The Department of AYUSH has retracted from its earlier move to exclude herbal preparations for external use from the purview of mandatory heavy metal testing for exports, and has also clarified that the rule would be applicable only for 'pure herbal' products.

Disclosing this at an interactive meeting of the exporters and officials organised by Pharmaceutical Export Promotion Council (Pharmexcil) in Mumbai to discuss problems faced by exporters due to the mandate on heavy metal testing and consignment clearance delays, Dr. S.K. Sharma, advisor (ayurveda), Government of India, said that the Government cannot exclude herbal preparations for external use from the purview of mandatory heavy metal testing as it contains arsenic, which directly gets absorbed into the blood stream.

"The government was considering exclusion of herbal external preparations. When the issue came up for discussion, I pointed out most of the herbal skin ointments have arsenic content, which gets absorbed into the body through the skin. Officials also accepted this view and we have decided the rule should be applicable for external preparations as well," Dr.Sharma told Pharmabiz.

As reported earlier, Pharmexcil on behalf of the exporters had convinced the top officials of AYUSH that there was no need to test for heavy metal content in herbal preparations that are not internally used in human beings. At present herbal external preparations, mainly in the ayurveda sector, constitute about 10 per cent of the ASU drug exports worth Rs. 250 crore from India and the relaxation in rules would have helped numerous exporters in this segment.

Dr. Sharma also clarified that the rule would be applicable only for pure herbal products. Some of the classical preparations have more than 50 ingredients and these need not be tested for heavy metal content. The basic ingredients prescribed as per the classical texts have to be tested for heavy metals. The exporters also can go by the labelling requirements of the importing countries. However, separate leaflets have to be inserted as per the rules of the land. In case of small size bottle preparations, it will not be practical to insert labels and leaflets on each of these products. In that case, the exporters should insert the leaflets in the pack, elaborated Dr. Sharma.

The Central Government had earlier diluted the order mandating compulsory testing of ASU products for heavy metal content, following the intervention of Pharmexcil. As per the modification, the exporters have been given an option to either display on the label that heavy metals are within permissible limits or merely submit batch-wise test data to the regulatory authorities at the time of shipment. It will be the responsibility of the representative of DCG(I) deployed at the airport or port of shipment to examine and ensure that all exporters of purely herbal ayurvedic, siddha and unani medicines comply with the order, effective from 1st January 2006.