Dehradun Pharmaceutical Plant Continues Operations Despite CDSCO Shutdown Recommendation

DEHRADUN — Daffohils Laboratories Private Limited, located in Dehradun’s Selaqui industrial area, has continued its manufacturing operations despite a recommendation by a joint inspection team to immediately halt production. The facility manufactures a range of pharmaceutical products, including tablets, capsules, syrups, dry syrups, ointments, creams, and dusting powders.

The development follows a confidential complaint sent in March 2026 to the office of Drugs Controller General of India (DCGI) Rajeev Singh Raghuvanshi. The complaint alleged serious violations of Good Manufacturing Practices (GMP), issues with laboratory records, and gaps in quality control. It detailed 12 broad categories of violations, which included a lack of environmental monitoring, poor oversight of pharmaceutical water systems, and incomplete testing of raw materials and finished products.

Among the serious allegations was the release of finished products without proper microbiological testing. The plant allegedly lacked an operational microbiology laboratory for a period and did not regularly outsource tests, yet microbiological results appeared in Certificates of Analysis (COAs) without supporting data. The complaint further claimed that products were dispatched before testing was complete and that testing records for roughly 12 products were prepared retroactively ahead of a regulatory inspection.

Subsequent responses under RTI and CPGRAMS revealed that a joint risk-based inspection involving the Central Drugs Standard Control Organisation (CDSCO) and the State Licensing Authority took place between July 8 and 10, 2026. An August order from the CDSCO’s First Appellate Authority indicated that the team recommended an immediate halt to all manufacturing activities at the facility. It also suggested that the Uttarakhand State Licensing Authority issue a show-cause notice under Rule 85 of the Drugs Rules, 1945, alongside the potential suspension or cancellation of the manufacturing licence.

However, regulatory records do not show whether a formal shutdown order was issued, whether the company halted production, or what specific actions the State drug regulator took. CDSCO stated that under the Drugs and Cosmetics Act, 1940, State authorities are empowered to grant licences and act on violations, advising the complainant to approach the State regulator. CDSCO did not provide the inspection report or an Action Taken Report in an October response.

DCGI Rajeev Raghuvanshi and Uttarakhand State Drugs Controller Tajbar Singh Jaggi remained unavailable for comment.

Addressing the development, IPS Chawla, Managing Director of Daffohils Laboratories, stated that the joint inspection was part of the established regulatory process. He noted that all relevant facts, explanations, and necessary clarifications concerning the inspection observations have been submitted to the competent regulatory authorities, and the matter has been handled in accordance with applicable statutory provisions.

Regarding specific references to microbiological testing, COAs, and data integrity, Chawla stated that these are technical and internal company records that must be examined in their entirety within their appropriate regulatory context, making selective interpretations or independent comments inappropriate.

"This situation highlights a critical governance and coordination challenge between central and state regulatory bodies in India's pharmaceutical sector. When compliance issues and shutdown recommendations are raised, clarity in enforcement responsibility is vital to maintain industry standards and public trust. For businesses operating in highly regulated domains like healthcare and manufacturing, adhering strictly to audit observations and maintaining transparent communication with both state and central authorities is essential to mitigate operational and reputational risks." — Dr. Shishir Gupta, Founder & CEO, StartupLanes