UK MHRA’s Bans On Herbal Medicines Without Registration Or A Product Licence Would Impact Indian Manufacturers

UK MHRA’s Bans On Herbal Medicines Without Registration Or A Product Licence Would Impact Indian ManufacturersThe international crackdown on illegal online pharmacies and spurious medicines has started making an effect. Law enforcement and regulatory authorities around the world, including India, have started apprehending the criminals and shutting the illegal online pharmacies websites.

Many of these illegal online pharmacy websites are being managed by criminal elements. However, there are many more who are managing illegal online pharmacies websites in India simply to earn money. They are not criminals but in order to earn money they are actively violating the laws of India.

For instance, fields like online pharmacies, dietary and health supplements, ayurveda, healthcare technology, nutraceuticals, e-health, m-health, telemedicine, etc require compliance with techno legal requirements as prescribed by various legislations of India. These include compliance with laws like Prevention of Food Adulteration Act, 1954 and Rules 1955 (PDF), Food Safety and Standards Act, 2006 (PDF), information technology act, 2000, etc. A complete list of various laws that are required to be taken care of by various healthcare and nutraceutical companies and businesses can be accessed here.

However, Indian healthcare stakeholders are not complying with laws of India and other jurisdictions. Many online pharmacies websites of India are already on hit list of U.S. and technology companies and search engines like Google, Yahoo, etc. U.S. has already undertaken the detention without physical examination of drugs from firms which have not met drug GMPs as per the import alert 66-40 of US FDA. These include Indian companies as well that were prohibited form selling their medicines in U.S.

Now it has been reported that the latest directive by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) intends to ban all herbal medicines without registration or a product licence and it is likely to affect the Rs 850-crore annual sales of Indian herbal and Ayurvedic medicines in Europe.

As of 1st May 2014, unlicensed manufactured herbal medicines without a traditional herbal registration (THR) or product licence (PL) can no longer be sold to consumers and must be removed from shelves.

Dr Linda Anderson, from the MHRA Licensing Division, said: “The aim of the THR scheme is to give people access to traditional herbal medicines that are safe, of good quality and have information on how to use the product correctly. The public should only buy herbal medicines that they know have met standards which can be identified by the THR or PL number on the product. Most of the THR products also have the THR logo which can easily be identified on the packaging. Natural doesn’t always mean safe. Some unlicensed herbal medicines can cause serious side effects or may interact with other medicines that a patient is taking.   Over 300 products are now registered under the THR scheme. This provides consumers with a wide range of products from which to choose”.

“Companies should no longer supply unlicensed manufactured herbal medicines. People also need to be aware that not all of the products they are using, fall under the MHRA’s licensing system. A herbal practitioner is allowed to make up an individual preparation following a consultation. And other products can legally be sold as foods, cosmetics or general consumer products”, says Dr. Linda Anderson.

The MHRA has been providing help and advice to the herbal industry for 10 years, since the Herbals Medicines Directive introduced manufacturing and quality standards. Herbal manufacturers originally had seven years to bring their products up to the required standards and have had an additional three years during the sell through period. The MHRA has had continual dialogue with the herbal industry to help ensure that companies meet the required manufacturing and quality standards.

With the introduction of Directive 2004/24/EC, all manufactured over-the-counter herbal medicines in the UK, require either a Traditional Herbal Medicines Registration (THR) or a full Marketing Authorisation (MA). This includes manufactured Traditional Chinese Medicines and Ayurvedic medicines.

Ayurvedic drug makers 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 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.

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.

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.