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Events
Is India 'somebody'?
Arshiya Khan - Mumbai
Dr Venkateswarulu, Drug Controller General of India |
"From nobody in 1977, we are somebody today," remarked
Dr Venkateswarulu, Drug Controller General of India, at ISPE India's annual
conference on 'Aseptic Manufacturing and Contamination Controls—Current
Issues and Trends’, in Mumbai. India has been declared as the hub for clinical
trials and a hot spot for contract research and manufacturing services (CRAMS).
Indian pharmaceutical companies have gone international and foreign players
are looking at India as never before for APIs, contract research, clinical trials
and even drug formulations. And now, it is the turn of the ancillary industry.
The impact of pharma engineering industry is being felt by the industry now.
"If somebody is looking for aseptic manufacturing, India is the destination,"
Venkateswarulu added.
Being trendy…
In the current regulatory approach based on risk analysis, sterile products
and aseptic manufacture are at the top of the list for quality risk. "Aseptic
manufacturing is for the people. And if we get it wrong we might kill people,"
warned Rob Sullivan, VP-Quality, Regional Pharma Supply, GlaxoSmithkline. Indian
companies have not been very successful in outsourcing sterile formulations
or in attracting outsourcing partners in the aseptic space. But the trend is
changing now. Earlier when companies wanted to go for USFDA approvals it was
tough and they were scared. But now competition has given rise to more accuracy.
"If there is one person I have to pick up who is GMP compliant, then it
is the pharma engineering people as they know everything," remarked Venkateswarulu.
The seminar showcased the latest in facility design as well as manufacture of
sterile products, giving current requirements for exporting to regulated markets.
It also featured case studies, the latest in clean room techniques and a workshop
on sterilisation. The track on contamination control was conducted by Dr Nigel
Halls, Executive Director, Science and Technology, International Academy of
GMP Training, while Gordon Farquharson, Principal Consultant, Technologies,
Bovis Lend Lease led the aseptic manufacturing track. "The regulatory environment
of aseptic manufacturing is changing. Standards will move ahead regardless of
the industry performance," said Farquharson. "Manage the future, don't
take comfort from the past," exhorted Sullivan.
Being cheap will not help!
Delegates at the conference |
India's future does not lie in being 'cheap'. Just being a
low cost manufacturing host will be a short term goal. Value addition will come
through the development of novel processes and products. There are great opportunities
for equipment vendors; success in international markets requires equipment to
be good value, state-of-the-art, and fully supported. Just being cheap will
not deliver success. "India, in the long run, cannot compete with China
for supplying low-cost commodity type products and on availability of cheap
labour. India with its highly educated, inventive and creative people should
move into drug discovery and development as this is the area where larger margins
can be obtained for greater benefit of the economy," opined Halls.
Accredit them!
Talk about raising standards always leads to the question of who will judge
these standards. Accreditation is one way of benchmarking companies but this
needs an accreditation organisation. Should this organisation be ISPE? Delegates
at the seminar questioned the wisdom of making a non-aligned and not-for-profit
organisation like ISPE to accredit and validate others. As there is no body
to examine and accredit the ancillary industry, will this come true in the future?
Irrespective of this debate, the conference proved that machinery exports in
high-tech areas like aseptic manufacturing and contamination control offer tremendous
scope for India. In the long run, India will have to offer more value addition
with discovery and R&D.
arshiya.khan@expressindia.com
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