The Department of AYUSH will exclude herbal preparations for external use from the purview of mandatory heavy metal testing for exports. Further, the department will permit ayurveda, siddha and unani (ASU) drug makers having in-house laboratory facilities to test and certify for the heavy metal content.
The developments come in wake of a recent meeting held in this connection between the Pharmaceutical Export Promotion Council (Pharmexcil), the authority entrusted by the government to boost herbal exports from India, and the department officials.
Talking to Pharmabiz, Dr. P.V. Appaji, executive director and D.B. Mody, chairman, Pharmexcil said that the government was likely to come up with an order in this regard soon. Pharmexcil contended that there was no need to test for heavy metal content in herbal preparations for external use.
"At present herbal external preparations, mainly in the ayurveda sector, constitute about 10 per cent of the ASU drug exports worth Rs. 250 crore odd from India and the relaxation in rules would help exporters in this segment," said Appaji.
Further, the government will permit manufacturers having in-house laboratory facilities to test for heavy metal content. Earlier, the department had published a list of laboratories having facilities to test for heavy metals.
As Pharmabiz reported earlier, the Central Government had modified 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 the 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.