to the policy, the Indian Council of Medical Research (ICMR) has started a hospital-based National Registry for Rare Diseases, which is expected to yield the “much-needed epidemiological data for rare diseases”.
Considering India’s large population, ORDI on its website suggests that a disease to be defined as rare if it affects 1 in 5,000 people or fewer.
The difference in or lack of definitions means estimating the number of patients affected by rare diseases becomes harder.
“The WHO says 6-8 per cent of the global population suffers from a rare disease,” Shirol said. “In India, the number is estimated to be anywhere between 70 and 90 million patients.”
Positive impact, much-needed move
Before the notification was issued, Congress leader Shashi Tharoor had taken to Twitter Tuesday recounting how the finance ministry had stepped forward to waive the tax on a much-needed injection for a particular case.
Tharoor recounted a story of how he was recently approached by the parent of a child afflicted by a rare form of cancer. He said that the only treatment was an injection that cost Rs 65 lakh, which the family had managed to raise by borrowing and crowdfunding. However, they were unable to pay the tax on this, which amounted to an additional Rs 7 lakh.
Tharoor said that he contacted Finance Minister Nirmala Sitharaman a few times through a letter, and then called her directly, and that she was “instantly sympathetic”. He said that, soon after his phone call with Sitharaman, he received a call from her personal secretary saying the FM had spoken to Vivek Johari, chairman of the Central Board of Indirect Taxes and Customs (CBIC) .
“Within ten minutes Johari called me asking for more documentation. By 7 pm today (Tuesday) the exemption was granted,” Tharoor said in his tweet.
“Whenever I am assailed by doubts about spending so much of my life in politics, something like this happens and makes it all worthwhile,” he added. “Thank you Nirmala-ji, thank you Sernya (PS to the FM) and thank you Vivek (Johari). You have reaffirmed my faith in government, in politics, and above all in humanity. Jai Hind.”
Benefits extend beyond price
Shirol explained that the benefit of the government’s decision extends beyond just reducing the price patients would have to pay for medicines and food. It would address anomalies in the tax structure as well.
“In other cases, where these drugs are given for free by companies abroad on compassionate grounds, earlier even this free drug attracted customs duty,” he explained. “But now there will be no tax.”
Yet another benefit of Wednesday’s notification, he said, was that the patient could now produce a certificate from a state or district official, which would ease the process significantly as compared to the previous system, where only a certificate issued by a central government officer would do.
(Edited by Geethalakshmi Ramanathan)
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