Definition of New Drugs
Under the Drugs and Cosmetics Act, a "new drug" is:
A drug not previously used in India.
A previously approved drug proposed with new claims.
A fixed-dose combination of drugs not previously approved.
Steps in New Drug Approval
1) Pre-Clinical Studies
Objective: Assess safety and efficacy through lab and animal studies.
Studies Conducted: Pharmacodynamics, pharmacokinetics, toxicology, reproductive, genotoxicity, and carcinogenicity.
Compliance: Must follow Good Laboratory Practices (GLP).
2) Investigational New Drug (IND) Application
Purpose: Seek approval for human trials.
Submission Includes: Pre-clinical data, clinical trial protocols, and an investigator's brochure.
3) Clinical Trials
Conducted in phases under the New Drugs and Clinical Trials Rules, 2019.
Phase I: Small group of healthy volunteers to assess safety.
Phase II: 100-300 patients to evaluate efficacy and side effects.
Phase III: 1,000-3,000 patients for efficacy and safety.
Phase IV: Post-marketing surveillance for long-term safety.
4) New Drug Application (NDA) Submission
Purpose: Approval to market the drug.
Contents: Administrative details, data summaries, quality data, study reports, and labeling information.
5) CDSCO Review Process
Screening: Initial application completeness check.
Expert Evaluation: Subject Expert Committees (SECs) review data; Technical Committee provides recommendations.
Approval Decision: CDSCO grants permission if data is satisfactory, with conditions for post-marketing requirements as needed.
6) Post-Approval Requirements
Pharmacovigilance: Adverse drug reaction reporting and periodic safety updates.
Compliance: Additional studies and labeling updates as needed.
Special Considerations
Fast-Track Approvals: Available for drugs addressing unmet medical needs.
Global Clinical Trials: Requires ethics committee approval and regulatory permissions.
Regulatory Framework
New Drugs and Clinical Trials Rules, 2019: Governs approvals, ethical considerations, and trial conduct.
Ethical Guidelines: Compliance with Good Clinical Practices (GCP) and informed consent is mandatory.
Intellectual Property: Patent status may influence market exclusivity and generic competition.