Health ministry to amend Rule 122 P of DnC Rules for easy availability of blood

PSM News /


Mumbai, Sept 19, 2015

The Union health ministry will soon amend Rule 122 P of Drugs and Cosmetics Rules, 1945 for easing out the availability of blood in the country and also to help in making blood available to the needy patients. According to sources, the Drugs Technical Advisory Board (DTAB) of the health ministry in its recent meeting has given its green signal to make the amendments in the D&C Rules in this regard. 
Earlier, the issue of amending the Drugs and Cosmetics Rules in respect of the provisions relating to the blood banks and blood donation camps was examined by the National Core Blood Bank Assessment Committee chaired by Dr. Jagdish Prasad, director general of health services. The committee held its meeting on May 26, 2015 in New Delhi. 

Issues related to blood banking such as bulk transfer of whole blood and components between blood banks; blood storage centres; NOC from State Blood Transfusion Council for application for licensure to any blood bank; and criteria for Regional Blood Transfusion Council were discussed during the meeting. 
The recommendations of the National Core Blood Bank Assessment Committee were then forwarded to the DTAB for its green signal. The specific recommendations which required amendments to the Drugs and Cosmetics Rules were considered by the DTAB in its meeting held on August 18, 2015.
On the issue of bulk transfer of whole blood and components allowing between blood banks where there is facility to store and monitor the same, the DTAB agreed to amend clause xiv of Rule 122 P relating to conditions of licence for blood banks to insert, “the whole human blood and blood components in bulk may be transferred, under prescribed storage conditions, to another blood bank which have facilities to store and monitor blood distribution. The recipient blood banks shall not further transfer units obtained from another blood bank except to another blood storage centre or a patient”. 
On conducting of blood donation camps by all government, IRCS and blood banks possessing no objection certificate from the SBTC, including hospital based corporate blood banks, the DTAB agreed to amend Part XII B of the Schedule F, under the heading  BLOOD DONATION CAMPS-- to inserted, “a private hospital blood bank”.

For allowing any hospital to apply to become a blood storage centre, as already permitted under the Drugs and Cosmetics Act, the DTAB agreed to omit the entry under clause 2 at serial number 5(B) of Schedule K, “The captive consumption of Whole Human Blood I.P. or its components in the First Referral Unit, Community Health Centre, Primary Health Centre and/or any Hospital shall not be more than 2000 units annually”.