News + Font Resize -

Gujarat FDCA suspends 201 product licences in 10 months
Gireesh Babu, Mumbai | Saturday, February 13, 2010, 08:00 Hrs  [IST]

The Gujarat Food and Drug Control Administration (FDCA) has ordered withdrawal of 22 pharma products from the market and suspended 201 product licences in the first 10 months of the current financial year, following negative reports from the samples tested in its drug testing lab.

Following the inspections conducted in various parts of the state, the drug regulator has cancelled manufacturing licence of an Ayurvedic drug manufacturer and has issued 92 odd severe warnings to drug manufacturers, according to the top official of FDCA. The action was taken mainly based on the drug testing reports from the state drug testing laboratory at Baroda and on the random inspections conducted by the drug inspectors in various parts of the state.

The administration has conducted tests on 20,314 samples during the period from April 1, 2009, to January 31, 2010 and identified 289 products as not of quality standards as per the Indian Pharmacopoeia.

Out of the total products found lacking standards, 65 products were manufactured by units outside Gujarat. “We are ensuing strict vigilance on ensuring the standard of products and have taken prompt action against the erring units. Action against the not of quality products identified is on the way,” said H G Koshia, commissioner, Gujarat FDCA. The action was taken on case-by-case basis considering the seriousness of the error identified, he added.

The administration, at present, is in an effort to expand its reach in the state by setting up local offices in six more districts. The process of setting up six more district offices, to extend accessibility for the pharmacies and to strengthen the monitoring system, is expected to complete by the end of the current financial year.

Premises for office in four districts - Patan, Porbandar, Dahod and Navasari – has already been identified even as office premises for two more district offices, at Anand and Ahmedabad West Zone, are expected to finalise soon. Plans are to make all the offices operational by April 1, 2010, said Koshia.

“The pharma industry in the state is growing at a higher pace and we want to expand our infrastructure to enhance our performance both in regulatory and monitoring activities in tandem with it,” he averred. The administration has allocated Rs 24 lakh from its budget for 2009-10 for the purpose.

As reported, the FDCA is also strengthening its work force with more than 200 fresh staff, including 115 junior scientific assistants, 59 drug inspectors and 41 food inspectors. With the induction of 59 more drug inspectors, the administration will have a work force of 84 drug inspectors. The government has also approved a proposal to include additional posts to the administration for better performance.

Post Your Comment

 

Enquiry Form