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Pharma Undergoing Paradigm Shift

Vishal Rajgarhia
Director & CEO, Finecure Pharmaceuticals Ltd

There has been a paradigm shift in the way the government is now interacting with the pharma industry “ from one of assertiveness and insistence; it has now become one of collaboration and assistance, says Vishal Rajgarhia, Director & CEO, Finecure Pharmaceuticals Ltd, in conversation with Elets News Network (ENN).

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How is Make in India helping Finecure Pharmaceuticals boost its manufacturing capabilities?

Make in India is one of the major reforms that our Prime Minister (Narendra Modi) has taken and it is certainly going to boost the pharma industry, given that the pharmaceutical industry is one of the 25 key sectors that the government has identified as a potential sector for foreign companies to invest in. Furthermore, a dedicated team to respond immediately to business entities through a web portal and easing of statutory and regulatory procedures means that the pharma companies will at last be able to work to their full potential. There has been a paradigm shift in the way the governent is now interacting with the pharma industry “ from one of assertiveness and insistence; it has now become one of collaboration and assistance. There will be new infrastructure and a new mindset where we will be competing with the best. Furthermore, increased competition will fuel challenge and make us less complacent and motivate us to higher standards of customer satisfaction and product innovation.

What implications do you see for the pharma sector once it is delinked from the medical devices industry?

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To be honest and fair to the government, over the last many years, many attempts had been made to enact a law regulating medical devices but somehow it could never be done. It is also true that nowhere else in the world are the pharma and medical device sectors governed by the same set of regulations. So, the delinking was inevitable, something that was waiting to happen. I personally feel that it is a step in the right direction. It is a policy decision and the intention of the government should be respected and appreciated. My only concern is that since the medical devices industry is in an embryonic stage and was so heavily dependent on the pharmaceuticals industry for its nourishment, there could be problems that we cannot foresee for the moment. There certainly was scope for a gradual phasing and delinking of the two industries. But it has made price control for medical devices a reality and thumbs up to that.

The lack of a regulatory framework along international lines, the industry body felt, has been a major factor as investors were discouraged by the initial move of 22 medical devices being regulated as drugs by CDSCO and state drug controllers. The government has taken the first step in the appropriate direction. But there needs to be a separate law book, separate rule book and separate regulatory authority.

The lack of a regulatory framework along international lines, the industry body felt, has been a major factor as investors were discouraged by the initial move of 22 medical devices being regulated as drugs by CDSCO and state drug controllers. The government has taken the first step in the appropriate direction. But there needs to be a separate law book, separate rule book and separate regulatory authority.

The government has taken the first step in the appropriate direction. But there needs to be a separate law book, separate rule book and separate regHow do you see IoT, big data analytics, and artificial intelligence impacting the pharma sector? What role these latest technologies are to play in improving inefficiencies across the sector?

The arrival of Internet of Things (IoT), big data analytics and artificial intelligence has woken up the pharma industry and made it aware of its immense potential and its ability to bring the Indian pharma industry on par with the best in the world. IoT, big data analytics and artificial intelligence are the future of the pharma industry in India. The ability to convert massive amounts of data into key performance indicators, the ability to check their plants from anywhere in the world over their smart phones, identifying potential problems and implement corrective action, it has offered a new pathway to pharma companies to develop actionable insights, organize their future vision, boost up the outcomes and reduce time to value regarding their management, planning and the measurements. Logistical planning becomes that much easier and production costs will become lower and increase productivity and efficiency. It is a blessing and boon to the industry and will change the face of how we work.

Promoting R&D, innovation and discoveries in technologies and molecules in Indian context is the need of the hour. How is India placed with regard to the industry-academia partnership for promoting innovations in the pharma sector?

We must confess and agree that most pharma companies are under investing in research and development (R&D). Offhand I cannot name even a single company that has tie-ups with the research academia. R&D is the backbone of any company and helps it to develop new products and services that drive growth and progress. The government should do more to increase this awareness and also initiate incentives and programs that will motivate the industry to channel their resources towards research and development. Without doubt the landscape of partnership between academia and industry has to be expanded and become a prominent feature in the industry. It does seem counter-productive to share data and give away information that can negatively impact business but the benefits of collaboration are huge. It will provide access to new talent and modernisation and enlarged conviction and clearness with customers and other stakeholders. These advantages will happen not only for the pharma companies but also for the academia. its a win-win situation for all concerned.

What key challenges do you see impeding the growth of the Indian pharma sector?

There are many factors that hinder us from realizing our full potential but instead of looking at them as impediments I look upon them as challenges that need to be overcome so that the Indian pharmaceuticals industry can achieve its potential and convert these challenges into success stories. However, for this to happen it needs the support of the policymakers, academia and financial investors and all other stakeholders. However, since a question has been posed I would say that the three biggest impediments are an unsatisfactory energy infrastructure and poor transport infrastructure. India needs to focus on API to remove dependency on imports of bulk drugs for making drugs. The industry needs to focus on innovative drugs and value addition instead of just making generic drugs. The GMP issuance should be for a longer period and GMP should be recognized in other countries so that they do not need to re-inspect facility having Indian GMP which will give Indian Products a better brand value and revenue.

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