CDSCO invites feedback to create a level playing field in new drug approval process

CDSCO invites feedback to create a level playing field in new drug approval process

The Central Drugs Standard Control Organisation (CDSCO) has initiated a major consultation process to ensure a level playing field in the approval of new drugs in India. The move aims to resolve ongoing concerns regarding unequal regulatory requirements between first-time applicants and subsequent applicants in the new drug approval process.

According to a notice issued on October 8, CDSCO has invited comments from pharmaceutical manufacturers, research organizations, and other stakeholders within 30 days. The feedback will help the regulator draft a more balanced and transparent drug approval policy that encourages research and development (R&D) while maintaining fair competition across the pharma sector.

“There is a lack of level playing field between the first applicant who conducts clinical trials and subsequent applicants who obtain approval with only bioequivalence study data,” said Dr. Rajeev Singh Raghuvanshi, the Drugs Controller General of India (DCGI).

Under the current framework, as per the New Drugs and Clinical Trials Rules, 2019, a company seeking approval for a new drug already approved abroad must usually conduct local clinical trials on the Indian population. However, certain provisions allow for clinical trial waivers in specific cases.

The regulator observed that multiple applicants often submit protocols for clinical trials and bioequivalence (BE) studies for the same new drug. In many such cases, only one applicant completes the full clinical trial process, while others obtain approval later based solely on bioequivalence and pharmaceutical data.

This has led to a cost imbalance where the first applicant bears heavy expenses for conducting clinical and BE studies, whereas later applicants spend significantly less for compliance.

The CDSCO stated that it will deliberate on the matter with stakeholders and concerned departments to introduce a fair system that promotes innovation, ethical practices, and equitable regulatory standards for all applicants.

Click here to know more and access the official guidance document

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