Ravi Udaybhaskar, Chairman -Organising Committee and Secretary General, All India Drugs Control Officers Confederation shares the glitches and opportunities behind organising the 66th IPC with Usha Sharma
Why did the Local Organising Committee of IPC decided to organise the 66th IPC in January 2015 instead of December 2014?
The decision to organise 66th IPC in 2015 instead of 2014 is not taken by the Local Organising Committee and is taken by the Council of the Indian Pharmaceutical Congress Association. The decision is based on the feedback received from pharmaceutical industry, pharmacy teachers, potential speakers from abroad and regulators. Some of the difficulties expressed were semester examination in pharmacy colleges, winter session of the Parliament, CPhI India event in Mumbai and non-availability of foreign speakers due to Christmas holiday.
The 66th edition of IPC will have the theme ‘India-Pharmacy of the World – Role of Indian Regulators and Pharma industry.’ Reveal more on the same.
The president of IPC selects the theme for the congress. The theme is selected after taking into consideration factors such as host association which represents drug regulatory officers in the country and the current industry scenario.
Thanks to various government initiatives, robust regulatory mechanisms, focus on quality and innovation, India is poised to become pharmacy of the world. The Indian pharma market is expected to reach $25-30 billion by 2016 and Indian pharma industry has been able to penetrate the regulated markets such as the US and Europe. In this context, the theme of the 66th IPC is appropriate and in line to showcase India’s capabilities.
Many Indian pharma firms received warning letters and import alerts etc in 2014. Will the 66th edition look into these issues?
Yes, the 66th IPC will certainly address these issues in depth, have deliberations amongst stakeholders and try to evolve strategy to overcome these challenges. We have designed the programme in such a manner that these issues are addressed and the stakeholders are sensitised on relevant issues e.g. there will be an independent session on importance on documentation, data integrity etc. Focused discussions are also proposed to be held during President’s symposium, CEO’s conclave and the regulators meet organised in association with Pharmexcil. For this purpose, we have invited international regulators and we expect representation from 20 countries.
We have also invited Drugs Controller General (India), most of the state drugs controller and some senior officers in the state and Central Drugs Standard Control Organization. We have also invited CEOs of 60 to 70 pharma companies. We are sure the deliberations in such interactive meetings and sessions will yield fruitful results and will also help the regulators and the pharma industry to establish synergy enabling them to address the issues.
Globally, the image of the Indian pharma industry has been tarnished. What steps should be taken to re-build trust in the global market?
In our view, it is not correct to draw such generalised inference. It is true that there have been certain instances wherein few companies have been questioned on certain issues. However, these should be viewed as specific cases which have been dealt with by the concerned manufacturers by addressing issues raised. Ever increasing export of medicines from India to both regulated and semi regulated market is a testimony to the fact that the international community has confidence in the quality of medicines manufactured in India. Certain specific issues like documentation, data integrity etc. need more focused attention and therefore an attempt will be made to sensitise the stakeholders on these issues and raise bar on quality management exercise. A strong apprehension prevails in India about an other angle to these controversies and a strong feeling about deliberate attempts by certain interested parties outside India to tarnish the image of the Indian pharma industry. It should be noted that the competitive edge of the Indian pharma industry is to provide quality generic medicines at cheaper prices as compared to the foreign competitors, perceived as a big challenge by the foreign competitors. Due to this competitive edge, Indian pharma companies will play a crucial role by capturing significant global market share of generic medicines. Controversies may be perhaps to create obstacles in pharma industry’s capacity to claim substantial market share of generic medicines in 2015 when many blockbuster drugs will be off patented. While specific incidences will have to be addressed specifically, we have to certainly project the positive features of the Indian pharma industry and capabilities of Indian regulators to ensure availability of safe, standard and efficacious medicines at affordable prices to needy patients in every country. We also have to showcase the capabilities of the Indian pharma industry and Indian regulators so that message is conveyed that both are at par with international standards.
What efforts need to be taken for uniforming the regulations in all states?
