Intellectual property rights and stable drug prices and policy are among the top priorities of the Organisation of Pharmaceutical Producers of India, said A Vaidheesh, president of OPPI. Vaidheesh, who is also managing director and vice president, Sout Asia, GlaxoSmithKline Pharmaceuticals, was reelected as OPPI president for the third term this year.
Vaidheesh discussed IPR, drug prices and the issue of NDMA in an interview with CNBC-TV18's Ekta Batra. Here are the edited excerpts from the interview:
Congratulations on being elected as the OPPI head for the third consecutive year. What will you do differently this year?
More than happy to lead OPPI for the third time. One should not be doing anything different but just pursuing what is important for the industry. These are all long haul priorities. The matter of intellectual property rights is very important for the industry. India is evolving as a country and recognizing IPR as very important for innovation. I will continue to drive that agenda.
Another important point is a stable pricing policy for business, so we are able to invest in India and invest in what we do for patients in the country. Another agenda would be over-the-counter Drugs. OTCs don’t have a comprehensive policy. OPPI has been investing time along with other associations to drive the agenda. Hope to see policy on OTC fructifying in 2020. Broadly, OPPI stands for a corporation that is leading science. I want the concept of understanding science and how it helps patients. Quality is a very important part along with supply chain integration. These are areas where we would like leadership position. I want to ensure every patient in India gets quality drugs, working with concerned authorities on appropriate regulations.
> We have a track record of managing any financial setbacks: GSK Pharma on suspension of Ranitidine When talking about quality, one of the big issues is the detection of NDMA in Ranitidine. While tests are going on, do you think this particular problem could emerge in other drugs or can it be solved, nipped in the bud?
The NDMA issue with Ranitidine is recent. Drugs at the end of the day is science and science is evolving. New information flows in for things that are discovered even 20 years ago. You correct those processes and keep advancing. Today, there are new test methods that are developed. As an industry, it needs to recognize that science will always evolve. As and when it evolves, we need not panic but adopt new processes, build on it and move on. Doing a recall is the right approach as at the end of the day as the interest of patients need to be protected. Don’t need to wait for test results to come. Will it happen in other drugs? Surely, as science is evolving. New protocols will come in.
Have the industry and the government been behind the curve or lax? We didn’t make any recalls or undertake testing as much as developed markets when it came to Valsartan. We have been more proactive for Ranitidine, but do you think we can do more? Do we have to improve testing methods? Does the government need to be more proactive?
In India, drugs are not discovered. We use branded generics. The government should work with OPPI member companies, which have a repository of knowledge. The OPPI can work with the regulators to come up with new standards on quality, etc. In fact, we are trying to do that in quality standards. OPPI has a working committee that focuses on creating awareness and is getting good traction from regulatory authorities. Science comes from the western world and we have to keep up to date, send regulators for training.
Is the burden of quality, safety and efficacy more on the private sector? Does the private sector have to take the onus of safety more than what you would like?
Expecting the government to do all this is also not possible. They are also evolving as we go along. Regulated markets have innovators over there. They have a developed ecosystem. India does not have the innovation ecosystem even for regulators to understand. Hence, it is important for OPPI to work with regulators to help raise standards and give access to training programs. Regulators are very keen on talking to us. We are seeing a positive trend in the direction.
One of the challenges in the industry, which is highly debated, is price control and what happens to quality because of that. Should there be a better method for drugs to be in the market?
Debatable question. At the end of the day, a country like India or China and Indonesia, the population load is too high. Too much to expect from countries to not undertake methods to keep prices in check. Having said that countries have to learn how to come up with financing models. With price control, one will reach an endpoint which you can't get out off. Price control becomes counter-productive and quality will begin suffering, and the country won't have good companies wanting to invest. Enough is done on price control.The government should look at the financing mechanism. Should not have compromised patients asking for discounts from doctors. In a healthcare system, a sick patient must focus on getting better versus worrying about how much money they have. Price control has its own limited space. Ayushman Bharat is a great start and maybe Ayushman Bharat 2 or Ayushman Bharat 3 should start addressing the financing of the whole healthcare model.