In a bid to ensure smooth exports, the pharmaceutical industry has approached the Drug Controller General of India (DCGI), seeking relaxation in the new export guidelines. According to sources, “pharma companies indicate that the new export norms are hurting about $3 billion worth of immediate annual exports.”
The industry has also argued that “DCGI’s new pharma export norms are becoming a roadblock for both existing and future contracts,” sources said on the condition of anonymity.
The DCGI amended the export guidelines for pharmaceutical products, and under the new norms issued on 7th March 2025, companies must first obtain national regulatory approval from the importing country. Based on this approval, they can then apply for a No Objection Certificate (NOC) from the DCGI, without which exports cannot proceed.
Sources further revealed that “the pharma industry, in its discussions with the drug controller, has sought relaxation to this mandatory norm.” The industry argues that not all importing nations have the systems or processes in place to issue regulatory approvals prior to imports.
“Many nations like Yemen, Ghana, and Rwanda have no system to issue national regulatory approvals, which is a requirement to seek the NOC—leading to delays and pushing exports further,” sources added.
On the other hand, sources said the Indian drug regulator maintains that the revised guidelines are aimed at streamlining the export process. “The new guidelines are designed to ensure regulatory oversight. Not just this, DCGI is of the view that the new pharma export norms align Indian regulations with the latest global standards. They also ensure domestic safety and responsible export practices,” sources said.
What remains to be seen is whether the DCGI will ease these norms in line with the pharma industry’s demands—or if, as the industry claims, companies will be forced to forgo $3 billion worth of export business.
