Pharmaceutical Business review

Gujarat FDCA to review GLP deployment in pharma SMEs

Reportedly, the Drug Controller General of India (DCGI) office has directed the state regulatory bodies to begin inspections to take stock of the situation.

Out of the 3000 manufacturing units in Gujarat, 375 are said to be World Health Organization certified, and around 40 are internationally accredited, business-standard.com reported.

The business-standard.com has quoted FDCA commissioner HG Koshia as saying that 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.

"According to the norms, specific types of machinery and equipment should be installed by all pharmaceutical SMEs to maintain quality testing conditions," Koshia said.

"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.

"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 government of India."