Pharmexcil, with five to six pharma industry members, part of delegation
Usha Sharma – Mumbai
The Ministry of Commerce, Government of India organised a multi-sector trade committee meeting in Vietnam recently to discuss and find solutions to various industry issues. India’s pharmaceutical sector was represented by Pharmaceuticals Export Promotion Council of India (Pharmexcil) along with five to six industry stakeholders.
Indian pharma companies are finding it difficult to operate in Vietnam due to regulatory hindrances . The Drug Regulatory Authority of Vietnam recently ‘red listed’ 53 Indian pharma companies (which includes small, mid and large pharma companies) for regulatory non-compliance. Most recently, the Drug Regulatory Authority of Vietnam ‘redlisted’ products of Flaming Pharmaceutical for the next 12 months and has cancelled 115 product registrations of Ahmedabad-based Intas Pharma. Presently, the Vietnam pharma market is worth $2.4 billion and growing at seven per cent annually. The Indian exports to the Vietnam market has decreased by 15 per cent from $220 million in 2013 to $195 million in 2014.
Commenting on the trade committee meeting in Vietnam, Dr S Eswara Reddy, Joint Drugs Controller of India, Central Drugs Standard Control Organisation said, “The core reasons for these issues are the differences in the regulatory mechanisms followed in the two countries. The regulatory bodies in Vietnam follow the dual regulatory mechanism which are different for importing countries to their indigenous players. In our meeting we will be discussing the industry’s issues in details and will also be explaining to them the urgency of making the regulatory process uniform.”
On the sidelines of the recent International Pharma Business Meet organised by the Pharmexcil in Ahmedabad, Sudhansu Pandey, Joint Secretary of Department of Commerce mentioned, “We have realised that several Indian pharma companies are facing difficulties in Vietnam and based on their concerns, we had organised a three-member official delegation from a laboratory, regulator and a technical expert from Pharmexcil to understand the issues of the industry. The key findings of the visit were that the test protocols which are in practice are different from Indian mechanism and they do not follow good distribution practices. Considering these issues, we have advised them to streamline their regulatory process. In the trade committee meeting, we will be discussing these issues and trying to get the Central Drugs Standard Control Organization (CDSCO) and Vietnam drug authority to sign an MoU for better cooperation so that both countries can exchange information and smoothen the business process.”
Dr PV Appaji, Director General, Pharmexcil said, “We have received the confirmation from Fourrts Laboratories, Glenmark Pharmaceuticals and Aurobindo Pharma to participate in a meeting. This interaction will help the industry in identifying the issues as well as in resolving them.”
MB Radha Krishnan, Country Manager of the Vietnam-based pharma company Zyanya Healthcare shared, “It is becoming a difficult endeavour for Vietnamese pharma companies to do business with Indian partners. Drug regulatory authorities of Vietnam are making it difficult for India pharma companies to comply with regulatory requirements.”
He also highlighted that as per available information, from 1/1/2014 to 30/08/2014, almost 38 cases of punitive actions were taken against Indian pharma companies, which were initiated by the Ministry of Health Vietnam and their associates and close to 50 per cent cases occurred in July and August 2014. He also shared the insight that, in the last 18 months, the authority of Vietnam has not given a product registration approval to first time applicant from India.
India approximately imports 15 tonne of artemisinin which is used for making anti-malarial drugs worth of $50 million from Vietnam.