Content Provider | Supreme Court of India |
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e-ISSN | 30484839 |
Language | English |
Access Restriction | NDLI |
Subject Keyword | Notificationissued under s.26A of the Act Validity of Power of Central Government Drugs and Cosmetics Act 1940 |
Content Type | Text |
Resource Type | Law Judgement |
Jurisdiction | India |
Case Type | Appeal |
Court | Supreme Court of India |
Disposal Nature | Matter Referred to Larger Bench |
Headnote | Drugs and Cosmetics Act, 1940: s.26-A – Notification dated 27.04.2018 issued under s.26A of the Act by the Ministry of Health and Family Welfare – Validity of Notification challenged in these appeals – 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 while the manufacture of the drug for export purposes is kept open to both public and private sector companies – Held: These appeals raise serious issues having far reaching implications – The substantial questions of law which arose for consideration are: Whether a drug included in the National List of Essential Medicines published under Schedule 1 of the Drugs (Prices Control) Order, 2013 notified under s.3 of the Essential Commodities Act, 1955 would be subject to the provisions of s.26A of the Act; Whether the impugned notification has resulted in creating a monopoly in favour of public sector companies, to the complete exclusion of private sector companies, and if so, whether it would be protected by Art.19(6)(ii) r/w Art.14 of the Constitution; Whether the classification made by the impugned notification between licensed public sector and private sector companies, in the manufacture of the drug Oxytocin for domestic use, would achieve the object and purpose of preventing the unregulated and illegal use of the drug – Whether it would be in public interest to restrict the manufacture of a life-saving drug for domestic use, to a single public sector undertaking, to the complete exclusion of the private sector companies, particularly in view of the high maternal mortality rates in the country; Whether there was relevant and objective material before the Central Government to form the basis of satisfaction to exercise the power to prohibit the manufacture of the drug by the private sector companies for domestic use, under s.26-A of the Act; Whether the object of curbing the clandestine manufacture and unregulated use of the drug Oxytocin, which is covered by s.18 of the Act, can be achieved by taking recourse to s.26-A by imposing a ban on the manufacture of licensed drugs by private sector companies; Whether the exercise of power by the Central Government under s.26-A of the Act is legislative or executive in nature – Matter is referred to a larger Bench to consider these questions of law. Drugs and Cosmetics Act, 1940: s.26-A – Power of Central Government under – Notification dated 27.04.2018 issued under s.26-A by the Ministry of Health and Family Welfare – Legality of Notification – Held: There is no decision so far on issue as to whether the nature of powers exercised by the Central Government under s.26-A of the Act is legislative or executive – If the exercise of power under s.26-A is held as being legislative in nature, the parameters to examine the legality of the impugned notification would be different whereas if it is held to be executive in nature, the parameters would be somewhat different than the former one – The decision either way on any of these questions will have its far reaching effect on the rights and health of public at large and especially on the rights and health of the teenage girls, pregnant females and milching animals – In effect, it will not be a judgment inter party but it will be in rem laying down the law on the questions – Public Health Administration. (Abhay Manohar Sapre, J.) |
Judge | Hon'ble Ms. Justice Indu Malhotra |
Neutral Citation | 2019 INSC 947 |
Petitioner | Union Of India & Anr. Etc. |
Respondent | Bgp Products Operations Gmbh And Hagene Immermatt Weg. & Anr. Etc. |
SCR | [2019] 11 S.C.R. 170 |
Judgement Date | 2019-08-22 |
Case Number | 6588 |
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