There has been a spurt in spurious Ayurveda drugs since the government eased regulatory mechanisms, raising questions on their efficacy and safety.
New Delhi: On 5 February, the Modi government had announced that it would create a body to regulate the quality and standard of Ayurveda drugs with “immediate effect”.
It was to be along the lines of the Drug Controller General of India (DGCI), which regulates drug standards in modern medicine.
According to the government order, 12 posts of deputy drug controllers, assistant drug controllers and drug inspectors would be created to monitor the quality and sale of Ayurvedic and affiliated drugs.
The move was seen as an attempt by the government to further legitimise Ayurveda, Unani and Sidha (ASU) medicines, which it has been promoting as a native ancient health system relevant today.
But almost 10 months to the order, the plan remains in the pipeline.
“We are trying to fill up the positions,” Vaidya Rajesh Kotecha, secretary, AYUSH Ministry, told ThePrint. “We are looking for the best candidates.”
In between, however, the government has taken steps that could only end up muddling the mandate of the drug controllers it proposes to appoint.
The measures, experts say, also undermines the government’s own efforts to ensure credibility for the drugs.
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The steps towards lax regulatory controls
In July, the Modi government did away with clinical trials and safety studies for ASU drugs and then admitted that it did not have enough drug-testing laboratories.
The decision was an attempt to ensure that drug manufacturers don’t have to grapple with delays in getting licenses or renewing them in a sector, which the government itself expects to grow threefold in the next four years, from the current $2.5 billion to $8 billion by 2022.
The government reasoned that classical Ayurvedic formulations such as the metal-rich bhasmas (purified calcinations), distillates of the herb arka, churans (powders) and kwaths (decoction of herbs) among others need not undergo clinical trials as they are even mentioned in ancient texts such as Charaka Samhita and hence they are already time tested.
“There are over a lakh classical Ayurvedic formulations that require no clinical trials,” said an AYUSH ministry spokesperson. “But proprietary medicines that need a patent or if a manufacturer intends to use some herb or preparation that is not part of classical formulations, these would require clinical trials.”
The spokesperson added that while Ayurvedic drugs are not classified as over-the-counter and prescription drugs, the ministry has issued an advisory to that they must be consumed only under expert guidance.
Doctors, experts and even Ayurveda practitioners, however, argue that the easing of norms has created a sector shorn of regulatory oversight and one riddled with poor quality drugs, raising questions not only on the efficacy but the safety of the medicinal system.
Medical practitioners say they are receiving an increasing number of patients with severe side effects due to the consumption of these drugs, whose growth is being fuelled by their over-the-counter availability and aggressive advertising based on unverified claims.
The fallout
On the eve of Diwali, Dr. Joydeep Ghosh was called to the hospital to treat a middle-aged woman who had complained of recurring bouts of nausea and severe abdominal pain.
Ghosh said she looked pale and so he immediately recommended a liver profile blood test. The results were damning — the woman had severe deposition of lead in her liver that had damaged the organ beyond cure.
“Her husband told me that she used to consume an Ayurvedic tonic to boost immunity and fight deficiencies. I checked the ingredients and it had Ayurvedic bhasma, which is metal-rich composition,” said Ghosh, an internal medicine consultant with the Fortis Hospital in Kolkata. “The reason for lead-based poisoning in her body was obvious.”
Ghosh said he diagnoses 10-15 such cases every month — where patients have elevated sugar levels, imbalanced sodium, and potassium levels or heavy metal poisoning. All of them, he says, confess to consuming an Ayurvedic drug or tonic.
Dr. Anoop Mishra, chairman at Fortis C-DOC Centre of Excellence for Diabetes, Metabolic Diseases and Endocrinology in New Delhi, said that he has lost count of how many patients come to him with ‘dangerously’ elevated sugar levels.
“Screaming advertisements of such products are putting many lives in danger. There are several drugs, including the anti-diabetic drugs, which are being promoted on television just like a pack of snacks,” Mishra said.
He added that patients buy into the hype around Ayurveda only to give up on allopathic medicines.
“Plenty of my patients have tried Ayurveda drugs and in some cases, they have worked for the first few months,” said Mishra. “Eventually, these patients stop consuming the medicines that we prescribe. However, we saw them returning in worsen state and phenomenally high sugar levels.”
Among the Ayurveda drugs under the scanner is BGR34, an anti-diabetic medicine that was awarded the AYUSH brand of the year in 2016, by the Union Minister of Agriculture, Parshottam Rupala.
“The drug has been released with insufficient clinical testing and has relied on pre-clinical animal testing for the majority of its claims,” said Dr. Sumaiya Shaikh, a neuroscientist, and editor, Science, at the fact-checking portal Alt News.
“Moreover, contrary to popular belief, in some patients, treatment with these ayurvedic drugs has led to a plethora of side effects.”
Such is the rampant violation that even Ayurveda practitioners doubt the efficacy of the products being used.
“There are concerns about the quality of products used in the manufacturing of Ayurveda drugs,” said Pradeep Prajapati, head of the department, All India Institute of Ayurveda. “We have to be very careful about the quality while choosing the herbs and metals. Besides, prescribing or consuming medical preparations with bhasmas without proper guidance could be life-threatening.”
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A lax regulation regime
The government relaxing of rules is part of its efforts to push through Ayurveda.
“Ayurveda is witnessing a resurgence in India and around the globe,” Shripad Yesso Naik, Minister of State (Independent charge) in the AYUSH Ministry said in October. “The government has already begun work on building All India Institute of Medical Sciences (AIIMS)-like facilities for Ayurveda across India.”
Three months earlier, the AYUSH Ministry had issued the circular doing away with clinical trials for Ayurveda drugs.
“The term clinical trial as such is not mentioned in the context of ASU drugs,” reads the circular issued on 4 July. “Proof of effectiveness in the form of pilot study may be required for intended ASU drug if the textual rationale, published literature, and authoritative book-based indications are not furnished to support the claim of use or indication.”
The government, however, appears to have taken the step despite knowing the lapses in the regulatory ecosystem and quality control.
Sample this notification issued by the ministry on 27 July. “Review of the regulatory and enforcement mechanism in the states has revealed that the provisions of the D&C Act, Drugs and Magic Remedies Act issued by the central government are not being enforced to the desired extent and quality control of ASU&H drugs and their advertisements is not adequate,” it reads.
And in the list of actions, the ministry admitted that it lacks drug testing laboratories as well. “A properly functional drug testing laboratory with required infrastructural facilities and technical manpower ‘may be’ set up for testing and quality checking of drugs…,” says the notification.
Experts say that it is not just here that the government has not clamped down on illegal practitioners. They say it has not acted on illegal advertisements promoting dangerous ASU drugs.
Between May and October, the Advertising Standards Council of India (ASCI), a watchdog of the advertising industry, noticed 350 violations under Drugs & Magic Remedies Act — an act to control the advertisement of certain remedies which alleged to possess magical qualities.
But no strict action was taken on the complaints, the ads were only modified.
The government, however, expressed helplessness. “We, as central government, do not have any mechanism to take actions against malicious or false advertisement,” said Kotecha, secretary, AYUSH Ministry. “We send the reports from ASCI to state drug licensing officers and then there is no system of follow up.”