The Central Government is to set roll the five year World Bank aided programme for the strengthening of drug regulatory system within three months from now. The Rs 90 crore programme would run concurrently with the Tenth Five Year Plan and will concentrate on revamping the regulatory system by infusing requisite competence and technical backup. Setting up a pharmacovigilance system, strengthening the drug testing labs, setting up of new labs and formation of "Indian Pharmacopoeia Commission" are all part of the project.
Informing this to Pharmabiz.com, Ashwini Kumar, Drugs Controller General of India (DCGI), said that "capacity building in drug regulatory sector" is the central idea behind the whole programme.
The National Institute of Pharmaceutical Education & Research (NIPER) is known to be the nodal agency for training the regulatory personnel.
According to DCGI, capacity building "would involve lot of training to the existing staff and also increasing the capacity of testing laboratories. We intend to test one lakh drug samples per year on a routine basis." He explained.
At present, the DCGI is able to get test results of just 35, 000 samples from various testing labs across the country. Using the funds available with the WB aided programme the centre is to set up one central facility and three state level state-of-the-art drug-testing facilities in the coming years. With these additional facilities, to be shared by various states, the centre expects to double the number of samples tested in a year.
The Central Drugs Standard Control Organization (CDSCO)'s plan to have a network of pharmacovigilance centers across the country is also part of the WB project. As per this programme, there are to be six regional centers, two zonal centers and a supreme control nod at the CDSCO Headquarters in Delhi for the purpose of introducing a functional adverse drug reaction (ADR) monitoring system.