Workshops for upgradation of Schedule M units to WHO-GMP units

The regulatory forum also discussed opportunities for future collaboration in medical products - Dr Koshia.

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FDA

The Gujarat Food and Drug Control Administration (FDCA) is planning to conduct workshops for upgradation of Schedule M units to WHO-GMP compliant units. This is aggressively being done by the state drug regulator as part of the global harmonization programme for capacity building, training, networking, knowledge sharing and compliance.

This is the third year in a row that the state regulator has been actively conducting workshops in Gujarat towards audit preparedness for the Indian pharma industry.

The workshops will also cover relevant aspects like data integrity and role of data integrity in various functions, FDA regulatory expectations, current trends of FDA, 483 warning letters among others.

This is a relevant development as Gujarat has over 800 WHO-GMP units and maximum number of 130 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 including the US.

“We are taking this ahead also based on the US-based consulting firm World Compliance Seminars (WCS) workshops conducted earlier in 2018 which have been covering subjects for manufacturers like on how to be prepared or US FDA inspections and how to develop quality culture in Indian pharma companies,” informed Gujarat FDCA Commissioner Dr HG Koshia.


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The 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.

A team of US FDA officials last year visited Gujarat FDCA as part of the global harmonization programme for capacity building, training, networking, knowledge sharing and compliance. The meet between the two regulators is latest in the series of such programmes being ushered in since 2008, which has immensely helped Gujarat drug control officials in understanding regulatory requirements of US FDA.

Letitia Robinson, country director, OIP, India Office, US FDA met Gujarat FDCA Commissioner Dr H G Koshia as part of US FDA- Gujarat FDCA Regulatory Forum which was intended to usher in dialogue between senior leaderships of the US FDA and Gujarat FDCA to take forward the avenues for future strategic collaboration.

“The regulatory forum also discussed opportunities for future collaboration in medical products,” Dr Koshia.

Carl Sciachchitano, senior advisor for scientific international affairs, Office of International Programmes (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 earlier in 2018.

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

US FDA in 2018 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 apprised 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 has created 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.

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


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