India has announced a full exemption from basic customs duty on all imported drugs and "Food for Special Medical Purposes" for personal use to treat all rare diseases listed under the National Policy for Rare Diseases 2021.

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Additionally, the government has also fully exempted Pembrolizumab (Keytruda), which is used to treat various cancers, from basic customs duty.

To qualify for the exemption, an individual importer must produce a certificate from the Central or State Director of Health Services, District Medical Officer or Civil Surgeon of the district.

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Normally, medicines attract basic customs duty of 10 percent, while some categories of lifesaving drugs or vaccines attract a concessional rate of 5 percent or are completely exempt from duties.

While certain drugs have already been granted exemptions for the treatment of Spinal Muscular Atrophy or Duchenne Muscular Dystrophy, the Centre has been receiving numerous requests for customs duty relief for drugs and medicines used to treat other rare diseases.

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The cost of drugs or special foods required for treating these diseases is high and must be imported. The annual cost of treating some rare diseases for a 10kg child may range from Rs 10 lakh to over Rs 1 crore per year, according to a Press Information Bureau press release. Furthermore, treatment is lifelong and drug doses and costs increase with age and weight.

This customs duty exemption will result in significant cost savings and much-needed relief for patients with rare diseases, the government said.