The more than 100-year old Haffkine Institute of Mumbai will soon establish a BA/BE study centre which will be useful to the pharma industry in India and abroad in getting a more authentic bioavailability and bioequivalence (BA/BE) study results. The government-controlled Institute has already started the process in this regard and is expected to be completed within a year's time.
There will be a total of 24 healthy volunteers in the Institute for the BA/BE studies and the studies will be open to all the generic drug makers to test their products. The industry, both domestic and overseas, can approach the Institute for getting an authentic BA/BE study report at much cheaper rates, said S A Momin, deputy director, Haffkine Institute,who is in-charge of the BA/ BE programme and will be in charge of the BA/BE study section once it is completed.
"We are going to start the operation of the BA/BE study section within a year's time and have already started working on the same since November 2009," Momin said.
He informed that once the institute is fully ready after fulfilling the required compliance, they need about 27 professionals for 11 different categories and in fact they have already started the recruitment process for the same. About the total investment on the project, Momin said that it would be difficult to give the actual amount since the work is still in progress. However it is expected that the total amount will go to Rs 2.5 crore for the BA/BE study section, bio analysis and microbiology/sterility section, he said.
Momin said that the BA/BE study section will be established to study and observe the quality of generic drugs. Both BA and BE focus on the release of a drug substance from its dosage form and subsequent absorption into the systemic circulation. BA and BE data is therefore required to be furnished with applications for new drugs, as required under Schedule Y, depending on the type of application being submitted.
Apart from this, Haffkine Institute is also getting ready for revamping the whole facility to meet the GLP standards. Dr Abhay Chowdhary, director, Haffkine Institute for Training, Research and Testing, said that they will start the process of revamping the institute within a month's time. Around 1.5 crore will be invested for the whole process. Lots of activities are taking place within the institution as it is gearing up for the ISO 2001 certification and NABL accreditation. It is also gearing up for computerised chemical testing, digitization of library and also thinking of setting up vaccine research units in the near future. All this comes in the wake of the Government of India's move for mandatory GLP.
The Government of India has notified GLP as mandatory vide G.S.R.780 (E) dated 10th November 2008 under schedule L-1 with effect from the 1st day of November, 2010. This includes requirements in details about general requirements, premises, personal, equipments, chemicals and reagents, good house keeping and safety, maintenance, calibration, and validation of equipments, reference materials, quality system, Internal quality system audits, management review, standard operating procedures, protocols and specifications archive, raw data, storage and archival. GLP generally refers to a system of management controls for laboratories and research organisations to ensure the consistency and reliability of results as outlined in the Organisation for Economic Co-operation and Development (OECD) principles of GLP and national regulations.
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