The Delhi High Court permitted a competing pharma company's expert to examine confidential regulatory submissions in a sealed cover, overriding claims of confidentiality. The order precedes a Supreme Court hearing on the larger biosimilar litigation between Cadila and Hetero.
DHC Orders Disclosure of Confidential Regulatory Data in Biosimilar Litigation
In a significant development ahead of an impending Supreme Court hearing, the Delhi High Court on 1 November 2026 allowed a plaintiff in the Cadila-Hetero biosimilar dispute to have its expert examine sealed regulatory approvals submitted by the defendant. The court held that public interest in ensuring drug efficacy and safety outweighs commercial confidentiality claims when judicial scrutiny is necessary for adjudicating patent and regulatory compliance issues.
The order arose in the context of discovery under Order XI of the Code of Civil Procedure, where the court balanced the right to confidentiality of regulatory data under Section 22 of the Drugs and Cosmetics Act, 1940, with the principle of fair trial and effective adjudication. The court emphasized that access would be strictly limited to a court-appointed expert under confidentiality protocols, ensuring no commercial misuse.
"Transparency in regulatory processes cannot be sacrificed at the altar of blanket confidentiality, particularly where public health is at stake,"the court observed.
For practitioners, this ruling signals a shift toward greater judicial oversight of regulatory records in complex pharmaceutical disputes. It underscores the importance of crafting robust confidentiality undertakings during discovery and may influence how parties approach requests for inspection of drug approval dossiers in future IP and competition cases involving biosimilars.
Citations
- Order XI CPC
- Drugs and Cosmetics Act, 1940, Section 22
