Today non-pharma companies are also filing for drug approvals : Kunwar B Kishore Arora

There is a growing awareness for the drugs that are being consumed to be regulated and as the regulators in the Western markets in US, as well as in Europe are becoming more active, the regulators around the world are collaborating. In India as well, we have seen that collaboration is taking place.

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Shahid Akhter, editor, ETHealthworld spoke to Kunwar B Kishore Arora, Global CEO and COO, APCER Life Sciences, New Delhi. to know more about the trends and developments in pharmacovigilance industry.

Trends in pharmacovigilance industry
The global pharmacovigilance industry has evolved over the last decade and half, we have seen the number of molecules, the drugs that have been filed between 2000 and 2015 has increased by about two and half times. We have also seen increase in the areas of rare diseases, where the investments are being made by the innovator companies. This has actually helped patients who previously were not getting the appropriate amount of medical health care for rare diseases and that is an exceptionally good work that is being carried out. We have also seen a new trend in the industry, there are non-pharma companies that are also filing for drug approvals and that number has increased by above 20% at the global level. If I take a look at the number of drugs that get approved at FTA, they range from about a couple of dozen every year with the lowest number being 18 in 2007 and about 45 drugs were approved in 2015.

The statistics in India are limited and largely collected by the pharma companies themselves. What we have seen within the Indian market is that there is a growing awareness for the drugs that are being consumed to be regulated and as the regulators in the Western markets in US, as well as in Europe are becoming more active, the regulators around the world are collaborating. In India as well, we have seen that collaboration is taking place. This is not only going to benefit the Indian consumers, but also will also provide a level of confidence to the global regulators around the world to source drugs that are manufactured out of India. And that industry is increasing in a significant way.

Integrated pharmacovigilance cloud and services impact on the services industry
Pharmacovigilance market few years ago was a little over two and half billion dollars. We have seen the market increase till last year in the range of about three and half billion and it is poised to increase to about 8 billion by 2025. Large part of the pharmacovigilance spend is increasing within the outsourcing industry. The in-house spend for pharmacovigilance is relatively flat, because of the specialization that is required, we’re seeing more and more companies are preferring to work with companies, who are specialist within the pharmacovigilance space and who also offer allied services like medical information, medical writing, regulatory services, and with that we have got to have a level of technology which helps in short compliance within the pharmacovigilance industry.

Pharma industry regulations and changes
The most active regulators around the world are FDA, MHRA and the regulators of other countries are equally active. And with the collaboration what we are seeing is that patient data and safety is becoming a prime concern with all the regulators. There have been new regulations around the GDPR which have come out, which protect patient data and the regulators vis-a-vis patient health have also been making sure that the drug right from its inception to pre clinical, through clinical as well as post marketing is properly checked, documented and the level of scrutiny has been increased significantly. The regulators are also checking, visiting factories around the world and equally so in India, to make sure that the drugs that are getting manufactured, follow the standards and guidelines, quality and the assurance that patient safety and care is of prime importance for the regulator.

Services offered by APCER
APCER is a global company and we provide assured services within the pharmacovigilance industry. We have more than 65 customers, which we provide services to, two thirds of them are in the United States and about a third in Europe. We have also got a few in India. Large part of the work that we do is within the pharmacovigilance space, medical information, medical writing and to some extent in the regulatory space.

We also have certain allied services which is quality as a service, we also provide IT platform as a service for making sure that the customers were taking our pharmacovigilance services do get the latest technology platform. We also support two- thirds of our customers on the oracle platform and a third of our customers are on the ARIS platform. In APCER, we are roughly 700+ employees of which 90% of them are healthcare professionals, 15% of them are medical doctors with an MD and we cover most therapeutic areas, the balance 500 plus are Pharm.D’s, M. Pharm’s or B.Pharm’s within the company.

APCER Life Sciences’ partnership with ARISG
The ARIS Global and APCER relationship came together last year, and we have now seen the implementation of the latest ARIS G platform which is cloud based; it has a certain amount of automation already built in and the automation is now getting increased to ensure a higher level of compliance as we go forward. We have on the ARIS G platform migrated a little over 40 customers and it has been done very successfully and seamlessly. Is it probably one of the larger migrations that any company would have gone through on a fully compliant cloud based platform.

Key markets for APCER
The key markets will be the United States as well as Europe for these services. We already have customers not just within the life sciences space of the pharma companies but we also provide services to companies that are doing clinical trials of which there is an increasing number. We are also providing services to companies who are in medical device space so that they are compliant for pharmacovigilance as well.

What are APECR’s future plans?
APCER’s future plans within the medical pharmacovigilance, medical writing, regulatory space is to create global state of the art centres. We just launched one on January 18, 2018 in Ahmedabad and the next phase of expansion should be ready in about October 2018. This would increase the seating capacity that we would have to about 450 seats, for placing the talent over there…

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