Patients suffering from cystic fibrosis, a life-threatening genetic disorder, have petitioned the government to allow the manufacture of generic versions of the Trikafta and Orkambi drugs made by a US company.
In India, there are nearly 600 identified patients of the disease, which is characterised by the build-up of sticky mucus in the lungs and digestive system but as many cases are undiagnosed and underreported, it is estimated that the actual number of cases could be about 40,000. Those who are undiagnosed often die in infancy.
A new class of medicines, known as cystic fibrosis transmembrane conductance regulator (CFTR) modulators, has been proven to have a life-changing effect on patients. In their letter to the government, the patients emphasised that Boston-based Vertex Pharmaceuticals, the manufacturer of Trikafta and Orkambi, has not registered them in India.
Patients can obtain these medicines only through a personal use licence from the Central Drugs Standard Control Organisation. However, these medicines are highly priced – the annual dose costing $ 3,20,000 – and are mostly beyond the reach of patients and their families.
Cystic fibrosis a serious ailment, claim top doctor
According to Kuldeep Kumar Grover, head of critical care at CK Birla Hospital in Gurugram, cystic fibrosis was considered most common among Caucasians but is now being increasingly diagnosed among Indians too.
He added that if a person is diagnosed at the age of 20 or 21, the clinical symptoms may vary and may include persistent pneumonia, inability to digest food, obesity, and growth problems.
While many people in the West live up to their 30s and even their 50s with proper care and treatment, in India, the lifespan of patients with the disease is much shorter mainly due to the lack of diagnosis and treatment.
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Orkambi and Trikafta: Promising drugs
Both Orkambi and Trikafta are fixed-dose combinations and despite not having a patent yet on the fixed-dose combination, the individual components of these medicines are under patent protection in India. For this reason, Indian generic manufacturers are barred from producing affordable generic versions.
Vertex said Trikafta is the first approved treatment that is effective for cystic fibrosis patients 12 years and older and is a very effective remedy for almost 90 percent of the people suffering from the condition.
The letter by Indian patients to Anurag Jain, secretary in the Department of Industrial Promotion and Internal Trade, and Union health secretary Rajesh Bhushan mentioned that an Indian generic drugmaker had taken marketing approval for the drug in India but refused to launch it, apprehending a patent infringement suit.
Challenges to access
The patients said that the patent holder, by refusing to market the medicine and charging a high price, is abusing the monopoly rights granted by the patent, and stressed that the use of the patent, as of now, is prejudicial to public interest.
They pleaded with the government to either issue compulsory licensing to manufacture the drug in India, which will allow generic drug makers to make cheaper versions of the therapy, or allow hospitals and clinics to import cheap generic versions from anywhere in the world.
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Vertex told Moneycontrol that in some low-to-middle-income countries such as India, where the company does not currently have a presence, it is “actively evaluating options” that may facilitate access to the medicines including a product donation programme, which it began piloting last year.
Vertex’s revenue rose 18 percent to $8.93 billion in 2022. The US Food and Drug Administration approved the use of Trikafta in October 2019.
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