India ready to battle swine flu
The battle against swine flu is getting intensified with the fruitful
results of the clinical trials for developing H1N1 vaccines and
diagnostic kits by both domestic and international pharmaceutical and
The rapid pace at which H1N1 spreads has created panic among people
from all across the world. The surge is expected to continue for more
than a year from now. Understanding the gravity of the situation, the
Indian government has been taking various initiatives to procure
vaccines from international pharmaceutical companies to curb the spread
of the pandemic and to enhance the development of indigenous diagnostic
kits and vaccines for H1N1.
Swine flu vaccine scenario
In August 2009, the Indian government approached four international
pharmaceutical companies that are manufacturing H1N1 vaccine, but no
pre-bookings were made. The government said the booking would be made
only after conducting the clinical trials to ensure the safety and
efficacy of the vaccine in the country.
In the first week of December 2009, GlaxoSmithKline (GSK) got the
approval to start its clinical trials in India. Two other
pharmaceutical companies, Baxter and Novartis have also got the
approvals to conduct clinical trials. The process will take at least a
couple of months to complete.
While commenting on the current status of GSK’s H1N1 vaccine,
a spokesperson of the company says, “We are in talks with the
government on the procurement and supply of H1N1 vaccines and are not
in a position to further comment on the said matter.”
French drug company, Sanofi-Aventis’ vaccines division,
Sanofi Pasteur, is one of the international companies that is expected
to join hands with the government in the fight against swine flu.
Meanwhile, during a Parliament briefing in November 2009 on the
development of swine flu vaccine, Ghulam Nabi Azad, health minister of
India, said that India would be able to indigenously develop swine flu
vaccine by June 2010.
According to Azad, three Indian companies — Serum Institute
of India, Bharat Biotech, and Panacea Biotec — are working
towards developing indigenous vaccine for the swine flu and the
clinical trials would start in January 2010.
To cover the interim period, the government is importing pandemic
vaccine to vaccinate the high risk group. So far, the government has
procured 40 million capsules and 400,000 bottles of Oseltamivir, the
drug used to treat swine flu.
Approvals and partnerships
On the clinical trial front, the animal trials for the much-awaited
H1N1 vaccine have been completed by the Pune-based Serum Institute of
India (SII). The company has also started its human clinical trials. On
the other hand, Ahmedabad-based vaccine maker, Zydus Cadila has filed
the first clinical trial protocol with the Drug Controller General of
India (DCGI) and has entered the race to launch H1N1 swine flu vaccine
Two multinational drug makers — GSK and Baxter International
Pharmaceuticals has formed a joint venture with Novavax, a US-based
clinical- stage biotechnology company, to develop, manufacture and
market vaccines, pharmaceuticals and diagnostic products in India. The
joint venture will develop and commercialize Novavax’s
seasonal influenza virus-like-particle (VLP)-based vaccine candidate
and Cadila’s therapeutic vaccine candidates against cancer as
well as its adjuvants, biogeneric and biological diagnostic products
for the Indian market.
Ahmedabad-based Intas Pharmaceuticals (Intas) has entered into a
strategic partnership with US biotechnology company, Amarillo
Biosciences, Inc (ABI), whereby Intas will sponsor clinical trials of
ABI’s orally administered interferon-alpha lozenges for
influenza, which could also be used in combating the H1N1 virus.
When asked about the prospects of Intas Pharmaceuticals-Amarillo
Biosciences partnership, Dr Samir Sangitrao, assistant general manager
regulatory affairs, Intas Biopharmaceuticals,says,
“Intas has submitted the required documents to DCGI for
approval of its clinical trial in India. We are expecting the approval
very soon. After getting the approval, Intas is planning to conduct a
therapeutic clinical trial covering 500 patients with Amarillo
Biosciences’ patented orally administered interferon-alfa
lozenges. Amarillo has already completed animal studies including
toxicity studies as well as several other clinical trials in the US and
rest of the world.”
“Intas is developing a natural interferon-based therapeutic
solution for influenza in general (which will also cover swine flu).
Oral interferon will be used to prevent influenza, and, as a treatment,
it will also be used to reduce the severity of symptoms. The flu virus
does not mutate to evade the effects of interferon. Oral interferon
will have no interactions with influenza vaccines,”
He further says that the ongoing flu clinical trial in Australia, which
is preventive in nature, is well-timed to help Intas deal with the next
wave of swine flu or any other viral respiratory infections
efficiently. Report of this preventive study is expected in a few
months from now. This will further enhance the usability of orally
administered interferon-alfa lozenges for preventing influenza and
decrease the morbidity caused due to influenza.
The Defense Research and Development Organization (DRDO), a premier
defense laboratory in India, has developed a swine flu detection kit
and the process for transferring the technology for commercialization
is yet to be initiated.
This development was informed by AK Antony, defense minister of India,
in a written reply to the Lok Sabha in the last week of November 2009.
DRDO’s diagnostic kit is a rapid and cost-effective swine flu
virus specific isothermal gene amplification assay for reliable and
early clinical diagnosis of H1N1 in human patients.
The defense minister also emphasized that the kit works on a
single-tube method as compared to WHO approved Center for Disease
Control (CDC) recommended real-time reverse transcriptase polymerase
chain reaction test system. The assay is based on the principle of the
isothermal gene amplification protocol. No expensive real-time PCR
equipment is required as the result can be monitored by the naked eye.
The DRDO developed method gives results in an hour as compared to the
three-four hours required for the WHO-approved CDC-recommended kit. The
DRDO kit has been validated at the National Center for Disease Control,
New Delhi; Post Graduate Institute, Chandigarh and the National
Institute of Mental Health & Neurosciences, Bangalore.
Bangalore-based Bhat Biotech, is also in the process of developing a
H1N1 detection kit. Dr Shama Bhat, managing director, Bhat Biotech
India, says, “We have been developing diagnostic kits for
H1N1 virus detection for the past four months. We are planning to have
both quantitative PCR (qPCR) and rapid protein-based kits.”
“Bhat Biotech is collaborating with a German company for
developing qPCR-based kits. Within a month, soon after the validation,
the kits will be available in the market. For the past three months, we
are also working on the protein-based kits. Due to the lack of positive
samples, it is very difficult to test the kits. To overcome this
obstacle, we will be collaborating with some institutions, where this
test can be conducted,” adds Dr Bhat.
The way ahead
One of the challenges posed by the H1N1 virus is the mutation of its
strain. Though there were not much mutations identified in India,
Indian vaccine manufacturers have to take additional measures to tackle
this pressing need.
“Since swine flu virus is expected to mutate a lot,
developing a vaccine will not be a permanent solution. Vaccine efficacy
varies yearly due to antigenic drift. Anti-viral drugs lead to viral
resistance,” says Dr Samir Sangitrao.
The mutation of the swine flu virus is one of the major areas of
concern but with the kind of domestic and international
expertise, India can overcome the obstacle.
Pradeep Kumar in