The EU wants India to ease its Quality Control Orders (QCO) scheme as part of the proposed India-EU Free Trade Agreement (FTA) and has proposed measures such as online application and accreditation of EU Conformity Assessment Bodies for consideration in the ongoing negotiations.

Experts, however, point out that allowing accreditation may lead to more interference by foreign conformity assessment bodies, which is avoidable.

“The 12th round of negotiations is likely to take place in Brussels in early July, but intensive intersessional engagement will take place beforehand, both virtually and in person, on a range of topics, while further discussions will also be held at the political level,” according to a EU report.

The two sides hope to have more clarity in a number of other areas as well, such as market access, government procurement, and IPR. India and the EU want the FTA to be finalised by the year-end, but several sticky issues remain.

On the issue of QCOs, the EU noted that the 11th round in May allowed for the first time in-depth engagement on the EU proposal for easing the process of certification under the scheme. “While no detailed discussions could take place on the text during the round, negotiators clarified some procedural aspects and the areas where some improvements could be considered, i.e. online application, accreditation of EU Conformity Assessment Bodies (CABs),” the EU report noted. Special focus was on cars and car parts, and on pharmaceutical products, it added.

The EU has, at several times in the past, raised concerns at the WTO about the increasing number of QCOs being issued by India across sectors such as toys, tyres, auto parts, chemicals, pharmaceuticals and petrochemical products. It had alleged that many of them were protectionist in nature.

India had argued that members like the EU had many more stringent standards in place that have to be mandatorily met by all those selling in their markets. It said that the country had  drawn inspiration from the developed world to come up with product standards in important sectors, to improve the quality of products being manufactured domestically and also to prevent sub-standard imports.

Coverage of a product under QCO mandates compliance of a specified Indian Standard (IS), obtaining of a valid licence (from the Bureau of Indian Standards) and bearing of the standard mark on the covered products, before supplying to the Indian market.

Foreign sellers complain of challenges in meeting Quality Control Orders (QCO) requirements due to factors such as the complexity of the certification process, the need for physical verification and inspections, and the time required for registration and approval.

“Accreditation of EU CABs, as proposed by the EU, will imply more interference by them, especially the European Medicines Agency (EMA). The Indian pharmaceuticals industry will then have two bosses, the US FDA, which is already romping around, and the EMA. Another of my concerns is, what will we do if FDA and the EMA standards are not in harmony,” said Biswajit Dhar, Distinguished Professor, Council for Social Development.

Published on June 11, 2025