As both the state government and the Centre are keen to improve the quality of testing, the Gujarat Food & Drugs Control Administration, (FDCA) is planning to clamp down on those small and medium scale manufacturing units (SMEs) in the pharmaceutical sector who have not taken steps to implement the Good Laboratory Practices(GLP) norms.
The GLP norms necessitate installation of specific machinery and equipment to adhere to the standards specified under the GLP Act. "The details of the GLP have been laid out and mandated through the Drugs and Cosmetics Rule of 1945, which is an amended version of the Drugs and Cosmetics Act of 1940. And according to the norms, specific types of machinery and equipment should be installed by all pharmaceutical SMEs to maintain quality testing conditions", H G Koshia, commissioner FDCA informed adding that the government is now going strong about the implementation of the rules.
The GLP guidelines had come in around two years back, and the last date of implementation was given as November 1, 2010. Gujarat FDCA will thus now go about inspecting the pharma SMEs in the state to ensure adherence to the norms.
Industry insiders point out that SME units in the state have been quite slow in implementing the GLP norms due to high cost of machineries.
Koshia said that, "We have till date taken an educational approach to spread awareness among the SME units, but will soon start with investigation to find out about the GLP implementation levels at various pharma facilities especially among small scale units. They are on our top priority list. We always think that educating the industry is a better way to ensure complete implementation.” He pointed out that implementation of GLP at the SME level is very essential since 75 to 80 per cent of the pharma industry in Gujarat is composed of the small scale and medium scale manufacturers. Of the 3000 manufacturing units in the state, 375 are World Health Organisation (WHO) certified, and around 40 are internationally accredited.
"These units already have to comply with the Good Manufacturing Practices (GMP) norms specified by international regulatory bodies, but now the focus is on implementing the law of the land too in the form of GLP norms specified by GoI", Koshia explained.
The Drug Controller General of India (DCGI) office has recently sent a directive to the state regulatory bodies like the Gujarat FDCA, to start inspections to take stock of the situation.