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US FDA team to visit Gujarat FDCA for networking as part of global harmonization efforts towards compliance

Shardul Nautiyal, Mumbai
Wednesday, December 6, 2017, 08:00 Hrs  [IST]

As part of the global harmonization programme towards compliance, a US FDA team will be visiting Gujarat Food and Drug Control Administration (FDCA) for networking and knowledge sharing with the Gujarat drug control officers. This will help US FDA regulators to understand the effectiveness of Indian regulatory mechanism towards drug quality and patient safety.

Informed Gujarat FDCA Commissioner Dr HG Koshia, “The networking and knowledge sharing is the latest in the series of such programmes being ushered in since 2008, which has immensely helped Gujarat drug officials in understanding global regulatory requirements and that of US FDA. This becomes more significant as Gujarat shares 28% of drug exports to developed markets and the US.”

Accounting for nearly 40 per cent of India’s pharma production and 28 per cent of pharma exports, Gujarat saw an increase in pharma exports in the past one decade with 3,060 million US Dollars worth of exports in 2016 from a quantum of exports worth 562 million US Dollars in 2006.

This comes close on the heels of Gujarat FDCA inspectors being trained on compliance and audit readiness of Indian manufacturing units.

The Gujarat FDCA also recently rolled out new courses on current good manufacturing practices (cGMP) and good laboratory practices (GLP) in collaboration with US-based Underwriters Laboratories (UL) to train drug inspectors.  Besides the fact that these courses are as per the training imparted to US FDA inspectors, such online courses are of immense help to the drug inspectors who conduct inspection on the shop floor of a drug facility.

The initiative is also a part of strategic partnerships for knowledge sharing with UL which is a global safety consulting company offering about 700 such courses of which 125 courses are authored by the US FDA. Gujarat FDCA has till date concluded training of 100 drug officials to equip them on detecting faulty medical devices and sub-standard drugs in line with the training imparted through a collaboration with UL.

Seventy five drug control officials have been trained till date for implementing compliance related to medical devices by the Gujarat FDCA in collaboration with Abbott India as part of strategic partnership

The Gujarat government has signed MoUs worth Rs. 15,000 crore with both Indian and international companies in the pharma sector during the Vibrant Gujarat Global Summit (VGGS) - 2017 at Gandhinagar held between January 10 and January 13, 2017 under the theme Connecting India to the World with focus on ‘Make in Gujarat’.

Over 3,300 pharma manufacturing units are located across the state in four large clusters with 5 Special Economic Zones in an area of over 1,500 hectares.


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