Alkem Laboratories Ltd, which manufactures the top-notch anti-infective brand Taxim, is planning to launch an independent contract research organization next month, Alkem's President S P Maitra said here.
Dr M D Khubchandani, Vice-President (Corporate Production and R&D), will be head the state-of-the-art, 10,000 square feet research centre called Phoenix Biopharma Research Centre Ltd, to be located in Taloja in Navi Mumbai. The Centre has 50 scientists on its rolls.
The centre's thrust will be on clinical research, herbals, nutraceuticals, newer and difficultly synthesizable bulk drugs, and novel drug delivery systems. By mid-2003, Biopharma hopes to begin work on novel chemical entities in the areas of anti-infectives, anti-amoebics and oncology, Dr Khubchandani said. Ten scientists will be hired for development of NCEs, he said.
Alkem has already entered the high-growth segments by setting up separate divisions for oncology (Cytomed), neuropsychiatry (Pentacare), cardiology and diabetology (Mediva). A lot of efforts are required in these segments, but the returns are extremely good, he said.
The Centre's objective is to develop state-of-the-art technologies and processes to produce safe and efficacious quality drugs and dosages forms at affordable prices through innovative research in various healthcare areas. The centre has committed to punctual delivery of accurate reports to sponsors maintaining complete secrecy.
The centre will undertake clinical study management, and bioavailability/ bioequivalence in healthy human volunteers in phase I studies. There are 30 beds for volunteers at the centre.
The centre has a modern 7500 sq ft bioavailability/bioequivalence centre equipped with 30 beds for volunteers. This area is supplied with air quality to meet class 1,00,000 as per US standards. This has been carefully designed to give total comfort to the healthy volunteers during the study.
The analytical section is equipped with instruments like HPLC, HPTLC, GC, solid phase extraction instrument and SFC.
The instrument room is supplied with class 10,000 air quality to increase the sensitivity of analysis and to avoid any external contamination. The whole area is under access control to maintain secrecy and prevent any hindrance of research work. Only authorised persons are allowed to access the respective areas as per laid down protocols.
Alkem has invested around Rs 10 crore in the CRO project, and hopes to break even within an year, Dr Khubchandani said. The CRO is already in talks with several Indian and a few multinational clients to conduct clinical trials and bioequivalence studies.
Biopharma would be keen on doing studies for multinational clients as their payments would be much better than those of Indian counterparts, Dr Khubchandani said.
The centre is expected to be inspected by the Drug Controller General of India shortly and commercial business is expected to start in December 2002. The formal inauguration of the centre will be a high-profile event in January next year, Dr Khubchandani added.
He has called for co-operation between pharma companies to make the best use of research efforts and spend. He has suggested that companies come together to foot the bill for each phase of study and thereby reduce the overall cost for each of them in finding a new molecule. However, he agrees that this is not easy to achieve given the secretive nature of companies here.