In India, key active pharmaceutical ingredients are manufactured for orphan drugs. Despite this patients in India face problems of paying high prices for medication. Due to a lack of government support and policy hurdles, Pharmaceutical companies cannot develop drugs in the domestic market. Pharmaceutical companies cannot develop drugs domestically, a primary reason that drugs are sold at high cost.
Orphan drugs are the drugs used to treat rare diseases. Pharmaceutical companies can’t gain profits from developing orphan drugs without any assistance from the government because orphan drugs target a small number of the population. However, active pharmaceutical ingredients are exported to foreign companies, which sell finished products back to India at high prices.
For example, a dose of Trientine (treatment for Wilson disease)for a year costs around Rs 1.6 Cr when it is imported. Similarly,
At least 20 patients in India have died in the past 2 years due to a lack of access to necessary medicines for rare diseases like Wilson’s and Pompe. This situation takes place due to high cost.
Challenges of high import cost and manufacturing:
Ramiah Muthyala, president of the Indian Organisation for Rare Disease said, “Exported as powder, when the APIs are shipped back to India as a tablet, we need an import license. For that, we have to pay 10% of the cost of the drug along with the cost of the package. Also, since some drugs are unstable above room temperature, they have to be sent in a cold box. This further hikes the cost”. He also added only a few of these 400 drugs are genuinely expensive and the prices of other drugs are highly inflated.
If Indian Pharmaceutical companies are encouraged to manufacture orphan drugs domestically could lead to significant price drops in drugs. Industry experts believe that the price of these drugs can drop up to 20 thousand to 3 lakhs if it is being developed by generic drug manufacturing companies.
Local firms face significant challenges and to determine the demand for these drugs there isn’t a comprehensive database of patients available. India lacks marketing channels for such patients and firms.
Regulatory hurdles.
Dr. Jagadeesh Rangisetty, CEO of Biophore Pharmaceuticals said.
“Even though we have a ready product to treat Dravet Syndrome, which has brought down the cost to one-tenth of the US product, it’s a challenge to find patients”. Biophore Pharmaceutical is one of the Indian firms manufacturing Orphan drugs. Only 12 such drugs are developed in India and the rest can only be imported.
Getting clearance for these drugs from regulatory bodies is challenging.
Cumbersome process:
Dr. Ashwin Dalal, nodal officer for rare diseases at the Centre of Excellence (CoE) in Hyderabad said, “ In the absence of a patient database, we usually get in touch with the handful of distributors who procure the drugs approved for marketing in India. But this takes at least a few weeks”. There are 12 such CoEs across India.
The cost of orphan drugs in India shows the need for policy change and government support to support domestic manufacturing. These changes are necessary to prevent patients from suffering financial burdens.
