Wednesday, February 17, 2016

PHARMA SPECIAL .The pill that costs $9,000 in US sells for $70 in India

The pill  that costs 
$9,000 in US
sells for $70 in India


And that's just one leukaemia drug.
India's generic industry has been producing many
such life-saving medicines at a fraction of the
global price

The Hyderabad-based Bharat Biotech might be the first
to come out with a vaccine for the Zika virus if its
efficacy can be proved. If it does succeed, this won't
be the first time India has come to the rescue of the
world. Indeed, the country's generic medicines are a
lifeline for millions not only in low and middle-income
countries but also in the developed world.
India's generic industry hit global headlines in 2001
when Cipla offered a three-drug cocktail for AIDS at less
than a dollar a day , a fraction of the price charged by
multinationals. Today, apart from several HIVAIDS drugs,
the industry is producing affordable, high quality medicines
for several diseases including hepatitis B and C, cancers,
drug-resistant TB and asthma. This has been credited to
India's patent law, often held up as a model one in
preventing the abuse of patent monopolies, and in
balancing public interest and the growth of the
pharmaceutical industry .
Last month, generic manufacturer Natco announced
that it would be supplying daclatasvir, a Hepatitis C drug,
to 112 developing countries. In 2013, a medicine to
treat hepatitis C, sofosbuvir, hit international headlines
for its price -$1,000 per pill. Gram for gram, it cost 67
times the price of gold. The sofosbuivir and daclatasvir
combination used for the disease costs almost $150,000
per patient for the 12-week regimen in the US. But in
India, it is priced at just $700 or a little over Rs 46,500
per patient for the same regimen. And prices are expected
to fall further.
Typically, the price of many expensive patented drugs in
European countries like France, Spain or the UK is half of
what these cost in the US. In countries like Brazil or
South Africa, these are a third or a fifth of the US price. The Indian price is often 1100th.

BALANCING PATIENT AND PATENT
So how does the Indian generic industry manage to do it?
The patent law in India is stringent on what is innovative
enough to get a patent. Plus, the crucial section 3(d) in the
law, much criticized by multinationals, has prevented
“evergreening“ -the attempt to patent different aspects
and improvements of the same drug to extend the period
of patent -a lucrative game for the pharmaceutical business.
Indian courts, too, have played a role. In the case of
entecavir for hepatitis B and erlotinib for lung cancer,
for instance, instead of blindly handing out injunctions
or upholding the validity of patents, the courts ruled
in favour of public access to a lifesaving drug. This
encouraged companies like Cipla, Ranbaxy and Natco
to do a `launch at risk', a term that describes a company
deciding to challenge a patent by launching a generic
version. This forces the patent-holding company to take
them to court, thus testing the validity of the patent
granted. Patent oppositions filed by patient groups also
spurred the rejection of several frivolous patent claims
on cancer, hepatitis and HIV medicines, protecting
generic competition.
India's patent law also provides for granting of compulsory
licences -under which the government can give a licence
to a manufacturer other than the patent holder for a
royalty fixed by it -for public health reasons. This can be
used where drugs are unavailable or unaffordable.
The only compulsory licence granted was in 2012 when
the patent office allowed the Indian generic company
Natco to market sorafenib, a drug patented by Bayer
to treat kidney and liver cancer.This move, upheld by
the Supreme Court in December 2014 helped bring down
the price by 97%, unimaginable through a price
negotiation with the company .
“How long will this continue? We are already feeling
the adverse impact of monopoly and limited access to
important drugs. If India cannot manufacture newer
drugs, how can we be the pharmacy of the world?“
asked Dr Yusuf Hamied, of Cipla.

PRESSURE TO TOE LINE
About half the essential medicines that Unicef distributes
and 75% of those distributed by the International
Dispensary Association, which procures medicines for
130 countries, come from India. So do about 80% of
HIV AIDS medicines for the developing world. But there
is immense pressure on India from Europe, the US and
their multinational pharma companies to `strengthen
patent enforcement'. This could mean that the newer
cancer and TB drugs getting patented would be out of
reach for millions in India and the developing world
with no generic versions to force prices down.
For example, lapatinib for breast cancer and other solid
tumours, which costs over Rs 46,000 a month, or
dasatanib for a kind of blood cancer, which costs over
Rs 70,000 a month, have no cheaper generic versions.
Even drugs like delaminid, meant for drugresistant TB,
will not be available in India and the developing world
despite India having the highest burden of the disease.
This is because the Japanese company that holds the
patent has not made it available in India. In the pre-2005
patent regime, if a company did not bring the drug to
India, generic companies could step in to register it in
India and start supply, but not anymore.
India is just 1-2% of the global pharma market.
Yet there is intense focus on its patent law.
This is “to protect the markets of large pharmaceuticals
companies against competition from cheaper generic
drugs manufactured in countries like India and Brazil“,
explained Dr Amit Sengupta of the People's Health
Movement in an article on India's patent law.
Rema Nagarajan

TOI7FEB16

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