Mr. Mahesh Grover, J.:- CM No. 966-LPA of 2016

For the reasons mentioned in the application, delay of 16 days in filing the present appeal is condoned.

Application stands allowed.

LPA No. 444 of 2016

1. The appellant is in appeal against the judgment of the learned Single Judge dated 28.1.2016.

2. While preferring a civil writ petition bearing No.7135 of 2014, out of which the impugned judgment has emerged, the appellant had challenged a notification issued by the Ministry of Health and Family Welfare, Government of India, seeking to restrict and regulate the sale of a drug by the name of Oxytocin while exercising its powers under Section 26-A of the Drugs & Cosmetics Act, 1940 (hereinafter referred to as ‘the Act’).

3. The portion of the notification offensive to the petitioner’s cause may be extracted here below:-

“Now therefore, in exercise of the powers conferred by Section 26-A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby directs that drug Oxytocin shall be manufactured for sale or for distribution or sold in the manner specified below, in addition to the provisions contained in the said Act and Rules made thereunder, namely :-

1. The manufacturers of bulk Oxytocin drug shall supply the active pharmaceutical drug only to the manufacturers licensed under the Drugs and Cosmetics Rules, 1945 for manufacture of formulations of the said drug.

2. The formulations meant for veterinary use shall be sold to the veterinary hospitals only.”

4. Before the writ court as also this Court in appeal the argument has been similar that power under Section 26A of the Act can be exercised in three eventualities envisaged in the statute itself where, upon the satisfaction to be recorded, Central Government prohibits, regulates or restricts the use of a drug or cosmetic which is (i) likely to involve any risk to human beings or animals; (ii) the drug does not have the therapeutic value claimed or purported to be claimed; and (iii) it contains ingredients in such quantity for which there is no therapeutic justification.

5. Apart from this, notification is pleaded to be discriminatory and in violation of Article 14 of the Constitution of India.

6. Learned counsel for the appellant contends that the report of the Committee which led to the eventual issuance of the notification does not reflect any conscious thought to conclude in the manner indicated in the statute i.e. Section 26-A. According to him, there should have been a specific finding based on requisite material that the drug or cosmetic which is the subject matter of the intended regulation restriction or prohibition is likely to involve any risk to human beings and it does not have the therapeutic value claimed or has ingredients in excess of the therapeutic justification.

7. We have perused the experts’ report and their opinion arrived at in the 65th meeting of Drugs Technical Advisory Board and would like to quote the relevant portion therefrom :-

“......The drug oxytocin has medical use for induction and augmentation of labour, to control post partum bleeding and uterine hypo tonicity. The alleged abundant availability and use of the drug in a clandestine way, however, is a matter of great concern of public health.”

..... ...... ...... .......

“The Department of Animal Husbandry, Dairying and Fisheries, Ministry of Agriculture, whose opinion was sought in respect of banning of Oxytocin for Animal use has opined that the ban on production and use of Oxytocin for veterinary use is not recommended. The drug has therapeutic application in case of expulsion of fetus, retention of placenta. However, that drug should be used strictly with the prescription of the veterinarian.

Dr. A.K. Tiwari, from IVRI also agreed that the drug has definite use in veterinary practise and as such should not be prohibited.

The DTAB after deliberations agreed that as the drug has a definite use for therapeutic purposes, it need not to be prohibited. It however, agreed to the suggestion