The bio-services sector, which is currently valued at $ 5-6
billion, is set to increase to $50 billion soon. India makes pharmaceutical
products worth $30 billion every year. It is a world leader in generics. But
soon bio-pharmaceuticals will take over the sector. Small companies are making
it big in a short span of time. Growth is tremendous in this field and we
should be prepared to meet this growth. This was stated by Mr V K Subburaj,
Secretary, Department of Pharmaceuticals, Ministry of Chemicals &
Fertilisers at a round-table on Unleashing Opportunities in Bio-Services
Including Contract Research & Manufacturing which took place on the
occasion of the Global Exhibition on Services (GES) in New Delhi today.
The first-ever GES was inaugurated by Prime Minister, Mr Narendra
Modi on Thursday and it is a joint initiative of the Ministry of Commerce with
the Confederation of Indian Industry (CII) and the Services Export Promotion
Council (SEPC). One of the focus areas of GES is bio-services which is the
second largest sector of biotechnology and pharmaceutical industry in India
with about 33 per cent market share. The round-table discussed some of the
challenges which needed to be addressed to further this growing opportunity and
revitalise the sector with enabling policies.
Speaking at the round-table, Mr Subburaj said, “Conducive
atmosphere for growth has been missing in the past few years. This is about to
change and the message should go out loud and clear everywhere.” The government
is actively facilitating easing of regulations. The number of applications
being filed for clinical trials in India has come down from 500 to 25 in the
past three years. “We have all the hardware but software is missing. That is
the reason why we are lagging behind. In the US more than 30,000 clinical
trials take place every year. Israel does 4,900 clinical trials every year,”
said Mr Subburaj. Unless India provides equal opportunities, we will not grow.
One job in clinical sector creates five jobs in IT sector.
Mr Sudhanshu Pandey, Joint Secretary,
Department of Commerce, Ministry of Commerce and Industry said the first
edition of GES was to highlight the strengths of India in services sector. The
regulatory regime had been the country’s weakest link so far. He said India was
four-five times cheaper in terms of conducting a study, compared to other
countries but that advantage was being wasted because of ambiguity of rules.
That is going to change with the new policy on clinical trials coming in place
in three months’ time. The pharmaceutical sector has a huge service component.
Manufacturing is now being “servicised”. The cost-competitiveness of Indian
manufacturing should not be equated with poor quality, he emphasised.
Mr Rajiv Modi, Chairman, CII National
Committee on Pharmaceuticals and Chairman & Managing Director, Cadila
Pharmaceuticals said there were winds of change sweeping the government. It was
time to look at the big picture and not lose sight of the fact that weaknesses
and bottlenecks needed to be overcome at a fast pace.
Dr Eswara Reddy, Joint Controller
General, Central Drugs Standard Control Organisation (CDSCO), Ministry of
Health and Family Welfare said India had a $6-7 billion market in CRMS. Of
this, 65 per cent market was in the form of contract manufacturing. He said
regulations were now facilitating bio-services by being clear and transparent.
The Drugs and Cosmetics Act was silent on the role of clinical trials but the
area was being regulated through rules. Complete e-governance system was in
place. Accreditation of clinical trial centres was being done now. Track and
trace system is going to be introduced soon for drugs in domestic market.
During the panel discussion, Himangi
Bhardwaj, Senior Health Adviser, British High Commission said
that people overseas were “confused” about India. They were enthusiastic about
this market but didn’t know who to approach here. They didn’t have clarity on
intellectual property and the regulations which governed foreign companies..
Mr Rajesh Naik, Senior Vice-President,
GVK Biosciences reiterated that there was confusion in the minds of overseas
clients regarding India. Ms
Nupur Mehrotra, Vice-President, Scientific Affairs, Premas
Biotech said it was essential to identify both weaknesses and
Meenu Batolar, Associate Director of Biogen Idec said there was
a need for a cell or a platform where individual companies could also raise
their concerns and have the confidence that their voice would be heard.
24 April, 2015