Orders prohibiting production without a hearing violate natural justice principles, making them invalid.

JUDGMENT:

1. Rule. Rule made returnable forthwith, and, with the consent of the learned Counsel for the parties, heard finally.

2. As both the Petitions arise out of, by and large, similar set of facts, the Petitions were heard together and are being decided by this common judgment.

3. These Petitions assail the legality, propriety and correctness of the orders dated 10^th July 2025 passed by the Minister, Department of Food and Drugs, Government of Maharashtra, (R2) in Appeal Nos. 490 of 2025 and 579 of 2025, whereby the Appeals preferred by the Petitioners, in the respective Petitions, against the orders passed by the Joint Commissioner and Licencing Authority, Food and Drugs Administration (R1), directing the Petitioners to completely stop the production of the medicines, came to be dismissed.

4. For the sake of convenience and clarity, the facts in Writ Petition No. 10602 of 2025, are noted in a little detail; followed by the facts in Writ Petition No. 10603 of 2025, in brief.

5. FACTS IN WRIT PETITION NO. 10602 OF 2025 :

5.1 M/s National Pharmaceuticals, the Petitioner, is a Company incorporated under the Companies Act, 1956. The Petitioner claims to be a reputed pharmaceuticals manufacturing company. The Petitioner holds valid license under the Drugs and Cosmetics Act, 1940 (“the Act, 1940) and the Drugs and Cosmetics Rules 1945 (“the Rules, 1945). The Petitioner has its manufacturing facility at G-18/1, M.I.D.C., Tarapur, Boisar. It employs over 170 workers. The Petitioner claims to have been exporting over 400 products to various countries adhering to the Good Manufacturing Practices (GMP) and national/international standards.

5.2 On 21^st February 2025 a Circular was issued by the Government of India, Directorate General of Health Services, directing immediate withdrawal of the permission to manufacture all combinations of Tapentadol and Carisoprodol.

5.3 In deference to the aforesaid directive, the Petitioner surrendered its product license on 23^rd February 2025 and the same was approved by R1 on 24^th February 2025.

5.4 A joint inspection was conducted by the officials from Central Drugs Standard control Organization (CDSCO) (R3) and the State Food and Drug Administration (FDA) in the manufacturing unit of the Petitioner on 25^th February 2025.

5.5 A notice dated 26^th February 2025 was issued to the Petitioner under Section 22 (1)(cca) read with Section 18-B of the Act, 1940, to produce documents relating to the manufacture for sale of drugs manufactured under export NOCs issued by CDSCO, West Zone Office and FDA.

5.6 Simultaneously by order dated 26^th February, 2025, without providing any opportunity of hearing the Respondent No.1 directed the Petitioner to stop the manufacturing of all the products which mandated the cessation of production.

5.7 Subsequently, a show cause notice was issued to the Petitioner on 27^th February 2025 under Rule 85(2) of the Rules 1945 for alleged contravention of the provisions of Act of 1940 and the Rules thereunder and for failure to achieve and follow the requirements of the Good Manufacturing Practices and Good Laboratory Practices.

5.8 A compliance report of Corrective Actions and Preventive Actions (CAPA) was submitted by the Petitioner on 3^rd March 2025. A reply to the show cause notice dated 27^th February 2025 was also submitted.

5.9 As the permission to resume the production was not granted despite all the compliances, the Petitioner preferred an Appeal before the State Government (R2) against the order directing the Petitioner to stop production of all the products.

5.10 By the impugned order dated 10^th July 2025, the Minister