The Gujarat Food & Drugs Control Administration, (FDCA) may soon resort to action against those Small Scale Enterprises (SME's) which have not taken steps to comply with the Good Laboratory Practices (GLP). The GLP norms mandated through the revised Schedule L-1 under the Drugs & Cosmetics Rules, Third Amendment, 2008, demands installation of necessary machineries and equipments in every pharma units.

However many SME's have been quite slow in installing the machineries in their facilities. due to high cost of certain machineries The state FDCA has taken a serious note of this indifferent attitude of these companies.

According to H G Koshia, commissioner, FDCA till now the state regulatory body has taken only an educational approach but soon it will start with investigation to find out about the GLP implementation at various pharma facilities especially at the SME level.

Koshia informs, “SME's are on our top priority list and till now we had taken an educational approach towards the GLP implementation. Since as FDCA we wanted the industry to know how GLP implementation is essential for the development of the industry as a whole. We always think that educating the industry is a better way to ensure complete implementation.”

However, he added that enough time had been given and now its time to check on the results. 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 manufacturers and medium scale manufacturers. He pointed out that out of 3000 manufacturing units in the state which includes 375 WHO complied manufacturing units and other 40 internationally accredited units the rest will tremendously benefit from the GMP compliance.

This step from the FDCA comes in the wake of a recent directive from the Drug Controller General of India (DCGI) office to ensure that the pharma units are implementing GLP. Under this directive the state drug controllers will soon have to start inspections of the pharma units to verify the situation.

“Whenever quality is an issue we do not compromise and take the required action as soon as possible. However, when the change is needed due to an amendment we prefer to take an educative approach, where we educate the companies on the importance, in this case, on GLP and ensure that they implement it on their own rather than resorting to being forced,” Koshia added.

The drug authorities have issued circulars to the pharma units across the country asking them to comply with the GLP, which has become mandatory for the pharmaceutical units in the country from November 1 this year. However, financial constraints and lack of knowledge among the small scale manufacturers about the importance of the GLP implementation has become a major problem for the regulators. Now with the directive in force soon the state drug authorities will have to ensure that the pharma units are actually complying with the rules.