Nutraceutical Clinical Trials Services

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WHY IS INDIA A POPULAR DESTINATION FOR CLINICAL
TRIALS
A presentation by Dr. Nancy Agnes, Head,
Technical Operations, FoodResearchLab Group
www.foodresearchlab.com Email info_at_foodresearchla
b.com
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Introduction

• There is a greater emphasis on lowering the cost
  of clinical development due to the increasing
  pressure on the global pharmaceutical sector to
  manage RD (research and development) costs.
• New drugs launches are also being negatively
  impacted by the delayed development issue, which
  results in a loss of incremental revenue.
• Clinical trials are seeing exponential growth in
  several new areas as well.
• 1. Nutraceutical clinical trials,
• 2. Cosmeceutical clinical trials,
• 3. Herbal Clinical Trials
• Nowadays, its getting harder and harder for
  pharmaceutical corporations to get enough
  volunteers to test the medications that come out
  of their labs.
• For an experimental medicine to be approved for
  marketing by the Food and medicine
  Administration, an average of about 4000 patients
  must be involved.

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• However, in the US, less than 5 of patients are
  open to taking part in clinical trials. In the
  United States, 86 of clinical studies do not
  enroll the necessary number of participants and
  are delayed by an average of 366 days.
• Revenue is lost every day by one million dollars
  due to product delays in reaching the market.
• Due to the dual challenges of cutting expenses
  and speeding up clinical development, big
  pharmaceutical companies are now searching for
  other locations to source people for their
  international trials.
• Research along these lines prompts the
  pharmaceutical sector to show interest in nations
  such as Asia, Eastern Europe, and Latin America.
• India is a standout Asian nation because of its
  enormous population of treatment-naïve patients,
  English-speaking doctors, and a strong
  pharmaceutical industry that has dominated the
  global market thanks to low-cost generics.

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How does India solve the Problem?

• After signing the TRIPS agreement, the 1970s
  Patent Act had to be modified to give Indian
  businesses the same protection for their
  inventions as businesses worldwide.
• This encouraged Indian businesses to refocus
  their efforts from developing generic
  pharmaceuticals to manufacturing novel chemical
  entities.
• Prior to 2005, there werent many pharmaceutical
  MNC trials carried out in India.
• The International Conference on Harmonisation
  (ICH) standards were added to Schedule Y of the
  Drugs and Cosmetics Act of India by the Indian
  government in January 2005.
• A number of regulatory obstacles to conducting
  clinical trials in India were eliminated by these
  modifications. Some of the significant changes
  are highlighted in the diagram below

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• Looking at the graph 1, it is evident that the
  number of clinical trials occurring in India has
  risen from 4 in the last decade to over 10
  since 2013.
• One of the key factors in the dramatic change is
  excellent infrastructure and skilled doctors in
  India as depicted in graph 2.
• The other important factors are as follows

• Conducive regulatory environment
• Cutting-edge research and technology programs
• Diverse subject population
• Cost-effective pricing
• Hassle-free recruitment

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The Emergence of CROs

• Contract research organization (CRO) took a go
  global approach with experience of working in
  different national and cultural boundaries.
• They changed the landscape of clinical trials in
  India by introducing revolutionary research
  methodologies, new transferrable skills, and
  helped increase the clinical trial climate in
  India.
• However, more research is required to understand
  how established practices are adapted to these
  new settings and how they change inside these new
  locales.
• The outsourcing of clinical trials by
  multinational pharmaceutical corporations seeking
  untapped markets and treatment-naïve patients is
  transforming the current pharmaceutical industry,
  harmonising it to more closely resemble global or
  Big Pharma.
• Big-pharmaceuticalization entails the entry of
  CROs into India that carry out research for both
  domestic and foreign pharmaceutical corporations.
  
• As independent actors, CROs collaborate with
  sponsors, physicians at patient recruitment trial
  sites, and occasionally biotechnology businesses
  conducting basic research.
• They reaffirm how Randomised Control Trials
  (RCTs) take centre stage in a specific type of
  knowledge generation and start to supplant
  earlier generic medication production systems.

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CHALLENGES FACED IN INDIA
Some of the obstacles faced in conductance of
clinical trial in India are as follows

• Regulatory bottlenecks exist, and approval
  processes are still taking a very long period.
  Indias regulatory bodies are terribly slow in
  comparison to those in Canada and the UK, where
  clearance processes take 30 days.
• This is a result of insufficient financing and
  regulatory staff training.
• One of the most significant challenges the
  industry is having to draw in a lot of foreign
  clinical trials to India is the lack of hospital
  locations that meet ICH-GCP standards.
• A growing number of CROs are emerging without the
  necessary quality accreditation.
• The government ought to halt the operations of
  CROs that are not accredited.
• Education is a major obstacle to patient
  compliance. Since a large number of the patients
  in the trial scenario are from rural and
  semi-urban areas, it is important to make sure
  they are aware of compliance difficulties and
  have a good education.

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Conclusion

• Despite a few challenges that need to be ironed
  out, India is well-positioned to provide the
  international pharmaceutical industry with
  high-quality, reasonably priced contract services
  to aid in the discovery of new drugs.
• Added to this, the growth of CROs in India is
  becoming evident as they play a major role in
  bringing in technological advancements,
  cost-effectiveness, fastening the approval
  process, and so on.
• We at Guires FRL CDMO possess a highly skilled
  and expert team of scientists at your disposal,
  capable of overseeing every brick of clinical
  trials from planning to reporting without
  compromising on quality standards laid down by
  WHO guidelines, GLP standards, and ICH
  guidelines.
• We guarantee high standards of safety, quality,
  and ethical practice with a lightning-fast
  turnaround timeline.

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REFERENCES

• Sunil, S., Sameer, P. (2013). Realizing the
  Promise Indias Strategic Shift from Outsourcing
  to Innovation. The Open Clinical Trials Journal,
  3(1).
• Sariola, S., Ravindran, D., Kumar, A., Jeffery,
  R. (2015). Big-pharmaceuticalisation Clinical
  trials and contract research organizations in
  India. Social Science Medicine, 131, 239-246.
• Garg, T., Singh, O., Arora, S. (2011).
  Opportunities and growth of conducting clinical
  trials in India. Int J Pharm Sci Rev Res, 8(1),
  152-160.

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91 9566299022
EMAIL
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