Sandeep Singh is the Vice President of Clinical Operations at CBCC Global Research, a contract research organization offering a wide variety of clinical research services to advance clinical development programs worldwide across multiple therapeutic areas.
On this occasion, our conversation will focus on India’s general clinical research landscape, along with some key recommendations for biotechnology companies considering India as a territory to conduct their clinical trials.
Patricio Ledesma (PL): Sandeep, it is a great pleasure to have this conversation with you. Thank you very much for this opportunity.
Sandeep Singh (SS): You’re welcome; thank you for giving me this opportunity of speaking with you.
PL: Let’s start learning a bit more about the recent history of clinical research in India. Is India having a long tradition of clinical trials?
SS: India is fast emerging as a favorite clinical trial hub for global pharmaceutical companies. The Indian clinical trial’s market size is expected to reach USD 3.15 billion by 2025. It is projected to register a CAGR of 8.7% over the forecast period.
The Indian clinical trial market had started flourishing after the amendment of the patent law and Schedule Y of Drug and Cosmetic Rules in 2005. Foreign pharmaceutical companies had turned to India as a drug research opportunity by taking advantage of the vast population and loose regulatory system. Between 2005 and 2013, India has grown up as a preferred destination for clinical trials. However, by 2013 the problems with clinical trials had become troublesome to the point of media and public attention. The media attention and public discussion resulted in researchers conducting fewer trials. The number of trials went from 529 in 2010, to about 250 in 2012, to about 100 in 2013. Indian regulatory agency has taken enormous efforts to revive the situation, and the major milestone was NDCT Rules published in 2019. Currently, India is the hub for clinical trials that requires registration of generic drugs like healthy volunteer bioequivalence studies, Inpatient bioequivalence studies, Clinical endpoint bioequivalence studies, and phase 1 & 3 trials for biosimilars. India is also making notable progress in Global Clinical Trials.
PL: What are the main cities in India in which clinical trials are conducted?
SS: Due to the stringent requirements of having sites across all 4 zones (East, West, North & South) for local trial and drug registrations, we have a well-developed site network PAN India. The most preferred cities for clinical trials in India continue to be Delhi, Mumbai, Ahmedabad, Hyderabad, Bengaluru, Chennai, Nagpur, and Pune.
PL: Do sponsors from other countries (e.g., the United States or Europe) execute clinical studies in India? Why do they select India to conduct their studies? Any particular advantage or benefit?
SS: India is considered the ideal site for clinical trials to be carried out. In fact, 2/3rd of the CBCC trials are for US and EU clients for FDA & EMA submission. The existence of a large patient pool, English-speaking medical community, medical documentation in the English language, faster patient recruitment, lower cost for performing a clinical trial, well trained clinical research staff, a large pool of GCP trained investigators, plenty of clinical materials, and cost savings are apparent advantages for clinical research in India. The number of USFDA inspected sites in India is more than the number of USFDA inspected sites in any other country. This makes India a preferred location for clinical trials for registration in the USA, Europe, and other countries.
PL: What would be your most important recommendations to biotech companies planning to execute early phase trials in India?
SS: Biotech is typically thought of as a high-growth and high-risk industry. The upfront investment in R&D and clinical trials can soar into the tens of millions of dollars even before the initiation of large population human efficacy trials. India is the country who offer you to conduct early phase clinical trial with comparatively less budget as compared to USA/Europe. CBCC has state of the art 18 bedded phase 1 unit at Ahmedabad, India, approved by DCGI. It can be used for early phase trials in healthy volunteers. For patient-based early phase trials, we have a group of preferred locations based on the therapeutic area.
PL: Sponsors usually start their early phase clinical studies in their own countries for proximity reasons. However, as clinical phases advance, they often need to go overseas to recruit patients (especially when rare diseases are involved). For small biotech in the U.S., for instance, conducting a larger study in Asia-Pacific can seem challenging. What would be your advice for a biotech CEO in this situation?
SS: Rare disease is a complicated but rewarding space for sponsors. Most rare diseases have no approved treatment options, making clinical research the only care option for many of these patients. Due to this high unmet medical need, rare patient communities are often ready and willing to not only participate in clinical research but help shape it to ensure it meets the patient’s needs. This provides emerging biotech organizations with the opportunity to work closely with patients and their advocates on potential new treatments. In Asia-Pacific, India, China, and Japan are the clinical trials hub with well-established regulatory agencies. Indeed, India has an advantage due to the English-speaking medical community.
PL: From a regulatory and paperwork perspective, what are the general timelines to initiate a clinical study in India? How long does it take from study submission to authorities to the first patient in?
SS: In general, the timeline for disposal of an application is 90 days for Clinical Trials and 45 days for bioequivalence studies (PK endpoint & Clinical endpoint) from the date of receipt of application. India has well-defined checklists for different categories of applications, and all this information is available in the public domain with a very high level of transparency.
