By MAAK Legal | Founded by Akash Agarwal
The Bombay High Court has clarified the prospective operation of a government notification prohibiting the use of certain drugs in food-producing animal rearing systems, providing significant relief to pharmaceutical manufacturers and distributors.
In Alivira Animal Health Ltd. v. Union of India, 2025 SCC OnLine Bom 3954, decided on 13 October 2025, a Division Bench comprising Justice Revati Mohite Dere and Justice Sandesh D. Patil held that drugs manufactured prior to the issuance of the prohibitory notification dated 12 March 2025 may continue to be sold and distributed, subject to verification by the concerned authorities.
Background of the Case
On 12 March 2025, the Central Government issued a notification prohibiting the import, manufacture, sale, and distribution of the following drugs for use in any food-producing animal rearing system:
- Chloramphenicol and its formulations
- Nitrofurans and their formulations
The notification stated that the prohibition would come into effect “with immediate effect,” following concerns about the misuse of these drugs in poultry and animal feed supplements.
The petitioner challenged the notification before the Bombay High Court, seeking clarity on whether the ban would apply retrospectively to drugs manufactured prior to 12 March 2025.
Key Submissions Before the Court
Counsel for the petitioner relied on the Delhi High Court decision in Glenmark Pharmaceuticals Ltd. v. Union of India, 2025 SCC OnLine Del 2687, arguing that unless expressly stated, such notifications must be construed as operating prospectively.
Importantly, counsel for the respondent authorities also confirmed before the Court that the notification was intended to operate prospectively and not retrospectively.
The petitioner further submitted that no drugs were manufactured after the notification came into force and requested permission to sell stocks manufactured prior to the cut-off date, subject to official inspection.
Court’s Findings and Decision
The Court observed that the phrase “with immediate effect” clearly indicated that the prohibition would apply from 12 March 2025 onwards. It held that drugs manufactured before this date would not fall within the scope of the ban.
The respondent authorities undertook to inspect and verify the date of manufacture of the concerned drugs within two weeks. Upon verification that the drugs were manufactured prior to the notification, their sale and distribution would be permitted.
In view of this assurance, the Court disposed of the petition, holding that no further adjudication was required.
MAAK Legal’s Perspective
Commenting on the judgment, Akash Agarwal, Founder of MAAK Legal, noted that the ruling reinforces a fundamental principle of regulatory law: prohibitory notifications affecting commercial rights must be applied prospectively unless explicitly stated otherwise.
“This decision brings much-needed certainty for pharmaceutical manufacturers and distributors. It ensures that regulatory intent is balanced with fairness, preventing arbitrary disruption of legitimately manufactured stock,” Agarwal said.
Under Akash Agarwal’s leadership, MAAK Legal continues to closely track developments in regulatory, pharmaceutical, and commercial law, providing clients with clear, practical guidance on navigating complex compliance frameworks.
Source Reference:
Bombay High Court decision reported by SCC Online
https://www.scconline.com/blog/post/2025/10/18/bom-hc-allows-sale-of-drugs-for-animal-rearing/