With high voltage deliberations on core subjects of the pharma industry and regulations and with the theme “India- Pharmacy of the world and role of regulators and industry”, the 66th Indian Pharmaceutical Congress (IPC) being held in Hyderabad at Hitex will prove to be an all together different experience. Ravi Uday Bhaskar, Secretary General of All India Drugs Control Officers Confederation (AIDCOC) and Organising Committee Chairman for IPC, in an interview with Amguth Raju, sheds light on this year's IPC and the regulatory scenario in the pharma sector.

As IPC, premier national pharmaceutical event, is unfolding in Hyderabad, what are the initiatives taken by AIDCOC, as an organizer, to make this event a success?
We are taking up Indian Pharmaceutical Congress (IPC) as a prestige issue. As we are bestowed with the responsibility of holding the 66th annual IPC event, we are all set to make it a big success. In fact we are planning to conduct this event a bit different from the earlier ones. Earlier IPCs were more like an entertainment, where in delegates used to come, stay in five star hotels, enjoy food and hospitality and spent it like a vacation trip. Because of the lackadaisical attitude of earlier events, majority of pharmaceutical professionals did not take it seriously. Now we want to change this perception among the participants. We want to make this IPC a serious subject oriented event. At the 66th IPC, we are inviting leading players from domestic pharma industry and also inviting international regulators to deliberate on the various challenges faced by the industry.

There will be a series of seminars, paper presentations by research graduates, discussion forums among regulators and industry leaders, CEOs conclave and exhibition of pharma products by the industry players. Overall the AIDCOC wants to make the 66th IPC a memorable event wherein the regulators, industry and the academic institutions will come together on a single platform and share views, ideas and give suggestions for betterment of the pharma sector of the country.

Could you brief us on AIDCOC, its aims and objectives and the major focus during this IPC?
AIDCOC is a confederation of all India drugs controllers’ officers having officers from drug control departments from both state and central level as members. The body was formed on December 28, 1995 at Visakhapatnam as a result of untiring efforts of many officers across the country and the initiative taken by the Andhra Pradesh Drugs Inspectors' Association, the Kerala Drugs Control Enforcement Officers' Association and Tamil Nadu Drugs Inspectors' Association. The first Executive Committee elected R. Narayanaswami as the first President. The Executive Committee immediately swung into action and a constitution of the AIDCOC was drafted at the meeting held at Hyderabad. In this meeting, the objectives, mission, vision and the strategy to be followed was clearly defined and documented.

Our main contention right from the beginning is that the drugs control departments across the country are being neglected by the governments. Therefore we want to stress and make realize the government that we play a vital role in ensuring quality, efficacy and safety of the medicines and healthcare system by way of enforcing the Drugs and Cosmetic Act. Our main vision is to make society healthier and safer through enforcing laws and acts and we are moving with a mission to achieve professional excellence through continuous training, better co-ordination amongst the Drugs Control Officers and more interaction with fellow pharmacists. Overall objective is to establish pharmacists and regulatory officers as vital link in the chain of healthcare delivery.

In the 66th IPC, we want to bring together the industry, regulators and the academicians on a single platform to boost confidence not only among the international regulators but also among the domestic costumers in the country.

What is the theme for the 66th IPC and what are you aiming to tell the world through this theme?
This time our theme is ‘India - pharmacy of the world and role of regulators and the industry’. It is aptly selected to focus on contemporary issues relating to industry and regulatory confidence building. As in the recent days, the Indian industry has been bogged down with a lot of regulatory inspections and warning letters and notices of black listing of units, the theme calls for regulators, industry players to come together and work hand in hand.

Through IPC we want to tell the world that we are equally competent in terms of regulations and quality standards. Today there are a large number of USFDA and WHO approved manufacturing units in the country and some of the top pharma players in the country are having better standards that the pharma companies in USA or EU. With more than 20,000 small, medium and large-scale pharma and biotechnology industry base, India is considered as one of the leading generic drug manufacturing and exporting countries in the world. However recently a few international agencies have tried to lower the confidence of Indian industry and to tarnish the image of Brand India through their agencies and international business lobbyists for their own benefits in the aftermath of the off patent regime that is fast approaching.

So we have selected this theme not only to build confidence among the international regulators, leading global pharma players and investors, but through this forum we also want to tell the world that our regulatory systems, the industrial infrastructure, the educational system and the research laboratories are on par with the global standards and we are not less competent to any other nations in the world. The theme was unveiled by the commerce secretary Rajive Kher and it has been selected to give a new lease of life for the Indian pharma industry.

