The 58th Indian Pharmaceutical Congress (IPC) is all about enabling the pharmaceutical industry, regulators and teachers dream big. The Pharma Vision 2020, to be developed and finalized during the three-day deliberations, will aim at converting India as the medicine factory of the world, feels Dr M Venkateswarlu, Drugs Controller General of India (DCGI).In an exclusive interview with Joe C Mathew of Chronicle Pharmabiz, Dr Venkateswarlu, chairman, local organizing committee of 58th IPC shares his views on IPC. and his new role as the DCGI: Excerpts

A doctorate in pharmaceutical sciences, Dr. Venkateswarlu joined the drugs control department as a drugs inspector in 1974 and headed the Western Region of the CDSCO for the past 13 years. Recently he took charge as the country's top drug regulator

What are the special attractions of 58th IPC?
We want 58th IPC to be known for its theme, the "Pharma Vision 2020". It is an ambitious theme to visualize. The uniqueness of Pharma Vision 2020 is that it encompasses all three segments of pharmaceutical sector - the industry, the human resources and the regulatory affairs.

Keeping this in mind, we have, for the first time in IPC, decided to begin the Congress with the vision statements of six successful pharma entrepreneurs. They are going to say their vision. Stalwarts in teaching and regulatory segments will adopt a similar approach in the second and third day of the congress. The second major specialty of this year's conference is the CPhI show that goes along with IPC.

How concrete would be your Pharma 2020 vision? Would it be recommen-dations for time bound measures?
Everybody has a different vision. No two people can operate on a same vision. Our attempt would be to make people have a broad vision. Indian pharmaceutical companies that have made their mark abroad have done it because of their vision. Ranbaxy is a market leader not without reason. They will certainly have an interesting tale to narrate.The experiences they share would certainly be of value to the delegates. There is lot to learn from them. Actually, the motivation for vision document came from the President of India.

How do you view yourself as a regulator?
I am a pro-active regulator with a view to improve the system by making it transparent. I need to transform the industry-regulator relationship from the present state of mutual distrust to that of trust. Ideally, industry should self-regulate its practices. Regulators and penal provisions are meant only for perpetual violators. For all others, we are supposed to be an interface. Our role would be to facilitate their attempts to excel.

Being the top drug regulator of the country, you are undoubtedly the best person who can talk about the future drug regulation. What is your vision for Indian drug regulatory system?
At the moment we are in the process of implementing Mashelkar Committees recommendations. Lot of work has been done with regard to the setting up of central drug authority. Efforts are also there to eliminate the problem of counterfeit drugs. We look into a scenario where we go into DMF concept for product registration. We are moving towards dossier concepts. I feel that ultimately, we should follow the ICH pattern. In medical devices, we are straightaway thinking of introducing a world-class regulatory system. Since medical device industry is in its infancy, they can easily adopt to the new norms. Our initial focus would be to set standards for medical devices.

My vision would be to see India take its right place in the global scenario by reducing the unhealthy competition world over. We need to grow not just in volume but in value too. I want to see Indian products known for its value. Our industry should get the right price for right efforts. I would like to hear people say they prefer India for its quality. All this depends upon the credibility that can be built through a quality regulatory system. We have been selling cost-effective medicines all these years. Now India should be looked at as a centre for excellence in all fields of pharmaceutical industry. People should come here due to our strategic advantage as centre of excellence.

A regulatory authority without industry is of no use. Similarly, industry cannot grow unless there is a competent regulatory authority. A quality regulatory system automatically instillsconfidence in the quality of the products that are manufactured under their regulatory eye.

Every year, the number of participants to IPC seems to swell. Will the turnout be the biggest ever this time also?
The congress will definitely attract visitors in hundreds. But we are not too much concerned with the numbers. In fact we are trying to restrict the student participation this time. We want only third and fourth year students and post-graduate students to be there. It is difficult to provide accommodation if the visitors number swell beyond a limit. Further, we want quality visitors who can make maximum use of the opportunity. We expect full industry participation. CPhI is an additional attraction this time. CPhI, wherever it takes place, normally attracts 600 - 700 people from India. Now that it is happening in Mumbai, the turnout would be much bigger. Since CPhI is coinciding with IPC, the entire industry is certainly to be present at the congress.

Have you been able to bring together all federating associations of IPCA under one banner?
All issues among IPCA members have been amicably sorted out. Beginning from this year, IPC will be organized by the federating organizations on a rotational basis. IPA is the first to begin with. Next year it would be the choice of the teachers. Someone else will be in charge the year after. Thus all five associations will have equal role in organizing IPCs. We have accepted this change with a smile.

What are the future approaches towards auto-mation and machinery?
That is one area where we will focus upon. In fact IPC itself is to take up this theme with much importance. The focus will be to prepare Indian ancillary industry through Good Ancillary Practices. GAP is there today as a part of GMP. But we need full-fledged GAP. We will discuss the needs of Indian industry and the standards that should be set for ancillary industry. We will try to make the industry aware of this. ISP has a full-fledged guidance document for GAP.

Industry has to absorb this automation, validation of automation. Any automation is important for the industry as it means less contamination.

Indian SSIs were not happy with the existing GMP. How will they react to this automation plans?
We have to look at those people who look towards excellence. It is not the impact of regulation alone, it is their commercial compulsion. IPC through its vision document is going to address these futuristic issues. We have great future in contract clinical research and contract manufacturing. Ancillary machinery requirement will be more in the coming days.

How do you intend to utilize LOCs share of funds generated through the congress?
LOC's plan is to utilize the excess funds to set up an office for IPCA. This place will be turned into a hub for continuous education and human resource development. It will be a source for dissemination of information.