Bioneeds, a dedicated pre-clinical contract research organization (CRO) major, is poised to expand its presence in the US, EU and Australia after it bagged the OECD GLP certification from the National GLP-Compliance Monitoring Authority (NGCMA), Department of Science & Technology (DST). The certification takes the company to a premium league of CROs. India is now a signatory to the Organization for Economic Co-operation and Development (OECD) Mutual Acceptance Data (MAD) agreement for GLP.
Going by the promising growth prospects globally and the dependence on scientific- technical expertise besides economies-of-scale in pre-clinical studies from India, Bioneeds is looking to spur growth and enhance operational efficiency. It will invest between Rs.25 crore and Rs.30 crore on infrastructure expansion which includes dog facility, bio analytical lab, oncology unit and a BSL-3 laboratory facility to carry out efficacy and safety study models along with toxicology assessments in the next 24-36 months. As part of the expansion, the company will ramp up its manpower from the current 90 to 130 by the end of this year.
“For NGCMA compliance, the company was assessed on parameters like stringent GLP documentation on safety, precaution measures, infrastructure, instrumentation and training. The key objective of the certification is to assess the ability of a company to be able to trace the animal trial data, which is a result of documentation retention,” Dr SN Vinay Babu, head, Bioneeds told Pharmabiz.
In India, Bioneeds is the 19th company to bag the OECD GLP certification and is in the process of AAALAC certification. There are promising pre-clinical opportunities in the global arena.
The financial crisis in the US and EU has little impact as there is significant potential for pharma-biotech majors to grab a slice of the drug development opportunity coming out of patent expiries. The imminent slowdown in global research and development and the drying up of drug pipelines offer scope to develop life-saving drugs. “This opens avenues for Bioneeds to carry out pre-clinical studies. We are equipped for toxicity assessments, efficacy and safety studies with the ability to meet stringent regulations and delivery time lines for the global companies,” stated Dr Babu.
In the domestic market too, there is a need to develop novel generic and biopharmaceuticals. Further, Bioneeds has been recognized by the Karnataka drugs control department as a government approved Drug Testing Laboratory (DTL) to carry out third party analysis for raw materials and finished products. It is also working with the Karnataka directorate of Ayush and other government agencies to be the government approved test lab for Ayurveda, Homoeopathy, Unani and Siddha drugs.
“The big advantage for global majors is to maximize not just the expertise to test but also saving on cost, which is 50 per cent cheaper. Thus, it makes a lot of business sense to offload animal studies. But the big challenge for companies like Bioneeds is to put up with delayed regulatory clearances which are posing to be tough non-trade barriers leading to loss of business. Maintaining animal labs is also expensive, said Dr Babu.