Not under Drugs Act

PUNE, May 21: The Association of Rural Surgeons of India ARSI are persistent in their efforts to point out to the Food and Drug Administration FDA, Maharashtra State that Unbanked Directed Blood Transfusion UDBT was legal because it was not 8220;manufacturing,8221; 8220;offering for sale,8221; 8220;stocking8221; or 8220;distributing8221; a drug and hence did not come under the purview of the Drugs and Cosmetics Act,1940.

However, according to the legal framework for regulation of use of whole blood by the Indian Association of Blood Banks, 8220;since whole human blood is required in the diseased state and to cure diseases like anaemia 8211; as defined under Section 3 b of the Drugs and Cosmetics Act 8211; blood should be considered a drug. Since blood and blood products are drugs, the collection of blood which is a manufacturing process of blood transfusion 8211; a licence is required under Section 18 c of the Act.

However, ARSI vice-president Dr R R Tongaonkar argues that under the Act the definition of the word 8220;manufacture8221; did not include compounding or dispensing. So when a qualified medical graduate does UDBT for his/her own patient, this act will mean 8220;compounding8221; or 8220;dispensing8221; a drug whole blood to the patient.

Explaining further, Tongaonkar said that when a mixture of different drugs is prepared by the medical practitioner for the use of a patient in the treatment of ailment diagnosed by the practitioner8217;s professional skill and which mixture is normally incapable of being passed from hand to hand as a commercial commodity, the medical practitioner supplying the medicines cannot be said to be 8220;manufacturer of the mixture.8221;