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Pharmexcil Flags Export Risks as India Mandates Online-Only COPP Submissions, Urges CDSCO for Phased Rollout

While Pharmexcil welcomes the shift toward digital processes, it warns that enforcing this change abruptly—without time for exporters to adapt—could severely disrupt India’s pharmaceutical trade, especially exports to Rest of World (RoW) markets, which currently constitute 45% of the country’s pharma exports.

• By PharmaNews Live Desk
• New Delhi
• Jul 14, 2025

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In a move that has sparked industry alarm, the Pharmaceuticals Export Promotion Council of India (Pharmexcil) has urged the Central Drugs Standard Control Organisation (CDSCO) to delay implementing a new rule requiring exclusive online submission of Certificate of Pharmaceutical Product (COPP) applications via the ONDLS portal.

While Pharmexcil welcomes the shift toward digital processes, it warns that enforcing this change abruptly—without time for exporters to adapt—could severely disrupt India’s pharmaceutical trade, especially exports to Rest of World (RoW) markets, which currently constitute 45% of the country’s pharma exports.

Exporters Squeezed Between Domestic and Global Bottlenecks

“Exporters are now burdened with a dual regulatory bottleneck—domestically through delays in CDSCO’s No Objection Certificates (NOCs) and new drug classifications, and internationally due to slower regulatory submissions and approvals abroad,” said K. Raja Bhanu, Director General of Pharmexcil.

He stressed that while modernization is necessary, India’s export competitiveness could suffer if the transition isn’t managed carefully. Pharmexcil has formally petitioned the Ministry of Health & Family Welfare and CDSCO to defer the immediate rollout of the ONDLS-only system and instead adopt a phased implementation. The Council proposes running the new online system in parallel with existing processes for a transition period, allowing exporters to adjust without risking business continuity.

Striking a Balance Between Regulation and Trade

“This request has been made keeping in mind that regulatory policies must strike a balance between maintaining stringent quality standards and being trade-facilitative,” Bhanu said.

He cautioned that while the government’s goal of ensuring responsible manufacturing is justified, some of the regulatory shifts are perceived by industry as trade barriers. “Quality and commerce may not always align in the short term, but this balance is the only sustainable path forward—which will be transformative for Brand India,” he added.

Risks to India’s Global Pharma Standing

Bhanu further warned that delays in securing COPP approvals or NOCs could push overseas buyers to consider suppliers from competing nations, potentially causing “irreversible long-term damage” to Indian exporters.

“While the government rightly aspires to ensure responsible manufacturing, some of the regulatory developments are misperceived by industry players as commercial limitations,” Bhanu noted. “The inability to secure timely COPP approvals or No Objection Certificates (NOCs) has the potential to push overseas buyers toward alternate suppliers from competing nations, causing irreversible long-term damage to Indian exporters,” he concluded.

Additional Industry Concerns

Beyond the ONDLS issue, Pharmexcil flagged other regulatory hurdles threatening India’s pharma export momentum:

• New Drug Classification Delays: Several long-established drugs sold in India are being newly classified as “new drugs” merely because of changes in dosage forms—such as coated tablets—which triggers delays in COPP issuance and increases export turnaround times. 

• Global Reputation at Risk: Pharmexcil also raised alarms over premature regulatory alerts triggered by interim data published on CDSCO’s portal about domestic drug samples. These datasets, though often unrelated to export batches, are interpreted as red flags by global regulators, leading to unwarranted alerts in RoW markets. Bhanu cautioned that such misunderstandings undermine “Brand India” and could hamper trust among international buyers.

As India strives to digitize and modernize its pharmaceutical regulatory landscape, exporters and authorities now face the delicate task of aligning quality standards with trade imperatives. How swiftly the government and industry find common ground could shape the future of India’s standing in global pharmaceutical markets.