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A theme to unite, build confidence among stakeholders

Our Bureau, Hyderabad
Thursday, January 22, 2015, 08:00 Hrs  [IST]

The 66th Indian Pharmaceutical Congress (IPC) theme ‘India Pharmacy of the world and role of regulators and pharma industry’ is aimed at bringing pharma industry and the regulators on a single platform. Even as it focuses on India’s strength as a leading producer of low cost quality generic medicine of the world, it also stresses on the need for industry and regulators to work hand- in -hand and strengthen each other for the overall growth of the sector.

No doubt, pharma industry needs to abide by the highest standards and needs to be regulated tightly to ensure quality, safety and efficacy of the products. However, the increasing incidents of Indian pharma manufacturing units being labeled ‘not of quality’ by western regulators for even minute faults has given rise to doubts in the minds of various groups not only in India but also internationally.

To overcome the, apprehensions, doubts and repercussions in the aftermath of the international regulatory warnings, the Indian Pharmaceutical Congress has given a call to the regulators, industry, research and academia to work hand in hand to thrash out apprehensions and restore confidence among not only the international regulatory community, but also the domestic customers and millions of people across the globe.

In view of this, the 66th Indian Pharmaceutical Congress (IPC) has come up with the apt theme. Through this theme the congress is sending positive signal to the world about the competitiveness of the Indian industry and also want the world to realize the country’s capabilities to compete in the global arena. Overall the congress will be stressing on building confidence not just among the domestic consumers but also but also among the global audience about Indian pharma.

India’s capability in the generic segment is widely acknowledge in the global markets. Not just the regulatory markets like the US and EU are procuring low cost high quality generics from India, the country’s pharma industry has extended its reach to every nook and corner of the health care industry in the world.

As the time is fast approaching for the branded drugs to come out of the patent cliff, leading global pharma players, worried at the possibility of losing their traditional markets for the Indian players, are putting pressure on the Indian pharma industry through global regulators as has been witnessed in the recent times where the US FDA and EU putting stringent regulatory hurdles for Indian traders.

Taking into account the contemporary regulatory issues haunting Indian pharma industry, and to dispel the apprehensions about Indian regulatory system and the pharmaceutical industry among the global pharma fraternity, the 66th annual event of Indian pharmaceutical congress has chosen the apt theme to drive the three- day high voltage scientific congress in Hyderabad.

The major thrust of the congress is on building confidence among international regulators about the Indian pharma industry. As more and more global regulators are viewing Indian pharma industry with suspicion, the congress has roped in experts from top companies and regulators from across the globe to speak at the symposia to dispel their doubts on India pharma.

The theme also is apt as India is fast adopting regulatory reforms and is fast complying with global standards. The theme also stresses on creating an environment of transparency and a change in mindset among the Indian manufacturers. Regulators and the pharma industry should work in unison. Manufacturers should be more accountable by producing authentic data and shun manipulations during inspections.

By strengthening the regulatory system and becoming more transparent in research and experimental data, the Indian pharma industry and the government regulations are also touching up on the need to provide affordable medicines to the common man in the country. Not just in India, the world over affordability of healthcare and accessibility is a major concern and the congress is expected to focus on these lines, which is well encompassed in its theme.

Overall the IPC will be looking into loopholes in regulatory systems. It also wants the world to know that Indian pharma industry is equally well competent and can face any kind of challenge and at the same time will not budge to the pressures of the other countries by imposing sanctions on its exports.

According regulatory experts in India, the major reason for the US FDA, EU and other regulatory bodies to impose stringent regulations on Indian manufacturers is because of the pressure from international manufacturers. As more and more block buster drugs are expected to come out of patent regime by 2015, and as Indian manufacturers are well competent enough to cash in on that opportunity to develop low cost quality generics, the international pharma community fears heavy competition from India and are tarnishing the image of Indian pharma industry through their regulators.

“India is already recognised as a high quality low cost generic manufacturer in the world. With the end of patent cliff by 2015, India is poised to become ‘Pharmacy of the world’ as it has the knowledge, technology, capacity and infrastructure to develop generic drugs of all the leading brands. Our industry will give tough competition to the international players. Realising this negative campaigning is being spread against the Indian industry. Through IPC we want to tell the world we are equally competent in terms of regulations and quality standards. We want to build confidence among the global regulators, international manufacturers and domestic consumers that Indian industry will always keep pace with international standards and strives to provide high quality and affordable drugs not only to its domestic consumers but also to the international markets,” said Ravi Uday Bhaskar, General Secretary AIDCOC and organising committee Chairman for the 66th IPC.

The theme mainly focuses on regulatory aspects, contemporary issues relating to industry and scientific content. “We have selected this theme with an objective to bring back industry into IPC’s fold and create a common platform where industry, regulators and academia meet and build confidence among all stake holders,” said Raja Bhanu, secretary organising committee.

Regulators from across 20 countries have been invited and CEOs of all top pharma companies will be taking part in the international regulators meet and CEOs conclave which will be organised during the three-day IPC congress.


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