Leaders from all corners of the Drug Development Industry came together
on July 6th to discuss a variety of topics aimed at improving the
environment for the conduct of local and global clinical trials in India. The
conference, titled “Clinical Research Conference – Practical Solutions to
Challenges in Clinical Research” was sponsored by the Indian Pharmaceutical Association – Delhi Branch in partnership with Excel Life Sciences - a US and
India based clinical research and site management organization. Held at
the Double Tree/Hilton in New Delhi, the successful event was attended by more
than 75 industry executives.
Timing of the conference was well planned, as the Industry navigates a
variety of difficult growing pains and setbacks. In recent months,
national legislators have grappled with how to create an environment for the
review, approval and conduct of clinical research which is more transparent,
consistent, and ethical - while not abandoning the economic opportunities which
the industry creates for the country.
Attendees and speakers at the event consisted of some of India’s most
respected and influential stakeholders. Among the many notable participants,
were the following:
- Mr.A.K.Pradhan, DDC (I), CDSCO
- Dr.Naresh Sharma, ADC (I), CDSCO
- Dr.K.Satyanarayana, Scientist G, ICMR
- Dr. Saurendra Das, Excel Life Sciences
- Dr.Arun Bhatt, President, Clininvent
- Dr.Shoibal Mukherjee, Vice President, Quintiles
Despite some of the recent challenges, the mood of the event was one of
enthusiasm, optimism and urgency. There was wide consensus that the
industry is at a critical juncture in its early life cycle and that some recent
attempts to create better protections, came at the expense of scientific
advancement and economic growth. Speakers noted that global trial sponsors
from both private and government entities have pulled back the reins on their
India-based study efforts, under concerns that some legislative changes created
too much risk and uncertainty. Nonetheless, experts
generally agreed that the trend was reversible and that the right blend of
subject safety and economic opportunity could be created.
A variety of interesting data points were shared during the meeting that
were encouraging for participants, demonstrating India’s track record
to-date with regards Good Clinical Practice and quality, ethical studies, while
providing a glimmer of the markets potential. Specifically, in one session, Dr.
Saurendra Das, Executive Director for Excel Life Sciences, drew parallels
between international and Indian inspections and simultaneously acknowledged
the steps taken by Indian regulators inspecting the research site.
“Regulatory inspection starts the day you sign the contract to
participate in a clinical study as investigator and not when DCGI steps into
your institution premises. The regulatory inspection has actually started when
you consented or screened the patient. So do it right the first time, because
in clinical research when we are involved with something called life, there is
no second chance.”
Coming out of the meeting, attendees were encouraged about the future of
the industry over the next 24 months, with many expecting a strong rebound if
some of the recent regulatory changes can be revisited and revised.
About Excel Life Sciences
Excel Life
Sciences (ELS) is a US-based, India focused provider of comprehensive clinical
trial management services. ELS is built around passionate and experienced
individuals working alongside clients to ensure the most cost effective and
efficient execution of global drug and device development programs. ELS is
committed to improve and expand clinical research enterprise, evident through
their presentations at industry conferences, publishing in industry trade magazines
and journals and through visiting academic institutions.
(www.excellifesciences.com)
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