Hyderabad: The US Food and Drug Administration’s (FDA) import alert against India’s largest drug maker Ranbaxy Laboratories Ltd continues to have a cascading regulatory effect, with the Canadian drug regulator, Health Canada, issuing a notice and the German regulator, the Federal Institute for Drugs and Medical Devices, deciding to be particularly cautious about drug marketing applications from the drug company.
No end in sight: Ranbaxy’s research headquarters in Gurgaon. FDA found inconsistencies in quality control procedures and record-keeping at the firm’s manufacturing facilities at Paonta Sahib and Dewas. Rajeev Dabral / Mint
Responding to Mint, Health Canada spokesperson Stephane Shank wrote in an email: “A regulatory letter has been sent to the sole Canadian importer, who supplies products to Canada, requesting an action plan and a response to the warning letter issued by the US FDA. Upon receipt of a response, Health Canada will do a review of the requested information to determine if there is a risk to health and whether further regulatory action is required.”
Ranbaxy Pharmaceuticals Canada Inc., a wholly owned subsidiary of Ranbaxy, is the sole importer of Ranbaxy’s products in Canada.
According to the FDA order, Ranbaxy has to respond within 30 days of the receipt of the warning letter, issued on 16 September. FDA found inconsistencies in record-keeping and quality control procedures at Ranbaxy’s manufacturing facilities at Paonta Sahib in Himachal Pradesh and Dewas in Madhya Pradesh.
According to Ranbaxy’s 2007-08 annual report, Ranbaxy Pharmaceuticals Canada is ranked as the ninth largest in the Canadian market in terms of sales. In 2007, Ranbaxy had sales of about $29 million (Rs131.7 crore today) in Canada, up from 2006 sales of $12 million.
Mint had reported on 19 September that the pan-European drug regulator, European Medicines Agency, and other individual national drug regulators in the European Union are all reviewing the FDA decision.
Ulrich Heier, spokesperson for German drug regulator Federal Institute for Drugs and Medical Devices, said it will try and ensure that drug marketing applications involving the Paonta Sahib and Dewas units will be particularly scrutinized to ensure compliance with so-called good manufacturing practices.
The UK’s drug regulatory body Medicines and Healthcare Products Regulatory Agency has already initiated a laboratory testing process of all Ranbaxy drugs marketed in that country to ensure that those are safe for human consumption.
New Zealand’s drug regulator Medsafe is “seeking information from other trusted regulators (in Australia, Europe, Britain and Canada) to see if other audits can provide up-to-date assurance about good manufacturing practice at the two sites operated by Ranbaxy”, according to a statement posted on the regulator’s website.
In the 2007-08 fiscal year, Ranbaxy’s sales from Europe were $365 million, with the UK contributing $47 million. The North American market, which includes Canada, contributed $419 million to Ranbaxy’s total sales of $1.6 billion.
Ranbaxy had its stock rating cut by Citigroup Inc. The rating was reduced to “sell” from “buy”, Citigroup analysts Prashant Nair and Akshay Rai wrote in a note to clients on Monday. They cut the target price to Rs373 from Rs604.
Ranbaxy shares fell 2.7%, or Rs9.65, to Rs347.20 in Monday’s trading on the Bombay Stock Exchange.
Bloomberg contributed to this story.