The Bengaluru-based Bioneeds Laboratory Animals and Preclinical Services which serves the pharma, agro chemicals, biologicals, herbals, nutraceuticals, cosmetics and industrial chemicals space has now chalked out an ambitious growth path. Its OECD GLP certification from the National GLP-Compliance Monitoring Authority (NGCMA), Department of Science & Technology which it bagged early this year has taken it to the premium league of clinical research organizations in the country. In an email interview, Dr. SN Vinay Babu, managing director of Bioneeds , gives a tour de horizon of animal studies in India to Nandita Vijay. Excerpts:
How would you describe the current scene for clinical research services in the animal space?
Out of the countless tests done on numerous molecules, the chance of achieving at a successful molecule is to the extent of 0.1 per cent only.
Pre-clinical studies play a major role in drug development and acts as an eye - opener for the further advancement of the potential molecule. Pre-clinical experiments using animal models are now indispensable and mandate stringent regulations.
Generating safety data of each molecule that the companies are trying to bring in the form of a therapeutic entity is critical. For instance in the past there had been several tragedies occurring in the medical field due to the consumption of unsafe drugs including Thalidomide which is known for serious side effects.. This is where the animal studies can provide a direction on the initial toxicology and efficacy of the drug before it is taken on for human trials. Therefore the clinical research services in the animal space has scope for growth.
Could you provide us an overview of the sector in terms of number of companies?
As the outsourcing is increasing day- by - day, CRAMS (contract research and manufacturing services) business is almost getting doubled in 2012 compared to 2010. Pre-clinical opportunities are still untapped to the full extent in comparison with manufacturing and clinical trials. There is a surge in investments in infrastructure and adhering to the technical norms for setting up animal facilities. Many such centres are coming up in India.
Major player in the preclinical space along with Bioneeds include Advinus, Jubilant, Syngene, Anthem Biosciences, GVK, Ranbaxy, Vimta labs and many other laboratories.
Though we have many animal facilities to meet the needs of non-regulatory and exploratory animal studies , there are only very few good laboratory practice (GLP) certified laboratories to serve the needs of regulatory requirements. All the regulatory authorities are making it mandatory to conduct preclinical toxicity studies under GLP conditions in a GLP certified lab. However, the reality is that India lacks adequate GLP certified labs.
With the upcoming opportunities in preclinical research, we need more GLP certified labs in India to meet the increasing demand.
What do you think are Indian companies key strengths in the space?
The big advantage for India is the availability of skilled manpower with the required professional qualifications. There is access to graduates with good English communication skills.
India has the advantage of time zones to meet deadlines for companies located in the western world. The presence of state-of-the-art facilities provide cost-effective operations and high quality outcomes with reliability.
India has been working to accredit Ethics Committees to streamline animal trials--What are your views on regulations and time- frame for clearances to carry out the animal studies?
Bioneeds respect 3R’s (Reduce, Replace and Refine) in both planning and execution of animal studies in line with the international norms of Institutional Animal Care and Use Committee (IACUC) and national guidelines of Committee for the Purpose of Control and Supervision on Experiments on Animals(CPCSEA).
As long as any organization is in line with these guidelines, there will not be any problem from the point of either regulations or time-frame for clearances to carry out the animal studies.
Many leading pharma companies are now opting for the West to carry out animal studies. Could you identify the key challenges for animal trial companies in India?
The scenario in the preclinical CRO space has changed tremendously as Asia is emerging as a great platform for preclinical research. With the aforesaid positive points and with India inking the MAD (mutual acceptance of Data) agreement with OECD (Organisation for Economic Co-operation and Development), India has become a better choice for the preclinical research than any other country.
What according to you are the visible trends in the animal studies?
Increased concern among scientific community and the public is changing the way in which animals are used for research and safety testing. National and international regulations, mandate for pre clinical data (In-vivo, in-vitro) to seek approval for clinical trial. Hence already the trend has been set for safe animal studies.
Since Bioneeds has now consolidated its infrastructure expansion , what are your further efforts to tap the business?
We have a good business team supported by technical support. We are poised to expand our presence in the US, EU and Australia following the OECD GLP certification. The company is well on the growth track to tap new orders and adhere to timeline schedules.
How easy is to get the qualified personnel for animal studies and what kind of training is needed to make him ready for the job?
India has a pool of qualified professionals. But the only lacuna is the lack of proper channelization of the industry -ready talent. Bioneeds is tapping such candidates and imparting rigorous training both internally and offsite to help fresh candidates gain technical expertise.
What has been impact of the global recession on this sector?
In reality, pharmaceutical sector's preclinical CROs have not been affected much by recession unlike the information technology. However, we consider global economic gloom as a signal to take necessary precautions. We opt for cost cutting measures without compromising on quality.
By 2015, where do you see Bioneeds and what are the future plans to drive the company's growth plans?
By 2015, Bioneeds is working to become a leading pre-clinical CRO in India. We would like to become the one-stop solution for all animal studies. The categories include both regulatory and non-regulatory and the services include PK/PD, DMPK, efficacy, safety, toxicology and regulatory services except studies on non humane primate.
Currently we are offering efficacy and toxicology services and we are in the process of establishing a complete battery of studies required by different regulatory authorities and registrations like USFDA, EFA, TGA, EPA, REACH etc.