UK license rule to hit Rs 850-cr herbal medicine sales

The latest directive by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to ban all herbal medicines without registration or a product license is likely to affect the Rs 850-crore annual sales of Indian herbal and Ayurvedic medicines in Europe.

The deadline for registration was April 30. It has since been deferred. The MHRA has warned people not to use a number of herbal medicines online such as the Indian-made Shwasa Sanjeevani for asthma, found to contain dexamethasone, a prescription-only medicine.

Ayurvedic drug makers from India, under the Ayurvedic Drug Manufacturers’ Association (ADMA), are protesting the ban. They have approached the commerce ministry for asking the MRHA for a reimbursement of the fee or a subsidy. The major challenge for registration is the MHRA’s fee, which is based on the number of ingredients in a product and ranges from Rs 8 lakh to Rs 45 lakh.

Indian companies are yet to start registering their products and are waiting for an intervention by the ministry. Besides registration fees, the MHRA also requires traditional medicines to have been used in the European Union for 15 years. Indian Ayurvedic drugs had been banned in the UK because of the presence of heavy metals and toxic elements. In 2004, a study by the Journal of the American Medical Association found 14 products by firms like Dabur, Zandu, Baidyanath and Himalaya had harmful levels of lead, mercury and arsenic. After the study, the UK, Canada and Singapore had issued warnings.

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