All foreign drug trials must have patients from India

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All foreign drug trials must have patients from India

Saturday, 12 November 2022 | Praveen Sikri

Global pharma manufacturers are doing injustice by not having Indians in their drug trials for rare diseases

In a globalised world, just like most products, drugs and medicines are also made for a global patient population. During the recent pandemic, the world saw how India supplied vaccines, medicines and other material to the rest of the globe. However, manufacturing of drugs is a complex process which involves a series of clinical trials before a drug is finally approved for licensing, manufacturing, distribution and sale. And it is purely a pharma manufacturer’s prerogative to decide on a product and the target market based on which subjects for clinical trials are selected.

Typically for a global product, subjects would be chosen from a range of geographies and populations. Now a country like India not only has a high disease burden, but also a high rare disease burden according to estimates. And indeed the government in recent years has sought to formulate a comprehensive policy for rare diseases in the country. However, despite its high rare disease burden, research has pointed out that hardly any Indian patients are included in the international clinical trials for global drug development programs for rare disease patients.

Research has pointed out how the participation of Indians has been slim in global clinical trials for orphan drugs. For 63 orphan drugs approved after 2008, there were 202 trials according to the US government’s clinical trial registry. Of these, only nine had been conducted in India, which amounted to a paltry 4.4 per cent. In fact, not more than one per cent of the remaining 193 trials had included people of Indian origin.

India offers a widely diversified ethnic and racial profile of people which would be an interest to pharma researchers and manufacturers. There are more than 2,000 known ethnic groups apart from over 700 tribes and other people with a shared gene pool from neighboring countries and geographies. And just as some race and ethnic groups may be more predisposed to certain diseases and illnesses, some groups may also respond differently to different drugs and lines of treatment.

Research has established how genetic variations, differences in environmental exposure and differences in diet and health-related practices are critical to understanding how a certain population group would respond to a line of treatment.

Assuming the estimate that nearly 6-8 per cent population of a country is affected with rare diseases, this amounts to between 81 and 108 million people in a population of at least 1350 million. By not including Indian patients in clinical trials, global pharma companies are possibly overlooking the health and lives of nearly 80-100 million people afflicted with rare diseases. These numbers are more than double (or even more) of what they are in Europe and the US. Although in a world which has nearly 7,000 rare diseases, only about 450 of them have been recorded in India based on data from tertiary care hospitals.

Until the time India bolsters its rare disease surveillance and improves epidemiological data collection and analysis, global pharma companies could make a beginning with at least the already prevailing rare diseases in the country. Some of the existing rare disease conditions found in the country include Haemophilia, Thalassemia, Sickle-cell Anaemia and Primary Immuno Deficiency in children, auto-immune diseases, Lysosomal storage disorders such as Pompe disease, Hirschsprung disease, Gaucher’s disease, Cystic Fibrosis, Hemangiomas and certain forms of muscular dystrophies.

Typically, the cost of a clinical trial for a new drug for rare disease would be at least $ 200 to 300 million – even with a small sample of 100-150 subjects. If the size of the sample is increased, the cost could go up even higher. Another related challenge would be in terms of the uncertain business environment for the manufacturer in the post-approval phase.

Typically, in developed countries, once a drug is approved, the government takes over the costs of the treatment for patients who continue to get treatment from the company. Furthermore, there is also a chance of pilferage of sensitive proprietary information resulting in half-baked and unauthorized medicines coming into the market.

In addition to the unavailability part, given the high cost of treatment when available, the inclusion of Indian patients would at least provide patients the rare opportunity to get access to treatment for at least during the time of the trial. Also, given that 80 per cent of rare diseases are genetic in origin, they impact children the most. So, the inclusion of Indians in global clinical trials for rare diseases would not only address the needs of Indian patients but also make the entire drug research and discovery process more scientifically valid and robust.

(The author is CEO of Ikris Pharma Network)

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