Janssen, the pharmaceutical arm of multinational Johnson & Johnson, has been in the news for many reasons – right and wrong. Its new ‘miracle’ tuberculosis (TB) drug Bedaquiline was introduced in India this week as part of the government’s programme for treating multi and extensive drug resistant TB. While this has earned the company accolades, in the last few years there have been concerns over the safety as well as allegedly unethical marketing of some its drugs, such as (anti-psychotic) Risperdal. Sanjiv Navangul, Managing Director, Janssen India, discusses regulatory compliance, patents and the company’s position as a ‘global public health company’ with BusinessLine . Edited excerpts:

Your new drug, Bedaquiline, is meant to treat highly resistant TB, but in India where antibiotics are easily available, isn’t there a danger of further complications?

This is extremely important and, therefore, you have to look at the strategy. We had an option of going for full-blown approval and launch this drug and market it. We have avoided all that. We will not sell this drug in the private market. We are going through the government programme and are helping it develop a track and trace mechanism for every patient so that misuse is avoided, and appropriate use is encouraged.

What else are you doing in terms of R&D?

We are a global public health organisation that is concerned about different types of diseases prevalent in this world. Many drugs in HIV treatment that are being used today, that have shortened therapy and increased life expectancy, have been Janssen’s discovery. So, obviously research is going ahead in HIV, TB and other diseases. We are working on making adherence to therapy easier. For example, today you take one pill for HIV whereas in beginning of 1990s you had to take 28 pills a day. That development has happened. The other research that is happening is shortening of therapy, such as with Bedaquiline.

There has been criticism of J&J and other big pharma companies that they spend more on marketing than on research.

Actually if you study the data, this is not true. In the case of J&J, 14 new drugs have been launched in the past seven to eight years. Do you think 14 new best-in-class drugs can be launched without spending good money on research?

You recently settled a case in the US on Risperdal. This is one in a series of drugs that have suffered scrutiny over regulatory compliance and safety.

We are proud of the heritage of this company. We are very transparent and the company makes massive efforts to ensure its values are upheld. Lots of good is done but, obviously, there will be criticism. How many patients do we save every day, how many lives do we improve. That’s what keeps us going.

But has the public perception taken a hit?

There are things we will be criticised for and things we will be encouraged for. Just about a year ago, a story was done on how J&J transformed innovation by creating the concept of open innovation.

I would encourage everyone to remember those things as well. Look at prostrate cancer, do you know there is an oral drug which wasn’t there earlier?

You spoke about open innovation. What do you feel about patents?

Do you agree that there are still diseases in this world that need research? And, therefore, should not there be encouragement for companies that are doing this research? The only way you can encourage innovation in the healthcare industry is by having a strong patent regime. We get patents for about 20 years or so, out of which 10-12 years are lost in drug research and launch. So you get a very limited time to recover your costs.

We could not have developed Bedaquiline, if we did not have patents on other drugs.

The other question is access. We need to be upfront in trying to create access for patients who don’t get it. Among the big pillars, one is diagnosis. Second, getting the drug at reasonable price. We have to realise that patents and access have to co-exist. Bedaquiline is also under patent, but that has not hindered us from giving it free in this initial part.

What are your R&D commitments in India?

We have a development centre in Mumbai. With Bedaquiline, for example, part of the formulation development was done here. There are more than 150 scientists working here.

What about your manufacturing plans? Any plans for expansion?

We should not worry too much about manufacturing for two reasons. One, there is great manufacturing footprint in the country in pharmaceuticals, so we can utilise existing facilities of any company that matches our standards. Second, how does it matter where the drug is manufactured, as long as we get it for the right price.

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