The Drugs Controller General of India (DCGI), Rajeev Singh Raghuvanshi, has been granted a one-year extension to lead India’s apex drug regulatory body, focusing on eliminating substandard drugs, upgrading MSME pharmaceutical standards, and integrating medical device regulations.
Crackdown on Poor-Quality Drugs
India continues to battle substandard and counterfeit medicines, with recent alerts highlighting quality failures in widely used drugs like Pan D, Glimepiride, and Telmisartan. Addressing this, DCGI has intensified risk-based inspections, instilling a zero-tolerance approach to ensure manufacturing compliance. "The ministry is satisfied with his performance as he has drastically improved drug quality and created an environment of accountability," a senior official said.
Supporting MSMEs in Pharma
While large pharmaceutical firms have adapted to WHO-GMP (Good Manufacturing Practices) standards, MSMEs face challenges upgrading their manufacturing units. With the government mandating adherence to Schedule M, smaller drug-makers are seeking financial and technical assistance to modernize.
“We need guidance, not punishment. Many MSMEs lack the budget for immediate upgrades,” said an industry representative. The government aims to balance enforcement with support, ensuring MSMEs align with global standards to enhance India’s pharmaceutical exports and credibility.
Medical Devices Under a New Regulatory Framework
Medical devices, previously regulated like drugs, will now be categorized based on risk levels, spanning radiology, oncology, and non-sterile equipment. However, industry leaders demand regulatory clarity to avoid unpredictable licensing hurdles. “We need a stable policy environment; daily regulatory changes create uncertainty,” said Rajiv Nath, AIMED forum coordinator.
The government’s three-pronged approach aims to restore global confidence in Indian pharmaceuticals and medical devices while fostering innovation and compliance.
