The Union health ministry has decided not to extend the Good Laboratory Practices (GLP) and it will become mandatory for the pharmaceutical units in the country to comply the GLP norms set by the health ministry from November 1, 2010. The decision to implement GLP in the country was taken by the government more than two years ago and the ministry had given the pharma industry two years time to comply it.
Accordingly, the Drug Controller General of India (DCGI) Dr Surinder Singh has asked the state drug controllers to begin implementation of the GLP from November 1 this year. The DCGI directive in this regard was given to the state drug controllers at the Drugs Consultative Committee (DCC) meeting held on October 28 which also discussed several important issues which have been pending for some time.
Now that the DCGI has given his directive to implement the GLP, the state drug controllers will start inspections of the pharma units to verify the situation.
The government decision will put the industry in real difficulty as a large number of units, especially the small and medium players, have not yet complied the GLP norms due to the huge financial burden involved in it. The GLP standards mandated through the revised Schedule L-1 under the Drugs and Cosmetics Rules, Third Amendment, 2008, demands setting up of costly machines like FTIR (fourier transform infrared spectroscopy), HPLC, AAS, HSGC, IR machines in every pharma units. Adherence to these norms would require a considerable investments from the small scale units, which are struggling for survival.
In fact, the industry has been under the hope that the government will further extend the deadline fixed by the government two years ago. Several industry associations, including, IDMA, SPIC and CIPI, have been urging the government to extend the deadline by at least another two years. “Considering the financial situation of the small scale units after compliance of the revised Good Manufacturing Practices (GMP) and the increasing competition in the market, the government should relax the GLP norms so that some of the laboratory activities could be outsourced by these companies in GLP complied third party labs. The government should also consider extending the deadline for implementation, to help the small scale units to survive,” the industry argues with the ministry.