Labels of 18 Ayurvedic Medicines Violate Drugs and Cosmetics Rules
INSIGHT — The Consumer Magazine (November-December 2005) has published the findings of a study of labels of 18 ayurvedic medicines made in India. The medicines were selected on the basis of studies in the US and Canada.
None of these widely sold products declared on their labels the presence of heavy metals — lead, mercury and/or arsenic — that they contained according to a study (based on testing) published in the Journal of the American Medical Association (JAMA) and testing by Health Canada, the Canadian government’s health department. Health Canada has warned consumers against using some of these Indian Ayurvedic products.
As per the Drugs and Cosmetics Rules, 1945, the medicines have to mention all the ingredients. Even though one brand mentioned mercury, it contained lead, mercury and arsenic and that too above acceptable levels. Many of the medicines covered by JAMA are recommended for children.
Out of the 14 medicines covered by JAMA, 13 had lead above acceptable levels. Lead accumulation in the body leads to lead poisoning which has adverse effects on health like damage to the kidneys, liver, heart and central nervous system. In children, it is associated with learning disabilities, hearing problems and growth retardation.
The medicines with very high content of heavy metals were Mahayogaraj Guggulu with Silver and Makardhwaj (Baidyanath), Mahalaxmi Vilas Ras with Gold (Baidyanath), Navratna Rasa (Unjha Pharmacy) and Swarna Mahayograj Gugglu with Gold (Baidyanath). Products of big companies like Dabur and Zandu are also on the caution list. (See table for details)
In 1992 CERS had also sent some widely sold ayurvedic medicines to the Food and Drugs Laboratory, Vadodara, for testing the lead content. An analysis showed that the lead content in, among others, Suvarna Vasant Malati Bruhat (Raka Laboratories), was 3.73 per cent. At the recommended dosage of two pills twice a day this works out to a lead consumption of 149.3 mg per week which is nearly 50 times the maximum limit set by the World Health Organisation (WHO) of 3 mg per week. CERS has filed a case which is pending before the National Commission.
Some quarters have, however, accused what they call the powerful multinational pharma lobby of instigating the reports in the US and Canada.
CERS brought the JAMA article to the notice of the Department of AYUSH (Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy) through the Ministry of Consumer Affairs, Government of India. The department responded that mentioning the list of all ingredients along with the quantity of each is mandatory.
Further, the department has informed CERS that it has directed the Drug Controller General of India and state drug controllers to ensure that the labels of the medicines give details of composition for the information of consumers.
Meanwhile, the testing of all herbal medicines in India (ayurvedic, unani and siddha) for heavy metals will soon be compulsory. From January 1, 2006, every licensed manufacturer of herbal products in the country will have to declare ‘heavy metals within permissible limits’ on their containers before exporting them. It is disturbing that domestic consumers are not being protected by this directive.
As per Rule 161 of the Drugs and Cosmetics Rules, medicines containing poisonous substances like mercury, arsenic and red oxide of lead have to carry a warning. Only four of the products studied carried this warning.
Some of them — Maha Sudarshan Churna manufactured by Zandu and that made by D & K Pharmacy, Karela Tablet (Shriji Herbal Products) and Balguti Kesaria (Kesari Ayurvedic Pharmacy) — omitted the ingredients and their quantity. None mentioned the method of preparation, but some referred to the ayurvedic text which would have the method of preparation.
CERS has decided to take up the issue of inadequate labelling with the manufacturers and make a representation to the Gujarat State Food and Drug Control Administration for action. There should be no compromise in ensuring that manufacturers give the required information and CERS will campaign on this.
Details of the label study and the debate on use of heavy metals in ayurvedic medicines have been published in the November-December 2005 issue of Insight.