New Delhi, Apr 16 (KNN) India’s pharmaceutical industry has urged the Drug Controller General of India (DCGI) to relax newly introduced export guidelines, citing concerns over a potential USD 3 billion loss in annual export revenues.

As per sources, the revised rules—effective from March 7, 2025—mandate that companies obtain prior regulatory approval from the importing country before applying for a No Objection Certificate (NOC) from the DCGI. Without the NOC, no pharmaceutical exports can proceed.

Industry representatives argue that these norms are proving to be a roadblock for ongoing and future export contracts.

“Many nations like Yemen, Ghana, and Rwanda lack the regulatory systems needed to issue such approvals,” sources told CNBC-TV18. “This has already caused delays and threatens to push exports further into uncertainty.”

The pharmaceutical sector has formally approached the DCGI, requesting exemptions or a more flexible approach to the rule.

According to insiders, the absence of a functional regulatory framework in several importing countries makes compliance nearly impossible for exporters.

In response, the DCGI maintains that the revised guidelines are part of a broader strategy to enhance regulatory oversight and bring Indian practices in line with global standards.

“These norms aim to ensure the safety, integrity, and accountability of exported drugs,” sources within the regulator’s office stated.

With both sides standing firm, the industry anxiously awaits a decision. Whether the DCGI will revisit the policy or stick to its regulatory stance remains to be seen.

Meanwhile, pharma companies warn that without immediate relief, India risks losing a significant share of its global pharmaceutical trade.

(KNN Bureau)