EU stipulation a hurdle for herbal exports

Even as China and Korea are increasing their share in the $62 billion herbal drugs market worldwide, Indian exporters of ayurvedic drugs are finding it extremely difficult to tap this high-growth segment.

There are a number of big names like Lupin, Cipla, Alkem and J B Chemicals in this area, but exports of herbal or ayurveda medicines from India stand at a tiny $0.25 billion.

Exporters have been strapped by a European Union (EU) stipulation that requires 30 years safe usage data. This effectively prevents the entry of new players from India who also face the possibility of being blacklisted for the presence of heavy metals in their medicines.

The absence of an official system that certifies or guarantees the quality of the export consignment has also curtailed exports of herbal medicines.

Ayurvedic products to be marketed in EU countries require data on safe usage for 30 years, including 15 years of documented safe usage in an EU country,

While many ayurvedic drugs have been in use in the country for decades, exporters have found it difficult to get data on safe usage for 15 years from any EU member country.

Exporters have complained that several of their consignments, tested and cleared as per norms specified by the importing country, are being rejected and companies blacklisted, after tests differed with those conducted abroad.

Back home, testing laboratories are unwilling to take the blame for the variation in the results for, they say that they can be responsible only for the quality of the test on the sample drawn and not the entire consignment.

"The problem is more serious with manufacturers of medicines for internal consumption. If a random sample in one batch fails, the importing company blacklists the exporter," said Inder Setia, managing director, Surya Herbal Ltd.

The government should introduce a system where the entire consignment can be certified. In case a consignment was not acceptable, only that consignment should be rejected, but this should not affect the credentials of a genuine exporter.

Surya Herbal is among dozens of companies like Crown Impex and Bliss Ayurveda that have lowered or completely stopped their exports due to increasing non-tariff-barriers.

Meanwhile, sources in the Pharmaceutical Export Promotion Council have explained that the EU permits the introduction of new drugs (which do not conform to its stipulation on 30 years safe data) if they undergo fresh tests and register themselves as drugs.