With many of the central drug laboratories and those in the States are ill-equipped to handle the foreign substances, the Central Drugs Standard Control Organisation (CDSCO) has mooted creation of a Pharma Research Laboratory with sophisticated facilities.
The CDSCO has prepared a detailed proposal in this regard and sought Rs.50 crore for this purpose from the Planning Commission so that it can be set up during the next five year plan period, sources said.
“Although many Central Drugs Laboratories have adequate facilities for testing of drugs (quality) as per the prescribed standards, these laboratories are not well equipped to test foreign (contaminated) substance in drugs. Hence there should be a state-of-the-art Pharma Research Laboratory to carry out sophisticated analysis of drugs to detect such substances,” sources said.
According to the detailed proposal, the lab will require Rs.4.5 crore for civil construction and another Rs.30 crore for latest equipment and instruments. About Rs.1 crore is expected to be the annual costs for reagents and chemicals. Excluding the land cost and manpower, the proposal has put a cost of Rs.50 crore for the lab.
As per the details collected by the CDSCO, many drug testing laboratories of the State Governments are not working properly. “For example in the States of Jharkhand and Chhattisgarh, the drugs testing laboratories are not functional at present because of manpower shortage. The State Governments are responsible for their functioning,” sources said.
Another proposal from the CDSCO is to equip the drug regulators to meet the rising challenges in the field of pharmaceuticals in which globalisation had fundamentally changed the environment, especially in the regulatory sector.
“With increased globalisation of the regulatory mechanism apart from the changing profile of the pharma industry, it is important to impart continuous training to the drug regulators. We need at least another Rs.50 crore for this purpose during the next five years. Besides, Rs.20 crore would be sought for travel expenses including the foreign trips for training,” sources said.