As the Indian drug regulator takes steps to align with the global regulatory system, the Indian pharmaceutical industry needs to undergo a cultural shift, take ownership and focus its efforts on quality, said Rajeev Raghuvanshi, the Drugs Controller General of India (DCGI).
The regulatory authority is taking steps to become a member of PIC/S (Pharmaceutical Inspection Co-operation Scheme), a non-binding arrangement between global regulators on good manufacturing practices (GMP) for medical products. Raghuvanshi pointed to the State Regulatory Index system, that had been launched to score states on manufacturing and consumption. But the growth of the pharmaceutical industry can be successful, he said, only if its efforts at innovation were matched with quality. As the head of the National Regulatory Authority, he said there was excitement on the product development front when applications are reviewed. However, that dipped when it came to the NRA’s monitoring function, he said, calling for a “cultural shift” and urging the industry to take ownership of its quality efforts.
The DCGI was addressing representatives of the pharmaceutical industry, at a meeting on GMP organised by the Indian Pharmaceutical Alliance, a platform of top domestic drugmakers.
Gregory Smith – Country Director (India) of the United States Food and Drug Administration, said that half of the 3,000 odd sites inspected by the US drug regulator were outside their country. He outlined measures taken under the present administration to accelerate product development and approvals and reduce animal testing, among other things.
Pointing to India’s record on “OAIs” (official action indicated) classifications, Smith said, “At the end of FY 24, 13 percent of facilities in India had a most recent inspection outcome of OAI, the highest percentage compared to any other region.” This is a measure of site compliance that may not equate directly with product quality, his presentation pointed out. Outlining the top 10 regulatory citations issued in India between 2018 and 2025, he pointed to absence of written procedures and investigation of discrepancies, among others.
India has the highest number of drug manufacturing facilities (over 600) outside the US, reviewed by the US regulatory authority.
Published on November 20, 2025
