US dept says no to Ranbaxy AIDS drugs

US dept says no to Ranbaxy AIDS drugs

Washington: AIDS drugs made by India’s Ranbaxy Laboratories Ltd won’t be purchased under an American programme to supply medicines to developing countries after the US cited the company for violations in two of its plants.

The US President’s Emergency Plan for AIDS Relief (Pepfar) suspended funding for three Ranbaxy generic drugs until the Food and Drug Administration (FDA) says deficiencies have been resolved in one of the plants in India wherethey’re produced, a spokeswoman for the programme said on Wednesday. Pepfar had provided $8.9 million (Rs41 crore today) for Ranbaxy’s AIDS drugs last fiscal year, according to the spokeswoman.

FDA had said on 16 September that more than 30 generic drugs made by Ranbaxy, India’s largest drug maker, would be blocked at US borders because of manufacturing failures at the two Indian plants. Ranbaxy declined 23% in Mumbai trading after FDA’s action through Wednesday. The stock fell 4.7% to close at Rs296.20 on Thursday.

“Funds cannot be used to support new orders" for the three Ranbaxy drugs—zidovudine, lamivudine and nevirapine—manufactured at one of the plants in India, according to an email from Pepfar spokeswoman. She provided the information on the condition that her name not be used, citing policies of the state department, which runs the initiative.

Charles M. Caprariello, a spokesman for Ranbaxy, said he didn’t have first-hand knowledge of the government’s decision and couldn’t comment.

Ranbaxy is working with the US government “to resolve all of the issues and concerns that have been raised", Caprariello said in a telephone interview.

There is no evidence that Ranbaxy’s medicines are harmful, though the violations could lead to defective products, according to FDA.

The US is blocking import of more than 30 drugs from Ranbaxy’s plants in Paonta Sahib in Himachal Pradesh and Dewas in Madhya Pradesh, the agency said. Drugs made in other Ranbaxy plants aren’t being blocked. The Paonta Sahib plant makes the three drugs that are part of the AIDS programme, according to Caprariello.

FDA issued warning letters to Ranbaxy last week citing numerous violations in the two plants, including inadequate sterile processing operations and inaccurate record keeping.

Products will be blocked until Ranbaxy resolves deficiencies at the plants, according to FDA.

Though FDA’s action applies only to the US market, the government decided to suspend funding for the AIDS drugs supplied overseas. It is a “principle" of the president’s AIDS initiative to “meet standards equal to those established for patients in the United States", the programme’s spokeswoman said.

Hyderabad-based Aurobindo Pharma Ltd and Mumbai-headquartered Cipla Ltd are among Indian pharmaceutical companies that have been cleared by the US to supply the three AIDS drugs under the government programme, according to FDA’s website.

Pepfar plans to provide $1.9 billion in support of antiretroviral treatment programmes for AIDS during this fiscal year, according to the programme spokeswoman.