SUBODH S SHAH Vs. DIRECTOR FOOD AND DRUGS

JUDGEMENT

(1.) Is human blood a "drug" ? And Are Pathologists tapping blood from human beings manufacturing "drug" so as to incur liability to obtain licence under Sec. 18(c) of Drugs and Cosmetics Act, 1940 ? are the questions posed for consideration of this Court in this petition under Art. 226 of the Constitution of India filed by some of the Pathologists and Association of Pathologists.

(2.) The respondents, namely, the Director of Food and Drugs has by notices, dated 8th July, 1983 called upon the petitioners individually to show cause as to why action should not be taken against them for breach of Sec. 18(c) of the said Act inasmuch as they have been carrying on the activities of tapping blood, collecting the blood and of selling the blood for which licence is required under Sec. 18(c) of the said Act and since such activity was being carried on by them without obtaining licence, actions were required to be taken against them. The issuance of such notice to various Pathologists has given rise to the present petition whereby the petitioners have challenged the legality and validity of said notices issued under Sec. 18(c) and they have also prayed for issuance of appropriate writ, order or direction declaring that the Pathologists are not liable to obtain any licence under the provisions of the said Act.

(3.) It is the case of the petitioners that the petitioner Nos. 1 to 4 are registered medical practitioners possessing necessary medical degrees carrying on the noble profession as Pathologists in the city of Ahmedabad. It is their case that they only tap the blood from donor willing to donate his/her blood for a particular patient who may be in need of his/her (donor's) blood for treatment and who is referred to the Pathologist by a medical practitioner. It is their further case that they do not stock the blood, they do not sell the blood nor do they distribute the blood to needy patients. It is their further case that the donor of the blood himself comes to the Pathologists for tapping his blood for being given to the patient who is in need of blood and to whom the blood is offered by such donor at the recommendation of or at the instance of medical practitioner. It is their positive case that they do not sell the blood and by tapping the blood and making the same available to the relatives of the patient for being transfused they are simply discharging their professional services. The petitioners further contend that they have been carrying on such activities since long and therefore, they were surprised when they received the impugned notice, dated 8-8-1983 whereby the Director of Food and Drugs - the respondent No. 1 herein has called upon them to obtain licence under Sec. 18(c) of the Drugs and Cosmetics Act, 1940. According to them human blood cannot be regarded as "drug" and secondly Pathologists cannot be treated as "manufacturers of blood" so as to incur obligation to obtain licence under the provisions of the said Act. They have further submitted that all throughout the country nowhere such a demand is made by any authority acting under the provisions of the said Act, and therefore, also the respondents were not justified in calling upon the Pathologists to obtain licence under the provisions of the said Act.