Himachal regulator lifts ban on Wockhardt drug

Generic drugmaker Wockhardt Ltd said on Monday the drug regulator of Himachal Pradesh has revoked a suspension it imposed on the manufacture and sale of a combination drug for pain treatment.

Wockhardt said last week the drug regulator suspended the manufacture, sale or distribution of fixed dose combination of Dicyclomine Hydrochloride IP 10mg, Tramadol Hydrochloride IP 50mg and Acetamenophen IP 325mg.

Navneet Marwah, Himachal Pradesh's drug regulator, said the suspension came into force on April 22 as he had some concerns about the "safety and efficacy" of the product, and sent a report to the Drug Controller General of India (DCGI).

The suspension was revoked on April 26, after the DCGI responded to Marwah saying it found no problems with the products' safety and efficacy, the state drug regulator told Reuters.

In a statement issued on Monday, Wockhardt said the state regulator has lifted the ban and it would continue to make and sell the product.

The company has not given any reason for the ban or its revocation, but when it disclosed the suspension on April 23, it said the product contributed less than 3 percent of the consolidated sales of the company in the financial year ended March 31.

A Wockhardt spokesman did not have immediate comment.

Wockhardt shares rose 8.5 percent to 703.10 rupees on Monday in a Mumbai market that was down 0.2 percent.


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