Sun Pharma received US import ban

Troubles for the Indian pharmaceutical industry do not seem to end as Sun Pharmaceutical Industries, India’s largest drug maker by market capitalisation, joins the likes of Daiichi-controlled Ranbaxy and Khorakiwala-promoted Wockhardt in receiving an import alert from the US Food and Drug Authority (USFDA).
USFDA issued import alert for its ‘cephalosporin’ manufacturing unit located at Karkhadi, Gujarat in India. Cephalosporin is a class beta-lactam antibiotics manufactured, both as an active pharmaceutical ingredient (API) as well as formulation, for oral and injectable drugs.

This import alert was issued as a follow up to the last inspection of the facility, during which some non-compliance of current good manufacturing practice (cGMP) regulations.

The ban comes only weeks after FDA Commissioner Margaret Hamburg returned from a trip to India where she discussed quality issues with government and industry officials. The country provides about 40% of the generic and over-the-counter drugs U.S. consumers take, and so the FDA has been placing more personnel and more emphasis on Indian drug plants. She noted during her trip that many of India’s drugmakers have modern facilities with top-notch operations.

The recent past has seen foreign drug regulators, including USFDA and UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), tightening the noose on Indian drug manufacturers resulting into a series of warning letters and import alerts for companies like Ranbaxy and Wockhardt, among others.

“Foreign regulators, primarily the USFDA, are going tough with all the pharmaceutical companies. And India being the largest supplier to the US with over 200 USFDA approved drug manufacturing facilities, the regulator is leaving no gaps in terms of compliance of its cGMPs,” said the analyst.

On measures taken post the import alert, Sun Pharma said, it remains fully committed to compliance and has already initiated several corrective steps to address the observations made by the USFDA. As far as impact on their business is concerned, Sun Pharma said that the facility in question has negligible contribution to the company’s consolidated revenues and hence maintains its FY2013-14 consolidated sales growth guidance.

Govt suspends import/manufacture of rosiglitazone with immediate effect

Following its ban in Europe and the restricted use in the US, the union health ministry has suspended the import or manufacture of the controversial diabetes drug rosiglitazone in the country with immediate effect.A decision to this effect was taken by an Expert Committee constituted by the ministry to examine safety issue and to recommend regulatory action to be taken in country in respect of continued marketing of rosiglitazone in the country in view of its ban in Europe and restricted use in US.

A meeting of the Expert Committee was held on October 7, 2010 and it recommended the suspension of import/manufacture of rosiglitazone and its fixed dose combinations in the country with immediate effect as its continued use would lead to more cardiovascular events and adverse effects on lipid profile, Drugs Controller General of India (DCGI) Dr Surinder Singh said.

The DCGI has directed all the state drugs controllers in the country to suspend all the licences granted to manufacture for sale and distribution of rosiglitazone and its fixed dose combinations with other drugs with immediate effect.

Rosiglitazone and its formulations as single drug or as combinations are being marketed in the country as anti-diabetic drugs. European Medicines Agency in its press release dated 23 September, 2010, has recommended the suspension of the marketing authorisations for the rosiglitazone-containing anti-diabetes medicines, and the US Food and Drug Administration (US FDA) had also announced on the same day that it will significantly restrict the use of the diabetes drug rosiglitazone to patients with type 2 diabetes who cannot control their diabetes on other medications.

Rosiglitazone is sold by GSK and its generic versions are manufactured in the country by Sun Pharmaceuticals Ltd, Dr Reddy’s Laboratories Ltd and Torrent Pharmaceuticals Ltd, among 30 other manufacturers. GSK sells the drug as Avandia overseas and Windia in India.