Could you elaborate on the Brand India concept and what does “India- Pharmacy of the world” convey?
The Brand India concept is nothing but promoting Indian pharma industry as a global pharma hub. And that is why it is called “India-Pharmacy of the world” so as to make this concept capture the role of Indian regulators and role of the industry. India has already opened its markets for 100 per cent Foreign Direct Investment in the pharma sector. The government is already providing necessary infrastructure and creating conducive environment for the pharma industry to flourish. Moreover India already has national and international companies which are not only catering to the needs of the entire globe but also serving the Indian consumers.

Therefore this is the right time to build up confidence among the global players in India. The country has all ingredients like good infrastructure, skilled and affordable workforce, English speaking and well qualified pharmaceutical and biotechnology professionals, research laboratories and other infrastructure facilities like roads, power and abundant water needed for setting up the pharma base in the country. What more is needed is to create confidence among the international regulators and investors.

What are the apprehensions and doubts created by the foreign regulators and how is IPC helpful in clearing them all and build confidence among various stake holders?
Of late the international regulators are creating apprehensions about the capabilities of Indian regulators as well as quality of drugs manufactured by Indian companies. No doubt, we need to strengthen our regulatory systems in terms of employing more inspectors, establishing a training academy for regulators and building more testing laboratories across the country.

At the same time our governments are also trying to move towards this end by amending the acts and incorporating new regulations from time to time. In fact in the 12th Five Year Plan, the central government had allocated about Rs. 1750 Crore to strengthen the regulatory mechanism in the country.

Having said this, the existing mechanism and regulatory norms are no less to any international regulations. We are following the same regulatory protocols as that of WHO and USFDA. Except in one or two cases, our industry has been one of the best regulatory compliant in the world.

But the point to be noted is the recent stringent regulations imposed by international regulators, seems to be a deliberate effort to tarnish the reputation of Indian pharma industry. If you look at post 2015 period, most of the block buster drugs are going off patent and it is going to be a big market for generic makers. So many Indian big players as well as medium level units are also trying to explore the situation and venture into the new markets.

But unfortunately, since past two years there is a growing surveillance by global regulatory agencies on India pharma exporters. Even some of the foreign regulatory heads are talking against quality of drugs and capabilities of the Indian Industry. What is surprising to note is even some of the top and leading industries are being warned for quality compliance. Keeping this in view, through this IPC we have to build up the confidence and remove all apprehensions and doubts among the global regulators. We want to tell the world that Indian regulators have all the capabilities and are equally competent with the global regulators. The industry is also capable of producing drugs of quality and efficacy. So we are in no way inferior to anyone in the world. To achieve this, Indian regulators and the industry players have to work hand in hand.

Will IPC also be focusing on quality, efficacy and affordability of drugs?
Of course we have also incorporated affordability of drugs and medicines as an important component of discussion in this congress. Stress is also given on deliberations regarding the maintenance of quality and efficacy of drugs.

Earlier, at many forums, only issues relating to exports were discussed. If one look at the total pharma industry of about Rs.1.40 lakh crore, 80 per cent of it is export oriented and just 20 per cent caters to the domestic needs. Through this forum we want industry to focus more on domestic requirement and deliver their responsibility to manufacture more affordable and low cost drugs to meet the requirements of the poor in the country.

Unlike earlier, the industry should think out of the box. Apart from becoming exclusively business oriented it should also deliver its corporate social responsibility. If I say regulators and industry must work hand in hand it does not mean that we will let industry be the loser. It means we need to work together sharing knowledge, resolving issues, and make the regulatory and industry environment more robust and transparent. As regulators, our objective is to ensure that the Indian Drugs and Cosmetics Act is implemented in letter and spirit and at the same time ensure that the Indian public will get quality, efficacious and affordable medicines.

Recently many international regulatory agencies have been issuing warning letters and blacklisting manufacturing units in India. As a drug control officer, how do you view the quality compliance by manufacturing units in the country?
No doubt, it is important that the pharma and biotechnology manufacturing units must abide by the regulatory standards stipulated both by the domestic and international regulators. But at the same time it is wrong to paint the entire industry in the country and the regulatory system as incompetent based on one or two cases of minor violations.

In fact compared to a decade ago, the Indian pharma industry is well placed today. Today many leading pharma companies are filing new drug applications in the USFDA and registering their products in different countries across the globe. One should not forget that today India is a leading exporter of generic drugs to US, Europe, Africa and rest of the world. Had we not been compliant with quality, efficacy and safety, we would have not even ventured into highly regulated markets of the US, Europe and Japan. No doubt we have achieved major breakthroughs which many other countries could not make. Only thing we need to do is to work in unison without giving scope for others to point fingers at our industry or our regulatory system. At the same time we need to create an environment which will build confidence among the foreign regulatory agencies and other international stake holders.

