Even as the Good Laboratory Practices (GLP) is being implemented in the country from November 1, there are apprehensions among the industry that if Schedule L-1 is enforced strictly, it will have an adverse effect on WHO GMP and CoPP certification as it will take some time for all the pharmaceutical units to comply with the norms.

There have been lacks of clarity in the industry on the repercussions of lack of full compliance of Schedule L-1. Kapil Bhargava, retired Deputy Drugs Controller (I), CDSCO points out that this confusion is because the state licensing authorities had issued only the instruction to manufacturers for GLP compliance, whereas the directives did not mention the action to be initiated against the manufacturers who fail to comply.

He points out, “There are many small scale companies who lack knowledge on the provisions or rules in the Drugs and Cosmetics Act, thus it is essential to sensitise them on this matter so that they there is no panic in the industry. As of now, the industry is not fully aware of what actions are they supposed to take as well as what will be the impact of not following those actions. The main fear in the industry is that if they do not demonstrate full compliance of Schedule L1, will it have an adverse effect on grant of WHO GMP and CoPP certification.”

According to T S Jaishankar, chairman, Confederation of Indian Pharmaceutical Industry (CIPI), if Schedule L-1 is enforced strictly, it will have effect on the WHO-Good Manufacturing Practice (GMP) and Certificate of Pharmaceutical Products (CoPP) certification. Under the rule, WHO GMP guidelines very clearly mention that all rules of countries legislation shall be followed and assessed at the time of inspection. This clearly means that for getting WHO GMP and CoPP certification the manufacturers must strictly comply with Schedule L.

However, Jaishankar clarifies that it is important to have GLP since it is a standard by which laboratory studies are designed, implemented, and reported to assure the public that the results are correct and the experiment can be reproduced exactly, at any time in the future. He stressed, “If a company is seen to be applying and adhering to the highest standards of laboratory practice, it will gain significant competitive advantage and will compete successfully for business and recognition within its operational environment.”

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 investment from the small scale units, which are struggling for survival.

Jaishankar pointed out that GLP ensures that all the companies have calibrated and validated equipments in their labs. Moreover the government has made it clear that in case a company cannot afford to have the machines they can outsource certain testing from other source provided that the lab from which testing is outsourced comply with GLP standards.

“CIPI has been conducting seminars and meetings with many small scale companies from past six months on the importance of Schedule L-1 and its implication, since manufacturers are at a loss to understand this interpretation and can only guess,” Jaisankar added. At present to avoid confusion there is a need to sensitise the industry on this issue so that there is no panic on the implementation of Schedule L-1.