22/09/2026
🚨 CIPLA × MAHARASHTRA FDA | REGULATORY UPDATE
Cipla Pharma & Life Sciences Ltd.’s Wadki, Pune C&F facility became the subject of regulatory action by the Maharashtra Food and Drug Administration (FDA) following an inspection concerning Reactin Plus Tablets.
According to reports:
🔴 27 August 2026
The Maharashtra FDA cancelled the drug-sale licence of the Wadki, Pune C&F facility, citing alleged irregularities relating to packaging, storage and recall procedures involving Reactin Plus.
⚖️ 29 August 2026
During proceedings before the Bombay High Court, the FDA agreed to withdraw the cancellation order and issue a fresh show-cause notice to Cipla, followed by a reasoned order after considering the company’s response.
📌 What this means:
The earlier licence-cancellation order was withdrawn. The matter was therefore not finally concluded by that cancellation order, and further regulatory proceedings were contemplated.
👨⚖️ The proceedings involved the Maharashtra FDA under Commissioner Tukaram Mundhe.
Key legal takeaway:
Regulatory enforcement must follow the applicable procedure and principles of natural justice, particularly where an order has significant consequences for a regulated business. The Bombay High Court proceedings highlighted this issue in the Cipla matter.
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This post is for general informational and educational purposes only.
