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Indian pharmaceutical exporters are facing hiccups in Vietnam market due to tightening of regulatory requirements for drugs imported into the country and the Vietnam government's push to promote domestic drug industry.
According to Business Monitor International (BMI), Vietnam’s pharmaceutical market has grown by 10 per cent to US$ 5.2 billion in 2017 and the northward trend of the drug market is projected to continue with the rising expectations of a better quality of life.
Lack of uniformity in certification of pharmaceutical products (COPP) issued by various state drug regulatory authorities in India has become a major stumbling block for the exporters in Vietnam. The land of the ascending dragon is insisting on uniformity in COPP, said Nipun Jain, CEO, SME Panel, Pharmexcil.
Another challenge for Indian exporters is change in Vietnam's bidding criteria for imported drugs last year, giving top priority on EU’s GMP certified drugs or Pharmaceutical Inspection Co-operation Scheme Good Manufacturing Practice (PIC/S GMP)-certified drugs, he said.
The country heavily depends on imported generics, its bidding grade system for the same is making it difficult for many foreign companies including Indian firms to export drugs to the country.
Foreign drug exporters receive one of the five grades from the Vietnamese government and take part in a public bidding for medicines. The drug firms with higher grade have advantage in the bidding. They can bid with higher drug prices than low-grade rivals.
Grade 1 goes to companies from member countries of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), or Australia-based pharmaceutical firms, PIC/S GMP-certified drug makers, or those who sell the drugs to ICH members after winning the World Health Organization’s (WHO) GMP certification from the Vietnamese government.
Grade 2 is for makers of European Union GMP or PIC/S GMP-certified drugs. Grade 3 is given to manufacturers who won the WHO’s GMP from the Vietnamese government, and Grade 4 is for drugs that went through bioequivalence test, and Grade 5, for other drugs.
Upset with this, pharmaceutical exporters had taken the issue with union ministry of commerce. The ministry has appealed to the Vietnamese government to consider GMP-certified plants for imported drugs thus giving opportunity to maximum players to take part in public bidding for procurement of drugs.
India's pharmaceutical exports to Vietnam remained stagnant at US$ 226 million in fiscal 2017-18. The country had seen a small growth in pharma export to Vietnam in fiscal 2016-17 which rose to US$ 227 million from US$ 221 million in fiscal 2015-16.
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