 "Submit licence application data within 45 days: DCGI")
Taking a grim view of incomplete applications, which ultimately delays the licence-approval process, the Drugs Controller General of India (DCGI) has decided on a time limit of 45 days for supplementary clarifications or information, whenever asked for.
If the companies do not give such information within 45 days, DCGI would dispose of such applications with the incomplete data. “It will be presumed that the applicant does not intend to pursue its application further,” DCGI said.
“In a large number of cases where we had requested the applicants for further technical details/clarification, the applicants do not respond within a reasonable time,” added DCGI.
Till date, there was no time limit for such data and companies used to take months to respond, said a source.
The regulator has also advised companies to approach it if a licence is not granted within two-thirds of the requisite time period specified for the purpose, despite giving all requisite information.
For example, if the requisite time specified for a particular licence is three weeks, and if the company has not been granted it within the first two weeks, the firm can approach the DCGI in the third week to pursue the matter.
If the companies do not give such information within 45 days, DCGI would dispose of such applications with the incomplete data. “It will be presumed that the applicant does not intend to pursue its application further,” DCGI said.
“In a large number of cases where we had requested the applicants for further technical details/clarification, the applicants do not respond within a reasonable time,” added DCGI.
Till date, there was no time limit for such data and companies used to take months to respond, said a source.
The regulator has also advised companies to approach it if a licence is not granted within two-thirds of the requisite time period specified for the purpose, despite giving all requisite information.
For example, if the requisite time specified for a particular licence is three weeks, and if the company has not been granted it within the first two weeks, the firm can approach the DCGI in the third week to pursue the matter.