The drug testing laboratory of the Maharashtra Food and Drugs Administration (FDA) will soon get accreditation from the National Accreditation Board for Testing and Calibration Laboratories (NABL) for its chemical and biological drug testing facilities. This will be the first drug testing laboratory under a state drug control department to get a NABL accreditation in the country, informed FDA officials.
According to sources, a three-member assessment team from the Board has visited the FDA's laboratory at Mumbai, in the middle of April 2008, and cleared the laboratory from any non confirmative issues declaring the quality of the lab is up to the required standards. The administration expects the formal announcement from the board within a fortnight.
"The clearance from NABL is for international standards for calibration, which means the materials used in the laboratory is of global standards and the technical staff has been trained to conduct tests without practical error," said a higher official from FDA Maharashtra. The FDA has to keep the calibration of the equipment under check in a regular interval, for maintaining the standards required for NABL accreditation.".
Even as the accreditation expected is for the chemical and biological testing standards, the administration is also upgrading its microbiology section to the NABL standards. The upgradation process is expected to complete within next four months and the FDA will apply for the Board accreditation once the lab is ready with facilities including Air Handling Unit (AHU).
The administration has used up Rs six crore for technology upgradation fund in 2007-08 and has a fund allocation of Rs four crore sanctioned for upgradation projects for the current financial year.
"The recent changes made in the standards of monographs by the Indian Pharmacopoeia Committee has brought the Indian drug standards closer to international quality standards and the drug control mechanism has to upgrade itself with latest quality checking equipments and trained manpower," said an expert close to the development. He added that the NABL accreditation for the laboratory shows that the facility under Maharashtra FDA is well equipped for the kinds of tests.
The Maharashtra FDA has two drug testing laboratories, one at Mumbai and another one at Aurangabad, to test the quality standards of the pharmaceutical products manufactured in the state. The testing lab at Mumbai, which is expected to receive the board accreditation, was established in 1968 and currently has strength of 70 analysts with a capacity to conduct 6500 sample tests per annum.
The FDA is also planning to shift its Aurangabad laboratory from the district municipality premises to its own two-acre land, allotted by the state government of late. The civil works for the new lab is expected to begin within the year, with an initial fund of more than Rs 130 lakh allocated by the state government. The new facility will be built as per the Good Laboratory Practice norms though the capacity for tests will remain at 2500 samples per annum, sources said.