Central Drugs Body Revamps Testing Permissions To Fast-Track Drug Approvals in India

In a significant regulatory reform aimed at reducing drug approval times in India, the Central Drugs Standard Control Organization (CDSCO) has modified existing norms for testing permissions. Under the new framework, pharmaceutical companies can begin laboratory testing of drug samples immediately after filing applications, without waiting for detailed preliminary scrutiny. The change is intended to accelerate the approval process for new drugs and vaccines while preserving core quality and safety checks. Previously, CDSCO required applicants to submit comprehensive product specifications and detailed development reports before issuing a No Objection Certificate (NOC) for testing, a prerequisite for final regulatory approval. Under the revised regime, this step is streamlined, with file movement prioritised and detailed technical review conducted later in the process.

The updated system is set to come into effect on June 1, 2026, and applies to testing across multiple government laboratories, including the Indian Pharmacopoeia Commission and other central facilities. The reform signals a broader shift in regulatory policy designed to balance efficiency and compliance, aligning India's drug approval environment with global practices while supporting domestic innovation and faster patient access to essential medicines.

What The New Testing Permission System Entails

Under the revised circular, CDSCO will issue the No Objection Certificate (NOC) for drug sample testing immediately upon receipt of an application, provided that applicants submit finalised regulatory specifications aligned with prevailing pharmacopoeial standards and relevant quality management protocols. Finalised specifications must adhere to the Second Schedule of the Drugs and Cosmetics Act, 1940, and include necessary quality attributes and management system details.

By contrast, the earlier process involved detailed upfront scrutiny of multiple technical documents, including product development reports, forced degradation studies and compliance with pharmacopoeial monographs, before testing clearance could be granted. Under the reformed process, companies can begin laboratory testing sooner, with technical scrutiny and potential requests for revised specifications taking place later in the regulatory timeline.

Testing is conducted in designated Government of India laboratories such as those operated by the Indian Pharmacopoeia Commission (IPC), Central Drugs Testing Laboratory (CDTL), Central Drugs Laboratory at CRI Kasauli, and the National Institute of Biologicals (NIB) in Noida. These institutions perform laboratory assessments that form the basis of CDSCO's final regulatory decisions.

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Why This Matters For Drug Development

The CDSCO's reforms dovetail with broader changes in India's regulatory framework intended to improve ease of doing business in pharmaceutical R&D and approvals. For example, amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019 earlier this year replaced certain licensing requirements with prior intimation mechanisms, cut statutory timelines and increased digital transparency in regulatory processes. These changes collectively aim to reduce development timelines by several months while maintaining oversight, particularly for products that pose higher risks.

By allowing immediate testing upon application, CDSCO is effectively reducing procedural bottlenecks, potentially shortening the time to regulatory decisions and enhancing predictability for drug sponsors. Quicker laboratory testing is expected to benefit new chemical entities, generics, biosimilars, and novel therapies, all of which play a critical role in addressing India's growing health needs.

Balancing Speed with Safety

While the new procedure expedites the initial testing phase, the regulator retains the authority to request revised specifications and conduct re-testing if necessary. This ensures that technical scrutiny and quality checks are not bypassed,but are instead deferred to later stages of the regulatory review process.

Public health advocates and industry stakeholders have underscored the importance of maintaining rigorous standards even as timelines shrink. In recent years, the CDSCO has flagged several drug quality issues in routine surveillance, highlighting the importance of robust testing and monitoring systems. Maintaining the delicate balance between regulatory efficiency and patient safety remains central to India's drug policy. Expedited testing can reduce delays in launching important therapies, but oversight mechanisms must continue to guard against quality lapses that can impact public health.

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