Pharma industry urges drug controller to relax new export guidelines

The Indian pharmaceutical industry has approached the Drug Controller General of India (DCGI), filing a plea for relaxation of the revised export guidelines.

The new rules state that any company intending to export must first obtain regulatory approval from the importing country before applying for the No Objection Certificate (NOC) from the DCGI, without which the nation cannot carry out exports.

As per industry sources, these guidelines are impacting the immediate export of about $3 billion annually. They further allege situations that, in many countries, lack the infrastructure to even recognize regulatory approval before DCGI NOC is issued.

The industry had in recent meetings requested the DCGI to reconsider or relax this mandatory requirement. Sources say, however, that the drug regulator insists the modifications are to ease pharmaceutical exports and strengthen regulatory oversight.

The situation has given rise to concerns throughout the sector, with companies warning of export losses should the DCGI firm to current expectations. Whether the DCGI gives the industry concession on the proposed processes or continues its present course remains to be seen, putting a large chunk of India’s pharma export business in jeopardy.

The sources added, "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. 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".