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DCGI calls for focused interventions to enhance drug quality
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Shardul Nautiyal, Mumbai
February 11 , 2025
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At the 63rd Annual Day Celebrations of the Indian Drug Manufacturers Association (IDMA) in Mumbai recently, Dr Rajeev Raghuvanshi, Drugs Controller General of India (DCGI), delivered a compelling address emphasizing the need for quality enhancement in the pharmaceutical industry. Highlighting concerns over the repeated instances of Not of Standard Quality (NSQ) drugs, he called for focused interventions in key areas such as dissolution, assay content, and microbial control.
Dr. Raghuvanshi expressed serious concerns over the recurrence of NSQ drugs, often involving the same companies and products. He emphasized the need for targeted improvements in dissolution, assay content, and microbial control, urging manufacturers to strengthen their quality control measures. Regulators, he stated, will intensify monitoring while also assisting companies in achieving compliance.
He remarked, “Focus less on regulation and more on execution,” underscoring the importance of proper implementation rather than excessive regulatory burden. He highlighted that if manufacturers adhere to quality standards voluntarily, regulatory interventions can be minimized.
Dr Raghuvanshi discussed the revised Schedule M, which aims to align India’s pharmaceutical manufacturing practices with global Good Manufacturing Practices (GMP). Recognizing the challenges faced by Micro, Small, and Medium Enterprises (MSMEs), he announced an extension of the compliance deadline to December 2025, allowing them time to upgrade infrastructure and processes.
Collaboration emerged as a key theme in his speech. He urged larger pharmaceutical companies to mentor MSMEs, sharing best practices and technological know-how. Such partnerships, he emphasized, would contribute to overall industry standards and strengthen India’s position in global healthcare.
In a notable statement, he quipped, “Give the regulator a chance not to regulate,” encouraging the industry to proactively maintain high-quality standards. By ensuring strict internal checks, companies can reduce the necessity of external regulatory enforcement.
Dr Raghuvanshi outlined his vision of a self-sustaining, quality-driven, and globally competitive pharmaceutical industry. He emphasized empowering MSMEs, fostering industry collaboration, and ensuring India continues to provide affordable, high-quality medicines worldwide.
“His emphasis on execution, collaboration, and proactive compliance reflects a forward-thinking approach. As India advances as a global pharmaceutical leader, these measures will be crucial in ensuring long-term growth, reliability, and sustainability,” an industry expert stated.
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