The Confederation of Indian Pharmaceutical Industry (CIPI) has urged the central government to provide adequate training and education for the staff in pharma units in maintaining quality standards as per Good Laboratory Practices (GLP) free of charge, as every company has to mandatorily comply with the laboratory standards as per the regulation from November 1, 2010.
The confederation has already sent a representation to the government seeking assistance in equipping its staff to keep standards as required in the Schedule L – 1 in the laboratories. The knowledge should be disseminated for free of charges, for the small scale units to avail the maximum benefit in keeping laboratory standards, said the CIPI officials.
“There is no dearth of experts to train and educate the work force in each state. The government could conduct training programmes in each of the state for the benefit of pharma units for free, so that the small scale units could also get thorough knowledge about the practices,” said T S Jaishankar, chairman, CIPI. CIPI will encourage all its members to participate if the government initiates such a project.
Though expressed its apprehension on the impact of implementing the norms in the small scale sector earlier, the confederation has now conveyed its members that the small scale units have no need to worry on the mandatory implementation of GLP, since the law does not insist them to invest heavily at this stage to set up full fledged laboratories.
The fear was that with the implementation of GLP, every unit has to equip themselves with costly machines which may lead to closure of several small scale units due to lack of funds to invest in laboratory facilities. However, the Drugs and Cosmetics Act itself allows the manufacturer to outsource some of the laboratory works to third party units which complies with the GLP standards, and the small scale units can avail this for the time being, said Jaishankar.
He added that the confederation welcomes the implementation of GLP and realises it as the need for the improvement of quality in the industry. The GLP implementation only mandates that the laboratory equipment and facility existing in a pharma unit should comply with the quality standards and does not go further demanding establishment of a full fledged facility in each unit.
However, the upgradation of existing equipment and laboratory facility or even outsourcing would add to the cost of manufacturing of products to the manufacturers and the drug price control authority should revise the price of medicines considering this factor, he added.