Karnataka Ayurveda sector has welcomed the announcement made by the Centre on the compulsory heavy metal testing to be carried out in herbal drugs. The sector has stated that this would be the only way to maintain high quality standards and get its acceptance in the international market where herbal drugs are still grappling to be acknowledged. But the Foundation for Revitalisation of Local Health Traditions (FRLHT) views it as a massive exercise for the department of Ayush to supervise the progress and an expensive proposition for the herbal industry.

Ravi Prasad, president & CEO, Himalaya Drug Company said, "We welcome and support the government's initiative to make testing of heavy metals in herbal medicines mandatory. Himalaya has always tested its products for heavy metal content, through in-house and independent laboratories, for all markets and we conform to limits set by international health regulatory authorities like the World Health Organisation (WHO) and Food and Agriculture Organisation (FAO). The government's move to raise quality and safety norms for herbal medicines will definitely benefit the entire Ayurvedic industry by making the products more competitive in domestic and global markets."

Each and every batch of Himalaya products, for both export and domestic markets, undergo extensive tests to analyse presence of heavy metals. "Should there be traces of heavy metal, the products are not released into the market," averred the Himalaya Drug Company chief.

Dr. GG Gangadharan, joint director, Foundation for Revitalisation of Local Health Traditions (FRLHT) stated that the order would have double implications on the herbal sector. There are around 500 raw materials that come in for formulation development and small units in Kerala itself prepare at least around 400 classical formulations. The whole process is going to be a costly affair for the industry. Hence, there is a need for the government to set up a dedicated facility that would be cost-effective and time saving.

Presently, the private units in Karnataka seek the assistance of FRLHT, MS Ramaiah and Bangalore Test Labs for research clearances in pre marketing of products because the drug testing lab attached to the Government Central Pharmacy (GCP), which is a production unit for drugs for hospital supplies in the State, cannot analyse drugs from 120 companies.

Currently, there are 8,000 small-scale units, about 100 medium-sized units and a handful of large herbal units in the country. Certain drugs are prepared in small batches, which will add on to cost when tests for heavy metals need to be conducted. At least 99 per cent of the materials in herbal products are sourced from the wild and metal content was miniscule.

Another point brought out by Dr. Gangadharan is that if the final product is being tested and rejected for metal substance, it would be difficult for the company to trace it. The metal content in herbal drugs is used only for therapeutic purpose and efforts are made by companies to use only permissible levels.

While the Centre's order calls for printing amount of metal content in the packaging, Dr. Gangadharan opined that at times metal content presence in final product could be attributed to the vessels in which the drugs were prepared.

Drug inspectors at the Directorate of Indian System of Medicines, Government of Karnataka stated that the government announcement would prevent recurrence of derogatory remarks by international regulatory authorities in future. They are apprehensive how the industry would be able to handle the tests because the industry will be now faced with the dilemma of high cost and delayed reports that could affect the future of the herbal sector.