JUDGMENT

INDU MALHOTRA, J.

Leave granted.

1. The issue which arises for consideration in the present appeals is the validity of the Notification dated 27.04.2018 issued under Section 26A of the Drugs and Cosmetics Act, 1940 (hereinafter referred to as the “Act”) by the Ministry of Health and Family Welfare.

The impugned notification restricts the manufacture of Oxytocin formulations for domestic use, only by public sector undertakings or companies, to the complete exclusion of the private sector companies. However, the manufacture of the drug for export purposes is open to both public and private sector companies.

It was notified that the notification would come into force on 01.07.18.

By a subsequent notification dated 29.06.2018, the date was extended to 01.09.18.

2. Till the issuance of the impugned notification, Oxytocin was being manufactured by private sector companies to meet the entire need in the country.

After the issuance of the impugned notification, Karnataka Antibiotics & Pharmaceuticals Ltd. (“KAPL”), a public sector company has commenced the manufacture of Oxytocin in May 2018.

3. The Active Pharmaceutical Ingredient (“API”) or the bulk drug is manufactured in India only by one private sector company in India, viz. Hemmo Pharmaceuticals Pvt Ltd. (“Hemmo Pharma”).

4. The impugned Notification dated 27.04.2018 was challenged in a group of Writ Petitions by various private sector companies who are inter alia manufacturing the drug Oxytocin in W.P.(C) No. 6084/2018, W.P.(C) No. 8555/2018, W.P.(C) No. 8666/2018 and W.P.(C) No. 9601/2018 before the Delhi High Court on various grounds. The Delhi High Court granted stay of the operation of the impugned notification vide Interim Order dated 31.08.2018. The order of stay was extended by subsequent Orders, which remained in force till 15.12.2018. The Delhi High Court vide a detailed Judgment and Order dated 14.12.2018 has quashed the impugned notification. As a consequence, the impugned notification did not come into force at all.

5. The Appellant-Union of India has filed the present Special Leave Petitions before this Court, to challenge the judgment passed by the Delhi High Court.

6. The subject matter of the present appeals is the drug Oxytocin, which is notified as an essential drug by the World Health Organization (WHO) Model List of Essential Medicines since 2002. The concept of “Essential Medicines” was first introduced by the WHO in 1977, and has now been adopted by many countries, NGOs and international nonprofit supply agencies. Oxytocin continues to be notified in the 21st edition of the WHO Model List of Essential Medicines published in 2019. It is listed under the head “Medicines For Reproductive Health And Perinatal Care” and the recommended form of dosage is “Injection: 10 IU in 1 mL”.

6.1. Oxytocin is an essential lifesaving drug, which is included in the National List of Essential Medicines, 2011 (“NLEM”). It continues to be listed at S.No. 26.1.5 in the latest notification published in 2015. The NLEM is published under the 1st Schedule to the Drugs (Prices) Control Order, 2013 (“DPCO”) under Section 3 of the Essential Commodities Act, 1955 (“EC Act”).

The NLEM specifies the recommended dosage and strength of Oxytocin injection as 5IU per 1 ml and 10IU per 1 ml. Oxytocin injection in the form of “5 IU per ml in 1ml ampoule pack” is included in the “Essential Drug List for the year 2016-2018” at Serial No. 228 published by the National Health Mission, Department of Health and Family Welfare, Government of Himachal Pradesh.

6.2. The objective of the National List of Essential Medicines (NLEM) is that the drugs included in it are adequate to meet the contemporary health needs of the general population of the country [Press Release on “Essential Drugs” dated 15.03.2013 by the Press Information Bureau, Government of India, Ministry of Health and Family Welfare. ]. It is one of the key instruments in balanced healthcare delivery system of a country. The first NL