In a major step towards improving the blood banking system in the country, the office of the Central Licence Approving Authority (CLAA) under directorate general of health services has decentralized the power of renewal of licences to blood banks with effect from June 20.
 
Under the new system, a section of powers has been delegated to the zonal officers of CDSCO to sign, on behalf of the CLAA, renewal certificates for the operation of blood banks which process whole human blood IP and its components.

However, fresh or renewal of licences for manufacture of blood products shall continue to remain with the CLAA. The circular warns that the signing of certificates of renewal by the zonal officers should be exercised only in those cases that were granted or renewed at an earlier stage by the CLAA.

In case the licence has not been granted or renewed previously by the CLAA, such licences cannot be signed by the deputies in the zonal offices, and they should be forwarded to the central CDSCO office for further action.

The DCGI as CLAA, by exercising the powers conferred under rule 122 L of the drugs and cosmetics rules, 1945, issued a circular in this regard on June 4 which says that the delegation of powers empowered to the zonal offices has come into force from June 20, this year. The order will be in  force till June 30, 2012.

According to information received from reliable sources, the main purpose of delegation of powers is to decentralize the process for quick disposal of licensing of blood banks as well as to improve the blood banking system in the country. For this, the deputy drug controllers in the CDSCO offices should visit periodically the concerned state licensing authorities as well as the stale blood transfusion councils to devise better ways to improve the system.

For improvement of the system, the CLAA has given some instructions to the zonal officers. The circular, signed by Dr Surinder Singh gives special instruction that a separate record should be made concerning request received on renewal of licences from the VIPs, and such records should be sent regularly to his office.

Since the order has come into force, all the state licensing authorities will henceforth forward the applications to the regional CDSCO offices. The deputy drug controllers in the CDSCO zonal offices will act on behalf of the CLAAs. Whereas, the sub-zonal offices in Hyderabad, Ahmedabad, Bangalore, Chandigarh and, Jammu & Kashmir have not been delegated the powers to sign the renewal certificates. They have to forward the files to the concerned zonal offices.

Previously the applications were being sent to the CDSCO office in New Delhi by the state SLAs and the CLAA had to decide on the files received from all over the country. The new system will enable for a speedy disposal of blood bank licences, it is learnt.

While carrying out inspection at the blood banks, the zonal officers must ensure that the blood banks have adequate mechanism of collection of blood from the voluntary blood donors and in no case the blood shall be collected from professional donors, which is being banned as per the direction of the Supreme Court. The order of the DCGI empowers the central regulatory authorities to take any action against the licensee under the Drugs & Cosmetics rules 1945 so far as matters relating to renewal of licences for processing of whole human blood and its components are concerned.

The circular also wants the regional officers to exhort upon the state blood transfusion councils and director of health services not to encourage commercialization of blood banks in the private sector with a view to curb the mushrooming of commercial blood banks where quality control system cannot be enforced stringently.