Herbal drug exports from India are heading to a crisis following the recent Central Government order mandating to test for heavy metals and display ‘Heavy metals within permissible limits’, in the labels of exported herbal products since January 1, 2006.

Exporters said the order would necessitate them to get consent from the regulatory agencies of respective countries to amend the contents of labels. ASU preparation exports will come to a standstill since 1st January, as it is impossible for them to fulfil the Government rule, a hasty one-sided order issued without consulting the industry stakeholders. Since it is impossible to come up with new labels before the deadline, exporters fear port authorities are unlikely to clear the goods for exports.

As per Government of India’s general practice, before issuing any order or circulators, a notification is published in the Gazette and adequate time is given for receiving the suggestions and objections. In this case, the Government came out with an order on 14/10/2005 without consulting the industry and the rule was being implemented with effect from January 1, 2006, they said.

The Pharmaceutical Export Promotion Council (Pharmexcil) has strongly opposed the decision and has requested the commerce ministry to intervene in the matter and request the Department of Ayush to keep the order in abeyance till an acceptable solution is found after detailed discussions with the stakeholders.

The exporters note that all the technical data/information about the product being exported is submitted to regulatory authorities of importing countries, who review the data, and if required, ask for additional data/information. Drug registration is granted only after satisfied with the required data/information. The ‘text matter on the label’ is also reviewed and approved by the regulatory authorities and it is impossible to make any changes in the label text without prior approval from those authorities. If any changes in label text have to be made, the exporters will have to get approval from the respective Ministry of Health of various countries. Exporters cite that there is no requirement from importing countries for claiming the clause of ‘Heavy metals within permissible limits’ on the label. Hence this need not be made compulsory.

“Now most of the countries do not insist to display the heavy metal content in the label. When we do that, naturally the consumer will think this drug has some carcinogenic content and hence should not use it. This will affect our herbal exports in the long run,” D B Mody, chairman, Pharmexcil told Pharmabiz.

He said Pharmexcil has written to the commerce ministry and the health ministry to intervene in the matter. In its letter to Shiv Basanth, joint secretary, Ministry of Health & Family Welfare, Pharmexcil said though it welcomes the policy objective for implementing requisite standards for herbal Ayurveda, Siddha and Unani (ASU) preparations in the interest of the consumer and to improve the image of the country as the provider of quality ASU medicines, there is an urgent need to amend the order suitably to enable continue export of herbal products in accordance with the labels approved by the authorities of importing countries. Pharmexcil also requested the ministry to include it in the process of formulation of any policies or guidelines related to export/import of drugs.

The notification, following a recent controversial JAMA study which led to ban of certain Ayurvedic drugs in Canada and UK, was issued by the Department of Ayush under the Drugs and Cosmetics Act prescribing permissible limits of mercury, arsenic, lead and cadmium as recommended by WHO. The notification had said that the labelling and batch wise testing of products would be the sole responsibility of the exporters.