As of Now the Standards for Licensing Proprietary AYUSH Drugs Are Pretty Lax’ - homeopathy360

As of Now the Standards for Licensing Proprietary AYUSH Drugs Are Pretty Lax’

In a wide-ranging interview with The Wire, the outgoing secretary of the AYUSH ministry, Ajit M. Sharan, says the rules to the Drugs and Cosmetics Act will soon be changed to have strict guidelines for safety trials of AYUSH medicines.

New Delhi: It’s been three years since the Modi government set up the AYUSH Ministry. What has the ministry achieved and what are its policy priorities? The Wire sat down with the outgoing secretary Ajit M. Sharan, for an interview. He says the inspections of AYUSH institution are lacking, and Indian Ayurvedic drugs are not exported as they find it difficult to meet global norms on safety and efficacy. But the government is soon going to introduce new rules that make safety trials of AYUSH drugs necessary.
The ministry of AYUSH was set up in 2014. What would you say are its achievements over these last three years?
AYUSH has been there for a long time, but previously as a department only. Among the different components, yoga has had the biggest increase in visibility and acceptance. The credit for this goes to International Yoga Day. People are accepting yoga both for wellness and therapy. Enrolment in yoga schools, yoga tourism, yoga as a career and research into yoga has all gone up.
In Ayurveda, the second big thing, we are in the process of is creating a number of new institutions. The All India Institute of Ayurveda in Delhi is functional. But with Ayurveda, there are two kind of people. One says there’s no credibility at all. Absolute skeptics. They are the rough lot of people to address. The second are those who would like to experience Ayurveda but are apprehensive about quality concerns. So we are trying to address the quality of drugs in the market and of Ayurvedic services. For this we have undertaken major amendments to the rules under the Drugs and Cosmetics Act to address quality concerns. Hopefully in a couple of months from now they would take care of a majority of the concerns. At the moment, licensing of Ayurvedic drugs is a state subject. So there was no uniformity in the approach of different states – some were strict and some were liberal.
Do states make their own rules for licensing?
The rules are the same but yardsticks are ambiguous. Basically it says that licensing authorities should be satisfied on the safety and efficacy of the new drug. What we are trying to do by amending the rules is put in place a mechanism where there’s a central technical authority which will vet all applications for new formulations from the view point of safety and efficacy. So that the same uniform yardstick is applied. Once its cleared here, it can go to the state licensing authority for licensing. Also in terms of labeling, today whether it’s for cosmetics or geriatric care, it’s all under one label. Now we’re trying to put in place a mechanism where we can specify if it is pediatrics, geriatrics, cosmetics or general medicine or so on. So these are the two major amendments we are putting in- on uniform licensing of new drugs and on labeling. The legal vetting is going on so I presume in another month or so it should go through. The third aspect of this is on mis-branding of Ayurvedic drugs. Especially in the electronic medium, advertisements on Ayurvedic drug formulations seem to have a solution for everything on earth.
And the Advertising Standards Council of India is looking into it right now…
Yes, we have tied up with ASCI to have a 24×7 surveillance on advertisements which come out in all media, to curb mis-branding. This just started about a month back. They are an independent regulatory body. So these are measures we have taken for drugs. For Ayurvedic services, in terms of quality, we have taken up the accreditation of panchkarma centres and Ayurvedic hospitals, by National Accreditation Board for Hospitals & Healthcare Providers (NABH), who has developed and published the guidelines. For teaching hospitals we have made it mandatory in the next two years they have to acquire NABH accreditation. For panchkarma centres we have to create a pull-factor so that they see the value-add for NABH accreditation. So the standards are there and we should see change over the next few years.
What is the status of inspections of these hospitals and centres, in the way that MCI does random inspections?
There are 350 Ayurvedic colleges in the country. We also have a similar regulatory body which is the Central Council for Indian Medicine (CCIM) which is parallel to MCI. So far hospitals had to get approval only from CCIM on infrastructure, but now they have to get NABH accreditation as well, which focuses on their processes.
But the same ills which plague MCI affect CCIM. The credibility of the inspections by CCIM is suspect. So about two months back we have put in place a system where only senior faulty from government colleges go for inspections. They will  be selected on the basis of a random computer draw, similar to MCI.
We often hear AYUSH being talked about in the same breath as ‘Make in India’ –  that we want to take AYUSH to the world. But is the priority to promote this domestically or internationally?
Both. But internationally the hurdles are bigger and higher as there are many regulatory issues –  most Ayurvedic drugs go as food supplements. It’s very difficult, the type of scientific-based standards they want for efficacy and safety. They are not willing to accept the evidence we have.
What is wrong with our evidence that makes them concerned about the safety and efficacy of Ayurvedic drugs?