At the outset, it should be noted that regulations are common for all states, lack of uniformity is in implementation due to differences in interpretation, lack of sufficient trained manpower etc. In fact, there is an inbuilt regulatory mechanism under the Drugs and Cosmetics Act, 1940 by way of two statutory bodies namely Drugs Consultative Committee and Drugs Technical Advisory Board. We will try and strengthen this mechanism. We will also explore the feasibility of having guidance manual for the regulatory officers in India both in central and state drugs control organisation. Ongoing continuous training programmes is another area where we need to give more attention. Systematic efforts in this direction and complete adherence to the directives issued on the basis of deliberations in drugs consultative committee and compliance of guidance manual will play an important role in ensuring uniformity in implementation.
Which topics will be discussed at the event?
The focus of the scientific programme will be on two components namely quality management mechanism and ensuring compliance through effective regulations and implementation. We have designed scientific contents in such a manner that it is specific to the theme and is relevant to the industry and regulators. Experts from the pharma industry and regulatory agencies are invited to share their expertise on these issues with the delegates.
We have also invited social scientists to sensitise the pharma industry, regulators and the budding pharmacists about expectations of the consumers. There will be presentations from the stalwarts of pharma industry about expectations of the industry from academia.
Why do you think students and pharma companies should take part in the event?
This is a misconception. The Indian Pharmaceutical Congress Association (IPCA) is organising IPC and IPCA is a federation of associations of pharmacy professionals from various facets of pharmacy profession such as industry, regulatory, hospital pharmacy, community pharmacy. Therefore, the event is for all the pharmacists and not restricted to industry or any specific segment. For students, this is an opportunity to know about advances in technology, understand aspects of entrepreneurship and interact with the senior professionals of pharmacy professions. Scientific paper presentations and poster presentations will give them an opportunity to showcase their abilities before seniors. Participation by the students in IPC is certainly value addition for them.
According to you which curriculum urgently requires upgradation and why?
There is a strong feeling that curriculum has been not kept pace with the current scenario, advances in technology and the requirement of pharma industry and other sectors. Priority should be to change curriculum to give practical orientation. The methodology to make changes in the curriculum is also not dynamic.
In my view, the process should become more dynamic and should be such that inputs from industry, regulators and other sectors are considered while modifying the curriculum. The industry, academics, regulators and other stakeholders should sit together and modify curriculum to suit the requirements of the industry and other sectors such as research and development, clinical trials etc. It should also be such that students passing out of the colleges meet the expectations of the prospective employer thereby enhancing employment opportunities.
How is IPC 2015 different from previous years?
I am sure 66th IPC will be different from any other congresses. This is the first time an international regulators’ meet will be organised in association with Pharmexcil. This is the first time that all state drug controllers and most of the senior officers of CDSCO are invited to participate in the international regulators’ meet. Thus, we are providing a common platform for industry, Indian regulators, international regulators to interact with each other in order to understand and deliberate the relevant issues. I am sure we will be successful in bringing back the industry to the pharma. We have already set a record of having the highest number of delegates registered from industry.
As a host, what are the problems you face?
IPC has become a mega event and organising of the congress is a herculean task. It demands a lot of financial resources, talented and dedicated human resources. Fortunately, talented and dedicated manpower is available within the pharma fraternity. However, the cost of organising the Congress is increasing each year due to an increase in the cost of all inputs. Raising of funds is becoming difficult day by day. The money spent on each delegate is almost double the registration fee. However, there are constraints in increasing the registration fee. We also need to consider student delegates and therefore this year we have reduced the registration fee for the students by 20 per cent. We have also invited international and Indian regulators for the interactive meetings. All this adds to the cost and become an additional burden for the organising committee. We will have to deliberate on these issues in IPCA and take a serious look at the current format and device methodology whereby IPC becomes self sufficient and more meaningful.
What message would you like to convey to the industry?
The Indian pharma industry and Indian regulators need to ensure that robust quality management system is in place and there is a strict compliance of good manufacturing practices, zero tolerance to any deviation to ensure availability of standard, safe and efficacious medicines at affordable prices to the needy patients. We also need to focus our efforts on promoting rational use of medicines. Finally, we need to remember that we the pharmacists exist for safeguarding interest of the consumers and society.