Fighting Fake Drugs in India

By Sarah Williams

Recently approved legislation should help India in its battle against substandard pharmaceutical products.

The Indian government has at last signaled its intention to combat the menace of fake pharmaceutical products. Late last month, the upper house of parliament approved measures to create a comprehensive national food and drug authority. Penalties for those manufacturing and trading in fake drugs have been increased, and it will now be easier to capture and convict counterfeiters.

While the food and drug scandals in China have grabbed the recent headlines, India has been dealing with its own problems. The U.S. Food and Drug Administration recently banned a host of drug imports from India’s largest pharmaceutical company, Ranbaxy Laboratories, citing alleged breaches in manufacturing practices. The ban will be lifted if Ranbaxy offers credible evidence that its production processes are adequate.

The entire Indian pharmaceutical industry is estimated to be worth more than $10 billion and is growing an annual rate of over 9 percent. Yet it has become notorious for producing substandard drugs. Based on data supplied by local experts, the World Health Organization (WHO) reckons that perhaps 20 percent of the total Indian drug market is substandard, compared to 8 percent of the Chinese market. (To be sure, reliable statistics are hard to come by in China, and government numbers are particularly dubious.)

My own ongoing research of essential drugs sold in two dozen pharmacies across New Delhi, India’s capital city, suggests that more than 10 percent are substandard. Other analysts put the nationwide figure as high as 35 percent. The Indian health minister, Anbumani Ramadoss, insists the real figure is much lower, but he acknowledges that India has a serious problem. Speaking to journalists last week in New Delhi, Ramadoss pledged that the Indian government would “go all out to do away with spurious drugs.”

Since 1975, successive government commissions have urgently recommended product safety reforms and been ignored; now Indian officials are rushing to enact them. Almost as soon as the recent legislation was passed, the government held a ceremony to inaugurate the actual building of a central food and drug authority.

What explains India’s change of heart? For one thing, the country’s participation in the massive clinical trial market has been limited by its lack of international standards and regulation. In addition, the FDA ban on Ranbaxy’s imports was a major blow to Indian prestige. Meanwhile, the WHO has broadened its anti-counterfeiting efforts to target substandard drugs (both fakes and authentic products that are poorly made). Perhaps the final straw for India was witnessing how a series of product scandals took a harsh toll on China’s global credibility.

As Indian MPs debated the new legislation, some wanted to impose capital punishment on drug counterfeiters, noting that substandard drugs have proven deadly. The Indian health minister, however, replied that “the government feels it is not necessary to have the death penalty at this point in time.” Instead, the new law increases jail time for convicted drug counterfeiters from a minimum of five years to a minimum of ten years and increases the minimum fine for such offenses from 10,000 rupees (about $320) to a million rupees (about $32,000).

Squashing the trade in substandard drugs also require better policing and enforcement. If counterfeiters can simply bribe police or prosecutors—as they have traditionally done in India—the problem will only get worse. Thankfully, the new legislation strengthens police powers and establishes an autonomous Central Drug Authority (CDA). The CDA will coordinate all regulatory activities, including an expanded national drug quality monitoring program that will connect medical colleges and hospitals across the country.

Whether these new anti-counterfeiting mechanisms will function effectively remains to be seen. But for the first time in a long time, there is cause for optimism in India’s fight against fake drugs.