The Indian FDA had moved to cancel a manufacturing licence held by Cipla Pharma, citing alleged non‑compliance with quality‑control norms. The order triggered a petition in the Delhi High Court, where the regulator’s action was described as ‘overboard’ and lacking procedural fairness.
In its latest notice, the FDA announced it would rescind the cancellation order "forthwith" and instead issue a fresh show‑cause notice. The new notice will give Cipla an opportunity to respond, after which the agency will deliver a reasoned decision on the licence status.
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Legal experts note that the High Court’s intervention underscores the judiciary’s role in checking administrative excesses, while the FDA’s reversal aims to preserve procedural integrity and avoid prolonged litigation that could disrupt drug supply chains.
