Gujarat FDCA suspends licenses of 336 manufacturing units, cancels 2 manufacturing licenses for non-compliance to DC Act

Gujarat FDCA suspends licenses of 336 manufacturing units, cancels 2 manufacturing licenses for non-compliance to DC Act

Mumbai, July, 2017:


The Gujarat Food and Drug Control Administration (FDCA) has suspended licenses of 336 manufacturing units, cancelled two manufacturing licenses and issued stop manufacturing notices in 19 cases for non-compliance to Drugs and Cosmetics Act, 1940 during the last one year. These cases are related to non-compliance to good manufacturing practices (GMPs) and quality control systems.


Meanwhile, the Central Drugs Standard Control Organisation (CDSCO), Western Zone office based in Ahmedabad has declared 8 samples as not-of-standard quality (NSQ) based on 370 samples drawn as part of 200 inspections this year. It has also successfully issued 1347 export NOC till June 30, 2017.


Accounting for nearly 40 per cent of India’s pharma production and 28 per cent of pharma exports, state of Gujarat has a total of 4,021 manufacturing units. It has registered a growth of 445 per cent in pharma exports in the past one decade. According to official sources, exports worth 3,060 million US Dollars has been achieved in 2016 from Gujarat in comparison to exports worth 562 million US Dollars in 2006.


Gujarat today has 255 WHO certified manufacturing units with 23 MHRA certified, 24 TGA certified, 15 EU certified and 16 PICS certified. Besides this, it boasts of 158 formulation units and 97 bulk drug units. It has 40 per cent of CROs and 40 per cent of CRAMS companies.


Early this year, the state drug regulator has cancelled licenses of two wholesalers for marketing spurious drugs as a part of huge inter-state drug racket. Gujarat FDCA officials detected products giving negative results through hand held near infra-red machine and Raman spectroscopy machine based on a tip-off that these drugs have been supplied in a clandestine manner.


Gujarat has been leading in the country in terms of collection and analysis of drug samples as part of its ongoing crackdown on spurious and NSQ drugs through its post-marketing surveillance programme.


Official figures also indicate that Gujarat FDCA collected 13,540 samples in 2015-16 and 8,632 samples in 2016-17. The FDCA's Vadodara based drug testing lab had also tested the maximum number of 6,025 drug samples as part of a pan India spurious drugs survey which concluded last year to assess for the first time complete testing of NSQ drugs as per Indian pharmacopoeia and other pharmacopoeias.


This was followed by Central Drug Testing Lab (CDTL) Hyderabad which tested 5,461samples, CDTL Mumbai which tested 5,418 samples, CDTL Chennai which tested 5,257samples, CDTL Bengaluru which tested 2,033 samples. Pharmabiz