ORDER
H.G. Ramesh, J.
1. This writ petition is by a hospital praying for a direction to the Drug Inspector (respondent 3) not to interfere with the functioning of the hospital so far as it relates to collection, storage and transfusion of human blood.
2. Learned Counsel for the petitioner urged two contentions; that the Drugs and Cosmetics Act, 1940 (‘the Act’ for short) does not apply to the aforesaid activity of the petitioner-hospital as human blood is not a “drug” coming within the ambit of Section 3(b) of the Act. Without prejudice to the said contention, he nextly contended that a hospital engaged in collection, storage and transfusion of human blood is not a ‘Blood Bank’ within the meaning of Rule 122-F of the Drugs and Cosmetics Rules, 1945 (‘the Rules’ for short) and hence no licence as contemplated in the said Rule is necessary.
Learned Government Pleader opposed the petition and submitted that the respondents have the power under the Act and the Rules to regulate the collection, storage and transfusion of human blood by hospitals.
3. In view of the above, the two questions that neatly fall for determination in this writ petition are–
(i) Whether human blood would fall within the ambit of ‘drug’ as defined under Section 3(b) of the Act?
(ii) Whether a hospital is a ‘Blood Bank’ for the purpose of Rule 122-F of the Rules if it is engaged in the collection, storage and transfusion of human blood?
4. Re: Question No. (i)–To resolve this question, it is necessary to notice the statutory definition of ‘drug’ as provided in Section 3(b) of the Act–
“3. Definitions.–In this Act, unless there is anything repugnant in the subject or context.–
(a)…
(b) “drug” includes.–
(i) all medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on human body for the purpose of repelling insects like mosquitoes;
(ii) …
(iii) …
(iv) …”.
(emphasis supplied)
As could be seen from the above provision, all substances intended to be used for treatment of any disease in human beings or animals will fall within the ambit of the definition of “drug”. It is rightly not disputed by the learned Counsel for the petitioner that human blood is intended to be used for treatment of diseases in human beings. His contention is that it is not a substance. What is ‘substance’? “Substance” in the context means any physical matter or material in any form. It is useful to refer to the Second Edition of the book “Words and Phrases legally defined” (Volume V) for the meaning of ‘substance’:
“Substance” means any natural or artificial substance, whether in solid or liquid form or in the form of a gas or vapour”.
In my opinion, human blood is a “substance” and it is intended to be used in treatment of diseases in human beings and accordingly, it falls within the broad language of the statutory definition of “drug” referred to above. Hence, its collection, storage and transfusion could be regulated under the provisions of the Act. This takes me to question No. (ii).
5. Re: Question No. (ii).– Whether a hospital is a Blood Bank?
Explanation to Sub-rule (1) of Rule 122-F of the Rules requires to be noticed:
“Rule 122-F …
(1)…
Explanation.–For the purpose of this Rule, ‘Blood Bank’ means a place or organisational unit or an institution, or other arrangement made by such organisational unit or institution for carrying out all or any of the operations of manufacture of human blood components or blood products or whole human blood for its collection, storage, processing, distribution from selected human donors.
(2)…”.
A plain reading of the above “Explanation” will show that any hospital engaged in all or any of the operations of collection, storage, processing or distribution of human blood will come within the statutory definition of ‘Blood Bank’ for the purpose of Rule 122-F and hence is required to obtain a licence as contemplated in the said Rule. Question No. (ii) is answered accordingly.
6. As both the contentions urged by the learned Counsel for the petitioner fail, the writ petition is liable to be dismissed and is accordingly dismissed. However, there will be no order as to costs.