Additionally, if the drug is discovered in India, research and development of the drug are being done in India, and the drug is proposed to be manufactured and marketed in India, then the timeline for disposal of an application for conduct of such clinical study is 30 working days from the date of receipt of application. In such a case, if the Central Drugs Standard Control Organisation (CDSCO) issues no response within 30 working days, the clinical trial will be deemed approved.
PL: How can CBCC Global Research help biopharmaceutical companies to execute clinical trials in India? How do you make a difference with respect to other CROs? What clinical and operational added value can you provide?
SS: CBCC global Research can help you execute clinical trials in India as well as the Asia Pacific region, as we have a large patient pool, GCP trained staff, a large pool of investigators, documentations in English language, scientific and medical writing team, regulatory affaire team, and clinical operation team which can help you to execute clinical trial in India. CBCC is one of the fastest-growing clinical trial service providers CRO in India. Most of the Indian CROs are specialized in healthy volunteer bioequivalence studies, and CBCC is specialized in patient-based trials. CBCC provides a one-stop solution to all the needs of the pharma, medical device, and biotech companies. CBCC provides Regulatory, Medical writing, Clinical Operations, Site Management, Data Management, Biostatistics and statistical programming, Image core lab services, early-phase trial services, etc.
PL: Is CBCC particularly strong in certain therapeutic areas? What are your capabilities in oncology?
SS: CBCC stands for comprehensive blood and cancer center. As the name suggests, we are very strong in Oncology. CBCC started as an oncology cancer care provider in the USA and then came to India. We own and manage 6 oncology sites in the USA and 6 in India. We have an Oncology site network of > 200 sites in India and > 150 sites in the USA. We have a very strong Oncology experience. Currently, we have many Oncology CT ongoing and at various stages for novel molecules, 505(b)(2) program, and ANDA submission.
PL: If a sponsor wishes to have a trial in India but does not have contacts with clinical investigators, can you facilitate access to key opinion leaders and top recruiting sites?
SS: Yes, as I mentioned, we have a large pool of GCP trained investigators in the field of oncology, psychiatry, cardiology, and accredited sites for executing the clinical trial in India. We have a pool of identified KOLs/SMEs for various therapeutic areas. We also have a medical/scientific advisory board for Oncology, Neurology, Psychiatry, Ophthalmology, and other therapeutic areas.
PL: Concerning drug manufacturing for clinical trials, how difficult is it to export clinical trial drugs manufactured in the U.S. or Europe into India? Can you help with export/import issues and related regulatory aspects?
SS: There are no special permissions required for the import & export of investigational products and ancillary supplies. We apply for an import license along with the application for a clinical trial. Whenever DCGI approves a clinical trial, we also receive an import license. Export of biological samples also does not require any special permissions. CBCC helps sponsor to export/import and related regulatory aspects. CBCC has vendors and custom agents to take care of customs clearance and material delivery to CBCC/Clients.
PL: Does it make sense for biotechs in North America or Europe to manufacture their drug products in India in the context of a clinical trial? Or is it better to follow the importation path?
SS: India is the growing economy, the second-largest populated country in the world. This can give you a large market for your company’s growth. India is also known as the pharmacy of the world because the manufacturing cost of the drug or raw material is a bit cheaper than European and American countries. Both options are equally good for Clinical trials. However, if the sponsor is looking for a cost-effective solution for drug manufacturing, they can prefer the get the drugs manufactured in India.
PL: Looking from the present into the future, what type of drug development programs are on the rise in India? What kind of compounds are more popular now, and what is the trend you foresee in the clinical research landscape for the coming years?
SS: Barring the exception of COVID-19, Oncology remains the therapeutic area where maximum trials are ongoing both in India and worldwide. Neurology, Psychiatry, Ophthalmology, Dermatology, Inhalation, Autoimmune, and Metabolic disorders are some of the other therapeutic areas where we see a lot of traction and research happening. Apart from the novel therapeutic agents, there are a lot of repurposed and specialty products gaining a lot of popularity. CBCC has a special focus and experienced team to help companies on such 505(b)(2) and hybrid applications.
PL: Any final word of wisdom or piece of advice you would like to share with biotech officers considering the execution of clinical trials in India?
SS: CBCC is one of the premier CROs having a strong presence in the USA & India. In CBCC, due to our roots in the healthcare domain, we understand and put our patients first in any clinical trial, making us different from our competitors. We have a vast network of sites for various therapeutic areas and are ready to help pharma & biotech companies expedite their drug development programs.
PL: Sandeep. Thank you so much for this interesting chat. I really enjoyed it. Thank you for providing our readers with a more complete perspective on conducting clinical studies in India.
SS: You are welcome. I really enjoyed this conversation. Please feel free to contact us in case of any queries.
About CBCC Global Research
CBCC Global research is an Oncology focused CRO headquartered in the US with operations in the US and India. CBCC Global Research, with 30+ years of clinical research experience, has partnered with more than 20 innovative biopharmaceutical companies.
For more information about CBCC Global Research, please visit CBCC’s website.
For further information about conducting clinical trials in India, please contact info@sofpromed.com
