Customs duty lifted on drugs for rare diseases

In a notification, the Union finance ministry said the annual cost of treatment for some rare diseases may vary from ₹10 lakh to over ₹1 crore annually.

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The government on Thursday announced a full exemption from basic customs duty for drugs and food imported for personal use for the treatment of rare diseases, saying that this will result in substantial cost savings and provide much-needed relief to patients.

It added that individual importers need to produce certificates from central or state officials to avail of the exemption for the diseases listed under the National Policy for Rare Diseases, 2021.

Basic customs duty of 10% is generally charged on medicines. In some categories of lifesaving drugs and vaccines, it is either a concessional 5% or zero. Exemptions were earlier provided to specified drugs for the treatment of spinal muscular atrophy.

Treatment for Lysosomal Storage Disorders (LSDs) - a set of at least six known diseases could cost between ₹40 lakh and ₹60 lakh a year for a child with 10kg body weight. With the exemption applicable now, the cost is likely to come down to ₹36 lakh-₹54 lakh.

Alglucosidase alfa, which is prescribed to treat one of the LSDs, Pompe Disease, costs around ₹40 lakh a year.

There is no universally accepted definition of rare disease; however, the World Health Organization (WHO) defines a rare disease as an often debilitating lifelong disease or disorder condition with a prevalence of 1 or less, per 1,000 population.

Different countries have their own definitions to suit their specific requirements, and as per the Indian Council of Medical Research (ICMR) it is one in 2,500 people or less.