US FDA Officials Visit Gujarat FDCA For Capacity Building Towards Global Regulatory Harmonization

Mumbai, 24 Aug 2018: A team of US FDA officials recently visited Gujarat Food and Drug Control Administration (FDCA) as part of the global harmonization programme for capacity building, training, networking, knowledge sharing and compliance. 

US FDA visit is an important development as Gujarat has the maximum number of 125 US FDA approved drug manufacturing units in the country. Gujarat also has the distinction of having 28 per cent of drug exports to developed markets and the US. 

Carl Sciachchitano, senior advisor for scientific international affairs, Office of International Programs (OIP), US FDA, Letitia Robinson, country director, OIP, India Office, US FDA, Thomas Arista, deputy director, OIP, US FDA, Kristan Callahan, international relations specialist, OIP, US FDA, Sarah McMullen, supervisory consumer safety office, OIP, INO and Dipesh Shah, consumer safety officer, OIP, US FDA were part of the US FDA team which visited the Gujarat FDCA office.

The visit is significant as domestic industry is also gearing up towards risk based inspections and embracing global standards through upgradation of Schedule M units to WHO -GMP compliant units. 

US-based Underwriters Laboratories (UL) had also trained around 100 Gujarat FDCA inspectors through online modules on current good manufacturing practices (cGMP) and good laboratory practices (GLP) in collaboration with Gujarat FDCA. 

These courses are as per the training imparted to US FDA inspectors which are of immense help to the drug inspectors conducting inspection on the shop floor of a drug facility.

Said Gujarat FDCA Commissioner Dr HG Koshia, “US FDA team also visited the Vadodara drug testing lab which is the largest lab in the country and also houses Asia's first government rapid microbiological testing lab. The team was very happy to apprise themselves about the advanced and upgraded drug lab testing infrastructure in the state.”

Equipped to handle and test multiple samples in two hours time, Gujarat FDCA will create a milestone in terms of testing and analysis of contamination of pharmaceutical products through setting up of Asia's first government rapid microbiological testing lab at Vadodara very soon.

The lab which is now being validated and calibrated will check contamination in medicines imported and exported as per global regulatory requirements.

Setting up of a rapid microbiological testing lab by Gujarat Medical Services Corporation Limited (GMSCL) is done with assistance from BioMérieux. This is followed by an MoU of Gujarat FDCA with French company BioMérieux as part of strategic partnership for knowledge sharing on microbiological testing technologies for the pharmaceutical sector.

US-based consulting firm World Compliance Seminars (WCS) has also been actively conducting workshops in Gujarat towards audit preparedness for the Indian pharma industry. The workshops have already covered subjects for manufacturers like on how to be prepared or US FDA inspections and how to develop quality culture in Indian pharma companies.

The workshops have covered relevant aspects like data integrity and role of data integrity in various functions, current FDA expectations, current trends of FDA, 483 warning letters among others. Pharmabiz