India slams US report on counterfeit medicine, says it’s an attack on affordable generic drugs

India has outrightly rejected allegations in a US report about the country being a chief source of counterfeit medicines to the world and said it is an attack on low cost generic drugs – crucial to make healthcare affordable.

The ‘Special 301 Report’ by United States Trade Representative (USTR) slammed India and China as leading sources of counterfeit medicines distributed globally with 20% of all pharmaceutical products sold in the Indian market estimated to be counterfeits.

“We strongly disagree with the observations made by USTR. We do not know the genesis and methodology of their findings. Instead, we view this as opposition to low cost generics and the thriving Indian drug manufacturing industry which is the ‘Pharmacy of the world’,” health secretary Preeti Sudan told TOI.

The USTR report, an annual review of the state of IP protection and enforcement in US trading partners around the world, has again put India on the ‘priority watch list’ for violation of intellectual property rights.

“In particular, China and India are reportedly leading sources of counterfeit medicines distributed globally. While it may not be possible to determine an exact figure, studies have suggested that up to 20% of drugs sold in the Indian market are counterfeit and could represent a serious threat to patient health and safety,” the report said. It also claimed that India exports counterfeit drugs to Africa, Canada, the Caribbean, the EU, South America, and the US.

However, emphasising that generic drugs are low cost but quality products, Sudan said only certified pharmaceutical products are exported from here. Locally, over 75% of sales come from generic medicines.

Not surprisingly, India is named in the report for the country’s patentability criteria, compulsory licensing criteria and absence of an additional intellectual property monopoly-data exclusivity.

At a time when medicine prices are soaring… the report undermines the efforts… seeking to make medicines more affordable domestically. USTR’s push for more protection and enforcement of IP policies would keep medicine prices high globally and place lifesaving treatments out of reach for longer in developing countries,” says MSF which advocates access to medicines.

The report also said inadequate protection for trade secrets in a number of countries, notably China and India, puts US trade secrets at risk.