From bugs to drugs

Though they were viewed with scepticism earlier, probiotics are slowly making their way into conventional medicine. Kanwaldeep Chadha, Country Manager, CD Pharma, India and Director Asia Pacific, VSL Pharmaceuticals speaks to Arshiya Khan, on the company's strategies for tapping the probiotics market in India

What is the market for probiotics in India?

As per IMS figures (March 2007), the market is about Rs 80-90 crore and is growing at almost 40 percent or even more. It was hardly Rs 30 crore a few years back but the last four years has seen a tremendous growth. In India, players like USV, Cipla, Aristo, Lupin, Tablets India and Ranbaxy are present in this market segment. Now, there are a growing number of companies in the business of probiotics, which was a handful a few years back.

Why did probiotics made a relatively late entry into the Indian market?

The data on probiotics was too limited and industry specific for it to gain wide acceptance. Large pharmaceutical players had not focused their attention to popularise and promote it earlier. The stakes were not high, and therefore we did not hear about probiotics in the past. But now awareness, industry and stakes are becoming high, as big companies are getting into this field. Aristo has a brand called Darolac, and Cipla and USV have their brands too. In general, the concept of probiotics is gaining momentum, internationally. People have started to accept probiotics as an alternative method of treatment, which was not the case, a few years back.

How does CD Pharma position its probiotic brands—OTC or prescription?

In regulated markets such as the US and West Europe, probiotics are not sold as prescription products. In US, there is a category called medical food, which is ideally in between a diet/health supplement and a drug. In India, the office of the Drug Controller General (India) (DCGI) passed a regulation in 2005, according to which any probiotic or a product having strain(s) of bacteria has to be licensed as a drug.

What is the acceptance of probiotics in India? Are there any risks associated with these products?

The acceptability of probiotics is higher in India because we already consume a lot of curd, milk and cheese, which are prime providers of strains for probiotics. These are good for general nutrition but have a limited role in serious disorders such as Inflammatory Bowel Diseases (IBD ).

There are many benefits associated with probiotics that are now accepted by the medical fraternity. But, at the same time there are risks as well. In probiotics, helpful bacteria are provided to the body. But if they are not safe enough, pathogens are being given to a person who is already unwell, which would do more harm. Hence, a Generally Recognised As Safe (GRAS) certification from the USFDA is mandatory if you intend selling in the US market. We have obtained GRAS certification for our product VSL#3. We manufacture the products at one of the largest facility in the US and each batch is tested for safety to rule out contamination. Along with this, we do an RNA testing to ensure that the product is made with the same strain as the starter and for which the activity has been claimed. Apart from this, each batch of the active blend of strains is put through different stresses such as osmotic stress, oxidative stress and mechanical stress, to ensure right fermentation and in exact concentration.

There are some controversies surrounding probiotics that they do not work and have lax labelling laws. How has CD Pharma tackled these?

I do agree that there have been issues of acceptance and awareness in the past. As far as we understand, probiotics have been tried and tested in serious conditions, which is why we have earned creditable reports in medical journals. Apart from the reports, we provide sufficient matter on VSL#3 and other brands through packaging and our Web-site. Also, since we publish medical papers in some of the best peer reviewed journals that are accepted globally, we are able to combat some of the controversies with a 'top-down' approach. GRAS certifications are usually helpful in satisfying other issues.

What are the kinds of bacteria used in your products?

In general, probiotics can be referred to as lactic acid bacteria. We use this as the technology for all our products. But we use different strains of friendly bacteria for different products. For eg VSL#3 has eight strains of bacteria including four different strains of Lactobacillus, three strains of Bifidobacteria and one strain of Streptococcus thermophilus mixed in different quantities. We also have a product for oral inflammatory condition, which uses just one single strain of bacteria and another product for vaginal infections using three strains of bacteria. We are also making cream for anti-ageing and select inflammatory conditions such as psoriasis or dermatitis.

All our technologies are derived from lactic acid bacteria and are patented based on the mechanism of action at the enzymatic or molecular level, due to the use of specific strains of bacteria proprietary to us. The strains of bacteria used across all our products find its origin in food such as yoghurt and fresh cheese. Our source is food to isolate friendly bacteria (using a special proprietary technology), ferment and grow. It is from the safety point of view that we use foods, which have been in use for many years.

What product offerings do you have for AIDS?

Using one of our products developed for vaginal infections we were able to demonstrate some very encouraging in-vitro results proving an inhibition of up to 70 percent in HIV and Herpes Simplex Virus 2 (HSV2). We are now working to see its role in prevention of pappiloma virus and would be starting some in-vitro studies followed by human trials in India. But since HIV prevention is an area that requires a lot of investment and funding we are talking to a few government agencies such as National Institute of Health, USA and Indian Council of Medical Research, in India to start some collaborative projects. Being a natural product it has got some favourable response from the medical fraternity.

When is the anti-HIV product expected to hit the market?

This will depend upon the funding and how soon the clinical trials can be initiated. So far we have not started any clinical trial and we believe that it will take a few years. However, institutes like ICMR in India have recognised the work done so far. Unlike most of the others microbicide(s) put through clinical trials, our product is considered safe and non-toxic. Also, we have already done a few trials in other indications and it has been found to be well tolerated.

Why did you chose to enter the probiotic segment?

We have a pipeline of products/technologies, which are proprietary with recent patents granted and extended to a number of countries including India. Besides, we see it as a big opportunity because like there was a big wave of antibiotics, the world is now moving to probiotics. We have been successful to some extent with VSL#3. Also, internationally we have been able to do license deals with companies like Ferring and are in talks with other top pharma companies, globally. In India, we have already signed a license agreement with one amongst the leading Indian pharmaceutical companies in the last three years.

How much investment do you drive into the business of probiotics?

Globally, our major cost has been for on formulation development and the investments done in initiating clinical trials. Considering the costs of doing trials in the US and Europe we have already invested about $40-50 million. We started India operations three years back and have a team of around 15 people. We don't need too large a team, considering our business model, which is mainly developing intellectual property and commercially out-licensing to large companies. This approach has been followed globally.

We are going to launch two products in India in the next one year, with our partners. The next few years will see more probiotics brand launches. Apart from this, there are already 8-10 on-going clinical trials with one completed on rotavirus. We are also in the process of starting another five to six trials within the next one year.

arshiya.khan@expressindia.com