Regulating the use of lead in Ayurvedic formulations

Lead is a potent neurological and cardiovascular toxicant responsible for nearly 1.5 per cent of annual global deaths — that is 900,000 deaths. This is as many deaths as due to HIV/AIDS (954,000 annually), and more than from malaria (620,000), war and terrorism (150,000), or natural disasters (90,000).

In India, deaths due to lead poisoning have continued to rise even though lead use in petrol — a key source — was phased out by 2000. In addition, lead in household paints has been strictly regulated since 2017 in the country.

CSIR and NITI Aayog evaluated 89 data sets from 36 studies conducted between 1970 and 2014 to corroborate the UNICEF report findings that 270 million of the 800 million children suffering from lead poisoning worldwide are found in India. The NITI Aayog's June 2022 report assessed India's high burden of lead poisoning, with 23 states exceeding the 5 μg/dl (microgram per decilitre) blood lead level limit.

The sources of childhood lead exposure include water from leaded pipes, lead solder in food cans, and lead in adulterated spices, cosmetics, kohl/ surma, Ayurvedic medicines, toys, and other consumer products. In addition, cookware and service ware made of lead-based pottery continue to expose adults and children to high lead levels.

Moreover, environmental media studies have reported elevated lead concentrations in tube wells, rivers, and soil.

Also Read: Despite regulations, lead in paint remains a health concern in India

The Growing Ayurveda Market

The global Ayurvedic market size is projected to reach US$ 16,230 million by 2028, from US$ 7,273.3 million in 2021, at a CAGR of 12 percent during 2022-2028. India has the highest market share for Ayurveda, accounting for roughly 80 percent of global sales.

The key manufacturers are Patanjali Ayurved Limited, Dabur, Emami Group, Himalaya Drug, Maharishi Ayurveda, Baidyanalh, Shahnaz Husain Group, Vicco Laboratories, Amrutanjan Healthcare, Charak Pharma, Boutique, Herbal Hills, Basic Ayurveda, Natreon, etc. The top three companies occupied about 68 percent market share. But many more fake brands are available online and in stores that have flourished in recent years.

According to a report by the Confederation of Indian Industry (CII) and PricewaterhouseCoopers (PwC), 77 per cent of Indian households used Ayurvedic products in 2017, up from 69 percent in 2015.

Several studies mentioned Ayurveda and kohl use as risk factors for elevated lead burden among Indian children. Many Ayurvedic medicines contain heavy metals (particularly lead, arsenic, and mercury) in large quantities that are well above recommended limits. The Canadian government banned the sale of Chyawanprash in 2005 because of its high levels of lead and mercury.

Heavy metal toxicity can result from the frequent use of Ayurvedic medications; lead poisoning tends to be the most prevalent type of heavy metal toxicity among the regular incidences reported globally.

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Lead poisoning in children

Children are especially impacted because lead is absorbed through the intestines more readily in infants and young children than in adults. As a result, children's health may suffer significantly due to lead exposure.

When exposed to lead at high levels, the brain and central nervous system are attacked, resulting in coma, convulsions, and even death. Lead is dispersed throughout the body's organs, including the bones, kidneys, liver, and brain. Lead is deposited in the teeth and bones of the body, where it accumulates over time.

During pregnancy, lead in bone may be released into the blood, exposing the foetus. Children at the highest risk are the very young (including the developing foetus) and the economically disadvantaged.

Undernourished children are more susceptible to lead because their bodies absorb lead more readily when other minerals like calcium or iron are deficient. Lead toxicity presents sporadically, making it difficult to diagnose and requiring high suspicion. A blood film showing basophilic stippling remains an important diagnostic tool for lead toxicity.

Heavy Metals in Ayurvedic Preparations

Traditional Ayurvedic Healers and Traditional Siddha Healers use heavy metals for treating common problems like loss of appetite, weakness, generalised itching of the skin, diabetes, infertility and rheumatoid arthritis.

There are multiple published series and anecdotal reports of heavy metal poisoning from Ayurvedic herbal formulations. Since the liver is one of the major reservoirs of lead accumulation, lead poisoning can cause chronic liver injury and liver failure.

Picture input is provided by Dr. Cyriac Abby Philips (https://twitter.com/theliverdr/status/1577999695313457152)

There are detailed lists of products to which a Certificate of Pharmaceutical Product (COPP) is granted as per the WHO-GMP certification scheme by CDSCO for public awareness. But the general public does not care to check it before buying the spurious products available in the market.

The Ministry of AYUSH is implementing a Central Sector Scheme of Pharmacovigilance of ASU&H Drugs to address the integrity of Ayurvedic drugs. The Ministry of AYUSH received a total 859 complaints and it resolved about 274, and it forwarded about 585 such complaints to the concerned state authorities for appropriate action.

From April 2016 to July 2018, Thane drug inspectors seized Ayurvedic products worth Rs 64.28 lakh in 30 raids. The Kanpur police busted a fake Ayurvedic medicine and Chyawanprash manufacturing unit in December 2021. These cases are more concerning as after the pandemic, people are more actively buying such remedies as an immunity booster.

It is rare for the authorities to punish violators. Additionally, there is little cooperation among state-level enforcement agencies. So, a manufacturing firm/ seller blacklisted in one state can sell products in another.

We met Maharashtra and Telangana CDSCO regarding high levels of mercury in skin-lightening creams. But the state CDSCO commissioners stated that the state drug controller's offices do not have enough staff for regular inspections. There should be regular posting of Drug Inspector per district; however, almost all the states have vacancies in such crucial posts.

In 2020, UNICEF also found that lead poisoning can reduce India's GDP by 5 per cent due to lower economic productivity and reduced lifetime earnings. The oldest and most extensively utilised of the conventional Indian medical systems is Ayurveda, which has been around for more than 2000 years.

It emphasises the need for standardisation and quality control to curb the use of lead and other heavy metals in Ayurveda to save public health, trust in Ayurvedic, and the health of the Indian economy. The drug regulatory authorities at the central and state levels must collaborate closely. Authorities should take punitive action against the manufacturers of fake Ayurvedic drugs, substandard food items, paints, and corrupt officials.

Shania Tahir is a consultant with Toxics Link, focusing on the research and policy aspects of chemical management in the context of health. Views are personal.