In a major reform aimed at boosting the pharmaceutical sector, the Government of India has proposed to cut the timeline for drug approvals to just 45 days, a significant reduction from the current months-long process. The move is expected to streamline operations for drug manufacturers, attract global investment, and accelerate patient access to essential medicines.
According to officials, the revised framework will apply to both new drug applications and manufacturing licenses. By introducing digitalized application tracking, simplified documentation, and stricter adherence to timelines, the government seeks to eliminate unnecessary delays. This initiative comes in response to long-standing concerns from industry stakeholders that slow approvals have hindered innovation and competitiveness in India’s pharma ecosystem.
India, which is already known as the “pharmacy of the world” due to its robust generics production, is expected to strengthen its global position with this reform. The new system will particularly benefit small and mid-sized pharma enterprises struggling with compliance bottlenecks and extended wait times. Faster approvals are also likely to spur research and development investments, enabling quicker introduction of novel therapies and vaccines.
Industry experts have welcomed the proposal, highlighting that predictability and efficiency in licensing will not only improve the ease of doing business but also enhance patient outcomes by ensuring faster availability of critical medicines. However, they have also cautioned that while reducing timelines is vital, quality assurance and regulatory oversight must remain uncompromised to maintain international credibility.
Key Highlights
- Govt proposes 45-day timeline for drug approvals and licenses.
- Reform to benefit both large and small pharma enterprises.
- Digital tracking and simplified paperwork to reduce bottlenecks.
- Industry welcomes reform but calls for balancing speed with quality.
Who Should Take Action – Specific Advice
Pharma companies should begin preparing robust compliance systems to adapt to the faster timelines and avoid rejection due to incomplete applications. SMEs in the sector must leverage this reform to expand product portfolios and explore export opportunities. Regulators and policymakers should ensure the balance of efficiency with stringent safety checks.
India Advocacy Insight
This reform signals India’s intent to align with global best practices in drug regulation, boosting investor confidence and accelerating healthcare delivery. At India Advocacy, we see this as a turning point that could redefine India’s pharmaceutical leadership on the world stage.
