In a move that would further strengthen the collaborative efforts between the Gujarat Food and Drug Administration (Guj FDCA) and the US Food and Drug Administration (FDA), Altaf Ahmed Lal, the new country director of US FDA in India recently visited the state drug regulators office to understand the regulatory set up adopted in the state. Interestingly, this is his first official visit to the state after taking up the key position as the country director, reinstating the growing importance of the state as a key exporter to US.
It is understood that the officials from both the regulatory agencies deliberated and discussed on regulatory measures that can be adopted further to improve the health care delivery mechanism across both the countries. The key focus of the meeting was to formulate ways to work together to create an ideal environment to boost best patient safety measures. Gujarat drug officials informed that Lal and his team were eager to extend their expertise and know how on global regulatory requirements with their Indian counterparts, while expressing their keen interest in developing a mutually beneficial arrangement for the same.
According to Dr Khoshia, comissioner, Guj FDCA, “It is a matter of huge pride for us that the US FDA officials has commended on our efforts at implementing best regulatory practices in the state. We have always made it a point to never compromise with the standard of delivery so that the patients not only in Indian bur across the world do not suffer in the end. Our highest priority have been and will be on patient safety and welfare and we will take all the possible measure to strengthen the already ongoing measure to ensure that only the best and highest quality of medicines are manufactured in the state,”
Dr Koshia pointed out that they further had a detailed discussion on key areas that needs focus like training the officials on lasted regulatory requirements, upgrading the regulatory know how as excepted globally etc as some of the key area that needs to be pondered upon. The US FDA officials were also taken on a tour across the Gujarat FDCAs the drug test laboratory and its office along with visit to the
SEZ zone which is home to eight to nine of the US FDA Approved plants
Gujarat contributes to about 28 per cent of overall pharma exports from the country and has 40 US FDA plants in the state.
Source : pharmabiz.com