Archive · 20 Nov 2025
DCGI Urges Pharma Industry to Focus on Quality
The head of India's drug regulator, DCGI, told the pharmaceutical industry that they should focus more on quality to make their innovation efforts successful.
He also mentioned that India is working to join a global group of drug regulators.
The US FDA, which checks drugs made in India, said that many Indian drug factories have issues that need to be fixed.
DCGI Rajeev Raghuvanshi emphasized the need for quality in the Indian pharmaceutical industry
DCGI is working towards aligning with global regulatory systems like PIC/S
DCGI launched the State Regulatory Index system to score states on manufacturing and consumption
US FDA's Gregory Smith highlighted India's high 'OAIs' classification and top regulatory citations
India has the highest number of drug manufacturing facilities reviewed by the US FDA outside the US
- Who
- DCGI Rajeev Raghuvanshi, US FDA's Gregory Smith, Indian pharmaceutical industry
- What
- Discussed quality, innovation, and regulatory issues in the Indian pharmaceutical industry
- When
- November 20, 2025
- Where
- Meeting organized by the Indian Pharmaceutical Alliance
- Why
- To improve the quality and global competitiveness of the Indian pharmaceutical industry
DCGI's Perspective
US FDA's Perspective
Quality Focus
DCGI's Perspective
DCGI emphasized the need for quality in the Indian pharmaceutical industry
US FDA's Perspective
US FDA highlighted issues in Indian drug factories, such as absence of written procedures
- Regulatory Body
- Drugs Controller General of India (DCGI)
- Global Regulatory Group
- Pharmaceutical Inspection Co-operation Scheme (PIC/S)
- US FDA Inspections in India
- Over 600 drug manufacturing facilities
- India's 'OAIs' Classification
- 13% of facilities in FY 24
- Top Regulatory Citations in India
- Absence of written procedures, investigation of discrepancies