Making sustainable antibiotics should be the onus of the pharma industry: Anurag Roy

Almost 7 lakh deaths are happening globally because of AMR.
Making sustainable antibiotics should be the onus of the pharma industry: Anurag Roy Anurag Roy, Business Unit Director, DSM Sinochem Pharma Ltd, Gurgaon, talks to ETHealthworld about the importance of sustainable antibiotics and its role in eliminating anti-microbial resistance. Edited Excerpts:

What is the current scenario of anti-microbial resistance in India?

When we talk about AMR, we are talking about the bacteria that have lost its resistance with antibiotics. Antibiotics have a history of 100 plus years in the pharma world. Their uses have been very relevant across therapeutic areas, different surgeries, normal cough, cold or any kind of minor medications which are required right from kids to adults.

What has happened from then to now, and what we are seeing in the last two decades is the misuse of those antibiotics which has primarily happened because of the prescription for those antibiotics - whether the course has been done in an appropriate way by the patient, are they following all the required dose patterns, or from the medical/doctors side has it been prescribed correctly or not.

Over the last 5-7 years, specific research has been undertaken by WHO and it has been forecasted that almost 700 thousand deaths are happening globally because of AMR. By 2025, it's forecasted that the number of deaths could go up to 10 million every year because the problem is kind of being exhibited or the bacteria is becoming more resistant year by year, and the cumulative cost to address this problem could even run into 10 trillion dollars, so that’s the vastness of the impact of this AMR issue.

Coming to India, what we have found out is almost 58 thousand deaths of infants have been through AMR issue. But one of the other important issues which have not been picked up is the contributions from the industry and this issue comes from the manufacturing of some of the API's for these antibiotics. Currently there is no prescribed regulation to measure the amount of antibiotics that go into the waste water stream, and the amount of impact that the antibiotics in the waste water stream have on the ground water is phenomenal.

What are the main factors responsible for this condition?

India, China and some of the developing economies have API manufacturing plants, so most of the effluents that is being generated from these API plants goes into these developing economies. In some of the waste water streams that were generated in India and some other levels in China, we were estimating the level of one particular antibiotic – Ciprofloxin; the content level was even higher than what you find in the blood stream of the patient who is been prescribed with antibiotics. So, that is something which is very disturbing and it is the onus of the industry to implement it and make much cleaner antibiotics.

The implementation part, through the awareness is something wherein we still need to cover lot of ground on, because what is happening is lot of these antibiotics goes to the patients in lower economy strata. They are looking for cost effective solutions for these antibiotics, but they cannot afford to buy high price antibiotics. On a rule of thumb if we need to clean up those antibiotics from that waste water stream, it will require almost half a dollar per kg, and not many industry people or pharma companies are willing to make those investments to make cleaner and sustainable antibiotics. So, the awareness is there but the implementation is not there.

Is there any global protocol? How can we tackle the issue? What needs to be done by the pharma industry?

It is surprising that though the antibiotics industry has been there for decades now, there has not been a global protocol to test the antibiotic content in the waste stream that is generated from the manufacturer of these antibiotics. That is the global status and currently there is no prescribed norm to test that. What is happening now with this increased awareness and impact on AMR is that a lot of companies and scientific research has been done to fundamentally address this issue and it has been recently been picked up in world economic forums, WHO and the UN Assembly on how to address this problem.

DSP or DSM Sinochem Pharma is proud to say that we been in this industry and we understand this portfolio very well. We have been the first one to come up with an in-house R&D and technology test to measure the antibiotic content in the waste water stream. A lot of R&D and research work has been done on how to formalize that test, but we are even spending from the investment perspective. Our goal would be to share our approach with the industry, with the government bodies across the globe to spread the awareness so that we can fix the AMR issue for long terms and benefit the society in general.

What do you mean by sustainable antibiotics?

Sustainable antibiotics means right from the key starting material, which you use for the production of active pharma ingredients, to the finished drug substance, to finally the drug product and doing it in a much cleaner and technology-savvy way across the value chain. The effluent streams which are generated are tested for antibiotic content from it, the impurity profiling at each stage, formally and technologically addressing it and then the final step once the doses are out in the market, how will they have been prescribed is also something which covers the entire sustainable antibiotics space.

So very clearly two things which we are focused on and advocate different stakeholders on - one is obviously the right uses of antibiotics which has been a well understood topic among stakeholders in this particular field and the consumers obviously. The other important advocacy point which actually DSM has been the first one to talk and been more vocal about is the issue of anti-microbial resistance which is coming from the waste water stream of API manufacturing.

How can we address this issue?

One is the general awareness, it comes with time and it also depends on what economic strata you have within the countries. The second issue which DSP as a company is actually working actively on is for various regulatory bodies to put together a norm on the waste water stream, to measure the antibiotic content. So, that is the advocacy which we have been very actively working on within the company, customers, employees and to outside stakeholders. So, as a company we are working very closely with each country's ministries, WHO, health departments to actually share our technology, our thinking with them and in turn make people aware.

What are the latest initiatives made by DSP?

Our latest initiative is the very dedicated STEM conference or programme which DSP has started from last year. We have a tie up with IIT Delhi, with one of the leading professors in this technology area. We invited all the industry participants, typically our customers and some of the other key stakeholders, wherein we talk about these sustainable antibiotics and some of the technology for manufacturing excellence. So we have been spreading that awareness internally also, going above and beyond to organize these conferences.

We did a similar conference in Thailand and we are planning a similar one in Egypt this year. It is generating a lot of interest among various stakeholders and has been received very well across the industry.


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