Victorious VerGo
Over the years cost effectiveness and service quality of the Indian Contract Research Organisations (CROs) have lured a considerable chunk of global pharma players towards India. This global interest into the Indian market encouraged many entrepreneurs to start their own CRO services. However, not many of them survived and a very few have excelled. Goa-based VerGo Pharma Research Laboratories is one of the CROs that has not only survived but also excelled. Sachin Jagdale reports
Every year since its inception, VerGo has added something new to its credit. In December 2006, the company acquired 3.5 acres of land in Verna Industrial Area in Goa. Ground breaking of VerGo Pharma Research as division of LC-GC, Mumbai, took place in August 2007. April 2009 proved to be a crucial period for the company as formulation development and analytical development verticals were inaugurated in the same year. Incorporation of VerGo Pharma Research Laboratories, Goa and VerGo Pharma Research, Mumbai took place with the change of partnership from LC-GC, Mumbai to V. G. Quenim Goa in June 2010. In July 2010, expansion of VerGo Pharma Research division with verticals of formulation development, analytical development, clinical batch manufacturing, ICH stability testing and regulatory services took place.
VerGo Organics was established in January 2011 for impurity, metabolites, reference standards and process development and scale up. The company expanded its footprint and opened its Asia office in Mumbai in March 2011. In December 2011, Dr Anil Kakodkar inaugurated the extended facility of VerGo Pharma Research and VerGo Organics at Verna, Goa. In February 2012, the company acquired a 100-bed clinical facility at Corlim, Goa to establish VerGo Clinicals, a CRO for bioequivalence, bioavailability and clincial trials.
Able entrepreneur
“An innovation driven R&D platform, which offers an |
Dr Nitin Borkar, Chief Executive Officer, VerGo Pharma Research Laboratories, is a well known figure in the Indian pharma industry. After spending many successful years in the industry he started his own company. What prompted him to become an entrepreneur? Borkar explains, “An innovation driven R&D platform, which offers an end-to-end service, is an unmet need of global clients. The approach of major CRO’s was always to do a fee for service development for a client. A single window, IP landscape aligned and patented technology driven global development with licensing for all major developed countries was never a focus. The global client working on several products would find this risk shared, value added, patent non-infringing and end-to-end product development a great option. To fulfil this need, utilising the rich industry experience was the major reason to start the company. Several other reasons to come back to native Goa, fulfill a dream to develop a state-of-the-art R&D having Indian talent, was always on the back of the mind.”
Obstacles Vs optimism
Unfortunately, in India, red tapism has always been a point of concern. Even Borkar had to face this problem during the initial days. He faced many challenges when he was trying to acquire land in Goa and got frustrated due to government red tape. However, he received help from the then Chief Minister of Goa, Manohar Parrikar. “Because of Parrikar’s vision to bring a knowledge driven global R&D programme to Goa, this was overcome,” says Borkar. He adds, “Even after specifications laid down, the construction of the facility and finishing requires constant vigilance in India. The major hurdle in the initial stages was the alignment of the financial partner towards long-term approach in pharma business. The present financial partner has a long-term goal to diversify in the pharma sector, which lends the stability to work on several initiatives.”
Borkar had a 25 year-career in the US and India with large pharma, generic and OTC companies before he turned entrepreneur. “My passion to develop excellence in R&D has been the driving force to work with several multinational companies. I have been associated in the past to develop four R&D centres in the US, China and India. Successfully designing and managing pharma R&D programmes for several companies helped me to cultivate the platform for VerGo,” informs Borkar.
An achiever
VerGo’s journey may not be that long; however, its achievements are worth accolades. In a very short span of time, the facility size was doubled from 20,000 to 40,000 square feet and saw an addition of 65 team members. Moreover, the company has filed eight patents, qualified the facility to meet requirements from Department of Scientific and Industrial Research (DSIR), Drug Controller General (India) (DCGI), Goa FDA and Bhabha Atomic Research Centre (BARC). The company has established three divisions to offer end-to-end service to bring new products to the market place and followed environment friendly approach. “We have developed an environmental friendly programme to ensure that water is recycled, rain water is harvested and recharge pits dug to increase ground water, zero discharge zone with natural ventilation is formed to reduce consumption of energy,” informs Borkar.
New Drug Application (NDA), Abbreviated New Drug Application (ANDA) and Over The Counter (OTC) products are developed by VerGo for global clients like JPH Pharmaceuticals and Jubilant Organosys Inc. in the US, Morningside Healthcare Ltd. in the UK, Generic Partners Inc. Australia, Servier in France.
The recent acquisition of a 100-bed clinical facility at Corlim, Goa to establish VerGo Clinicals, a CRO, for bioequivalence/bio-availability and clinical trials endorses the company’s endeavour for growth. VerGo Clinicals has been setup in a 40,000 square feet long-term leased facility on a 150,000 square feet plot in Corlim, Goa.
According to Borkar, the CRO industry in India is developing with several pharma companies also joining the bandwagon. The CRO contribution was at four per cent of global requirement in 2007 and is expected to grow to 20 per cent within the next five years. The cost effectiveness, quality centred development, meeting global requirements with a talent pool of professionals are the major growth drivers. The patent blocks, government challenges to timely approve study protocols, longer approval times from regulatory bodies along with competition will threaten the prolific growth which has been targeted.
Future perfect
VerGo has three major divisions, which would provide sustenance in the coming years. The certifications for Department of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy (AYUSH), Bureau of Indian Standards (BIS), Agricultural and Processed Food Products Export Development Authority (APEDA), National Accreditation Board for Testing and Calibration Laboratories (NABL), US FDA, European Union (EU) and other developed country regulations will be helpful for the company to scale up business for analytical development and formulation development.
Borkar feels that the labelled compounds and nucleic acid synthesis will bring more prominence to the VerGo Organics programme bringing synthesis to kilo level.
He also expects the approvals for VerGo Clinicals from various regulatory bodies will increase the business potential. The company plans to pursue Contract Research and Manufacturing Services (CRAMS) model for herbals, anti-cancer and liquid products. A range of 100 per cent natural products in the lifestyle sector will further fuel the herbal interest. VerGo Pharma Research Laboratories is one of the most promising CROs in India. Looking at the pace with which the company is growing, the day is not far when VerGo will be the face of Indian CROs in the global arena.