All Ayurvedic drugs are herbal and plant-based. Sometimes they want the passport-data of the drugs used in trials such as the information on where the ingredients were harvested. This data is not maintained in the scientific trials we do here. Secondly, the approach of Ayurveda is individualised. The same thing doesn’t work for all people. Because of this, the approach to scientific evidence also has to be different, it cant be looked at through the same prism as non-traditional medicine.
So given that these are the hurdles, where is our priority? On the domestic or international drug market?  
My personal view is, there needs to be a local demand for it. For example, in Switzerland and Germany, there’s a big constituency of Ayurveda lovers. Two of the biggest conferences on Ayurveda are held in Germany annually. If local citizens ask for it, then local governments will listen. Otherwise, no matter how much we push or evidence we send from here, local governments will not listen. So we’re trying to reach out to these constituencies through conferences. We are also having joint research and publications in association with Western universities. Recently there was some research we supported on osteoarthritis in collaboration with Charity University in Germany. The papers which they published got far more publicity and acceptability. We are in the process of setting up an international Ayurveda alliance which will provide a common platform internationally to set standards of teaching, examinations and licensing.
So right now in terms of breaking into the European Union for example, are we making any headway with even a few drugs?  
This is not a matter of negotiation. It’s not like a trade negotiation. So we are following the model of joint research.
We have lost control over our indigenous knowledge many times in the past. But to confirm… are we close to having more Indian Ayurvedic drugs exported? Yoga has been easy in its transferability, but how is ‘Make-In-India’ progressing on the drug front?
It’s a bit of all these things. In terms of misappropriation of knowledge, it has already been documented in the Traditional Knowledge Digital Library (TKDL), where this documented knowledge has been transferred and stored. Most patent offices look at this before granting a patent. Doing research on active molecules in these Indian Ayurvedic herbs is something which we can’t prevent and I think we should encourage it. This is not the same as doing Ayurveda. If people are able to find leads that serve the purpose of humanity, from Ayurvedic knowledge, why not? But in terms of us trying to push Ayurvedic drugs across the world, I think with much lesser effort if we try to promote inbound Ayurvedic tourism, it will have much better dividends.
Which brings me back to my earlier question. Are we interested in fostering AYUSH domestically or globally? What is the available infrastructure to reach there?
The benefits we can reap from inbound Ayurveda tourism would be far more. But there’s also the issues of infrastructure. We have a very limited number of good world-class Ayurveda hospitals, even though there is a high demand from tourists. Personally I think its much easier and more beneficial to India, to develop India as an attractive destination itself. Exporting Ayurvedic drugs is good for individual companies or for branding the country but very difficult. Exporting AYUSH services may be a bit easier, so you have Ayurveda spas coming across the world. I think the Ayurveda alliance, if it matures, will go a long way in globalising Ayurveda by setting standards across these three segments.
On a related note is the issue of trials and standardisation.  Western countries expect us to adhere to their standards but as you have explained, it is difficult to fit into their structures. The Ayurvedic community here has raised oppositions to clinical trials. But even for us domestically – what is our guarantee on safety and efficacy of these drugs? What standards do we have and what standards are we developing? What should we ourselves be worried about?
There are two categories of drugs here. Classical medicines have been there for thousands of years. In terms of safety of medicines and efficacy, the fears here are largely unfounded. For others, there are good manufacturing practices which are mandatory. But how rigorously these are followed and how strong are our inspections and surveillance mechanisms, that’s an issue which is debatable. So inspite of these practices and certifications, the quality may still not be up to the mark.
But if you stick to standard reputed brands, it may not be an issue.
But what about proprietary drugs?
As of now the standards for licensing proprietary AYUSH drugs are pretty lax. When you go in for a new drug, best is to look at the ingredients, the reputation of the manufacturer and take the indications with a pinch of salt, and you will be fine.
‘Pinch of salt’ is somewhat unscientific…
In the sense, don’t believe all the indications. For example, if it says, “You’ll grow six inches in six months” – these are the kind of advertisements, so take it with a bit of skepticism.
Maybe one won’t lose 20 kg and will lose only 18 kg. That’s not very grievous. But with things that are more serious, like diabetes, even a completely harmless but useless drug will still be a setback to a patient if she is not on another regimen.
On this I always suggest: don’t give up your current treatment. This is always a very gradual adjunct treatment, especially in the case of diabetes where a lot of drugs are coming in the market. At worst they may not work. But don’t give up your allopathic treatment.
Staying on the subject of trials, you’re saying there are a few companies we can trust. But what is the policy right now in terms of safety trials? Clinical trials require a very large sample size and across different centres. What happens here?
