Industry invited to design guidelines for regulatory clearances for clinical trials

[Apta]

Government of India is determined to boost the clinical trials
industry to attract foreign investment and projects with measures like
improving regulation, speeding up procedural process in clinical
trials and creating institutions to increase the talent pool. But
these have to be done by keeping the well being of human being in
mind,” said Dr R Ramakrishna, Deputy Drugs Controller (I), Central
Drug Standards Control Organisation at the International Conference on
Clinical Trials organised by Confederation of Indian Industry (CII) in
cooperation with many agencies.

The two-day conference brought together clinical research
organisations from across the country and offered the right platform
to discuss the current status of this industry viz-a-viz the global
market. Another result of this conference was the prospective
association between CII and Association of Clinical Research
Organisations (ACRO) to conduct seminars across the country, with an
aim to spread the knowledge of the benefits of doing clinical research
in an ethical manner.

Though India has made giant leaps in many sectors, clinical trials
sector has not grown substantially and hence, offers a great
opportunity and chance to improve people’s lives. However, this
nascent industry is fraught with problems.

“India should aim for 25 percent of the global clinical trials
business. Factors that can help us reach the target exist in the
country”, said Dr Rama Mukherjee, Managing Director, ARA Healthcare.
She gave an example of China which has gone beyond generic drugs
trials and have been active in emerging technologies and easing
regulatory mechanism to achieve that goal. “India should also follow
suit.

Arun Bhatt, President Clinivent Research said, “The regulatory
mechanism has to work in a way that is more pragmatic in nature.” He
was of the view that the clearances should be time bound. Talking
about the impact of recession on the global CTO industry, he said,
“Recession forced companies to cut development programs resulting in
fewer new projects and delaying new studies. This has also led to the
reduction of fixed costs and consolidation of manpower and
infrastructure. However, the need of the hour was the emergence of
specialised niche players whose market is growing by over 20 percent
every year.”

Suneela Thatte, Executive Director, Quintiles, highlighted the global
scenario in clinical trials. She said,“Globally the industry is
pressurised by rising cost and declining productivity. Therapies have
become complex with large patient numbers and longer trials, there’s
increased stringency of regulations and trial designs are getting more
complex. Though the amount spent in R&D has doubled in 2009, new
biological entities are in constant decline. Failure rate of the
industry has gone up, the time for research has increased but
recruitment rate has declined. These pressures have forced companies
to move beyond their own regions resulting in a surge in new clinical
trial areas making it a truly global industry.”

Shiva K Mishra, Vice President, Clinical Research and Medical
Services, Fresenius-Kabi Oncology, highlighted the reasons for the
failure of new drug development and how they can be corrected.

During the conference Dr GJ Samathanam, Advisor-Department of Science
and Technology, Government of India, invited ACRO to step in to design
the guidelines which would help augment regulatory clearances.

During a panel discussion titled 'Can India be the Hub for Clinical
Trial Research and its Data Acceptance Globally?', Samathanam hailed
the Indian pharma industry for its reported turnover of Rs 1 lakh
crore, but pressed for the country's further growth in this sector.
“Although 50 percent of the turnover of this industry is from exports,
we still have a long way to grow in the field of drug research.

Apurva Shah, Chairman, ACRO, and Group Managing Director, Veeda
Clinical Research, gave statistics about India's progress in clinical
research. He also cited the example of South Korea, whose
infrastructure and easy government-intent in R&D had helped push the
country to have a growth rate of 36 per cent in the time period from
2005-2009. “While the progress made by India in clinical research
since 2005 cannot be ignored, our growth rate has been a meager 16 per
cent. The need for doing clinical research in an ethical manner was
also touched upon, and in a bid to emphasise regulatory transparency,
Samathanam invited all stakeholders of the industry to help design
guidelines for regulatory clearances. “Clinical research cannot be
complete without ethics being observed. At the same time, focus should
be laid on training researchers about processes and ethics, so that
the outcome is optimum.”

Samathanam also shared his ideas on the ways in which the Government
of India would try and thrust the progress of clinical research in the
country. “The Government of India is also trying to encourage drug
development, and for this, it is ready to share 50 per cent of the
cost to develop the infrastructure towards achieving this goal. It is
also planning to set up a special pathogen free (SPF) monkey facility
in the outskirts of Mumbai.”

CII will soon be submitting a white paper to the Government of India,
on the guidelines that would help augment regulatory clearances.