“Transparency in Approval Process Is Essential”: Delhi High Court Orders Pharma Companies Hetero and Cadila to Disclose Regulatory Documents
Kiran Raj
The Delhi High Court has directed Hetero Drugs Limited and Cadila Healthcare Limited to disclose regulatory documents related to their bio-similar versions of bevacizumab and trastuzumab, respectively. The order stems from legal action by F. Hoffmann-La Roche Ltd. and its subsidiaries against the regulatory clearances granted by the Drugs Controller General of India (DCGI) for the sale and manufacturing of the defendants' drugs.
Presiding over the matter, Justice Amit Bansal mandated the production of clinical trial data, regulatory dossiers, and approval-related correspondences. The court also ordered the establishment of confidentiality clubs to limit access to sensitive business information, ensuring fairness in the litigation process.
The plaintiffs, including Roche and its affiliates, are the original developers of bevacizumab (AVASTIN) and trastuzumab (HERCEPTIN, HERCLON, and BICELTIS). These drugs are used in the treatment of various types of cancers, including breast and gastric cancers. The plaintiffs argued that the approval process for bio-similar versions must comply with established regulatory guidelines to ensure the safety and efficacy of the products.
Roche challenged the approval granted to Hetero for its version of bevacizumab, contending that Hetero had not conducted the necessary clinical trials mandated under the Drugs and Cosmetics Act, 1940, the Drugs and Cosmetics Rules, 1945, and the Guidelines on Similar Biologics, 2012. The plaintiffs claimed that the regulatory approval granted to Hetero was based on incomplete data and that the defendants failed to establish bio-similarity.
A similar contention was raised by Roche regarding Cadila’s trastuzumab product, arguing that its approval was in violation of established protocols. The plaintiffs asserted that Cadila had bypassed critical testing requirements, including independent comparative clinical trials, thereby jeopardizing patient safety.
The plaintiffs submitted that the defendants had misrepresented data to regulatory authorities and sought full disclosure of all relevant documents, including applications, clinical trial reports, and correspondence with DCGI, to ascertain whether the approvals were granted in compliance with legal standards.
The court examined whether the regulatory approvals granted to the defendants adhered to prescribed protocols. Justice Bansal noted:
“The plaintiffs have questioned the validity of clinical trials conducted by Cadila and Hetero and the approvals granted by the regulator as being non-compliant with the applicable laws and procedure.”
The court referred to M.L. Sethi v. R.P. Kapoor (1972), stating that discovery of documents must be allowed where it is necessary for determining the veracity of a party’s claims. The court observed that the plaintiffs' allegations warranted further scrutiny and held that transparency in the approval process was essential.
The judgment also cited prior litigation, including Genentech Inc. v. Drugs Controller General of India and Roche India Pvt. Ltd. v. Drugs Controller General of India, where similar concerns about bio-similarity approvals were raised. The court noted that the disclosures made in those cases had been critical in assessing compliance with the regulatory framework.
The court issued the following directives:
- Production of Documents: Hetero and Cadila must submit the requested regulatory documents, including clinical trial data, correspondence with DCGI, and reports from the Review Committee on Genetic Manipulation (RCGM), in a sealed cover within four weeks.
- Confidentiality Club: To protect proprietary information, the court mandated the formation of confidentiality clubs, comprising two legal representatives and one expert from each side, to have controlled access to the documents.
- Inspection and Review: The documents will be reviewed exclusively by members of the confidentiality club, who will be bound by strict non-disclosure agreements.
- Scope of Documents: The defendants must provide complete dossiers related to bio-similarity studies, quality and safety data, and any modifications recommended by regulatory bodies during the approval process.
- Additional Filings: The plaintiffs are permitted to seek further documents if any discrepancies are found in the disclosed records.
The plaintiffs raised several concerns regarding the regulatory process followed in granting approvals to the defendants:
- Whether the bio-similarity claims of the defendants were supported by adequate clinical evidence.
- Whether the defendants conducted comparative trials against the plaintiffs’ original drugs as required.
- Whether the regulatory authority followed due process before granting the approvals.
- Whether the defendants' submissions to the regulator contained complete and accurate information.
The court held that these questions required thorough examination, and the production of documents was necessary to ascertain the facts.
Case Title: F. Hoffmann-La Roche Ltd & Others v. Drugs Controller General of India & Others
Case Numbers: CS(COMM) 540/2016 & CS(COMM) 1119/2016
Bench: Justice Amit Bansal
[Read/Download order]
