Pharma exporters body Pharmexcil has appealed to the Central Drugs Standard Control Organisation (CDSCO) and Union Ministry of Health and Family Welfare to defer a proposal to only permit applications on ONDLS portal for certificate of pharmaceutical product (COPP) from July 15.
Regulatory policies must strike a balance between maintaining stringent quality standards and being trade-facilitative, Pharmaceuticals Export Promotion Council of India Director General K. Raja Bhanu said.
COPP or the no-objection certificate CDSCO issues certifies that the manufacturing unit concerned complies with World Health Organisation Good Manufacturing Practices norms.
“Exporters are now burdened with a dual regulatory bottleneck – domestically through CDSCO’s NOC/new drug classification delays and internationally due to slower regulatory submissions and approvals abroad, Mr.Bhanu said in a release. Pharmexcil has requested the Ministry and CDSCO to delay implementation of the circular that mandates exclusive online submission of COPP applications via the ONDLS (one nation, one drug licensing) portal.
Seeking a phased rollout with existing processes running in parallel to allow time for exporters to align, the exporters body under the Commerce Ministry said it supported digital integration and modernisation of regulatory frameworks. However, if the mandate is abruptly enforced without a transitional roadmap there is a possibility of a major disruption to the pharmaceutical exports – particularly to Rest of World markets. About 45% of India’s pharma exports are to ROW markets.
“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. While the government rightly aspires to ensure responsible manufacturing, some of the regulatory developments are misperceived by industry players as commercial limitations. The inability to secure timely COPP approvals or NOCs has the potential to push overseas buyers toward alternate suppliers from competing nations, causing irreversible long-term damage to Indian exporters,” Mr. Bhanu said.
Pharmexcil said it has identified additional challenges, including brand India being undermined by premature regulatory alerts, especially those triggered by interim data published on CDSCO’s portal regarding domestic samples, many of which are unrelated to export batches. Global regulators interpret these incomplete data sets as red flags, leading to alerts across ROW markets.
Several drugs that have been on Indian pharmacy shelves for years are being newly classified as ‘new drugs’ based solely on dosage forms (e.g., coated tablets), triggering delays in COPP issuance and drastically increasing export turnaround time, it said.
Published – July 11, 2025 09:40 pm IST