Call for a change

Ayurveda is one of the world's oldest medical sciences. However, even after five thousand years, it is still struggling to cross borders. Sachin Jagdale finds out why

The benefit of natural products cannot be disputed but the international community seems to continue favouring modern medicines. This is in spite of ayurveda taking on a more modern avatar in terms of presentation. Though every form of medicine has its merits and demerits, the scientifically and clinically more reliable allopathic medicine category clearly outweighs alternative forms of medicines like ayurvedic and unani.

Clash of the titans

"Regulation of medicines is necessary to expand a market, as the confidence of consumers in a product is determined by the regulatory process" - Vikram Naharwar Managing Director AMSAR

The Chinese Traditional Medicine (CTM), which has a lot in common with ayurveda, has been more successful in the international traditional medicine market. There is a lot that the Indian traditional medicine industry can learn from the Chinese system that provides a blend of allopathic and herbal medicines to western communities. So where are we lagging behind? Vikram Naharwar, Managing Director, Amsar, opines, "Chinese manufacturers are supported by the Chinese Government that maintains offices in various countries for the specific purpose of promoting CTM. Whereas the Indian Government plays no constructive part in export promotion. Chemexil has proven to be a failure with internal politics destroying any attempt to assist manufacturers."

In stark contrast, Naharwar says, "Chinese manufacturers work as a cohesive unit, pooling resources for mutual benefit. Contrary to this, Indian manufacturers act individually and in most cases they undermine the efforts of other Indian companies."

Safety matters

"In measuring the amount of heavy metal, the testing of the presence and activity of nano particles gives a scientific angle to ayurvedic products" - Dr Durga Prasad Senior Manager-Medical Marketing Dabur India

Another barrier is the huge question mark over the purity and reliability of Ayurvedic medicines. In November 2005, UK's Medicines and Healthcare products Regulatory Agency (MHRA) withdrew bottles of Ayurvedic blood purifier Safi, from London's cash and carry stores, as they were said to contain 57 ppm of arsenic. The Safi case was not an isolated incident. The same story was replayed in the US, where many of ayurvedic products were found to contain heavy metals like Lead and Arsenic beyond permissible limits. The international regulatory authorities have become suspicious about ayurvedic products.

Thus, the biggest challenge lying ahead for India's ayurvedic industry is to counter these allegations of higher than permissible limits of heavy metals. Dr Durga Prasad, Senior Manager-Medical Marketing, Dabur India and an ayurvedic practitioner himself, cites possible remedies to prove their credentials to Western regulatory authorities, "Going a step ahead of measuring the amount of heavy metal in a sample, the testing of the presence and activity of nano particles gives a scientific angle to ayurvedic products." Prasad adds, "The other way of ensuring safety, efficacy and activity of a drug is the clinical trial. An alternative path was evolved to test ayurvedic medicines, called reverse pharmacology. Instead of testing a medicine in Phase I to Phase IV trials, a patient is given an ayurvedic drug and the results of the medicine are observed in the patient. The path suggests robust documentation of the changes in the patient with good objective tests."

"To make international presence stronger, toxicity reports should be provided by manufacturers to fulfil the requirements of western regulations" - Ram Shroff Director Charak Pharmaceuticals

Ram Shroff, Director, Cha rak Pharmaceuticals, talks about some other crucial issues. He says, "To make our international presence stronger, ayurvedic product manufacturers should be able to convince western authorities, and for this, they need to provide toxicity reports along with their products. These reports should fulfill the requirements of western regulatory authorities. There are objections about some of the herbs as well."

Setting the standards

People in the Third World have still persisted with indigenous forms of medicines. As per World Health Organization (WHO) data, healthcare needs of around 80 percent of the population of developing nations are fulfilled by traditional medicines. Such a huge population dependent on traditional medicines increases the need for stringent quality norms and standardisation methods.

Industry experts feel that the current norms lack the stringency required. Accordingly to a law that has come into existence from January 1, 2006, it is compulsory for licensed manufacturers of herbal medicines in India to declare "heavy metals within permissible limits" on the container before exporting them. Indian Ayurvedic product manufacturers have different takes on this issue. According to Shroff, "Standardisation starts with raw material, which needs to be processed and used in a proper way. Quality control and high quality equipment are among other requirements."

Pharmacopoeia can also play a major role in standardising the preparation of ayurvedic medicines. Technically, pharmacopoeia is a book that contains directions for the identification of samples and preparation of compound medicines. Government authorities or pharmaceutical societies publish this information. It is said the first pharmacopoeias were written by Muslim physicians in the eleventh century. Prasad gives information on the government initiatives to enhance the pharmacopoeia standards of Ayurveda. "The ministry had taken up the task of developing pharmacopoeial standards through pharmacopoeia committees. These standards are important and mandatory for implementation of the drug testing provisions under the Drug Cosmetic Act, and rules there under 1940. These standards are also essential to check samples of drug available in the market for their safety and efficacy," says Prasad.

The department of Ayurveda,Yoga and Naturopathy, Unani, Siddha and Homeopathy (AYUSH) launched a central scheme to develop standard operating procedure of manufacturing process to develop pharmacopoeial standards and shelf life studies of ayurveda, siddha and unani compound drugs under tenth five year plan. According to Naharwar, modern instruments such as HPLC, HPTLC, LCMS etc, gives company the ability to standardise products to an extremely high degree.

Regulation is must

As far as regulatory aspects of Ayurvedic medicines are concerned, there are many issues which need to be considered. It is often said that alternative medicines are comparatively less regulated than conventional medicines and this might be one of the prime reasons behind the disinterest of Western countries in traditional medicine. In fact, regulation should start from cultivation and harvesting methods, which largely decide the quality of herbs. "Regulation of medicines is necessary to expand a market, as the confidence of consumers in a product is determined by the regulatory process. Ayurvedic medicines need regulation from production to sale, including toxicology, pharmacology, pharmacokinetic and pharmacodynamic studies," says Naharwar.

Shroff opines, "We need to keep on upgrading our systems. Anything, which is improper, will lead to unscrupulous consequences. The mistake by one producer gives a bad name to the entire community."

Negative responses from the Western community should not be a deterrent for Indian ayurvedic product manufacturers. They should try to become a part of the solution and not of the problem. The Western regu-latory authorities’ demand for solid scientific and clinical evidences will only improve the trustworthiness and service of ayurvedic product manufacturers. Ayurveda is a spiritual and philosophical identity of India. Even the world communities are entitled to have a pious touch of Ayurveda. After all, healing is an act of humanism and humanism has never been confined to boundaries.

sachin.jagdale@expressindia.com