is completely trained to meet the current GMP standards”
-Dr Cyrus Poonawalla, chairman and
founder, Serum Institute of India, Pune
Dr Cyrus Poonawalla,
founder and chairman of India's leading manufacturer and
global supplier company for vaccines, Serum Institute of India, is the
visionary credited for making India the epicenter of the
global vaccine industry. In an exclusive conversation with BioSpectrum,
Dr Cyrus Poonawalla shares his views on the performance of the Indian
vaccine market this year and reveals Serum's initiatives to help the world to combat against swine flu.
Last year, the Indian
vaccine industry received a jolt with the WHO giving an ultimatum to
the NRA to upgrade its GMP standards, what is its current status?
The ultimatum given by WHO to those companies for not falling in line
with the GMP standards, both in the private and public
sector, is the best thing that happened in the past one year.
This was a wake up call for the Indian vaccine industry wherein all
vaccine manufacturers including Serum Institute had to upgrade the
facilities. Here I would like to make a point and a clarification that
manufacturing and production of these companies given an ultimatum were
only suspended and these units were not closed down as commonly
believed. They needed to upgrade their facilities which they may or may
not have been able to do, because the current GMP manufacturing
requirements are of very high standard, according to our schedule.
Indian players had to come up with really good manufacturing
facilities, follow a lot of systems and protocols which were not being
followed strictly in the past. In this industry, upgradation to GMP
standards and quality compliance are important issues which are vital
for the sustained growth of the vaccine industry.
As of now, India has got the actual approval from WHO since they have
put all their controls into position and the National Regulatory
Authority (NRA) is now completely trained to meet the current GMP
standards and most of the vaccine manufacturers in India have also
improved their facilities. But, those who have not been given license
will not be given permission to carry on with their facility anymore.
Does Serum Institute
have any plans to manufacture vaccines for swine flu?
We have been the only vaccine company in India which has been
identified and given the go ahead by WHO for developing swine flu
vaccines in the near future. We have taken up this challenge. But, at
this stage we do not want to make tall and ambitious claims in terms of
production and investment.
In your perspective
how is the Indian vaccine segment expanding?
We have recognized that more players have come into the vaccine segment
especially for the new pentavalent vaccines. This is a combination
vaccine for DPT, hepatitis B and Hib (haemophilus influenza type B). We
have witnessed the entry of around four to five new players into the
vaccine market. This is a growing trend in India wherein the vaccine
segment is now expanding and we will now see a number
of vaccine manufacturers playing an important
role in the supply of vaccines
in India as well as abroad. That in a way should increase the
total use of vaccines world wide.
What are the other
challenges confronting the Indian vaccine segment?
The vaccine segment in India entirely depends on the amount of vaccines
that the health ministry of India decides to procure to meet the
country's need. The ministry is not procuring enough
vaccines. The health ministry should take a serious note of this
matter, buy vaccines and immunize all the children in India with the
newer vaccines including the pentavalent vaccines. According to the WHO
report, it is pitiful that the number of children immunized in India is
far lower than countries like Bangladesh and the African countries. It
is also appalling that the health ministry is not taking initiatives to
provide immunization to children in India with hepatitis vaccines
despite having the largest vaccine manufacturers here.
In what respect has
the vaccine industry been affected by the slowdown?
I don't think that the vaccine industry has been affected by
the recession and slowdown. Vaccine industry may get affected in the
future, if the international donors cut back their donations and stop
pumping in funds to the UN agencies.