CDSCO Flags GMP Concerns at Uttarakhand Pharma Unit, Recommends Immediate Halt to Production

The facility manufactures a range of pharmaceutical products, including tablets, capsules, syrups, dry syrups, ointments, creams, dusting powders and other healthcare products.

The inspection followed a confidential complaint submitted 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), deficiencies in laboratory records and gaps in quality-control procedures at the manufacturing facility. It identified 12 broad categories of alleged violations, including the absence of environmental monitoring, inadequate monitoring of pharmaceutical water systems and incomplete testing of raw materials and finished products.

One of the major allegations concerned the release of finished pharmaceutical products without appropriate microbiological testing. The complaint claimed that the facility did not have an operational microbiology laboratory for a certain period and did not regularly outsource the required tests. Despite this, microbiological test results allegedly appeared in Certificates of Analysis (COAs) without supporting laboratory data. It was further alleged that products were dispatched before completion of the required testing, with the corresponding COAs being prepared later when customers requested them.

The complaint also alleged that testing records for approximately 12 products were prepared retrospectively for presentation during a regulatory inspection, with certain data apparently backdated. Other deficiencies cited in the complaint included issues relating to equipment qualification, process validation and calibration.

In an order dated August 17 concerning an RTI first appeal, CDSCO's First Appellate Authority confirmed that a joint risk-based inspection had been conducted at the facility and that the inspection team had recommended an immediate halt to all manufacturing activities. The team also recommended that the Uttarakhand State Licensing Authority issue a show-cause notice under Rule 85 of the Drugs Rules, 1945, followed by suspension or cancellation of the manufacturing licence and related product permissions.

An order dated August 19 under the Centralised Public Grievance Redress and Monitoring System (CPGRAMS) stated that the inspection was conducted between July 8 and July 10, 2026. An RTI response quoted the inspection team's recommendation that "all manufacturing activities undertaken by the firm at subject facility may be stopped immediately".

CDSCO stated that the inspection was conducted jointly with the State Licensing Authority. However, it clarified that under the Drugs and Cosmetics Act, 1940, the responsibility for granting manufacturing licences and taking action against violations rests with the respective State authorities. The central regulator stated that State Licensing Authorities are empowered to take action against violations of licence conditions, including initiating prosecution before the appropriate court of law. It also advised the complainant to approach the State authority.

In a subsequent response dated October 14, CDSCO again directed the applicant to approach the State regulator for further information. The regulator did not provide the inspection report, details of the deficiencies identified during the inspection or an Action Taken Report (ATR) explaining the steps taken following the recommendation to stop manufacturing.

Drug Controller General of India Rajeev Raghuvanshi and Uttarakhand State Drugs Controller Tajbar Singh Jaggi remained unavailable for comment.

Responding to the development, IPS Chawla, Managing Director of Daffohils Laboratories, stated that the joint inspection conducted at the company's Selaqui facility by CDSCO and the Uttarakhand State Licensing Authority was part of the established regulatory process. He said that all relevant facts, explanations and necessary clarifications concerning the inspection observations had been submitted to the competent regulatory authorities and that the matter had been dealt with in accordance with applicable statutory provisions and regulatory procedures.

Regarding the specific references to microbiological testing, Certificates of Analysis (COAs), data integrity and related quality-control documentation, Chawla stated that these were technical and internal company records that needed to be examined in their entirety and within the appropriate regulatory context. He added that it would not be appropriate to provide selective interpretations or independent comments on such matters, reports The Hindu BusinessLine .