New Zealand drug regulator Medsafe has approached its counterparts in the UK, Australia, Canada and Europe seeking a renewed assurance of the quality of Ranbaxy medicines. The Medsafe move comes in the backdrop of the US Food and Drug Administration's (USFDA) decision to restrict entry of 30 Ranbaxy medicines in the world’s largest medicine market.
According to New Zealand health ministry’s website, Medsafe is seeking renewed assurance of 'good manufacturing practice' after Ranbaxy’s two manufacturing facilities at Dewas and Paonta Sahib failed to clear USFDA audits early this year.
“Medsafe is seeking information from other regulators to see if they can provide up-to-date assurance about 'Good Manufacturing Practice' at Ranbaxy Laboratories' two sites,” the ministry said. Three branded medicine products manufactured at these sites amoxicillin syrup (a widely prescribed penicillin-based antibiotic), aciclovir (an antiviral drug used to treat the herpes virus) and cefaclor (an antibiotic for wide range of infections) are licensed and funded in New Zealand, it added.
However, the agency referred to USFDA’s mention about the safety and efficacy of the medicines and recommended its continued use in the country.
Meanwhile, Ranbaxy shares fell 4.7 per cent to Rs 296.20 on the Bombay Stock Exchange on Thursday. The continuing negative sentiments, triggered by the decision of US government to suspend funding for sourcing Ranbaxy's three HIV/AIDS medicines for supply to developing nations under a government-sponsored AIDS relief programme (The President’s Emergency Plan for AIDS Relief).
Though the ripple effect of USFDA announcement continues to absorb the attention of drug regulators world over, Indian drug regulator, the office of the Drugs Controller General of India, under the health ministry termed the issue as a matter between an Indian supplier and a foreign regulator.
“There is no safety concern. Even USFDA does not say the medicines are unsafe. The USFDA has not taken up the matter with its Indian counterpart,” a senior health ministry official said.
