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The United States Pharmacopoeia (USP) has collaborated with the Gujarat Food and Drug Control Administration (FDCA) to adopt best practices on regulatory compliances and drug standards followed in the state of Gujarat.
A high level delegation led by Jeff Moore, senior director, Scientific Strategy And Planning, USP US with its Indian counterparts Dr Annu Uppal, senior scientific affairs manager, Biologics, USP India, Dr Chaitanya Kumar Koduri, associate director, Biologics, USP India and Dr Raasi Gaur, senior executive, Biologics, USP India discussed the broad contours of their mutual engagement towards strengthening drug regulatory mechanism.
This comes close on the heels of an MoU signed between Indian Pharmacopoeia Commission (IPC) and USP on the same. USP discussed among other practices the Gujarat model of e-governance which has already been replicated in more than 12 states across the country.
The Gujarat FDCA has been upgrading and updating skills of its regulators as per the latest drug regulatory requirements of its international counterparts like MHRA, US FDA and WHO.
With good governance through modernisation and infrastructural development, Gujarat FDCA is making efforts to strengthen and build its laboratory capabilities.
Its best practices include introducing hand held devices for onsite testing of medicines imported, exported and for domestic use like Raman Spectrometer, XRF metal analyser, NIR metal analyser, automation in microbiological analysis like the rapid microbiological testing to combat drug contamination, mass SMS alerts for effective drug recall to detect not-of-standard quality (NSQ) drugs in the market and the XLN system.
The Gujarat FDCA has a food and drug laboratory (FDL) in Vadodara to carry out testing of allopathic, ayurvedic and homoeopathic drugs equipped with state of the art testing facilities, AAS, spark emission, spectrophotometers, HPLC with auto sampler, gas and liquid chromatography, spectrophotometers and FTIR.
Gujarat FDCA also offers services of mobile drug testing lab equipped with high-tech devices at a total investment of Rupees one crore to the patients across far flung regions of the state. Through this initiative, the Gujarat FDCA has further strengthened its regulatory mechanism to conduct surprise drug testing while on the move across the state to check on counterfeit or substandard drugs.
This mobile drug testing lab has a near infra-red spectrophotometer, x ray fluorescence spectrometer, ion mobility spectrometer and the Raman spectrophotometer.
The Gujarat FDCA has also embarked on a massive vigilance drive across the state to crack down on incidents of malpractices among 40,000 plus pharmacists to check whether the retailers and pharmacists are adhering to the provisions of the Drugs and Cosmetics (D&C) Act and rules especially relating to the clause that stresses on presence of pharmacists in the retail outlets.
Gujarat FDCA has been streamlining its regulatory mechanism, through efficient use of information technology for some time now. One of the biggest endeavours of the Gujarat FDCA is its self-licensing software, Xtended Licensing and Laboratory Note (XLN).
XLN is a software for transparent and speedy disposal of various licensing applications and reducing the time lag between the collection of samples to declaration of results to dissemination of information to stake-holders.
This software helps regulate the sales and manufacturing aspects related to drugs, food and cosmetics and issuance of licenses. The best feature of this software is that it enables the registration of all the pharmacists and chemists which prevents multiple illegal enrollment of pharmacists.
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