Indian State’s Drug Controller Lifts Wockhardt Suspension

Indian drugmaker Wockhardt has received the regulatory green light to resume manufacturing and selling its combination drug to treat pain, the company said April 28.

Regulators in the state of Himachal Pradesh recently imposed a ban on the manufacture, sale and distribution of dicyclomine hydrochloride 10 mg, tramadol hydrochloride 50 mg and acetaminophen 325 mg. At the time, Wockhardt said it would appeal the suspension, though it declined to comment on the reasons behind it.

Wockhardt has come under fire internationally in the last year, as the FDA issued an import alert on the company’s Waluj and Chikalthana plants for good manufacturing practice and data integrity violations, though the agency had not found any problems in Himachal Pradesh.

Wockhardt also was in hot water in the UK, as the Medicines and Healthcare products Regulatory Agency recalled 16 of its products manufactured in Waluj in one of the largest recalls “in recent times.”

Concerns over the quality of products manufactured in India and imported to the U.S. has been high on the FDA’s agenda recently. During a 10-day visit to the subcontinent earlier this year, Commissioner Margaret Hamburg met with regulators and industry leaders, eventually signing a five-year accord assuring that U.S. and Indian regulators share information on quality inspections of manufacturing plants, clinical trial sites and testing laboratories. Under the agreement, the FDA also will beef up its Indian inspections staff.

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