Focus on counterfeit drugs

Failure of Indian whistleblower scheme points to deeper woes

India’s much-touted whistleblower scheme, that substandard drugs (legitimate medicines are not coming forward for fear of retaliation. launched this past December to burst the fake degraded through slow delivery routes, for According to Gulhati, however, there medicines racket with rewards of up to 2.5 example) present a greater problem in India, is a deliberate attempt, mostly by foreign million rupees ($55,000) for informers, has and estimates that fake drugs represent less companies, to magnify the problem in India by turned out to be a damp squib. than 0.4% of all drugs, at most. clubbing counterfeits and substandard drugs It was hoped that people would be lining Under the current Indian law, counterfeit altogether “in order to derive advantage.” up to rat out criminals and collect their due drugmakers can be sentenced to life in prison Yusuf Hamied, managing director of , payment. But India’s Health Minister Dinesh and fined up to 1 million rupees. India’s leading generics maker, told Nature Trivedi told the national parliament on 5 Industry experts have voiced skepticism Medicine he is furious over attempts by the March that there were only 20 tip-offs, and about the whistleblower scheme, given a local foreign corporations to treat genuine Indian not a single informer “has been rewarded so reality: criminals use tough tactics to keep generic drugs as counterfeits just because they far.” He added that the tips have not yet led to people quiet. “We tracked down a factory could not patent their original products in any convictions. duplicating our tablets,” a chairman of a leading India. “Such an interpretation means I cannot The ambitious scheme, overseen by the Indian drug company told Nature Medicine on ship my generics through their ports,” Hamied government’s Central Drugs Standard Control condition of anonymity. “We decided to keep says. He cites a February 2009 incident in which Organization (CDSCO), was prompted by quiet rather than informing the [CDSCO], as a shipment of Cipla’s HIV drugs was held up by media reports of a high prevalence—as much my life was threatened by the culprits, who had officials in Amsterdam en route to Peru (Nat. as 25%—of spurious drugs on the market. political connections.” Med. 15, 350, 2009). The scheme’s letdown does not surprise And, recently, according to Gulhati, when Amitava Guha, an organizer of the Kolkata Chandra Gulhati, editor of the Monthly Index duplicates of a popular cough remedy flooded seminar, says one key recommendation of of Medical Specialties based in New Delhi and markets in eastern India, its manufacturer the meeting (which was arranged in part by a keen observer of the . quietly opted for police help, fearing that local industry) is that the Indian government Gulhati, a speaker at a national seminar on informing the CDSCO and the consequent should reject the movement led by some global pharmaceutical policy, held in Kolkata in mid- media coverage would hurt the sale of the groups that wish to equate ‘generics’ with February, says that the reported high incidence medicine in the rest of India. Drug control ‘counterfeits’. of spurious drugs is just media hype. He notes officials admitted in confidence that insiders Killugudi Jayaraman, Bangalore, India

Substandard drugs overshadowed by focus on fakes

International drug monitoring efforts conceptualizing the problem” of substandard = total % of substandard drugs have largely focused on catching drugs drugs, says Meir Pugatch, director of research

© 2010 Nature America, Inc. All rights reserved. All rights Inc. America, Nature © 2010 made by counterfeiters, which infringe on at the Stockholm Network, a pan-European Delhi pharmaceutical companies’ intellectual think tank based in , who published property. But for all the talk about fakes, there’s a report in February calling on policymakers another problem with drug integrity that’s to address the issue and critiquing drug discussed much less frequently: medicines regulations in China, India, Brazil, Argentina made and marketed by legitimate drug and Turkey. companies that contain compromised levels Although counterfeiting is the major concern Kolkata Around 10% of active ingredient. in the West, “if you’re talking about the poorest of India’s total As opposed to a fake pill that sometimes cities, the problem is quality,” says Roger Bate, pharmaceutical contains harmful ingredients, a substandard an economic health policy scholar at the market is substandard drug simply does not produce the desired American Enterprise Institute, a conservative or illegal, according medical benefit. It effectively gets passed think tank in Washington, DC. And, as more to government figures; “through your stomach like a little pebble,” says medicines are being exported from developing Chennai World Health Organization estimates are even higher. But Andreas Seiter, who develops pharmaceutical nations, the reach of the substandard medicines the problem is not ubiquitous. policy for the World Bank in Washington, problem is rapidly growing. “Some states’ political actors have DC. Last year, Bate led a pilot study on drug good oversight of drug production and Regulators have had a tougher time cracking quality in India that showed regional not obviously corrupt policing; others have down on the production of substandard drugs differences in the prevalence of substandard woeful enforcement,” says Bate. Here, we compared to straightforward counterfeiting—a drugs (see map). A similar study in six show the extent of substandard antimalarial, antibiotic and antimycobacterial drugs crime with clear legal ramifications. Some African countries found that 35% of sampled sampled randomly from pharmacies in and countries, for example, need to institute better medicines tested failed quality control—many around three major Indian cities. quality standards, whereas others have strong of which were substandard rather than fake

Source: PLoS One 4, e6003 (2009); Roger Bate. rules on paper but require better enforcement (PLoS One 3, e2132, 2008). or monitoring. “There’s still a big gap in Alla Katsnelson, New York

364 volume 16 | number 4 | april 2010 nature medicine