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Cystic fibrosis patients ask DPIIT to allow local manufacturing of CFTR modulators to bring down price

Gireesh Babu, New Delhi
Saturday, February 3, 2024, 08:00 Hrs  [IST]

Patients of cystic fibrosis (CF) and their relatives have requested the Department for Promotion of Industry and Internal Trade (DPIIT) to take steps to provide CF drugs at an affordable cost using the provisions of the Patents Act, 1970, considering that the drugs at present cost anywhere from Rs. 21 lakh to Rs. 2.66 crore.

In a letter to Rajesh Kumar Singh, Secretary, DPIIT, Raghavendra Bharadwaj and R Balaji, parents of two 12-year old patients with the disease and Arouba Kabir, another 36-year old patient with CF, said that the rare disease can be treated using a new class of medicines known as Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) modulators, with proven life-changing effects on the patients.

There are four formulations including combination drugs in this class of medicines, and the cost of these medicines is high and they need to be used for a long period.

The patients said that ivacaftor, branded as Kalydeco is priced at Rs. 21 lakh, while a combination of ivacaftor and lumacaftor branded as orkambi at Rs. 2.25 crore, another combination of tezacaftor and ivacaftor branded as Symdeko at Rs. 2.14 crore and a third combination of elexacaftor, tezacaftor and ivacaftor branded as trikafta at Rs. 2.66 crore. All the four drugs are owned by US-based biopharmaceutical firm Vertex Pharmaceuticals.

They alleged that the high price of these medicines is because of the patent protection offered to these drugs in India. Though there is no patent till now on the fixed-dose combination, the individual components of these medicines such as lumacaftor, ivacaftor and tezacaftor are under patent protection in India.

"Therefore, Indian generic manufacturers are barred from producing affordable generic versions. It is very clear that the patent holder, by refusing to market the medicine and charging a high price, is abusing the monopoly rights granted by the patent. In other words, the way the patent holder is using the patent is prejudicial to the public interest," they alleged.

CF is a genetic disorder, which causes sticky mucus to build up in the lungs and digestive system. This condition is life-threatening as it damages both the lungs and the digestive system with those undiagnosed often dying in infancy. Estimates of the number of people identified as living with CF in India range between 600-1,200 but due to the lack of availability of diagnostics and under-reporting the total number is likely to be up to 40,000. A recent estimate suggested there could be up to 146,000 CF patients in South Asia, they said.

The National Policy for Rare Diseases also envisages the creation of a conducive environment for indigenous production and manufacture of drugs to treat rare diseases in coordination with the Department of Pharmaceuticals and the DPIIT. The National Policy for Rare Diseases also envisages the use of public health safeguards in the Patents Act, 1970.

The implementation strategy under Point No. 14 of the National Rare Diseases Policy 2021 states that the Ministry of Health and Family Welfare would request the DPIIT to take legal/legislative measures to create a conducive environment for the affordable local production, argued the patients. However, the Ministry of Health has till date not made any request to the DPIIT for the implementation of these strategies to promote local development and manufacture of drugs of rare diseases at affordable prices, they averred.

"In light of these above facts, as patients of CF, since the medicines for CF are totally unaffordable in India, we request you to take steps in the public interest under the Patents Act 1970, for issue of government use license/s under Section 100 of the Patents Act 1970 or to take measures for the speedy issuance of compulsory licensing under section 92 of the Patents Act 1907", said the patients.

"Alternatively, we request the DPIIT to take steps to invoke cancellation of the patents under Section 66 because in this case the 'mode in which it is exercised is mischievous to the State or generally prejudicial to the public'. These measures in public interest would enable the government to make these drugs available freely or at a reasonably affordable price to CF patients," they added.


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