The Delhi High Court permitted a rival's expert to inspect confidential regulatory submissions in the Cadila-Hetero biosimilar litigation, rejecting claims of absolute confidentiality. The order precedes a Supreme Court hearing on the matter.
Discovery Order in Biosimilar Dispute Sparks Confidentiality Debate
In a significant development in pharmaceutical intellectual property litigation, the Delhi High Court, in Cadilla Healthcare Ltd. v. Hetero Biopharma, allowed the plaintiff’s court-appointed expert to inspect confidential regulatory dossiers submitted to the Central Drugs Standard Control Organisation (CDSCO). The order, issued ahead of a Supreme Court hearing scheduled for 3 November 2026, permits inspection of the data in sealed cover, subject to strict confidentiality protocols.
The case revolves around a biosimilar drug, with the plaintiff challenging the regulatory approval granted to Hetero’s product. The core legal question was whether regulatory submissions—typically protected under Section 26(4) of the Drugs and Cosmetics Act, 1940—can be disclosed under the limited discovery provisions of Order XI of the Code of Civil Procedure, 1908. The court held that the public interest in ensuring lawful regulatory approvals outweighs the defendant’s claim to absolute confidentiality, particularly where complex scientific verification is required.
The court observed that 'confidentiality cannot be a shield to prevent judicial inquiry into the legitimacy of a market entry approved on technical grounds.'
This ruling could set a precedent for future drug litigation, especially in biosimilars, where scientific equivalence is central. Practitioners must now anticipate that regulatory data, though protected, may be subject to judicial scrutiny under controlled conditions. Parties should prepare robust confidentiality undertaking frameworks in such discovery applications.
Citations
- Cadilla Healthcare Ltd. v. Hetero Biopharma, DHC, November 2026
