Import duty on drugs for seven more rare diseases would be abolished, Union finance minister Nirmala Sitharaman said in her budget speech on Saturday, paving the way for easier availability of the prohibitively expensive medicines.

Historically, patients or their families had to submit an application to the Centre for every single case to waive the import duty on drugs. The Drugs Controller General of India issued a certificate, which was later presented to secure the exemption from paying the import duty.

The budget announcement on Sunday will eliminate the convoluted process that a patient’s family had to navigate to obtain the necessary medications.

“I also propose to add 7 more rare diseases for the purposes of exempting import duties on personal imports of drugs, medicines and Food for Special Medical Purposes (FSMP) used in their treatment,” Sitharaman’s budget speech mentioned.

The budget document adds that the basic customs duty for medicines procured for these seven diseases will be “nil”. Basic Customs Duty refers to the customs duty levied under the Customs Act 1962.

Dipanjana Datta, a medical geneticist, said the seven diseases added on Sunday were Congenital Hyperinsulinemic Hypoglycemia (CHI), Familial Homozygous Hypercholestrolemia, Alpha Mannosidosis, Primary Hyperoxaluria, Cystinosis, Hereditary Angioedema and Primary Immune Deficiency Disorders.

“There are 51 rare diseases already on the list for which one does not have to pay any import duty. After the finance minister’s announcement, drugs for 7 more rare diseases will get the same exemption,” said Datta, also the state coordinator of Organisation of Rare Diseases India, an umbrealla body of several patient advocacy groups.

Another medical geneticist stated that these seven diseases were not on the list of recognised rare diseases in India when the policy on rare diseases was framed in 2021, but were added subsequently. Most of the medicines for these seven diseases are still not manufactured in India and need to be imported.

Representatives of pharmaceutical companies stated that patients who needed the medicines had to apply to the Drugs Controller General of India for an exemption from import duty.

“The drug controller’s office issued a customs duty exemption certificate, which is then shown to claim the exemption,” said an official of a pharmaceutical company that imports some of the drugs.

It took around a month for the medicines to arrive since the application was submitted.

An official from a pharmaceutical company said that a pack of 100 capsules intended for cystinosis treatment is available for 93 Euro (₹1,01,58), while a pack of 100 capsules with a higher dosage for the same illness is available for 295 Euro (₹3,22,24).

Moreover, an additional customs duty will be charged if the exemption is not sought.

Ashwin Dalal, a medical geneticist with the Centre for DNA Fingerprinting and Diagnostics, Hyderabad, said the exemptions are granted only on named patient applications.

The institute is one of the centres for excellence identified as nodal centres for identification and treatment of rare diseases patients. In Calcutta, SSKM Hospital is the chosen centre of excellence.

“The applications must have the name of the patient for whom the exemption is being claimed. When the medicines arrive, they can be used only by the patient who applied for them and no one else. The side-effects, if any, are risks that the applicant has agreed to bear with,” said Dalal, a former member of the central technical committee on rare diseases (CTCRD).

The committee advises the union ministry of health on rare diseases.

It was not yet clear whether the changes would allow hospitals that treat patients with rare diseases to procure the medicines without paying the import duty.

Sitharaman also said that import duties will not be levied on food for special medical purposes (FSMP) used by patients of these seven rare diseases. FSMP is a formulation intended to provide nutritional support to people suffering from a specific disease, disorder or medical condition, as part of their dietary management.