The Central Drug Standard Control Organisation (CDSCO) attached to the Directorate General of Health Services is planning to review the implementation status of the Good Laboratory Practices (GLP) guidelines announced by the central government a year ago. A national wide inspection will be undertaken on all drug-testing laboratories early next year, it is learnt. The inspection team will consist of officials from the central and state governments and experts from the World Health Organisation.
The outcome of the inspection is likely to help the central agency decide on whether to make the GLP guidelines mandatory or not. It may also help the government laboratories by way of additional grants if found essential.
According to highly placed sources, the inter-laboratory inspections by the central team will provide an opportunity for the state governments to really assess the performances of the laboratories since framing of the guidelines. The government laboratories in various states that have received central grants for upgradation of their facilities will also be inspected. The laboratories who have properly made use of the funds are likely to be granted additional assistance if found necessary, it is learnt. The CDSCO had even supplied equipment to government laboratories after an initial visit to the laboratories last year.
The GLP norms, currently of recommendatory nature, are meant for both private and public sector laboratories. The guidelines, if implemented properly will help the laboratories face the problems arising out of the absence of Standard Operating Procedures (SOPs), lack of validation of equipment, non-adherence to protocols etc.
Specific parameters are laid down by the CDSCO with regard to the organizational structure of the laboratories, personnel standards, quality auditing, facilities and equipment standards maintenance, calibration and testing of equipments, reagents and solutions, raw data, animal care, microbial cultures, test control and article characterization and protocols. User-friendly SOPs should be maintained in respect of all these activities.
As regards facilities and equipment with the laboratory, the CDSCO had suggested that the size and construction of the facilities should be commensurate with the testing needs; there should be proper designing of the building structure to facilitate easy c cleaning and proper instrumental condition.