The Indian pharma exporters is likely to lose business if the recent circular issued by the Central Drugs Standard Control Organisation (CDSCO) which mandates that the applications to get WHO-GMP (good manufacturing practices) certificates will be processed only through its online portal (ONDLS), the Pharmaceuticals Export Promotion Council of India (Pharmexcil) said on Friday. The council said that while it supports the modernisation of process, there’s going to be a major disruption to India’s pharma exports, particularly in key markets such as Europe, Africa, Asia Pacific and Latin America where the government agencies require WHO-GMP certification to export drugs.
“It will affect both the fresh applicants as well the applicants who are required to renew their certification. In the offline mode, it was easy process for the drug manufacturers because they were able to align with the state licensing authorities and zonal CDSCO offices while applying for the certification. But with online mandate, that communication will be broken,” said Namit Joshi, chairman of Pharmexcil told FE.
Even though the Pharmexcil doesn’t expect delay in the certification timelines, Joshi said that problem is with the transition period. As per CDSCO circular, the new regulations would kick in from July 15 this year.
Experts said that there are ONDLS portal is already facing technical issues which makes it difficult for manufacturers to obtain necessary approvals. “Exporters are now burdened with a dual regulatory bottleneck – domestically through CDSCO’s new drug classification delays, and internationally due to slower regulatory submissions and approvals abroad,” said Raja Bhanu, director general of Pharmexcil adding that the council has requested the government and CDSCO to delay the implementation of the ONDLS-only submission model and engage in immediate stakeholder consultations.
“This request has been made keeping in mind that regulatory policies must strike a balance between maintaining stringent quality standards and being trade-facilitative. The inability to secure timely approvals has the potential to push overseas buyers toward alternate suppliers from competing nations, causing irreversible long-term damage to Indian exporters,” Bhanu said.