The decision of Central Government to make testing for heavy metals mandatory before export of herbal medicines will be a blow to the herbal drug manufacturing companies unless the government comes forward with a protocol to aid the companies, according to sources from industry.
As per the proposed rule, every batch of herbal drugs that are to be exported should undergo testing under a drug-testing laboratory. "Apart from one or two major companies, the herbal drug manufacturing companies have no such laboratories and testing of these batches through an approved drug testing laboratory is not that easy, as the number of such laboratories is very few," said Dr. Ramanathan, general secretary, Ayurvedic Medicine Manufacturers Association (AMMOI).
He said that the standard of the drugs could not be maintained by testing the end product. The standards should be kept right from the raw materials, and the need for raw material testing laboratories will be increased with the new decision, though discussions for launching such medicines is less.
"The major exporting companies already have such facilities, while the medium and small-scale companies, which are mainly into exporting, will be badly hit. At present, India's herbal drug exports account for Rs 3000 crore and if the government goes ahead with its decision, the exports may even drop to Rs 1000 crore," added Dr. Ramanathan.
The decision may, however, help to improve authenticity of herbal drugs in foreign countries. It should also be noted that the decision is meant for export and the domestic sales will not get affected.
"The decision of government will help the export marketing of herbal drugs and it should be accepted with pleasure by the industry," Vijay A Mahta, president, Ayurveda, Siddha and Unani Drug Manufacturers Association (ASUDMA) told Pharmabiz. The association is on a venture to launch a raw material standard testing laboratory, for herbal drugs, in collaboration with Chennai Pharma Industrial Infrastructure Upgradation Company (CPIIUC).