In a bid to further streamline the functioning of the Central Drugs Standard Control Organisation, the Drugs Controller General of India (DCGI) has delegated the power of licensing authority in the head office to six senior officials for timely clearance and approvals.
“Each Deputy Drug Controller of India (DDC-I) who is responsible for the division is required to shoulder additional responsibilities for showing attributes for excellent initiatives, inter-personal relationship, teamwork, relationship with public to ensure smooth functioning of the concerned division and also ensure that there is no pendency or backlog in the division. Further, there would be a quarterly review on the performance of each division in respect of works and duties delegated to them,” according to the order issued by DCGI Dr G N Singh.
Accordingly, Dr K Bangarurajan (DDC) will handle the test licence division handling the test licence for imported drugs. A K Pradhan (DDC) will head the new drugs division which will be responsible for test licence for import of new drugs and clinical trial NoCs, as per the order.
S P Shani (DDC) will be in-charge of the vaccine section to given clinical trial NoCs and registration certificates for vaccines. The division will also handle Form 10 Licence for vaccines and rDNA products and related test licence. R Chandrasekhar will handle BE NoCs, subsequent new drug approvals and related test licences while Annam Visala will be responsible for registration certificate of Ethics Committees and issue of show cause notices with respect to clinical trial sites and serious adverse events.
The order by the DCGI, under Rule 22 of Drugs and Cosmetics (D&C) Rules, has placed Dr S E Reddy (DDC) as in charge of medical devices and diagnostics. The division will give clinical trial NoCs, registration certificates for medical devices, import and test licences for medical devices and diagnostic regents/ kits.
Another order by the DCGI said all port officers of CDSCO had been delegated with the powers to permit for the import of small quantities of drugs for personal use in Form -12B, with immediate effect. “During the grant of personal licence, information should be obtained from the prescribing doctor whether the drug is approved in any other country (if yes, the name), whether drug is approved in India, what is the cost of drug and who will bear it, who will monitor adverse reaction, if any arising out of the drug, and the need and essentiality of drug for the patient and prescribing doctor’s final comments about whether the drug shall be permitted to be imported,” the order said.