Anil Matai: Director General, Organisation of Pharmaceutical Producers of India (OPPI) in an exclusive interaction with ETHealthworld’s Rashmi Mabiyan Kaur elucidates on the key aspects that can enable the Indian pharmaceutical industry to move up from volume-to-value in global pharma leadership.
Q. India is called the pharmacy of the world, what would be the the key factors that help the pharmaceutical industry move forward in the value chain?
We are already the pharmacy to the world, but what next, will we continue to remain that or will we move up the value chain? In the current context, there are a few things which we need to address, one is the issue of quality to ensure that the country at large and the industry more specifically don’t suffer in any way in terms of image because of quality standards.
We need to develop an infrastructure across the country both from an industry viewpoint and from a regulatory viewpoint to ensure that quality standards are there. First, to ensure and implement quality we need the regulatory infrastructure. Second, if we have to move up the value chain, then we have to look at some disruptive innovation. So far the focus has been on innovation, but incremental innovation alone will not help, we are here because of that. But if you look at the big changes which are happening and lifespans, it all happened because of disruptive innovations which we need to encourage. Third is clearly on access, because people talk of affordability but more important than affordability is that access itself is not there.
Q. In your experience, what measures can help India strengthen Indian Pharma’s reputation when it comes to quality and regulation?
Nearly 10,000 manufacturing units are there in the country out of these almost 7000-8000 are the smaller manufacturing units, which are not necessarily governed the way they should be in terms of their own internal governance system. So there, the regulatory quality infrastructure in terms of drug inspectors being available, who will go and inspect.
If you look at the top 3000 manufacturers they don’t have issues of quality. These are top of the range because over a period of time, they have been supported by global companies and they go through extensive audits. The need is to focus on upscaling the manufacturing units and upskilling the people working there. The bottom 500 or 1000 manufacturers who do not meet the standards need to find some alternatives.
We are at that stage in terms of evolution as a country that we cannot have small mom-and-pop manufacturing units, which tarnish the image. We need to use the existing setup or the infrastructure on how can we develop more resource centres. How can we use our scientific infrastructure to develop more people like them should be the focus.
Q. In your opinion, is India ready to implement a policy on mandatory prescription of generics?
I don’t think as a country, we are ready to roll out something like that. When you’re writing a generic molecule name, you are transferring the power to the pharmacist. The pharmacist will obviously dispense something where they make more money, they will not be concerned about quality. As a country, we are not ready with an infrastructure whereby generics could replace branded medicines. We need to have an infrastructure whereby we are assured of quality. In any case, we have branded generics. But there are several brands available. A manufacturer is building a brand by virtue of quality, and clinical efficacy, which is already been established and that gives a lot of confidence to the patients.
Q. How can policy reforms bring a transformational impact on the functioning of the Indian pharmaceutical industry?
If we have regulations in place whereby there is clarity and lack of ambiguity, then decision-making becomes fast. If there are regulations around innovation in terms of protecting intellectual property, global companies will be able to provide better comfort to their parent companies to launch products in India much sooner. There is ease of business in terms of manufacturing and also in terms of quality. So, if in place of ambiguities, we have a policy which is regularly updated, as the environment keeps changing I think life will be easy for people like us.
