[Ip-health] The Hindu: WHO launches plan for cheaper TB drugs

Thiru Balasubramaniam thiru at keionline.org
Thu Mar 8 23:52:58 PST 2018



WHO launches plan for cheaper TB drugs

Vidya Krishnan
NEW DELHI , MARCH 08, 2018 21:43 IST
UPDATED: MARCH 08, 2018 21:43 IST

The World Health Organisation (WHO), on Tuesday, invited pharmaceutical
companies around the world to submit proposals to manufacture affordable
versions of newer medicines for treatment of drug resistant tuberculosis.

A WHO spokesman said the aim was to replicate the success of addressing the
HIV epidemic. Competition among Indian drug producers had then brought down
the price of HIV medicines by 99% from $15,000 per patient per year to less
than a dollar a day.

WHO has now requested drug makers to submit an Expression of Interest (EoI)
for Bedaquiline and Delaminid, two new-generation drugs, recommended for
drug resistant-TB. Under WHO norms, drugs submitted upon such requests and
complying with its standards are included in a list for procurement by the
UN and other organisations.

India has nearly 1.3 lakh DR-TB patients, the most in the world, but the
Health Ministry gets only 10,000 doses of Bedaquiline and 400 doses of
Delaminid. The medicines are obtained as donations from Janssen (US) and
Otsuka Pharmaceuticals (Japan), the respective manufacturers.

“One of the aims of pre qualification is to ensure that a greater number of
manufacturers are supplying quality medicines, which in turn means a more
competitive market and more affordable prices. We have seen this with HIV,
where the pre-qualification of many predominantly Indian manufactured
products brought the price down of many anti-retrovirals. Inclusion within
the scope of PQ has also incentivised the development of fixed dose
combinations, which have yielded much better results for patients,” said
Daniela Bagozzi, Communication Manager, WHO.

In the case of HIV, one company, Cipla, came up with a ‘AIDS cocktail’
combination of Stavudine, Lamivudine and Nevirapine, enabling effective

Cheaper drugs to treat HIV became possible at the time as the Indian
Patents Act did not provide for product patents on pharmaceutical products,
until required by the Trade Related Intellectual Property Rights (TRIPS)
framework of the World Trade Organization (WTO). India became TRIPS
compliant with pharma product patents in 2005.

Open to generics

“The whole world looks to India to provide access to affordable drugs
because of our capabilities. With WHO’s backing, we will be able to
accelerate introduction of generics,” said D.G. Shah, Secretary General,
Indian Pharmaceutical Alliance (IPA).

Inclusion of the two new drugs, Bedaquiline and Delaminid, in the
pre-qualification call is being interpreted by aid agency Médecins Sans
Frontières (MSF) as WHO’s backing for generics.

Christophe Perrin, pharmacist at MSF said, “It is clear from the EoI that
WHO considers the two drugs key compounds to address challenges of
drug-resistant TB. It also means that they want to encourage generic
competition to start finding ways to make these medicines available in
countries where they are not yet registered. The EoI allows generics
manufacturers interested in producing these two drugs, and currently facing
technical challenges, to address their questions to WHO’s pre-qualification

Arun Kumar Jha, Economic Advisor, Union Health Ministry, said, “We are not
wasting a single moment in ensuring affordable versions of these medicines
are scaled up.”

Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org

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