India’s drug regulator the Central Drugs Standard Control Organisation (CDSCO) has intensified its enforcement drive against poor-quality medicines, with a strong message: quality is non-negotiable for innovation. Rajeev Raghuvanshi, Drugs Controller General of India (DCGI), outlined a series of tough regulatory measures aimed at eliminating not-of-standard-quality (NSQ) drugs and strengthening compliance across the pharmaceutical industry. “Without quality, it is not possible to undertake innovation,” he emphasised, underlining the regulator’s zero-tolerance stance.
850 CAPA Notices Issued in 10 Months
As part of a focused enforcement initiative launched in April 2025, the CDSCO has issued 850 corrective and preventive action (CAPA) notices over the past 10 months to manufacturing facilities found producing NSQ drugs. Importantly, facilities receiving CAPA notices face licence suspension until they submit a satisfactory remedial response. According to the DCGI, the regulator is still awaiting its first CAPA response that fully meets compliance expectations.
He made it clear that the CDSCO will not accept superficial or procedural replies. Instead, companies must demonstrate genuine corrective measures. The message to the industry, he said, is straightforward: “either learn or move out.”
Revised GMP Norms Now Fully in Force
The Centre remains firm on implementing the revised Good Manufacturing Practices (GMP) guidelines across all pharmaceutical manufacturers. From January 2026, the final phase of the revised GMP norms came into effect, extending compliance requirements to small- and medium-sized drugmakers as well. By enforcing stricter GMP standards, the regulator aims to enhance product quality, boost global credibility, and ensure patient safety across domestic and export markets.
Crackdown on Cough Syrup Manufacturers
CDSCO has taken decisive action against errant cough syrup manufacturers. The regulator has physically inspected 90% of the 1,300 facilities involved in cough syrup production. Authorities have taken action against non-compliant units in proportion to the severity of their violations. “The rot of cough syrup manufacturing will be removed from next season,” the DCGI asserted, signalling a determined effort to clean up the segment following global scrutiny of Indian-made cough formulations.
Creation of 1,500-Member Scientific Talent Pool
Beyond enforcement, the regulator is also strengthening its institutional capacity. Referring to provisions in Budget 2026, Raghuvanshi announced the creation of a flexi-pool of 1,500 scientific experts within the CDSCO. This talent pool will support:
*Clinical evaluation
*Regulatory assessments
*Technical review processes
By expanding scientific expertise, the CDSCO aims to improve regulatory efficiency while maintaining rigorous oversight.
Digital Governance Overhaul and NSQ Dashboard
CDSCO plans to launch an NSQ dashboard, which will provide a compliance-linked profile of companies flagged for quality lapses. This move will increase transparency and accountability within the pharmaceutical sector. Furthermore, the governance-related Sugam portal—the regulator’s online platform—will undergo a comprehensive revamp to integrate all aspects of the regulatory value chain. The ₹100 crore digital transformation project has already received approval from the Centre.
Raising the Bar for Indian Pharma
Collectively, these measures signal a structural shift in India’s pharmaceutical regulation. By tightening inspections, enforcing revised GMP norms, suspending non-compliant licences, and strengthening scientific capacity, the CDSCO aims to elevate quality standards across the industry. As reported by thehindubusinessline.com, as India continues to position itself as a global pharmaceutical hub, regulators are making it clear that sustained innovation and export competitiveness must rest on a foundation of uncompromising quality compliance.