That was the lacuna. Right now it is up to the state licensing authority to satisfy itself and say that safety trials have been carried out. What those trials are is not specified. Now in the new rules, we have devised a risk-profile and made classifications of low risk, high risk and medium risk drugs and then specified the kind of trials to be carried out. Broadly it is in conformity with what is followed in the allopathy side. This will come in the next few months.
So as of now if a state licensing authority gets an application saying the drug has been tried on ten people, and nothing bad happened, they could be given a license?
They are supposed to give evidence that safety trials have been done. Broadly there was a consensus but state to state it differed.  Some states like Kerala require a very rigorous proof. With Ayurveda, if the ingredients are okay, most of them are not dangerous like chemical molecules. The ones with metals and minerals will be classified as high risk and there even pre-clinical trials would be insisted upon.
The Wire has done a few stories on BGR-34, a diabetes drug which was developed by CSIR and then handed over to a private company for manufacture. For this drug, the company advertised that they are approved by the Ministry of AYUSH and that they had clinical trials, on about 48 people in one centre. What does it mean to be ‘approved by Ministry of AYUSH’ when that is not even a legal requirement?
With BGR-34, Ministry of AYUSH is nowhere in the picture. It’s from CSIR.
But in the case of BGR-34, the report in The Wire found that it was not listed in any journals. They claimed to have a patent but on cross-checking, they were not found in the Indian Patent Registry. They claimed to have done clinical trials but they weren’t registered in the Indian Clinical Trial Registry (ICTR). Yet they claimed to be approved by the Ministry of AYUSH. And they got a lot of publicity.
They would have got a license from any of the state licensing authorities.
Does an Ayurvedic drug have to be registered on the ICTR?
On that also there is an issue. As of now they are not registering for clinical trials.
And do they have to apply for a patent?
They just have to apply for a license, but a patent is voluntary.
Academic researchers have talked about the allopathisation of traditional medicine. One of the reasons they cite is the demand-supply issue. For example, very few Ayurvedic drugs are found in various districts and doctors begin to prescribe allopathic drugs instead. The government has only one manufacturer and they make only about 100 of the 1,600 approved formulations. It seems private manufacturers are more interested in over-the-counter type of products.
There is no monopoly of supply anywhere. There is one central government manufacturer and six or seven decent enough state level ones. But there is no monopoly supplier and it’s a free and open market so there should not be issues in demand-supply.
But what about other reasons for the allopathisation of traditional medicine?
This happens but it is not due to shortage of Ayurvedic medicines. It is because majority of Ayurvedic colleges, especially in the north, produce registered medical practitioners who often don’t have intention of practicing Ayurveda. They want to practice allopathy, especially in rural and semi-urban areas.
So are Ayurvedic degrees a backdoor entry for a lot of people who want to do biomedical science instead?
This is not necessarily a wrong thing as no MBBS doctors are willing to go there. In Ayurvedic degrees, about 40-50% of their syllabus is common with biomedical science. The health ministry is creating a small bridge course for these doctors to practice primary healthcare.
So is the policy perspective here to curb allopathisation and focus on traditional medicine, or to create a bridge?
There are competing opinions and I wouldn’t say one is right or wrong as there is merit in both. The solution is to give them a small bridge course and allow them to practice, up to a certain extent.
What stage are we at? Are we approving the course or still creating it?
The course is ready. It needs some resolution with MCI.
One might have thought that this ministry would be interested in curbing allopathisation instead.
I often cite the China-model, which is a ratio of 75:25. Every Chinese traditional doctor studies about 25% allopathy and is allowed to practice 25% allopathy, and vice versa. That’s the kind of integrated pluralistic health treatment there.
Once again on the basket of Ayurvedic drugs: we all seem to be thinking of Chavanprash kind of products. It seems to be where the money is, as evidenced by Patanjali. What is the policy perspective here? To push the medicinal drugs or the FMCG model?
I think its best left to the market. If the market wants FMCG kind of products with an Ayurvedic base, why not. But as a ministry, our focus in terms of research is for more clinical products. But there’s space enough for all the segments.
Finally, over the last few years we have had Indian scientists make some startling claims. An institute in Gujarat says cow urine can be distilled to get gold. Another said Indian cows don’t contribute to global warming. Minister of state for AYUSH, Shripad Naik, told the Lok Sabha that the CSIR is researching the effectiveness of cow urine in cancer treatment. Does this kind of research help what your ministry has been trying to do?
These kind of arguments are best rebutted by peer scientists [sic]. But there are strong mentions of the five elements of the cow in many texts. To what extent they can take it forward, the claims they make, I don’t know and wouldn’t like to make a comment. Let me put it this way: It shouldn’t be brushed aside simply because it talks of cow urine but we shouldn’t rule out research into these things.
Ajit M. Sharan retired on March 31. This interview was done prior to his retirement. 

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