)
The latest directive by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to ban all herbal medicines without registration or a product licence 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 drugmakers from India, under the Ayurvedic Drug Manufacturers' Association (ADMA), are protesting the ban. The body has approached the commerce ministry for resolution. The major challenge for registration is the MHRA’s fee, which ranges from ^10,000 (Rs 8 lakh) to ^50,000 (Rs 45 lakh).
| IN NEED OF HERBAL REMEDY |
|
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.
Shashank Sandu, the treasurer of ADMA, said, "We are studying the notification. We have shared our concerns with the ministry. We have tried talking to MHRA, but it did not respond.
“We are not sure how many years the registration will be valid. It is impossible to pay such a huge amount every year. We have approached the ministry for asking the MHRA for a reimbursement of the fee or a subsidy.”
The MHRA charges registration fee based on the number of ingredients in a product. “As ayurvedic drugs are poly-herbal, there is confusion on whether each ingredient is to be counted or be counted as a group of ingredients.”
He said the European Ayurveda Medical Association had shared these concerns with their respective authorities.
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.
“Traditional Chinese Medicines and Ayurveda traditionally use heavy metals and other toxic elements as ingredients. These include realgar (arsenic sulphide), cinnabaris (mercuric sulphide), calomelas (mercurous chloride), hydrargyri oxydum rubrum (red mercuric oxide). The current Chinese Pharmacopoeia includes 48 products containing at least one of these ingredients)," a notification from MHRA said.
