Rules not followed, Kala Amb drug firm ordered to stop manufacturing

Cracking its whip against Kala Amb-based drug firm, Digital Vision, for non-compliance of key regulatory provisions of the Drugs and Cosmetics Act, 1940, the drug authorities ordered it to “stop manufacturing” last evening.

The action comes days after the firm’s partner was arrested by the Chandigarh-based Narcotics Control Bureau for unauthorised diversion of psychotropic substances.

As per the orders issued by Assistant Drugs Controller (ADC), Baddi, Garima Sharma, the firm has been directed to abstain from manufacturing, sale and distribution of drugs during this period as its non-compliance would attract Section 18(c) of the said Act. Violation is punishable with imprisonment for at least one year, up to three years, and a fine of at least Rs 5,000.

An inspection of its premises conducted by the drug inspector in September had pointed out several inadequacies like lack of calibration of its vital manufacturing equipment besides issues in its air handling unit which regulates air quality, temperature, humidity and pressure to prevent contamination and ensure product safety among other issues.

“The firm management, however, exhibited no interest in addressing these issues and it did not respond to the show-cause notice issued on October 1,” noted Garima Sharma who added that “permitting manufacturing under these conditions would adversely hit manufacturing of safe drugs.”

Taking strict note of these inadequacies, the official issued stop manufacturing orders to the firm last evening while directing it to submit compliance on observations raised in the inspection report at the earliest.

The firm has remained in the thick of controversy earlier in February 2020 when 12 infants died in Udhampur after consuming a cough syrup found containing high levels of toxic adulterant diethylene glycol — 34.24 per cent and 35.87 per cent — as per two lab reports.

Its owners had been booked under the Drugs and Cosmetics Act, 1940, and Section 308 of the IPC by the Kala Amb police in this case.

To ensure safe and quality drugs manufacturing, officials are acting swiftly against drug firms found lacking in compliance and this is the second firm facing strict action in as many days in the state after YL Pharma, Baddi, faced cancellation of its manufacturing licence yesterday.