Indian foreign secretary: EU ban on generic drugs 'unwarranted'
- As of August 2015, the European Medicines Agency (EMA) had suspended more than 700 generic drugs manufactured in India, including drugs for diabetes, depression, hypertension, and other medical conditions, due to flawed clinical studies conducted at a CRO in Hyderabad, India. The ban started in January and the number of drugs included in the ban has grown considerably since then.
- Since 2007, the E.U. and India have been attempting to negotiate a free-trade agreement (FTA), but in light of the ban, talks have not progressed.
- Recently, German Chancellor Angela Merkel met with Indian Prime Minister Narendra Modi during a visit to New Delhi; however, FTA talks are still stalled.
In light of the recent progress with the Trans-Pacific Partnership, the idea of liberalizing trade pacts is more salient than ever. However, India's government officials are unhappy with the E.U.'s ban and continue to protest it. The Indian Pharmaceutical Alliance (IPA), a domestic pharma industry lobbying group, considers the ban "arbitrary," while the foreign secretary has referred to the ban as "unwarranted."
The goal of negotiating an FTA is based on the understanding that both the E.U. and India would stand to benefit from such an arrangement. Both leaders have vowed to work to unstall the talks and move forward as soon as possible.
This is a critical issue for India and Europe to solve considering the massive quantity of worldwide generic medications that are manufactured in India. India's manufacturing woes also come at the expense of medication access in the U.S., where as many as 40% of generics on the market are manufactured in India. The FDA recently added the 10th Indian pharma plant this year to its do-not-import list over manufacturing concerns.