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‘More
companies will focus on basic research post 2005’
Premnath
Shenoy K R, presently, general manager, Quality Assurance and
Technical Services at AstraZeneca Pharma India Ltd, Bangalore, has
over 20 years of experience in areas of manufacturing and technical
services. Shenoy started his career with formulations R&D and later
switched to production, operations and quality assurance. In conversation
with Vijaya K, he speaks on various issues involved in pharmaceutical
manufacturing and R&D. Excerpts:
On
the developments in pharma manufacturing and R&D over the years
in India.
The focus of R&D has changed post liberalization. Earlier multinationals
were dependant on the parent companies for basic research. Two or
three multinationals who did not have a research base in India were
getting molecule inventions from the parent company. Indian companies
then were focussing only on reverse engineering which enabled them
to copy other’s products and develop different routes of synthesis
that was done quickly. They introduced the same molecule which was
already available in other parts of the world. This was due to the
absence of product patent.
However,
with the signing of GATT, the pharma companies had to change the
situation. Indian companies introduced new procedures to meet the
challenges from January 1, 2005 during which product patent will
come into effect. This forced some of the leading Indian companies
to invest in R&D well in advance in late 1990s increasing their
expenditure in R&D because of which they are in a position now
to come out with new molecules.
However, of the total 20,000 and odd companies in India, majority
of them still focus on formulations research and reverse engineering
process wherein they develop a new process or a new molecule introduced
by the innovator and find cheaper routes of synthesis for the existing
drugs.
On
developments in pharma industry post 2005
Post
2005, the Indian companies will not be able to introduce the products
of innovators in India. However, the scenario will not change dramatically
for the patients or the user or the companies. Whatever products
are already introduced in the market, they will continue to be available
and smaller companies still work on those products. A new drug remains
new for four years after it receives DCGI nod. At end of four years
any company can come out with the same product without any bioequivalence
studies.
A small
company can approach and obtain permission from any local Drugs
Controller and introduce the same product after four years. The
smaller companies will not be affected however during the patent
situation. Post 2005 is favourable for innovative companies because
they were not getting the returns for products introduced in India.
The
situation will change after 2005. The non availability of product
patent has restrained many multinationals from bringing new products
to India. With the product patent coming into being, MNCs will start
introducing newer molecules and patients will have access to those
products. The new molecules to be introduced 2005 onwards will slightly
be overpriced than what is currently available. This will ensure
that the innovators can recover the cost involved in manufacturing.
Any new molecule will be manufactured at one location so that the
company will have the economy of scale and distribute it to different
markets.
Though
post 2005 will be an opportunity for new products to come in, existing
ones will continue and because of the competition the prices will
come down.
On
GMP requirements
Schedule
M will affect the industry because on the one hand the regulatory
authorities and the industry have to meet the requirements followed
by the developed countries and on other hand we have the price control
which will not look into the expenses involved. There is no provision
in the DPCO to ensure that we get the returns for what we invest.
The industry is ready to invest for in GMP and meet the requirements
of GMP, but this will not be the case with smaller companies. Majority
of the SSIs who perhaps number upto 19,000 are not able to invest
in research because they neither have funds nor infrastructure.
They will continue with generic products and cater to the domestic
market and healthcare institutions or take up contract research
for bigger companies. Some of them may even close down.
On
the need of the hour to boost pharma manufacturing and R&D
First
of all, the main issue of concern is the DPCO which should understand
the quality related expenditures of companies who need to follow
GMP norms. In addition, pharmaceutical manufacturers should upgrade
their facility to meet the requirements. Lot of changes in documentation
is required and the concept of validation has to be included in
Schedule M now. The government should try to reduce the number of
drugs under price control. This will help companies to invest in
R&D and infrastructure in order to increase the economy of scale
and quality of product. Market forces will decide the price of the
product.
An
innovator will be able to price the product and will be able to
get the returns as well as invest in research and infrastructure.
Ultimately, there may be only 500 or 1000 companies in the industry.
On
trends and challenges ahead
As
of today there are only 5-10 companies who are into basic research.
However, the number will increase post 2005. More number of companies
will be able to do basic research and come out with new molecules
which can be licensed into other companies abroad for clinical trials
and other stages. The challenge is to balance between new drugs
and existing drugs. Secondly there needs to be balance between the
DPCO requirements and making enough profits for further investments
in research. So they need to have a blend of controlled and decontrolled
products.
We should also try to develop a new form to have advantage over
the conventional dosage form. Indian companies should focus on this
method which requires less infrastructure and investment. Ancillary
industries catering to pharma manufacturing should also improve
in order to provide quality machines. Though they are self sufficient
they do not meet the same standards that of the imported machines.
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