Why are the foreign regulators like US FDA and EU strict against Indian formulators and not against API manufacturers?
There is a strong feeling among the industry and the Indian government that the international regulators are deliberately targeting the Indian players to exert pressure and tarnish the Indian image in the global market as majority of the block buster drugs are getting off patent by 2015 end. Post off patent period will throw open the global markets. Indian formulators are quite strong and are equally competent compared with the global formulators. The spate of recent international regulatory activity against Indian formulators is a pointer to the fact they are being pressurized by the strong international lobbies to put roadblocks on the growth of Indian formulators in the global markets.

There is a race going on between Indian majors and foreign companies. In order to expand their reach, Indian players are expanding like anything before by filing new drug applications and registering their products throughout the globe. Most of the USFDA and WHO approved units are there in India. At the same time, many foreign companies like Mylan, Abbot, GSK and many others are taking over many Indian companies. Even leading Indian companies like Hospira, Piramal, Strides and Ranbaxy and others have sold out their business.

The major reason for the foreign companies to buy smaller one in India is to take advantage of the low cost skilled man power and infrastructure available at affordable prices in India. Because of this, many foreign companies are showing interest to purchase small units. This shows that they have full confidence in Indian facilities, English speaking capabilities of Indian personnel and their education qualification. They are making use of our own people and our industry facilities to compete with Indian players in the global markets.

If one looks at the quality issues raised by the foreign regulators, most of the issues are not established as far as quality is concern. In fact most of the issues are not even relevant to the quality. Data integrity is the major issue raised. Their approach is only on the formulations units and not the API units. This is because they need the low priced APIs from India to manufacture formulations.

Negative propaganda: In my view, there is a negative propaganda going on against the Indian manufacturers. Post off patent regime the international pharma players are of the fear that India will soon grab this opportunity and capture their markets across the globe by exporting low cost affordable generic versions of their brands. In view of this, I suspect that the pharmaceutical business lobbyists in western countries might have influenced their governments and their regulatory agencies might have been pressurized to be strict with the Indian formulation manufacturers.

While on the other hand, the other major reason for the international agencies not being strict with the API manufacturers in the country may be due to the fact that they are totally dependent on India and China for procuring low cost APIs for their formulation units. If they apply stringent regulatory measures on API units in the country, their formulation units may be badly impacted.

Therefore their only focus is to contain the Indian competitors in the formulation segment. But we need to understand this and should be well prepared to overcome all the headwinds created by the international agencies in the name of quality. At the same time it is also important for our industry to be transparent and open to regular audits not giving scope to any suspicion or doubts among the regulators.

What is your comment on the government inviting investments through FDIs in pharma industry and at the same time lowering prices of essential drugs through DPCO? According to you how does this benefit the industry and domestic consumers at large?
I agree there is a contradiction. On the one hand we are talking about industry and regulators working together and on the other hand we are stressing on low price and affordability. There are ways and means to come to solutions wherein both the government and the industry will reach at a win-win situation. But as government regulators, our duty is to protect the interests of the poor patients and the common masses in the country. We are working for the government and our priority will be to see that people get quality and affordable medicines.

As a regulator I will give more weightage to quality and affordability, because, in India majority of the population has to pay for healthcare from their own pockets. According to a WHO report, about 65 per cent of India’s population is being pushed into poverty due to overburden of medical and healthcare expenditure. We are not a developed country and 90 per cent of our population doesn’t have healthcare insurance cover like in USA, Japan, or Germany and thus India decision to include more than 375 essential drugs under price control is justified.

Moreover Industry has nothing to lose much with the DPCO order. The losses incurred through DPCO are meager and they could be compensated by reinvesting revenues earned from exports. Therefore industry must not ignore their responsibility. If industry feels they can’t manufacture drugs under the drugs price control, then it is a different point to be discussed altogether. But again it is the responsibility of the government to ensure the essential medicines are affordable to the people.

In fact the government should come forward with a business model where in the industry should be made to spend the profits earned by their exports to compensate for the losses they may incur in producing essential drugs under price control.

How do you view the pharmacy education and quality of professionals in the country?
On one hand Industry is doing well and the regulatory system is also becoming stronger and stronger, but on the other pharmacy education is losing its link with the mainstream industry. The quality of pharmacy education in the country is coming down day by day. Out of 350 B. Pharmacy colleges in Andhra Pradesh 150 colleges had single digit admissions this year. This is a pointer to the fact that there is a need to bring in drastic policy changes in the pharmacy education system in the country. Excess pharmacy seats must be cut down and government should develop a regular inspection system to check the quality of education in the colleges. There is a need to develop the industry and academia linkage and bring in regulations to induct only pharmacy graduates in medical shops and pharma industry to solve the e unemployment problem of the pharmacy graduates.