Research grants and tax exemptions sought in India for orphan drugs

As the Indian government works on a comprehensive national policy on rare diseases, involved organizations have urged the Health Ministry to create a special fund and exempt the medicines and equipment required for treatment from import duties.

At a recent meeting, pharmaceutical industry representatives detailed several measures to the government including sustainable research grants and tax exemptions in R&D for orphan drugs, reports The Pharma Letter’s India correspondent.

Looking to boost the development of orphan drugs to treat rare diseases in India, drug companies have also sought a unified definition of rare diseases, apart from appealing to the government to allocate a minimum corpus of $66 million for the treatment of patients with rare diseases.

"Covid has presented a whole new perspective on intellectual property. This applies to orphan drugs as well," said a Health Ministry official.

He explained: "Take a look at what is happening around. Gilead applied and was granted orphan drug exclusivity for its drug remdesivir in the United States. After a public outcry, the company withdrew. India's since rescinded ban on the export of the drug hydroxychloroquine is also being shown as an example of the challenges that lie ahead. Faced with the prospect of compulsory licenses being issued, pharma company AbbVie waived any patent restrictions for the supply of 'lopinavir' and 'ritonavir' by generic drug manufacturers."

Noting that the intellectual property regime gains significance in this context, the official said it requires that both public and private sector interests are balanced adequately. This is exactly where a robust intellectual property regime such as prevalent in India should engage and rectify the imbalance between the public and private interest, he added.

Government aid sought

Financial aid and tax incentives have been sought for drugs to treat rare and orphan diseases. At the virtual conference, five pharma industry associations, including a patient group, Organization for Rare Diseases India (ORDI), deliberated on the various measures needed to ensure affordable orphan drugs.

The draft national policy for rare diseases released by the Health Ministry in February 2020 also came up for discussion. India currently has over 8,000 patients with rare diseases, including genetic disorders like Hunter syndrome, Gaucher disease and Fabry' s disease.

The ORDI had earlier termed India's draft national policy on rare diseases "unscientific" and had urged for greater budgetary allocation than the $20,025 cap on treatment cost.

In its list of 15 recommendations sent to the Ministry of Health and Family Welfare, the Bengaluru-based not-for-profit sought disease-specific financial packages, waiver of sales tax and import duty on essential drugs and medical devices.

"The draft policy does not speak about the government covering the treatment cost of rare diseases and only depends on crowd funding, which is not sustainable when the treatment runs into millions each year per patient. The earlier draft included a cost sharing between the state and the centre in 40:60 ratio which has been removed in the new draft," said ORDI executive director Prasanna Shirol.

The ORDI has suggested there should be centers for treatment in every state and has recommended a national treatment center, adding that state and central technical committees could meet annually and take stock of rare diseases, drug price and therapies.

Other organizations fighting to sensitize the government towards the seriousness of rare diseases have also pointed out that while the Indian government has special treatment funds for diseases like hemophilia and thalassemia, with $186 million and $93 million earmarked, respectively, it has completely ignored the more serious ones like Hunter syndrome, Gaucher and Fabry's disease.

At the recent virtual conference, Viranchi Shah, senior vice president, Indian Drug Manufacturers Association, suggested several measures to increase access to orphan drugs in the country. Mr Shah also appealed for fast track approval for orphan drugs applications in the country and wanted a provision to be made in clinical trial rules to ensure volunteers of orphan drug clinical trials get access to those drugs from the innovator company.