The Centre's quality upgradation programme for drug testing laboratories has begun to roll on with the Hospital Services Consultancy Corporation (HSCC), the nodal agency assigned the task of implementing the project, inviting bids for construction of new laboratories in the drug sector across the country. In order to augment the efforts of HSCC, the Central Drugs Standard Control Organisation (CDSCO) has called upon the state drug regulatory authorities to complete the preparatory activities in time.
The five year World Bank assisted project was approved by the Cabinet Committee on Economic Affairs last year.
Although major part of the expenditure for the programme is to be borne by the Centre, the states are required to make adequate land available for HSCC. The drug laboratories, which are strengthened under the project by way of laboratory equipments, should ensure availability of space with electric connection, adequacy for the requirement for equipment and availability of personnel for operation of equipment. Specification for furniture being provided under the project for laboratories should be got approved from the competent authority and it should also be ensured that there is adequate space for keeping the furniture.
It is known that HSCC is in the process of finalizing the price contract for chemicals and reagents. The laboratory should ensure that technical specifications have been approved for each item of chemicals, requirement have been worked out on realistic basis, before procurement against the price contract and that there is adequate record keeping in place for the chemicals received.
Under the project the government intends to develop infrastructure both under food and drugs by setting up new laboratories and renovation and extension in the existing laboratories. While the bulk of the expenditure (about 80 per cent) will be incurred at the central level and the participating states will incur the remaining expenditure which cover items such as furniture, chemicals, reagents, appointment of staff on contractual and regular basisand maintanence of building, equipment and other expenses.
The main components of the project are achieving uniform GMP and GLP and better enforcement of the D&C Act and Rules uniformly throughout the country. Increasing testing capacity in the government labs coupled with audit of the private drug testing laboratories and imparting training in the enforcement of D&C Act and Rules and consequent improvement in skills of regulatory staff, government analysts, quality control analysts also comes under its purview.
As part of the programme, the government has also announced to put in place an environment management plan in place. This is to ensure compliance with requirement in India and compatibility with international environmental practices. The environment management plan will be implemented with the objective to review and mitigate environmental risks related to upgradation, construction and operation of laboratories. The ministry will organize training of trainers for implementation of environmental plan. These trainers would organize training for all their staff at their respective labs. Each lab will identify two officers as trainer in environment safety. The laboratories have to identify two officers as trainer in environmental safety. The laboratories have to identify the officers who will be train the lab staff in environmental aspects.
Meanwhile the CDSCO has already made much progress in computerizing the functioning of drug testing laboratories. While the computer linkage of all central labs is almost complete, the authority needs to add a few state testing laboratories also to the network.