Pharmexcil warns new online portal threatens 45% of India's pharma exports

Mint

11-07-2025

New Delhi: A new rule centralizing the approval process for drug exports through a web portal could squeeze shipments by nearly 45%, an exports promotion body said, seeking time to shift to the new system.
A certificate of pharmaceutical product (COPP) is mandatory to ship drugs to a foreign country. It certifies that the product is manufactured in compliance with good manufacturing practices and is of appropriate quality, safety, and efficacy. Last week, the Central Drugs Standard Control Organization (CDSCO) said all COPP applications must be submitted solely through a single licensing portal.
This could severely disrupt India's pharmaceutical exports, said officials at Pharmexcil, which works to promote Indian pharmaceutical and healthcare exports worldwide.
'The circular was issued by CDSCO a week back. Earlier, this COPP was issued by the state authorities, which was a quick task process, and companies were able to manage to do their businesses. Now, CDSCO making it centralized on the online portal is making it difficult for companies to get the certification done. We are seeking some time from the CDSCO and the health ministry for this transition. We welcome this online process, but need some time to take it forward,' said Namit Joshi, chairman, Pharmexcil.
A health ministry spokesperson did not respond to queries.
Pharmexcil said that while it supports digital advancements, it is concerned about the abrupt change without a transition plan. This could jeopardize nearly 45% of India's total pharmaceutical exports, specifically those destined for 'Rest of World' (RoW) markets, it said.
India's pharmaceutical exports rose 2.35% in April 2025, reaching $2.486 billion. The US was the largest destination, with $898.34 million in exports, followed by the UK at $77.97 million, South Africa at $58.31 million, and Brazil at $57.15 million.
According to Pharmexcil, exporters are now grappling with a 'dual regulatory bottleneck.' Domestically, they face delays with the CDSCO's no-objection certificate (NOC) and internationally they face slow regulatory submissions and approvals.
K. Raja Bhanu, director general, Pharmexcil said, 'Exporters are already facing delays with domestic approvals from CDSCO, and now they will experience slower international regulatory submissions.'
Bhanu said Pharmexcil has formally requested the health ministry and CDSCO to delay the rule's implementation and discuss the matter with all parties involved. 'A proposal for a phased rollout with existing processes running in parallel has been put forth that will allow time for exporters to align without compromising ongoing business.'
Bhanu emphasized that regulatory policies must balance strict quality standards with facilitating trade.
'While the government aims to ensure responsible manufacturing, some new rules are seen by the industry as limitations on business. The inability to get timely COPP approvals or NOCs could push international buyers to choose suppliers from other countries, causing irreversible long-term damage to Indian exporters,' Bhanu said.
Pharmexcil has also highlighted additional challenges that many drugs that have been available in India for years are now being reclassified as 'new drugs' simply based on their dosage forms (like coated tablets). This leads to delays in getting COPPs and significantly increases the time it takes to export products, the council said in a statement.
'Publicly released interim data on CDSCO's portal, especially data related to domestic samples that are often not connected to export batches, is being misinterpreted by global regulators as red flags. This leads to alerts in RoW markets and undermines Brand India, it said.