ARE WE NEGOTIATING OUR HEALTH

Relying on DIETARY SUPPLEMENTS? Think Twice! 

Couple of months back, there was huge distress all across India and the world over against one of the most popular 2-minute instant noodles and a simultaneous ban on the product  imposed by Food Safety and Standards Authority of India. They stated that the noodle samples tested positive for excessive lead content. 
Now, it’s time for a well know Ayurvedic Pharma manufacturer, Shree Baidyanath Ayurved Bhawan (P) Ltd. 1 Gupta Lane,  Kolkata, India  which has fallen  under the cleaver of USFDA for exporting Ayurvedic Herbal ( dietary supplements) to Butala Emporium Inc, New York containing excessive levels of lead and mercury . 
Butala Emporium, Inc of Jackson Heights, New York has voluntarily recalled eleven Ayurvedic (dietary) supplements (list given below) based on test results published by the New York Department of Health and the US Food and Drug Administration (FDA), that the products contain elevated lead and mercury levels which can adversely affect consumers health, particularly infants, toddlers, small children, pregnant women, and those with underlying kidney disorders.
The Ayurvedic supplements from Butala Emporium were distributed in New York through retail stores and sold online in California, Connecticut, Florida, Hawaii, Massachusetts, New Jersey, Ohio, Pennsylvania, Vermont, Washington D.C., and Puerto Rico.
List of the recalled formulations:
Baidyanath brand Saptamrit Lauh--Batch No. SPL-04, Expiry Date 4/2018
Baidyanath brand Rajahpravartini Bati--Batch No. RAJ-15 0 & 126, Expiry Date 1/2019 & 07/2016
Baidyanath brand Sarivadi Bati--Batch No. SRI-09, Expiry Date 04/2018
Baidyanath brand Shankh Bati--Batch No. SHN-02, Expiry Date 08/2018
Baidyanath brand Marichyadi Bati--Batch No. 200, Expiry Date 08/2017
Baidyanath brand Agnitundi Bati--Batch No. 018, Expiry Date 02/2016
Baidyanath brand Arogyavardhini Bati--Batch No. 018, Expiry Date 03/2017
Baidyanath brand Sarivadi Bati--Batch No. SARI-015, Expiry Date 01/2019
Baidyanath brand Brahmi Bati--Batch No. HGB-18, Expiry Date 03/2019, Batch Nos. 244 & 242, Expiry Date 03/2017 (products without Batch No. or Expiry Date are subject to this recall)
Baidyanath brand Gaisantak Bati--Batch No. GAI-09, Expiry Date 08/2018 and Batch No. 141, Expiry Date 10/2017
Baidyanath brand Chitrakadi Bati--Batch No. 193, Expiry Date 02/2018
The 80-count-capsules were packed in white, plastic bottles with green, yellow or orange labeling under the brand name “Baidyanath” made by Shree Baidyanath Ayurved Bhawan (P) Ltd. 1 Gupta Lane, Kolkata, India and top cap sticker with imported by Butala Emporium.
According to USFDA deliberations, this is a matter of great concern as excessive exposure to mercury can cause kidney or gastrointestinal problems with short-term use. Longer term use (a month or longer) can cause neurological problems and potentially be fatal. Exposure to levels found in these supplements can also cause psychiatric and personality disturbances, ataxia (or loss of coordination), visual loss and hearing loss. Other symptoms of mercury poisoning include loss of coordination, "pins and needles" sensations usually in the hands, feet, and around the mouth, and muscle weakness.
Similarly, exposure to lead, even at low levels, is associated with neurological impairment, and in children, learning disabilities and lower IQ scores. The levels of lead found in these products exceeds the recommended daily lead exposure for children less than 6 years of age and women of childbearing age and can potentially cause serious injury. Symptoms of lead toxicity include abdominal pain, headache, changes in blood pressure, dizziness, kidney and brain damage.
Though till date, causalities or serious Adverse Drug Event has not been reported from the products already in circulation on being sold from retail and online stores, still the matter has raised alarm on the ethical values and credibility of famous Indian Herbal product manufacturer and exporter like Shree Baidyanath . Sri Baidyanath Ayurvedic Bhawan Ltd. (Baidyanath for short) was founded in 1917 in Calcutta, and specializes in Ayurvedic medicines, though it has recently expanded into the FMCG sector with cosmetic and hair care products The company reports having over 700 Ayurvedic products and is one of the key supplier of Ayurvedic medicine worldwide.
 Ayurveda is one of the most primitive and holistic medicine developed in India since thousands of years and globally it has great popularity in form of various herbal formulations and dietary supplements with the basic idea that they possess minimal side effects and have greater therapeutic impact and therefore can be consumed for longer time periods. Such incidents of presence of toxic levels of heavy metals, not only bring in shame for our countries’ ancient traditional medicinal practice but also raise concern on the efficacy and safety of herbal / ayurvedic dietary supplements/formulations. Also it nurtures query on the various testing methods of manufacturer where raised levels of fatal heavy metal gets ignored , unnoticed and unexamined before products  being exported to other countries.
Dietary Supplements are now well-known across the globe for the perception of being safer than allopathic medicines. As it was featured in our last edition of The PRESCRIPTION that "Natural" should not be associated with safe, hence dietary supplements are something to watch out for. 

Common motivations for having such formulations are to lose weight, stay healthy, build up immunity or curing sexual problems. The major protections that are in place for prescription and over-the-counter medicines don't apply to dietary supplements. Since supplements can be taken without professional supervision, bought from any sources (online/ retail/ advertised sites) and most of the times by people intent on preventing health problems, therefore such medicines should pass through regulatory check and stringent testing methods before being marketed and sold to consumers. 

Therefore, ethical commerce practice is the need of the hour in the Ayurveda Industry. Safety issues should not be compromised in-spite of huge challenges in following Global standards.
Finishing on a positive note,  PSM-India feels that the current recall and bans should be taken as a wake-up call for pharma manufacturers (Ayurveda- Allopathic) and as well as the Government to  accomplish their commitment and  role in ensuring safer medicine and  better healthcare  for all !