Case Note & Summary
The petitioner, Johnson & Johnson Pvt Ltd, a manufacturer of pharmaceuticals and cosmetics including 'Johnsons Baby Powder', challenged three orders passed by the Maharashtra Food and Drug Administration (FDA) and the Minister of Food and Drug Administration. The orders dated 15th September 2022, 20th September 2022, and 19th October 2022 cumulatively resulted in a complete stoppage of production of the baby powder. The petition was filed under Article 226 of the Constitution seeking a writ of certiorari to quash these orders. The court found that the orders were passed without providing the petitioner with copies of test reports that formed the basis of the adverse action, and without any opportunity of hearing. The appellate order was also a non-speaking order that did not consider the petitioner's submissions. The court held that the principles of natural justice, particularly audi alteram partem, were grossly violated. The court also noted that the product had been manufactured for over half a century and was also exported. The court quashed all three impugned orders and directed the FDA to provide the petitioner with all test reports and afford a proper hearing before passing any fresh orders. The court also ordered fresh testing of samples in accordance with the law.
Headnote
A) Natural Justice - Audi Alteram Partem - Right to be Heard - The impugned orders were passed without providing the petitioner with copies of test reports or any opportunity of hearing, violating the fundamental principle of natural justice that no one shall be condemned unheard. (Paras 1-10) B) Drugs and Cosmetics Act, 1940 - Cosmetic Rules, 2020 - Rule 4 - Prohibition Order - The orders prohibiting manufacture of a cosmetic product must be based on valid grounds and after following due process; failure to disclose adverse material renders the order arbitrary. (Paras 11-20) C) Administrative Law - Reasoned Order - The appellate order dated 19th October 2022 was a non-speaking order that did not address the petitioner's submissions, making it unsustainable in law. (Paras 21-30) D) Drugs and Cosmetics Act, 1940 - Section 33 - Rule 149 - Manufacture for Export - The court noted that the product was also manufactured for export and the orders did not consider the impact on exports, but the primary issue was violation of natural justice. (Paras 31-35)
Issue of Consideration
Whether the impugned orders dated 15th September 2022, 20th September 2022, and 19th October 2022, which resulted in the complete stoppage of production of Johnson's Baby Powder, were passed in violation of principles of natural justice and were arbitrary and unreasonable.
Final Decision
The court allowed the petition, quashed the impugned orders dated 15th September 2022, 20th September 2022, and 19th October 2022, and directed the respondents to provide all test reports to the petitioner and afford a proper hearing before passing any fresh orders. The court also directed fresh testing of samples in accordance with law.
Law Points
- Natural Justice
- Audi Alteram Partem
- Right to be Heard
- Reasoned Order
- Drugs and Cosmetics Act
- 1940
- Section 33
- Rule 149
- Cosmetic Rules
- 2020
- Rule 4
- Schedule S
- Prohibition Order
- Suspension of License
- Manufacture for Export
- Test Reports
- Disclosure of Adverse Material
