In a landmark move, the central government on Thursday announced that it has given full exemption from basic customs duty on all drugs and Food for Special Medical Purposes imported for personal use for the treatment of all Rare Diseases.
According to the government, this is for the diseases listed under the National Policy for Rare Diseases 2021 through a general exemption notification.
“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.Drugs/Medicines generally attract basic customs duty of 10%, while some categories of lifesaving drugs/vaccines attract concessional rate of 5% or Nil,” the Ministry of Finance said in a statement on Thursday.
The government also said that while exemptions have already been provided to specified drugs for the 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 the treatment of other Rare Diseases.
Drugs or Special Foods required for the treatment of these diseases are expensive and need to be imported. It is estimated that for a child weighing 10 kg, the annual cost of treatment for some rare diseases may vary from ₹10 lakh to more than ₹1 crore per year with treatment being lifelong and drug dose and cost, increasing with age and weight, it added.
According to the government, this exemption will result in substantial cost savings and provide much-needed relief to the patients.
It is noteworthy, that the Government has also fully exempted Pembrolizumab (Keytruda) used in the treatment of various cancers from basic customs duty.
“The field of rare diseases is at a very nascent stage . As per the National Policy for Rare Diseases, 2021 about 95% of rare diseases listed by the central govt have no approved treatment protocol and in the 5% that there are , the treatment regimen is either too expensive or unavailable . In such a scenario , this step by the govt is a welcome move,” Dr. Siddharth Gautam, Consultant Neurosurgeon, Cooper Hospital & HBT told Financial Express.com.
According to the National Policy for Rare Diseases, 2021, less than 1 in 10 patients receive disease-specific treatment.
It is estimated that globally around 6000 to 8000 rare diseases exist with new rare diseases being reported in the medical literature regularly. However, 80% of all rare disease patients are affected by approximately 350 rare diseases.
“Market for drugs to treat rare diseases is quite small given its very nature, and this significantly increases the costs of such drugs. Any effort to reduce the cost of drugs to the patient will play a crucial role, especially if necessary mechanism is also put in place to ensure that the drugs are made available on a timely basis. The notification also provides a list of rare diseases for reference which seem to be based on the criteria set out in the National Policy for Rare Diseases, 2021,” Shantanu Jindel, Partner, IndusLaw, told Financial Express.com.
Jindel also said that given the beneficial intent of the customs duty exemption, government will need to ensure this list is frequently updated so that the benefits reach all patient groups suffering from rare diseases.
”We welcome this move by the Central Government as the duty exemption will result in substantial cost savings and provide much needed relief and hope to people with rare diseases (RD). Other factors that also make a big difference in the lives of those living with these debilitating disorders are early diagnosis and timely treatment. Over the last 15-years, Sanofi has pioneered in building the rare diseases care eco-system in India to make rare disease treatment both timely and more accessible. We even have charitable access programs through which we currently provide free medication to around 170 patients,” Anil Raina, General Manager – India, Sanofi Speciality Care told Financial Express.com.