Context: The recent controversy around the patanjali’s coronil drug has raised some questions on the regulatory model of AYUSH (Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homeopathy) ministry.
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- The drug was first marketed as a cure for Covid -19 but after a backlash from experts, got converted into an immunity booster against Covid- 19.
- AYUSH Drugs are marketed for curing various diseases like diabetes, malaria, dengue etc. without submitting any proof of clinical efficacy which the pharmaceutical industry needs to show.
- Under the Drugs & Cosmetics Act in 1964, the industry can manufacture any product based on substances mentioned in traditional books listed under the legislation’s First Schedule.
- In 2018, the Ayush Ministry amended India’s Drugs & Cosmetics Rules, 1945, to prohibit manufacturers of Ayush drugs from advertising their products having therapeutic claims.
- However the industry managed to get a stay on this amendment from Delhi High Court in January 2019.
- The prohibition is limited to “publication" only and does not address direct marketing of these products to Ayush practitioners, who may prescribe these to their patients.
- The Ayush industry does not isolate its active ingredients from its plant based sources; rather, it uses the entire leaf or herb or root in its concoction.
- Isolating and stabilizing active ingredients from plants is one of the key challenges of chemistry.
- Without a pure form of a drug’s active substance, it is not possible to understand the dose at which it will deliver its intended therapeutic benefits to a patient.
- Further in some instances apart from being questioned on therapeutic efficacy, the AYUSH drugs have also been found to contain heavy metals like lead, mercury and arsenic, which are known to produce harmful toxicological effects in humans.
- Easy over the counter availability of drugs is also a problem as all drugs of AYUSH can be sold without a practitioner’s advice or prescription.
- There are many educated Indians who view Ayush products as an effective alternative to modern medicine without having adequately interrogated the science behind their claims.
Need of tightening rules:
- If the rules are not tightened, then more dubious products would enter the industry and undermine the relevance of good quality AYUSH products.
- Human health would be adversely impacted if products are sold without checking for efficacy and harmful effects.
- There is plenty of anecdotal evidence from Indian doctors on patients suffering severe liver damage after self-medicating themselves with Ayush based tonics.
- Masses might also lose faith in the industry if promised results are not delivered in a time bound manner, this would further erode their faith in our ancient texts.
- The pharmaceutical industry may start demanding for relaxed rules which may impair the efficacy for these drugs too.
- A relook at incumbent laws and provisions is required for revamping the sector.
- AYUSH Drugs must only be allowed to sell when the therapeutic efficacy of a drug has been proven scientifically just like the norm for the pharmaceutical industry.
- Where this is not possible, the advertising and marketing rules for its products should be significantly tightened to prohibit both the industry and ayurveda practitioners from making therapeutic claims in relation to their products.
- The government must support the industry in bearing the cost of clinical trials, else price rise would elude the drugs from the majority population.
- There has to be a wider movement in Indian society, led by doctors and scientists, in favour of science and reason so that masses believe in a drug based on reason rather than on societal perception.
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