A Review Article on a Basic Review on the Role of CDSCO in Approving Pharmaceutical Products in India

Abstract

The critical tablets wellknown manipulate company (CDSCO) is India’s national regulatory authority responsible for ensuring the safety, efficacy, and nice of pharmaceutical merchandise [1]. running under the Ministry of fitness and circle of relatives Welfare, CDSCO regulates pills, scientific gadgets, and medical trials through statutory provisions defined in the medication and Cosmetics Act, 1940 and associated regulations [2], in addition to the brand new drugs and scientific Trials regulations, 2019 [3]. The drug approval pathway involves assessment of preclinical records, granting permissions for scientific trials, assessment of excellent manufacturing Practices (GMP) compliance, and advertising authorization for new tablets [4]. CDSCO collaborates with kingdom drug regulatory government to implement a harmonized regulatory framework and follows a danger-based totally assessment method for choice-making [5]. current advancements—along with the digital SUGAM portal for submissions and increasing alignment with worldwide regulatory standards—have superior transparency, performance, and international credibility of India’s drug approval method [1, 6]. common, CDSCO performs a crucial role in safeguarding public fitness even as helping the boom of the Indian pharmaceutical quarter.

Introduction

India’s pharmaceutical regulatory framework is centered on ensuring that all drugs and medical products available to the public are safe, effective, and of high quality. The Central Drugs Standard Control Organisation (CDSCO)—operating under the Directorate General of Health Services (DGHS), Ministry of Health and Family Welfare—is the national regulatory authority responsible for enforcing the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945.

As India is one of the world’s largest producers of generic medicines, strong regulation is essential. CDSCO oversees new drug approvals, clinical trial regulation, import and export permissions, post-marketing surveillance, and manufacturing licensing (in coordination with state agencies). Recent reforms, such as the SUGAM e-portal, revised clinical trial rules, and the Medical Device Rules (2017), have modernized the approval process and enhanced transparency. CDSCO also aligns its practices with global standards from WHO and ICH.

The organizational structure includes key members:

• Ministry of Health: Sets national drug policies, approves regulatory frameworks, appoints senior officials, and supervises CDSCO operations.

• CDSCO: Regulates drugs, cosmetics, and medical devices; approves new drugs; oversees clinical trials; and ensures product quality and safety.

• Drug Controller General of India (DCGI): Heads CDSCO, regulates drug approval, monitors clinical trials, enforces quality standards, and ensures Good Manufacturing Practices (GMP).

• Deputy Drug Controller (DDC): Assists DCGI in supervision, licensing, GMP inspections, compliance enforcement, and coordination with state authorities.

• Assistant Drug Controller (ADC): Supports regulatory reviews, facility inspections, market surveillance, and clinical trial monitoring.

Conclusion

CDSCO remains the cornerstone of India’s drug regulatory framework, ensuring that pharmaceuticals, scientific gadgets, and cosmetics meet mounted requirements of great, safety, and efficacy earlier than achieving the general public.(58)through non-stop modernization— which include virtual structures like SUGAM, threat-primarily based inspections, and harmonization with global guidelines—CDSCO has strengthened regulatory transparency and efficiency.(59)The company also performs a vital role in supervising medical trials,undertaking publish-advertising and marketing surveillance, and controlling the import and manufacture of medicine, thereby protective public fitness at multiple degrees.(60)despite great progress, CDSCO nevertheless faces challenges consisting of confined manpower, increasing regulatory workload, and the want to keep pace with unexpectedly advancing pharmaceutical technologies.(61)

References

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Copyright

Copyright © 2025 Mubeen Ahmad Mohammad Aarif, Vishakha Chaudhari, Darshana Dhamne . This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.