About a year ago, Rupal Panchal of Haemophilia Society explored ways to bring in technology to develop treatments for people with haemophilia. It’s a plan he still has, if he gets a little support from local drug-makers or the government.

But why is Panchal insistent on local manufacture of quality biotech drugs? Especially since the last three months witnessed the India launch of two next-generation products to treat and prevent bleeding in people with Haemophilia A.

In April, Novo Nordisk brought in Novoeight for those with Haemophilia A (factor VIII deficiency).And last month, Shire plc launched its third generation products Advate.

Expensive foreign drugs These foreign products are good, but too expensive, says Panchal. And for State governments working with fixed budgets, it will be difficult to buy many units of these highly priced haemophilia products. And for this reason, many will continue to rely on the first and second generation ones that are also good, he says.

Haemophilia is an inherited, chronic bleeding disorder and people with this condition need several infusions of these advanced products to stop the bleeding. The products are priced between ₹23 and ₹38 per unit compared to international prices of about $1 (about ₹67).

This compares to blood based products used here, at ₹10-12 per unit, he says. However, local blood based products run the risk of infection (HIV, Hepatitis C), he points out.

There’s also another worry. As global acquisitions take place, it could create monopolies, where a few companies control products in this segment. Baxalta housed Baxter’s haemophilia products, but was bought by Shire last year. And now Shire is reportedly looking at acquiring Biogen (which also develops advanced haemophilia products), he points out.

For companies looking at bio-similar products, it is not easy to make, or get similar quality and efficacy as the original product, says Panchal. The Department of Biotechnology needs to incentivise research and making of products for this “orphan disease”. A significant step in this direction is the formalisation of biotech guidelines

Defending the new product, Melvin D’Souza, Novo Nordisk India-head, says a recombinant product treats better and works well as a preventive. This means the bleeding reduces and so do the number of units used, he says. And, it is pegged at about half the global price.

A Shire representative adds that they are looking to improve diagnosis of people with haemophilia (many remain undetected), besides improving access. Advate has 13 years of real world experience (US launch in 2003) and the product has an India-specific pricing, the official said.

But with haemophilic products being in constant short supply because of technical issues involving biotech products, Panchal implores local drug-makers to get involved and help address the shortfall. Especially because, for someone with haemophilia, not getting treatment to stop the bleeding means becoming progressively disabled, he says, of the difficulty they face constantly.

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