India's Counterfeit Claims on Counterfeit Drugs

Roger Bate | 01 Oct 2009
The Indian government is touting a new survey showing a low percentage of drugs within the country are counterfeit. But the reality is that India still has a major problem with poor-quality drugs.

One month ago, the Indian health ministry made a startling claim that only 0.04 percent of drugs it surveyed across the country were counterfeit. Superficially this is a fantastic result, but doubts remain about whether the data represent India's drug quality. Substandard drugs kill hundreds of thousands of people every year, mostly in Asia and Africa, and India has always been cited as a major seller of such drugs. Is this no longer true?

India's survey was massive, one of the largest ever undertaken anywhere, with more than 24,000 samples collected. Dr. Debasish Roy, India's deputy drugs controller, coordinated the survey, which began late last year with the collection of samples of 62 popular drug brands from nine therapeutic categories. Samples were collected from the states of West Bengal, Arunachal Pradesh, Assam, Bihar, Jharkhand, Manipur, Meghalaya, Mizoram, Nagaland, Orissa, Sikkim, Tripura, and Andaman and Nicobar; samples were collected from cities (such as Delhi and Mumbai) down to rural villages. The samples were sent to the original manufacturers to verify whether the products were original or fake. In total, only ten samples were thought to be counterfeit, with each region of the country having one or two failures from several thousand samples each.

The only other major government assessment of Indian drug quality was undertaken five years ago and consisted of several thousand samples. The government concluded that about ten times as many fake drugs were in the market (about 0.4 percent) compared to today. The earlier survey also claimed that about 8 percent of the market was made up of substandard drugs (those that are not illegally passed off as another brand, but rather simply do not work, either because of poor manufacturing practices, storage in conditions that degraded the products, or illegal selling of expired products).

I spoke with Indian experts from the law enforcement and drug industries at the time of the earlier survey and they were skeptical that the data represented the real size of problem. Vijay Karan, the former head of the Delhi Police Department, claimed that government interfered with the sampling methodology by telling pharmacies in advance that they would be surveyed.

Experts, including Karan, are even more adamant now that the newer survey is not representative of the country as a whole. The evidence supporting that conclusion is significant. First, the government has only released a press release with the headline data; it has not released the paper with the underlying methodology, or indeed any other data about drug quality from the survey. This classic tactic used by many governments and UN agencies ensures positive media coverage of the headline figure, while depriving analysts of the possibility of criticism of the headline at the time. Secondly, other research findings point to substandard and fake drugs in the market at far higher rates. One industry survey claimed a rate of closer to 20 percent, a figure publicly reported by the World Health Organisation.

My own research published in June in a peer-reviewed medical journal, PLOS One, looking at pharmacy drug quality in Delhi and Chennai, found a respective substandard rate of 12 percent and 5 percent in their pharmacies. While my own sample size (562 samples of five drugs from 52 pharmacies), is tiny compared with the Indian government's, I ensured that the pharmacies did not know they were being investigated by using covert shoppers. My subsequent ongoing research found one wholesaler in Delhi alone with a fake drug rate of 18 percent. This makes me very skeptical of the Indian government findings.

The Indian government wants to defend the image of its increasingly excellent pharmaceutical industry. Recent evidence from Nigeria showed that Chinese companies are passing their own fake drugs off as Indian products. The Indian government understandably used this to point the finger at China as the real culprit in the fake drug market. But more than a dozen Indian companies have been banned from selling to Nigeria because of shoddy products.

And while the Indian government has pushed through recent laws that will make would-be counterfeiters think twice—significant fines and a decade in jail await the guilty—there is a danger that the latest Indian survey may well encourage complacency. It might even be used to restrict policing budgets, which are still woefully low—criminals are not perturbed by harsher sentences if no one is enforcing the law.

So while the Indian government touts its survey, the reality is that India still has a major problem with poor-quality drugs.