The Drug Controller General (India) office will be strengthened by inducting more staff and filling up the remaining vacant posts, with a view to further streamline the functioning of the CDSCO and deliver better and faster service to the industry, according to DCGI Dr Surinder Singh.
"We have been managing with just 21 regular staff and 40 others on contract. Still we have succeeded in clearing all the backlogs in the applications and bringing the time-limits for clearing the applications of different types considerably. We will be inducting 63 more drug inspectors by July," Dr Singh informed Pharmabiz.
He said the Health Ministry has already given fast track approvals for strengthening the office and there was no problem in funding also.
About 75 posts have been created and the pending promotions of the officials were also cleared. "After inducting the next batch of drug inspectors, we will go for more depending on the requirements. We have already appointed 14 new drug inspectors recently as 77 posts have been cleared by the Ministry," he said.
He said the DCGI office had to handle thousands of applications an year and was understaffed for long, leading to backlog. Over 16600 applications were handled during the just completed financial year by the DCGI office. The total number of applications processed during the year of 2007-08 was 12640 while it was just above 10000 in the year of 2005-06.
The number of new drug applications went up to 2000 in the last year from 1200 in 2005. As many as 300 applications for global clinical trials were processed in the last year against 100 in 2005. The highest number of applications was for test licences (7500) while the number of export NoCs was 2500 during the last financial year.
Applications for diagnostic kits including test licences for diagnostics were 1000 during the year. The applications for medical devices made a huge jump during the last five years, from nil in 2005 to 500 in the last fiscal.