The Drug Controller General of India (DCGI) is planning to initiate an e-governance effort to consolidate a national list of drug manufacturers licensed in the country, in an effort to keep an updated database of the pharma companies for its use.
The database of the drug manufacturers licensed under the state drug controller will be consolidated at state level for preparing the national list. The drug regulator is planning to prepare a common format and software, to be distributed in every state, for collecting the information in a uniform manner, according to regulatory sources.
As the part of this effort, the DCGI, in the recent Drug Consultative Committee (DCC) meeting held in June 29, has appointed a subcommittee to work with the central government-run National Informatics Centre (NIC) or any such agency to prepare the format, software and categorization of the products licensed under various licences issued. The subcommittee includes Drugs Controllers of Delhi, Karnataka, Kerala and Nagaland.
"The DCGI has appointed the subcommittee to prepare the uniform format and software for consolidating a national list of pharma manufacturers. This is a huge task as many of the states do not have a computerized database of the manufacturers. An effort in this regard has been carried out in Gujarat Food and Drug Control Administration (FDCA) and would be helpful for the purpose," said M P George, drug controller, Kerala Drug Control Administration and a member of the subcommittee.
The committee is expected to submit its reports in two months time and the meetings of the committee would be facilitated by the North Zone office of Central Drug Standard Control Organisation (CDSCO). The challenge is to prepare a format and software which could be used uniformly in every state without overlapping the information of licenses or certificates issued by various states for the same product or facility.
Another major task in consolidating the data is the collection of every information available in the states where the licensing system is still done on papers and has no much experience with the Information Technology system. With the common format and software, the states would then be able to consolidate information in a uniform manner. "The information could be consolidated at the zonal level also as many of the states may not be having basic hardware or software facilities required for compilation," suggested the experts in the DCC meeting.
Even as the government claims that around 10,000 pharma manufacturing units exists in the country, the numbers and the specific information about these units are still not known to the regulatory body and the industry. Reliable information about the total number of manufacturers and units is not even available with the industry as the manufacturers are associated with various local and national level industry associations. However, the industry associations can help the regulator in consolidating the data, comments a regulatory source.
At present, Gujarat FDCA is the pioneer in implementing e-governance for its day-to-day activities. The state, which has initiated issuing sales licences through online months ago, has now prepared software to issue manufacturing licences online and has consolidated and verified information about almost 80000 product licences from nearly 900 manufacturers. The CDSCO, which is currently planning to implement e-governance as the part of its modernization projects, can follow the methods used by the Gujarat FDCA in preparing the software, said another DCC member.