Medical Devices in
India: Overcoming the Challenges and Capitalizing on
Opportunities
|
Mr. Chandrasekhar Padamkumar
President, Kerala Medical Technology Consultant,
Director, Kerala Life Science Park and
Former Managing Director, Penpol Pvt. Ltd., Trivandrum |
I am going to speak about the topic from the perspective
of someone who helped build up a medical device company
from scratch in the nineteen eighties: a time before
economic liberalization, when the business climate in
India was very different and hardly conducive to doing
business. We started a medical device manufacturing
company called Peninsula Polymers Limited (Penpol) in
Trivandrum, Kerala, in 1985, based on technology developed
by the Sree Chitra Tirunal Institute for Medical Sciences
and Technology (SCTIMST).
Some unique challenges that we faced in
the early days were the following: first generation
entrepreneurs, lack of capital, no background in business
and technology, untried technology developed by a new
Institute which had no experience of technology
development and technology transfer. These added to the
normal challenges that any startup would have faced.
Suffice it to say, that the company had a huge struggle in
the early days to absorb the technology and establish the
manufacturing process. If not for the strong and steady
support of government institutions including the Kerala
State Industrial Development Corporation (KSIDC), the
National Research Development Corporation (NRDC), the Bank
and SCTIMST during the early years of the company, I am
sure the company would not have survived for long. The
lesson here is the need for patient capital for the
medical device industry; it is not an industry for the
weak of heart, or impatient investors.
The company grew from modest beginnings to
become one of the largest Blood bag manufacturers in the
world after it was acquired by the Japanese multinational,
Terumo Corporation. It now occupies pride of place in the
Terumo group as the flagship Blood Bag factory.
It is necessary for us to consider the
background of the medical device industry in India before
we discuss the challenges and opportunities. The Indian
medical device industry can be said to have formally taken
shape in the nineteen eighties after the Government of
Kerala set up SCTIMST in 1976 and the Institute developed
first the Blood Bag and a host of medical devices soon
after, including the blood oxygenator, cardiotomy
reservoir, tubing for the extracorporeal circuit in
heart-lung machines and the artificial heart valve. This
period saw the advent of organized businesses into an
industry which had until then been a cottage industry. A
few companies were set up during this period like TTK
Biomed Ltd., SPIC Pharma, Trivitron Diagnostics, Core
Healthcare Limited, HLL Lifecare Limited, Peninsula
Polymers Limited, Transasia Instruments Ltd and Hindustan
Syringes Ltd. However, the industry did not really take
off thanks to a combination of factors that we will
examine in the following paragraph.
The main challenges that the industry
faced in the early years can be summarised as follows:
• Lack of regulations
• Legacy of poor quality due to poor infrastructure,
talent and organisation
• Capital intensive nature of the industry
• Flawed public procurement system with weak technical and
quality evaluation
• Poor supply chain
• Poor service and maintenance
The Government has taken a major step
forward by finally bringing medical devices under the
ambit of the law. While it will take some more time to
reach international standards of regulation and quality,
the die is cast and industry will have to shape up sooner
or later.
Industry needs to step us and invest the
needed amounts to make quality products. The investment is
needed in cGMP facilities, R&D, qualified and trained
people and biocompatible materials which meet
international standards. Industry also needs to reach out
to research institutions and universities and tap the
enormous, untapped resources lying hidden there.
The Government needs to overhaul the
public procurement system and bring it in line with well
proven global models like Australia, Japan, UK, Brazil and
Thailand.
As industry and the economy have grown
over the past 50 years, there is a sea change in the
infrastructure and general business environment which is
much more favourable today. Some opportunities that are
waiting to be seized by those who are willing to go the
extra mile are detailed below:
-
Fill the demand for high performance
biocompatible materials in collaboration with institutions
like SCTIMST, IISc, IIT Madras, IIT Kanpur, IIT Delhi, IIT
Bombay, CIPET and a host of others across India
-
A big opportunity awaits entrepreneurs who
can be ancillaries to medical device companies by
supplying subassemblies, cabinets, components, sheet,
tubing, bags and other intermediates
-
A very big opportunity exists in the
export market for high quality, competitively priced
medical devices, especially in Europe, Asia and Latin
America
-
The domestic market will gradually become
more in tune with global standards, and I expect that
there will be a surge in demand for international standard
products in the next 5-10 years as regulations are
enforced. Import substitution will be a major driver for
the Indian medical device industry
-
Services like testing, calibration,
contract manufacturing, labelling, packaging and assembly,
and maintenance are other large opportunities waiting to
be tapped
India has demonstrated its ability to be a
global player with successes in agriculture,
biotechnology, space, atomic energy and pharmaceuticals.
We started well in the nineteen seventies but missed that
particular medical device bus. The time is right for India
to get on board. Let’s make sure we get on the bus this
time. In conclusion, I would like to narrate a few
highlights of the Kerala medical device ecosystem which is
reasonably well developed and affords a good foundation
for the growth of the industry. Here are some salient
points about Kerala:
-
A number of top class research
institutions including SCTIMST, the Rajiv Gandhi Center
for Biotechnology (RGCB), the
Indian Institute of Science Education and Research
(IISER), the Digital University of Kerala
which is the first digital university in the country, the
Kerala Genomics Data Center (KGDC),
C-DAC, ERTL, NIIST, Institute of Advanced Virology, Fluid
Control Research Institute (FCRI),
National Institute of Speech and Hearing
(NISH), National Institute of Physical
Medicine and Rehabilitation (NIPMR)
and the Institute for Communicative and Cognitive Neuro
Sciences (ICCONS)
-
Universities such as Kerala university, MG
University, Cochin University of Science and Technology (CUSAT),
Kerala University of Health Sciences (KUHAS), Central
University of Kerala (CUK), Kerala Veterinary and Animal
Sciences University (KVASU) and University of Calicut
-
Hospitals like SCTIMST, Medical Colleges,
Aster Medcity, KIMS, Lakeshore, Rajagiri, Regional Cancer
Centre, Malabar Cancer Center, MVR Cancer Center, MIMS and
Dr. Moopen’s Medical College
-
Medical device companies meeting
international standards and doing global business for over
25 years including Dentcare, Agappe Diagnostics, Careon
Healthcare, HLL Lifecare, Dynamic Technomedical, Terumo
Penpol, TTK Healthcare, SFO Technologies, St. Marys
Rubbers, Kanam Latex and BPL Medical Technologies
The Government of Kerala has identified
the medical device industry as a sunrise, priority sector
industry and set up the Kerala Medical Technology
Consortium (KMTC) to catalyse the existing ecosystem and
help make Kerala the medical device hub of India by 2032.
We welcome you to be a partner in our journey to making
the country a global player in medical devices. |