Medtech backs India-NZ FTA, flags CDSCO exclusion as key regulatory gap

Medical device makers welcome India-NZ FTA for easing market access and exports, but flag absence of CDSCO in regulatory recognition framework as a key gap

Medical device makers have welcomed the India-New Zealand (NZ) free trade agreement (FTA) but flagged a key omission: the absence of India’s Central Drugs Standard Control Organisation (CDSCO) from the pact’s regulatory recognition framework.

 

This follows NZ’s decision to ease market access by accepting good manufacturing practice (GMP) and good clinical practice (GCP) inspection reports from the US Food and Drug Administration (USFDA) and other comparable regulators, including those in the European Union (EU), United Kingdom (UK), and Canada.

 

“This reduces duplicative compliance burdens and accelerates product approvals for Indian manufacturers,” said Pavan Choudary, chairman of the Medical Technology Association of India (MTaI).

 

However, industry executives said the framework stops short of recognising CDSCO approvals — seen as a critical gap as India scales up its pharmaceutical and medical technology (medtech) capabilities.

 

“As India’s pharmaceutical and medtech industry grows in scale, quality, and global reach, the CDSCO is rapidly maturing into a credible, reference-class regulator. Its inclusion in such bilateral recognition frameworks is not a diplomatic nicety, but a commercial and strategic imperative,” Choudary said.

 

Executives added that future trade agreements — or revisions to this FTA — should address the omission.

 

On the trade front, the agreement removes New Zealand’s tariffs of up to 5 per cent on select pharmaceutical products across all tariff lines, improving price competitiveness for Indian exporters. India’s pharma exports to New Zealand stood at $57.51 million in 2024-25 (FY25), against NZ’s total pharmaceutical imports of about $1.4 billion, according to the Press Information Bureau (PIB). The FTA is expected to help India expand its share, particularly in cost-efficient supply segments.

 

The pact also marks a first for New Zealand by including a dedicated chapter on health and traditional medicine services. This is expected to promote global recognition of India’s AYUSH systems, support medical value travel, and deepen collaboration in wellness services.

 

“A separate annex on health services and traditional medicine opens structured avenues for medical value travel, digital health, and evidence-based AYUSH, positioning India not merely as a goods exporter, but as a global wellness and healthcare services hub,” Choudary added.