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Himachal Cancels YL Pharma’s License for Violating Manufacturing Ban, Caught Producing Drugs Despite Orders

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Himachal Cancels YL Pharma’s License for Violating Manufacturing Ban, Caught Producing Drugs Despite Orders
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The Himachal Pradesh Drug Control Administration (DCA) has cancelled the manufacturing license of M/s YL Pharma, located in Katha village, Baddi, for serious violations of the Drugs and Cosmetics Act, 1940. The firm was found continuing drug production despite official suspension orders, marking a major regulatory action against non-compliance.

According to the DCA’s investigation, YL Pharma was caught manufacturing medicines in violation of a “stop manufacturing” order issued in March 2025. The company was served a show-cause notice on November 3, but the management’s response, submitted earlier this week, was deemed unsatisfactory—prompting authorities to take immediate and stringent action.

During a prior inspection in March, drug inspectors had seized 135 empty strips of Pregabalin capsules (Batch No. 8064036; Mfg: June 2025; Exp: May 2027) from the premises. The packaging carried the manufacturing address of a Sikkim-based firm, indicating a deliberate violation of labeling norms and potential misbranding.

As a result, all product permissions under YL Pharma’s manufacturing license have been revoked, with the firm found in breach of multiple provisions of the Drugs and Cosmetics Act and its associated rules.

Confirming the development, State Drug Controller Dr. Manish Kapoor said the license was cancelled due to the firm’s “repeated defiance of official directions and continued non-compliance.” He added that further legal proceedings would follow once the ongoing investigation is complete.

The enforcement action came after the Himachal regulator received an alert from the Rajasthan Drug Control Administration, which had shared test results showing that a Levocetirizine tablet (Vinset-L, Batch No. YLT25023) manufactured by YL Pharma contained no active pharmaceutical ingredient (API) and was declared spurious and substandard.

The case underscores growing concerns over illegal drug manufacturing and quality violations in some of India’s key pharmaceutical hubs—even as parts of the industry continue to seek relaxation in manufacturing compliance norms.

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