New Delhi, Aug. 19: Reforming India’s tainted herbal drugs sector will be neither fast nor easy because government regulators appear unwilling to correct flawed policies adopted decades ago, experts have said.
At least a year before the US and the UK discovered potentially toxic metals in herbal drugs from India, an expert panel had warned the government about the lack of science, standards and quality control in herbal medicines produced in India.
Drug regulatory authorities in the UK earlier this week had cautioned that some herbal remedies from India contain heavy metals. In December 2004, doctors at the Harvard Medical School had detected potentially harmful levels of lead, mercury and arsenic in 20 per cent of ayurvedic herbal medical products made in India or Pakistan and sold in grocery stores across Boston.
The licensing conditions for herbal products in India do not provide for mandatory evidence for safety, efficacy and quality control of the products, the Mashelkar Committee report examining drug regulatory issues had said.
Its report, submitted in November 2003, had warned that generation of scientific data to support claims and quality is not required by law and recommended a new system that would demand “science-based” considerations for safety and quality.
“This (herbal) sector is not on the radar screen of regulators,” said Harinder Sikka, senior president with Nicholas Piramal, a leading Indian pharmaceutical company. “There’s neither the machinery nor willpower to regulate it.”
Dr Raghunath Mashelkar, the director-general of the Council of Scientific and Industrial Research (CSIR), who had chaired the committee, said government action to reform the regulatory standards for herbal medicines has been “relatively slow”.
Drug industry experts estimate that the global market for herbal healthcare products is about $60 billion. India’s share of the herbal products market is about $1 billion, while China accounts for $6 billion.
“Existing Indian regulations are based on blind faith. India is living under the illusion that it is okay to approve herbal products just because they have been used for hundreds of years,” said Chandra Gulhati, the editor of the Monthly Index of Medical Specialities, an independent drugs journal.
Under existing Indian laws, herbal products do not require rigorous scientific tests to prove their efficacy, safety or absence of side-effects.
Regulators accept claims as long as each of the ingredients of a herbal cocktail is mentioned in ayurvedic texts recognised by the health ministry.
Experts in pharmaceutical sciences have in the past pointed out that plants can absorb metals from contaminated soils. “The juice of karela (bitter gourd) harvested in north India might be very different from karela juice from south India,” Gulhati said.
“In addition to the basic herbal extracts in a product, there might be other ingredients, including metals or other plant-based chemicals, that might remain unquantified in the final product,” Gulhati said.
Mashelkar said the “right way” to pursue herbal medicines would be to use traditional knowledge as a starting point to launch scientific investigations to isolate the “active ingredient” of a plant and put it through animal and human clinical trials.