YL Pharma loses licence for defying manufacturing ban

In a major crackdown on regulatory non-compliance, the Drugs Control Administration (DCA), Himachal Pradesh, has cancelled the manufacturing licences of M/s Y L Pharma, located at Katha village in Baddi, for serious violations of the Drugs and Cosmetics Act, 1940.

The DCA investigation revealed that the firm had continued manufacturing drug formulations despite “stop manufacturing orders” issued in March 2025. A show-cause notice was served to the company on November 3, but the explanation submitted by its management on Tuesday was deemed unsatisfactory, prompting the authorities to take immediate and stringent action.

During an earlier inspection in March, drug inspectors seized 135 empty strips of Pregabalin capsules (Batch No. 8064036, Mfg: June 2025, Exp: May 2027) from the premises. The packaging bore the manufacturing address of a Sikkim-based firm, confirming deliberate regulatory violations and potential misbranding.

All product permissions granted under the company’s licences have now been revoked, as the firm was found to have breached multiple provisions of the Drugs and Cosmetics Act and its associated rules.

Confirming the development, State Drugs Controller Dr Manish Kapoor said the cancellation followed the firm’s persistent disregard for directives and repeated non-compliance. He added that further legal proceedings would be initiated against those responsible once the ongoing investigation concludes.

The Himachal regulator acted after receiving a tip-off from the Rajasthan Drugs Control Administration, which shared test results showing that a drug sample, Levocetirizine Tablets (Wincet-L, Batch No. YLT25023), manufactured by YL Pharma had nil active content and was declared spurious and not of standard quality.

The case has highlighted growing concerns over illegal drug manufacturing and quality compromise within India’s key pharmaceutical hubs even as pharma firms demand relaxations on manufacturing compliances.