Bioneeds, the preclinical Contract Research Organization (CRO) has become the first company in the country to get license for conducting the trials/studies involving animals. The company has recently bagged certification from Karnataka drugs control department to carry out comprehensive animal studies.

Although, there are other companies having licensed for testing different categories of drugs/chemicals, Bioneeds is the first company in the country to get license for conducting only the trials/studies involving animals.

The drug testing approval license will enable us to conduct any tests, trials, bioassays, vaccine toxicity and sterility tests involving animals such as rats, mice, rabbits and guinea pigs as per the methodologies of Indian Pharmacopoeia (IP), Indian Veterinary Pharmacopoeia (I Vet. P), British Pharmacopoeia (BP), United States Pharmacopoeia (USP), Drugs and Cosmetics Act (Schedule Y) for the raw materials or finished products or final formulations mentioned in the monographs in respective pharmacopoeias. The results or report will be issued as per Form 39 for the products tested. The clients or sponsor's can use these reports to meet the regulatory requirements, Dr SN Vinay Babu, head, Bioneeds told Pharmabiz.

The license for conducting animal trials according to pharmacopoeia procedures will provide an additional fillip to the pharma and biotech production units R&D centres utilizing our services. It is a value-added approval from the government to meet the regulatory requirements. This will enhance customer base and business development for us, he added.

The three-year-old company installed the required automated equipments created at laboratory area for execution with dedicated separate experimental animal rooms for conducting the trials/testing/studies. Its current personnel strength is 50.

Efforts are on to set up a dog facility and have an additional block of rodent facility commissioned within four months.

Among the ongoing projects are a collaborative project to develop diet induced obesity (DIO) and diabetic C57BL6 mice model. It is also standardizing an infectious animal model to screen some of the antibacterial drugs.

As part of its inorganic growth efforts, Bioneeds is in talks with for collaborations and venture capitalists to take its business forward.

The global recession had not affected much to pharma industries research and development programmes. But at the same time we are offering our services at good packages for most of the preclinical and laboratory services without compromising on the quality, said Dr Babu.

Plans slated for fiscal 2009-10 include seeking Good Laboratory Practice (GLP) certification. Rigorous training to its technical staff for adherence to quality procedures and follow regulations are on. Post GLP certification, the company is planning to go for Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) accreditation. Once armed with these certifications, Bioneeds has also plans to establish a cancer research facility.