(PER : HONOURABLE THE CHIEF JUSTICE MR.BHASKAR BHATTACHARYA) An affidavit-in-reply has been filed by Dr. N.D. Gajjar, Joint Director, Blood Safety, Gujarat State AIDS Control Society and Incharge of Gujarat State Council for Blood Transfusion, to this Public Interest Litigation.
It appears that in paras 13, 14 and 15, the following averments have been made by the deponent:
13. It is most respectfully submitted that every whole blood license holder is required to carry out to collect the whole blood and thereafter, supply in the same form i.e. whole blood. If the license holder is having license for preparing components in that case he is required to undergo the procedure for collection, separation and storage of the blood within six hours of the collection which is reflected in the Schedule-F, Part XII-B, Chapter-III, Part-E[4] fresh frozen plasma, in The Drugs and Cosmetics Rules, 1945. A copy of which is annexed herewith and marked as Annexure-R-XIV.
It is most respectfully submitted that as per the same provision referred to earlier the plasma has to be stored at minus 30 degree centigrade and the same shall be preserved for a period of not more than a year then it can be discarded or sent for any other purpose by the blood bank but it is incumbent upon the blood bank to store it for one year for the benefit of the patients. A copy of the chart is annexed herewith and marked as Annexure-R-XV.
15. It is most respectfully submitted that it is necessary that once the blood is collected, the plasma from the blood is collected, the plasma from the blood has to be separated and stored at minus 30 degree centigrade. But it is a question of inquiry that when the camps for blood donation are held at a distance and far away places, the blood collected may not reach the blood bank for separation and storage within the period of six hours which might make the plasma unfit for the purpose of storage and usage to the patients, which might give rise to the situation wherein the blood banks are likely to take advantage by saying that as the plasma is unfit for the consumption for the patients, the same has to be sent for fractionation.
It further appears that according to Schedule F , Part XII-B, Clause-L under the Drug and Cosmetics Rules, 1945, it is mandatory for all the Blood Banks to keep all the records for checking and functioning of the Blood Banks.
In such circumstances, let notice be issued to all the 142 blood banks which are functioning within the State of Gujarat as appearing at page 244 of the paper book, to disclose to this Court whether formalities required under the aforesaid provision are complied with by those Blood Banks. They will also disclose whether they are complying with the requirement of collection, separation and storage of blood within six hours of the collection as reflected in the Schedule F Part XII-B Part-E[4] Fresh frozen plasma, in the Drug and Cosmetics Rules, 1945. They will also disclose whether they comply with the formality of storing plasma at minus 30 degree centigrade within six hours of its collection.
Those Blood Banks will also furnish the following information to this Court:
[a] Quantity of plasma separated every month [b] Quantity of plasma supplied to the patients every month [c] Quantity of plasma sent for further fractionation every month Let such report be given to this Court by January 17, 2013. Let the matter appear for further hearing on January 17, 2013. The above reports should be supported by an affidavit of the person in-charge of the respective Blood Banks. Let this order be communicated at the cost of the State Government to the Blood Banks indicated above.
(BHASKAR BHATTACHARYA, CJ.) (J.B.PARDIWALA, J.) pirzada/-
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