The voluntary withdrawal of anti-retroviral drugs from WHO pre-qualification list by Ranbaxy Laboratories Limited has given rise to heated discussions on the quality and efficacy of generic equivalents across the world. The announcement has also tempted pro-innovator campaigners to call for a review of the use of generics in international health campaigns.

While one section wants to discourage the use of "unverified generics--which are copies of drugs developed and patented by research pharmaceutical companies in the United States and Europe," aggressively promoted by WHO and NGOs like Doctors Without Borders, the Clinton Foundation, others dispel the allegations as baseless.

According to them, such critiques, "posing as independent researchers, pursuing Big Pharma's beck and call and acting as "smokesmen" for US."

Responding to a pharmabiz query, Habil K Khorakiwala, president, Indian Pharmaceutical Alliance (IPA) termed such debates as ongoing ones and felt that there was no need to take it seriously. "The withdrawal of drugs is not uncommon. The decision of one company cannot be generalized," he said. Khorakiwala also said that it would not have any adverse impact on the prospects of generic companies.

Opposing the claims of the WHO and NGOs, that generic companies in India, South Africa, Thailand and elsewhere can make sophisticated multi-dose combinations of AIDS drugs by cobbling together patented medicines, pro-innovator company experts had alleged that "the generic makers are turning out to be the gang that can't copy straight."

They also said that generic drugs are not really cost effective as research companies sell drugs in Africa at big discounts or give them away. According to them, on an average, patented drugs cost less than generics in poor countries.

The pro-multinational experts take note of the American Foundation for AIDS Research warning that a flood of untested generics, made by more than two-dozen companies in developing nations "could lead to widespread misuses and eventually to drug resistance, eradicating years of progress."
According to them, the worry is becoming reality and the US Congress should investigate the UN strategy and reconsider American funding. "Stubborn advocates of the current policy must stop playing deadly political games with the world's health," they warned.

Supporting the WHO stand, Health GAP has reasoned that Ranbaxy's decision to delist the ARVs are based on poor record keeping practices and the absence of scientific verification of bioequivalence. "The delisting did not prove that the medicines were unsafe or that they were not in fact bioequivalent. In fact, preexisting clinical evidence presented by MSF and multiple other researchers has established the clinical efficacy of the challenged products in resource poor settings: patient viral loads have declined, T-4 cell counts have risen, and patients' general well-being has increased," the NGO points out. They also feel that the WHO and the companies (Ranbaxy and Cipla) themselves have responded appropriately and promptly to the recently discovered discrepancies and they have not jumped to the unwarranted conclusion that the medicines are presumptively unsafe or inefficacious.