Fearing another wave of massive shut down of small scale pharmaceutical units in the country due to the proposed implementation of the revised Good Laboratory Practices (GLP) norms starting from November 1, 2010, the Confederation of Indian Pharmaceutical Industry (CIPI) is planning to meet the higher officials in the health ministry soon to once again seek relaxation of certain norms and restriction of the new regime only to the laboratories fully running and operational.

A delegation from CIPI is planning to meet the ministry officials in the end of September to convey the possible troubles GLP implementation would make in the small scale pharma segment. 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, said T S Jaishankar, chairman, CIPI.

“The decision to bring in standards in laboratory practices is a very good move and we welcome the move. But the government should also consider that the small scale units have already invested as much as they can to comply with the GMP standards and raising another such fund in a short period is apparently impossible for many of these firms,” said Jaishankar.

“We have raised the issue with the ministry several times. However, we will again try and meet the ministry officials in the end of this month, after our committee meeting in New Delhi,” he added. He also reminded that several small scale pharma units were forced to shut down due to the lack of available funds for upgradation of their facilities as per the revised Schedule M norms.

Though the government has issued subsidy schemes for the small and medium scale units to upgrade facilities, the industry alleges that the companies were not able to utilise it due to certain demands from the banking agency appointed to distribute the fund.

As reported earlier, 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.

The Small and Medium Enterprises (SME) Committee of Indian Drug Manufacturers Association (IDMA) also had urged the government to relax norms allowing the small scale units to outsource the laboratory works which needs high-end, costly machines for testing. The SME Pharma Industries Confederation (SPIC) has also raised the issue with the government, seeking more time for GLP compliance.