Accutest Research Laboratories India, a global Contract Research Organisation (CRO), is a leader in conducting BA/BE studies. Dr Satish Sawant, CEO, Accutest Research Laboratories India, reveals more in an exclusive interaction with Sachin Jagdale
Being one of the first entrants into the Indian CRO space, how will you describe the transformation of the Indian CRO market?
India has grown leaps and bounds as a clinical research (CRO) industry and is becoming the hub of the CRO industry due to cost effective expertise available to handle all kinds of complexities and regulatory challenges, ultimately leading to successful launch of the drug product.
Indian CROs have started transforming their business models through focusing on higher value-added services and turn-around-time, moving away from basic clinical development services. They are also catering to both, multinational pharmaceutical companies as well as their Indian counterparts. Indian CROs are also exploring acquisition opportunities. Going global offers them an extended market reach where they can offer their services to clients in multiple geographies obviating the need to work with multiple service providers. Moreover; CROs in India are today enhancing their delivery model to look beyond Indian shores.
Bioavailability (BA)/Bioequivalence (BE) has always remained a backbone of your business. Why?
Accutest is a leading global CRO, offering end-to-end product development and clinical research under one roof, with an estimated market share of 20 per cent in BA/BE space.
Our vast experience and track record of successfully conducting challenging studies allows us take up and execute challenging studies and also, to conduct multiple studies simultaneously. Our significant global regulatory experience plays a vital role to successfully conduct BA/BE studies in alignment with specific regulatory requirements. Dedicated team of professionals liaison with the regulators and ensure the regulatory approval process is managed efficiently.
We have an unmatched track record of 62+ successful inspections from global regulatory bodies like U S Food and Drug Administration (USFDA) World Health Organisation (WHO), European Medicines Agency (EMA), Drug Controller and General of India (DCGI), The Brazilian Health Surveillance Agency (ANVISA), ISP, Medical Counseling Commettee (MCC), Ministry of Health (MOH)-Turkey, Ministry of Health (MOH)-UAE, National Pharmaceutical Control Bureau (NPCB), Thai-FDA etc.
Our state-of-the-art infrastructure contributes to build an unmatched platform to tap the global BA/BE opportunities with Good Clinical Practices (GCP) and Good laboratory Practices (GLP) compliant facilities in India and other countries too.
Accutest has Certified Authorisation Professional (CAP) and National Accreditation Board for Testing and Calibration Laboratories (NABL) accredited Clinical Laboratories with 376 beds capacity, over 450 bioanalytical methods, a large pool of 44 LC-MS/MS and biologics laboratories with high-end machines complemented with in-depth expertise to design customised solutions as needed, while delivering quality results with quick turn-around-times exceeding our client’s expectations and market benchmarks.
Thus, we are the undisputed leader with an experience of conducting over 2,200 studies for pharma companies across the world including US, Europe, Brazil, South Africa, China, South East Asia, India and more.
In the last couple of financial years, Accutest’s clinical trial business couldn’t give much profit to the company due to unsatisfactory regulatory environment in India. However, Accutest considers the clinical trial segment as the main growth driver for the company in future. Why?
It is true that in last couple of financial years Accutest’s clinical trial business did not contribute substantially to its profit; the same case was with other players too. Now the scenario has changed in India. In last six months Drugs Controller General of India (DCGI) has published new guidance and regulations clarifying ambiguity in conduct of clinical studies in India. Similarly pending legal cases are now almost concluded by Supreme Court. Hence, considering this favorable changes and environment in India, Accutest expects that clinical trial industry will be back to normal rather back to flourishing in the country, and as a result will contribute to our profit margins.
Clinical trials are integral part of drug development; without clinical trial no new dug or product can be introduced in the market. Moreover, with increased complexity of diseases and niche treatment, the clinical trial industry will keep on growing and has great potential. Assuming our success in BA/BE segment and supporting our drug development partners, we are confident on our success in this space as well. We understand our clients, their requirements, and time pressure to launch of new drug / new product in the market. Therefore we have changed our approach and strategy. Until last financial year, our focus was limited to India delivery centers; however, in this financial year we have taken few steps and have added new geographies in our delivery capabilities. We have opened operations in Latin America and very soon we will be having our foot prints in Asia, and Eastern Europe.
We are the market leader in BA/BE segment, and have numerous clients happy with our procedures and relationship. Offering clinical trial services to the clients becomes synergetic to our existing business and in our approach; hence we consider clinical trials would be a new growth driver for Accutest in the years to come!
In 2004 you were the first CRO to get approved by the US FDA. What have been the subsequent achievements of Accutest?
Few of our key milestones are:
- 2004: first USFDA approval for BA/BE site
- 2005: approval from MCC-South Africa
- 2006: WHO and ANVISA approval
- 2007: approval from EMEA & MOH- UAE
- 2008: Initiated clinical trial operations
- 2009: Started operations in Mexico and Brazil
- 2010: Achieved milestone of 1500 BA/BE Studies
- 2011: approval from ISP- Chile
- 2012: Initiated Biologics services business
- 2013: Executed First to File ANDA, Approval from MOH, Turkey
- 2014: First DCGI approval for Quantimmune solutions (subsidiary of Accutest), approval from NPCB- Malaysia
What is the current size of your company?
Currently, we have 700+ employees working with us. Our GLP laboratories are spread across 35,000 sq ft and fully equipped with best in class instruments. Bioanalytical labs have a large pool of 44 highly sensitive and latest LC-MS/MS instruments spread over four sites across India and Mexico. Besides our existing geographic expansion plans, we are also open for acquisitions and mergers in future.
Tell us about your expansion plans.
We have our future plans to grow our business through organic expansion, joint ventures and acquisitions. We are planning to invest $15-20 million in three years to grow our business through organic expansion as well as through joint ventures, acquisitions and partnerships.
We are also introducing the latest technology platforms, while adopting new quality concepts and processes to cater and anticipate the changing needs of our clients. Apart from service expansions, our growth strategies are intended towards penetrating new markets and countries to offer end-to-end product development and clinical research services with a meticulous, structured and best-in-class approach. 70 per cent of our business is generated overseas in the US, UK, South-East Asia, Brazil and Europe. We are aggressively expanding further.