In a move to resolve the existing regulatory issues with the Vietnamese drug regulatory agency, the Pharmaceutical Export Promotion Council of India (Pharmexcil) is planning to meet the officials from Drug Administration of Vietnam (DAV) soon. Primary objective of this meeting will be to sort out the challenges faced by the Indian traders while exporting to Vietnam and insist on the delisting of the red listed companies by the DAV from its website.
In the recent past some of the Indian companies exporting to Vietnam had been red listed by the DAV due to some misunderstanding on quality issues. Pharmexcil strongly feels that this has been done without giving an opportunity to the member companies to present their stand on the facts.
Interestingly, the government of India is already working closely with the Vietnamese government to resolve this issue. Pharmexcil has been closely following this matter and will utilise this opportunity to give clarification on the rumoured quality defects found in the Indian products by the Vietnamese authority.
According to Dr P V Appaji, director general of Pharmexcil, this meeting is focussed on building confidence among the regulatory agency on the Indian drug regulatory mechanism, so as to remove any bottlenecks. He stressed that most importantly, this whole initiative is targeted to impress upon the capabilities of the Indian generic companies in manufacturing and supplying high quality safe and efficacious generic medicines worldwide at an affordable cost.
“We have got a favourable response from the Vietnamese counterpart to address this issue which is fast becoming a growing concern among many exporters. Getting things clarified and removing the names of the companies from the red list is our top most priority at the moment, so that normal business can resume and exports do not get hampered due to such misunderstandings,” stressed Dr Appaji.
This meeting is a follow up visit to finalise the matters post the Council's previous visit to Vietnam, last year. A four-member team of regulatory officials from the Central Drugs Standard Control Organization (CDSCO) and Pharmexcil had a strategic meeting with their counterparts in Vietnam to discuss issues on quality of Indian made drugs.
Interestingly, this was the first time that a technical team consisting of the Indian regulators and the Council had jointly visited a foreign country, to understand their issues and clarify doubts over the quality of Indian drugs. This was done in the wake of growing number of reports questioning the quality of Indian made drugs and the subsequent move by the Vietnamese drug authority issuing letters and red listing some Indian exporters. It is understood that nearly 53 Indian pharma companies including small, mid and large scale companies had been till now red listed by DAV for regulatory non-compliance.