Association of Contract Research Organisations (ACRO) has come into existence recently as the umbrella body of CROs operating in India under the aegis of Confederation of Indian Industry. It got registered as a society on February 2, 2005 with Dr SP Vasireddi, CMD of Vimta Labs as founder chairman. Dr Vasireddi shares his views on contract research sector, opportunities for CROs, and the initiatives ACRO is planning to take, in an interview with YV Phani Raj of Pharmabiz. Excerpts:
What is the current status of CRO industry in India today?
Unlike pharma and bio-pharmaceuticals in India, which are well established already, CRO industry is still an evolving business. The industry is now able to attract business opportunities across the globe. The entire CRO industry in the country is going to witness and experience a phenomenal growth in the coming years. ACRO is ensuring that 'India' brand is created and spread across the world.
Many new players are entering into the CRO business every year. As an industry in its nascent stage, do you think it has sufficient trained manpower to cope up with the rising demand?
Training is a continuous process. Every organization should be prepared to develop human resources. If trained manpower is scarce, it's the duty of the organization to recruit and train candidates as per organizational requirements. Contract research is an evolving business, we need to train in order to meet our requirements. Average growth rate of the industry has been 30-40 per cent and with the growing business. CROs should be equipped with adequate, trained manpower as per the requirements of the market.
Will a CRO's business be affected in the post-patent scenario?
All the CROs in the country have been serving both domestic and overseas markets for many years, much before the new patent regime came into being. So the new product patent regime is unlikely to make any drastic impact on CRO industry.
Pharma companies are now focusing more on drug discovery, need for effective and affordable medicine is increasing, which is ultimately going to increase opportunities for CROs.
What determines the success of a CRO?
Service sector grows only by reputation. It's a gradually building process. Short-term gains cannot be the goal of any CRO. Quality and consistency of service can only fetch further business. It's a sunrise industry, no bottlenecks for new entrants, but those who value quality services will alone remain and the rest will vanish.
What are the awareness levels in the CRO industry towards GLP and GCP compliance?
Many of the CROs are aware of the importance of good laboratory practices and good clinical practices. Compliance to these is a standard requirement. If one doesn't comply, he will not be doing business. It depends on all the stakeholders to see that only quality service providers exist.
The Government of India, industry associations and other stakeholders are initiating various programmes for drawing attention to GCP and GLP awareness and compliance by CROs. Even online programmes are available through various service providers. These programmes are proving fruitful.
How is the data generated by Indian CROs getting accepted globally?
Indian CROs are creating and setting standards in their services. Data acceptance has become global. Data generated in India is accepted even in the US. It may be noted that USFDA doesn't give blanket recognition to any CRO, but they qualify on project / audit basis.
What about venture capital funding in CRO business?
CRO sector is more human intensive in nature, its not capital intensive. Small capital is sufficient to run a show here. Venture capital companies in India have been more interested in matured ventures. CROs may need huge capital only if they are aiming at exceptional growth.
What are the prime goals set by ACRO to make CRO business further grow in India?
The association will strive to share best practices, identify and establish bench-marks, help each other in building global standards, enable global acceptance of data, promote 'India' brand services in the field of contract research / services, provide common platforms worldwide for exposure, promotion and recognition.
Who have taken the responsibility of spearheading the mission to make India a preferred destination for contract research activity, through the association?
Dr S P Vasireddi, managing director, Vimta Labs will be the founder chairman of the association. Dr Arvind Lal, managing director, Dr Lal Path Labs will serve as secretary.
Ashish Kumar Dasgupta, director, Lambda Therapeutic Research Ltd; Dr Sumedha Sahni
director-Operations & Clinical Trials, SRL Ranbaxy Limited; Dr Vijai Kumar, president & CEO, Neeman Medical International; Mr B R Das, director - R&D & Head - Molecular Diagnostics, SRL Ranbaxy Ltd; Dr Aravinda Babu P, head - Operations, Wellquest Clinical Research; Dr Venkat Jasti, managing director, Suven Life Sciences Ltd are the founder members, whereas N Srinivasan, director general, Confederation of Indian Industry will act as ex-officio member.
How many members are you expecting to join the association soon? Who all can become members of ACRO?
The executive council is expecting a membership of about 40-50 CROs in the next one year and up to 100 in next two years. The members will be representing varied fields such as CROs, clinical laboratories, pharmaceutical research organizations, bio-informatics companies, data management organizations, site management organizations, pre-clinical toxicology laboratories etc.
When are you planning to draw a road map for future course of action?
ACRO is in the process of drawing a road map for future course of action. We are planning to conduct our first conclave in September/ October 2005. In this conclave, discussions will be made in order to develop a clear plan of action for the initiatives to be taken up for the coming years.