365Telugu.com online news,Mumbai, July 11, 2025:The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has raised serious concerns about the recent directive issued by the Central Drugs Standard Control Organization (CDSCO) mandating the exclusive online submission of Certificate of Pharmaceutical Product (COPP) applications through the ONDLS portal.
While Pharmexcil supports the government’s push for digitization and streamlined regulation, it warns that abrupt enforcement of this mandate, without adequate transition support, could severely disrupt India’s pharmaceutical exports — especially to Rest of World (RoW) markets, which currently account for nearly 45% of the country’s total pharma exports.
Pharmexcil’s Director General, Shri K. Raja Bhanu, emphasized that exporters are already navigating significant regulatory delays, both domestically (due to CDSCO’s NOC and new drug classifications) and internationally (from slower approvals abroad). Introducing another sudden change could further burden exporters, risking long-term damage to India’s status as the ‘Pharmacy of the World’.
In response, the Council has urgently appealed to the Ministry of Health & Family Welfare and CDSCO to reconsider the immediate rollout. It has proposed a phased implementation, where the new ONDLS-only submission model operates alongside existing systems during a transitional period. This, they argue, would allow exporters time to adapt without hindering ongoing trade.
“We are not opposing modernization — we are asking for a balanced approach that doesn’t sacrifice commerce at the altar of compliance,” said Bhanu. “Maintaining quality is essential, but doing so without consulting industry stakeholders can send negative signals to global buyers, pushing them toward competitor nations.”
Key Concerns Highlighted by Pharmexcil:
- Regulatory Bottlenecks: Several commonly used drugs are being newly categorized as ‘new drugs’ simply due to changes in dosage forms (e.g., coated tablets), triggering delays in COPP approvals and increasing export turnaround time.
- Impact of Incomplete Data: Interim reports on domestic drug samples published on the CDSCO portal—often unrelated to export batches—are triggering regulatory alerts overseas. This miscommunication is damaging Brand India’s global credibility.
Pharmexcil asserts that without a stakeholder-driven approach, the current policy risks undermining India’s hard-earned leadership in global pharma exports, and may cause irreparable harm to exporter confidence and buyer trust.
The Council continues to engage with authorities to arrive at a more pragmatic and phased path forward, that preserves both India’s regulatory rigor and export competitiveness.