Importation of medicinal products from India

18.9.2017

Question for written answer E-005809-17
to the Commission
Rule 130
Mireille D'Ornano (EFDD)

The market for medicinal products in India reached a value of USD 20 billion in 2015, which is expected to rise to USD 55 billion by 2020. India accounts for 13% of world production of pharmaceutical products. The importation of pharmaceutical products from India into the European Union accounted for EUR 1.307 billion in 2016.

According to a study by the National Bureau of Economic Research (USA, 2014), 10.9% of the 1470 samples of antibiotics from India tested did not meet the requirements for active substances. In 7% of the cases, the antibiotics did not contain sufficient levels of active ingredients and in 3.9% of the cases they were counterfeit.

According to a study by the Association of Indian Chambers of Commerce (2014), counterfeit goods accounted for a quarter of the Indian market and of 2000 products tested, 180 did not meet the requisite quality standards.

European health authorities advocate an increased use of generic medicines and the substitution principle. This means increasing imports from India, which is the world’s largest producer of generic medicines (22% of world production).

Does the Commission intend to strengthen controls on pharmaceutical products from India, in particular for generic medicines?