The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has advised Mankind Pharma to initiate a Phase I clinical trial in India for its proposed Sintilimab Injection 100 mg/10 ml, instead of advancing directly to Phase III as the company had requested.

The recommendation follows Mankind Pharma’s submission to conduct a Phase III clinical study using data generated largely from non-Indian populations. The firm had presented PK/PD data and Phase III results, predominantly based on studies conducted in Chinese patients, where the drug is currently approved.

Concerns Over Safety & Study Design

Sintilimab, a fully human IgG4 monoclonal antibody targeting PD-1, is an established immuno-oncology therapy in China. However, the SEC raised concerns about the lack of safety evidence specific to the Indian population, noting that the currently available data does not adequately establish tolerability for Indian patients.

The committee also highlighted a key issue in the trial design:

• The comparator arm in the proposed Phase III study is standard chemotherapy, which the panel deemed inferior, considering that the indicated treatment options—including more advanced immunotherapies—are already available in India.
• This raised ethical and scientific concerns around clinical relevance and patient benefit.

Regulators Reinforce Local Safety Validation

Following detailed deliberations, the SEC concluded that progressing directly to Phase III without prior evaluation in Indian participants could pose risk and would not meet regulatory expectations for indigenous safety validation.

The committee has therefore recommended a Phase I study, specifically in the Indian population, before any late-stage clinical development can be considered. Mankind Pharma has been directed to submit a detailed Phase I protocol to CDSCO for review and approval.

Also read: Sun Pharma Receives FDA Approval for Updated Long-Term Label of UNLOXCYT, Strengthening Its Oncology Portfolio

Implications for India’s Immuno-Oncology Landscape

The decision reflects India’s strengthened regulatory emphasis on local clinical evidence, especially for high-impact biologics and immunotherapies. As PD-1 inhibitors continue to gain prominence globally, demonstrating population-specific safety and efficacy remains crucial for market entry.

For Mankind Pharma, the directive signals an additional development milestone but also aligns with India’s evolving pharmacovigilance standards, ensuring that advanced therapies meet the expectations of both regulators and clinicians.

The outcome underscores CDSCO’s increasing focus on patient safety, ethical study design, and robust scientific justification before approving global oncology products for the Indian market.

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