Regulatory Delays in Drug Approval: When Bureaucracy Slows Innovation
How approval timelines impact patients, industry, and access to medicines
Why regulatory timelines matter
- Drug approval is a balance between speed and safety.
- Delays can:
- Postpone patient access to life-saving medicines
- Discourage pharmaceutical innovation
- Increase development costs
Drug approval process overview
- Submission of preclinical and clinical data
- Review of quality, safety, and efficacy
- Inspections and compliance verification
- Post-approval commitments
Common causes of regulatory delays
- Incomplete or poor-quality dossiers
- Multiple review cycles due to queries
- Limited regulatory manpower
- Manual and fragmented review systems
- Lack of harmonization with global standards
Indian regulatory challenges
- CDSCO faces a high volume of applications with limited reviewers.
- Variability in state-level implementation.
- Longer timelines compared to the US FDA and EMA in some categories.
Impact on stakeholders
- Patients
- Delayed access to novel therapies.
- Industry
- Increased development costs and uncertainty.
- Startups
- Difficulty sustaining long regulatory waiting periods.
- Healthcare system
- Continued dependence on older therapies.
Global comparison
- The US FDA uses accelerated pathways like
- Fast Track
- Breakthrough Therapy
- EMA employs adaptive pathways for unmet medical needs.
- India is evolving but still catching up.
Role of regulatory professionals
- High-quality dossier preparation.
- Proactive regulatory intelligence.
- Early engagement with authorities.
- Ensuring compliance to avoid avoidable delays.
Future improvements
- Digitization of submission and review.
- Risk-based evaluation models.
- Increased reviewer training and staffing.
- Greater alignment with ICH guidelines.
MBH/PS
