New Drug Approval Process in India: A Comprehensive Review of Regulatory Requirements and Procedures

Author

Vaishnavi Bulhe, Sayali Pagire

Abstract

 (NDCT) Rules, 2019. Clinical development is generally conducted through Phase I, Phase II and Phase III studies to establish safety, tolerability, appropriate dosage and therapeutic efficacy. Ethical review, informed consent and protection of clinical-trial participants are important components of the process. Following successful clinical development, the regulatory authority evaluates quality, safety and efficacy data before granting permission for manufacture, import and marketing. The SUGAM portal facilitates online submission and regulatory communication. Post-marketing surveillance and pharmacovigilance continue after approval to identify rare or long-term safety concerns and maintain a favourable benefit–risk profile. Overall, the Indian regulatory framework provides an evidence-based approach for the development and approval of safe, effective and quality medicines. The new drug approval process in India is a systematic and highly regulated pathway designed to ensure that medicines introduced into the market meet acceptable standards of quality, safety, and efficacy. This review provides a comprehensive overview of the regulatory requirements and procedures involved in the development and approval of new drugs in India. The process begins with drug discovery and pharmaceutical development, followed by preclinical evaluation of pharmacological, pharmacokinetic and toxicological properties. After satisfactory preclinical results, permission for clinical trials is obtained from the Central Drugs Standard Control Organisation (CDSCO) under the New Drugs and Clinical Trials

Keywords

CDSCO , New Drug Approval, Drug Regulatory Affairs, Clinical Trials, Applications & Guidelines, General Regulatory Overview.

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References

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