‘‘GCP culture is the key to success in clinical research’’

Brijesh Regal, the founder – CEO of Apothecaries Limited and an M Pharm from Delhi University, has vast experience of organising clinical trials in various therapeutic areas for some of the major global pharmaceutical giants. He holds various positions such as WHO consultant and member, National Pharmacovigilance Advisory Committee of Ministry of Health. Regal has immensely contributed to the documentation of several statutory guideline and project documents for Ministry of Health, Government of India, including Schedule Y, Indian GCP guideline, BA-BE study guideline for India and the National Pharmacovigilance Programme. In an exclusive interview, Regal tells Jayashree Padmini that quality is a non-negotiable issue in clinical research. Excerpts:

Clinical research has been touted as having huge business potential in the country. How far is this true?

While it may be fascinating to project huge figures and business potential, a major metamorphosis would be required before India can match contemporary global standards of infrastructure, processes and regulatory measures required for credible clinical research. Islands of excellence do exist in our country, but, I feel it will take about three to four years of sustained collaborative efforts before GCP culture takes firm roots in India. Only then will the business mature in India and realistic estimates of market potential will be made.

Besides, India will be competing with Latin American and east European countries which offer similar advantages as India, with the added advantage of proximity to the US – the established global hub of clinical research.

It looks like the opportunity so far has been in the clinical trial phase I to III. How do you assess the market in early stage studies including pre-clinical evaluation?

Infact, one of the major opportunities for India lies in the segment of bio-availability and bio-equivalence studies because the market of generics is growing faster than ever before. Phase I trials need sophisticated clinical pharmacology centres, besides personnel with in-depth understanding of science and experience of processes involved in early phase studies.

Contrary to the common ruse, it is not just the regulatory infrastructure that needs to be upgraded to facilitate early phase clinical trials in India; sponsors, investigators as well as study sites will need a lot of determination and resources to present themselves as credible options.

It will be relatively easier to upgrade ourselves for phase II & phase III trials in the short and medium term. These are also the areas where country’s innate strengths will provide synergy.

Are MNCs open to tie-ups with Indian firms in this area?

All major global companies have been keenly observing and seeding the emerging clinical research scenario in the country through their Indian counterparts. Their cautious optimism is clearly visible as now they are beginning to develop partnerships in India. Apothecaries has been working with several global pharmaceuticals companies.

Recently, MSD from US has validated our systems and has engaged Apothecaries as a major clinical research partner in India. Evidently, MNCs are willing to develop partnerships with credible organisations.

Refer to letrozole trials on 400 women for ovulation induction. It is said as an instance where regulation failed to ensure patients’ rights. Your comments.

Informed consent remains a major issue even in ICH region countries. Clinical trials without regulatory permission have also been conducted in almost all countries and India is not expected to be an exception. Thiruvanathapuram oncology study is still vivid in our memory. There has been some debate about whether Letrozole episode was a case of off-label-use or a clinical trial.

In my understanding, it was a structured and organised clinical trial for a new indication and not an off-label-use. Having said that, I would like to emphasise that even according to the new schedule Y, which is in line with global regulatory norms, ensuring patient’s rights is primarily the responsibility of investigators (clinicians) who are expected to obtain ethics committee clearance.

Clinical research is a specialised activity in which investigators are expected to practice a high degree of professional discipline and ethics, commensurate with their education and responsibilities in the society. No one will be very happy if regulatory inspectors are breathing down our necks.

Infact, unethical or unaware investigators decisively harm the clinical research discipline by generating a poor public opinion.

Do you think the quest for clinical research must shift from cost to quality standards? As a career how do you assess the opportunity in clinical research and what are the study options available?

Quality is not one of the issues in clinical research: it is the issue. It is a non-negotiable issue. One of the major impediments in India is the shortage of trained manpower. The demand and supply is so skewed that irrational compensations are being offered even to inadequately trained professionals. Clinical research is poised to offer tremendous career opportunities to not only doctors and pharmacists but also to nurses and others qualified in various life-sciences, but only if they pursue excellence.

Please elaborate the activities of Apothecaries in the area of clinical research

Our major strengths include a highly scientific organisational temperament, very high level of commitment to ethics and excellence, and capability to transparently integrate with clients’ teams to ensure compliance with timelines. Moreover, we have an in depth understanding of regulatory requirements and processes.

Apothecaries have been a part of several Indian as well as global clinical trials across Phase II, III and IV. Besides, we have conducted a large number of BA and BE studies. Besides the quintessential cost competitiveness - Apothecaries offers competence competitiveness. We have never failed to meet time or quality targets set by our fastidious clients.

Could you list out the major milestones since inception and how did you see the clinical research market growing over the years?

Apothecaries initiated clinical research activities in 1993. In the last twelve years we have worked in several therapeutic areas including oncology, diabetology, psychiatry, cardiology, nephrology, dermatology, gastro-enterology, hepatology, anti-infectives, analgesics and dentistry.

We have operated in intensive-care as well as GP settings in all the metro cities in India as well as many smaller towns. We are now poised to initiate a vaccine clinical trial which would open up new opportunities.

We are increasing the capacity of our clinical pharmacology and bio-analytical facility by three times. Apothecaries has an independent Quality Assurance department headed by a senior Director who has extensive clinical research operations experience.

Steadily, we are moving to redeem our vision of being the “most recognised and the best” CRO.

— jayashreep@expressindia.com