What inspired you to write the book, Blue Ocean of Compliance? Is there a dearth of material to guide companies on compliance?

It has been more than 20 years now and I have seen practically and very closely the psychological conditions of the people at the time of regulatory inspections. I have noticed tremendous pressure at the time of inspections and also, on the other hand, come across people preparing for the regulatory audits in a relaxed mode. After going through many customers and regulatory inspections, after going through the observations and gaps, after reading many warning letters and 483s; I could only imagine the experience, the psychological conditions of the people, and business owners, and the impact of these inspections on their families.

When I look back at the inspections I have experienced, I think to myself: instead of operating from fear or operating with a worrying mindset, why don't we operate with a winning attitude and confidence? Why can't we work for “no observation” instead of "not to fail" in the regulatory inspections? I think we should change our thinking patterns and work to win, instead of "not to lose". We have to win; we have to work for the outcome of the inspection with "no observation". We have to prepare for the inspection every day, we must act as if there will be an inspection every day instead of preparing when the time comes.

While these thoughts of pain and gain were going on, the idea of this new concept came into my mind; to help the pharmaceutical industry develop a winning strategy to face the audit.

The concept behind writing this book is to give a new angle to look at the regulatory Inspection, and to help reduce and solve the problem of non-compliances on the site.

This book will make the reader understand the concepts and the reader will be able to decide their path towards compliance.

There are guidelines available for every regulatory compliance. But the gap is in implementation, the gap is in the thought process, gaps are that reasons of non-compliances are many times not because of any technical reason but only due to the wrong mindset of the people. This topic is discussed in detail as a separate topic in this book.

At times, trainers are very knowledgeable but the training has not created a deep impact on the minds of those attending the training.

The technical aspects are discussed in the guidelines. But there are elements which are beyond the scope of the guidance.

Many of the elements which I observed and understood are discussed in “Blue Ocean of Compliance”.

So, whoever is part of the Pharma Industry, irrespective of any area must read this book at least once to be familiar & read it multiple times to reemphasize and should implement the ideas in their routine to achieve the results.

The Indian pharma industry is known as the pharmacy of the world. However, quality issues do surface at regular intervals. What are the reasons for the same?

Yes, it’s our pride that our Indian pharma industry is known as the pharmacy of the world.

India is the pharmacy of the world but this does not mean that there will not any issues or problems in this. In fact, more growth more problems. More R&D on new molecules, more new medicines, new processes, new markets, different regulatory requirements and hence new challenges. Problems shall be directly proportional to the growth. For example, if one is moving forward then it’s obvious that new challenges will crop up along the way. Success is achieved when those challenges are overcome by responding in a proper & accurate manner as per the regulatory requirement to get the quality product.

Indian Pharma Industry has grown so much because it has overcome many problems.

The problem happens when instead of investigating the problems in depth and taking corrective actions they are suppressed or hidden. As the actual root cause is not being solved the same problem is repeated. It means that CAPA (corrective and preventive actions) are not effective.

You have mentioned that one needs to strike a balance between compliance and commercial benefits. How does one achieve that?

It is an illusion that by compromising the Quality & Compliance of the product commercial benefits will be lasting and permanent. In the short run, it might seem that by compromising the compliance/quality of the products one has saved the cost but in the long run, the company has to pay a very high price for that.

On the other hand, it should not happen that under the pretext of compliance unnecessary expenses are incurred. Which is not the actual requirement.

Many a time, the problems are due to the mindset or other elements. Many of those elements are discussed in the book

Many Indian pharma companies find it difficult to navigate the complex regulatory issues in regulated markets. Is there a gap between their understanding of compliance and that of the USFDA?

Following Regulatory & Compliance is simple but not following simple requirements makes it complex. It is right that to follow regulatory requirements there should be some systems, processes, and standard operating procedures which may require investments.

And Regulatory guidelines are nothing but the practices to make quality medicines which are safe for the patient. It is not only for Indian Pharma companies. It is applicable globally.

There may be different reasons;

(a) People have knowledge and awareness but they do not have the intention to follow the compliance.

(b) People do not have enough knowledge but they have a willingness to learn and implement.

(c) People who neither have knowledge nor willingness to improve. Who have a casual attitude towards Quality & Compliance but are only interested in commercial gains.

The above aspect is covered in the book.

What does your book aim to address and who should be buying this book?

As per the subtitle of the book, it is a holistic approach toward achieving regulatory compliance for pharmaceutical industries with No Observation.

There are six Chapters in this book;

Chapter One Why Regulatory Inspections?

Chapter Two Types of Regulatory Enforcement Actions and Regulatory Actions on Non-Compliances and Devastating effects on the Pharmaceutical Industry due to non-compliance

Chapter Three Reasons for Non-Compliances

Chapter Four Actions to be taken

Chapter Five Part I Wisdom is to learn from other's mistakes (Warning Letters Case Studies)

Chapter Five Part II Wisdom is to learn from other’s mistakes (Comparative study of four year’s 483s)

Chapter Six Blue Ocean of Compliance

In short Blue Ocean of Compliance is a book employing a one-of-a-kind thought process for achieving compliance with No Observation. It takes you through a guide of Regulatory Inspections elaborated on the US Regulatory Market. This book will not only equip you with regulatory knowledge but will also empower you to solve complicated non-compliances, in the context of factors that we do not even think of. The ideas in this book are very simple to understand. They will imbibe the seeds of "acting to win" instead of only being good enough to survive. If you are a Founder, a CEO, an entrepreneur, or anyone in the pharmaceutical industry. If you are a part of the pharmaceutical industry or are even just starting out, this book is a treasure for you.

Following is the extract from my book which comes under the title “Can this book possibly drive a change in your life?”

“If you ask me for whom is this book aimed, I would reply: if you are working in the pharmaceutical industry in the cGMP environment, if you are working in the quality assurance, or quality control or, production department, if you are part of the team that is responsible for the audit, then this book is for you. If you face customer audits, then this book is for you. If you worry about inspections and are stuck in finding a way to proceed on this path with a better and more efficient approach, then this book is for you. If you are in R&D and development, then this book is also for you to expand the dimension of your thought process to support cGMP department.

If you are a fresher and you don't know anything about the audits, why the audits happen, how to prepare for audits, then this book is for you.

If you are a CEO, President, Vice President, General Manager, Manager of any Pharmaceutical company and you want to make your organization pass regulatory audits with no-observation, then this book is for you.

If you are a CEO or Founder of a pharmaceutical company and you want a brand that everyone trusts, this book is for you.

If you are any of the above and you want to know what are the practices that one should and shouldn't follow, then this book is for you.

In this book, I have covered many of the incorrect practices which led international pharmaceutical companies to the path of getting enforcement actions, warning letters, and 483s.

Hence, this book has been written to help those people working in the Pharmaceutical Industry who are a part of Regulatory Inspections, who are business owners of Pharmaceutical Organizations, people who are founders and CEOs and the people who are working in the cGMP areas.”

The premise of any successful organization is its culture of quality. Why do Indian drug companies fail to adhere to Quality Culture and safety standards?

Yes, Quality Culture should be the highest priority to be in compliance. So that good quality medicines can be manufactured effortlessly. In that case, people shall work to win instead of surviving. If the people are highly competent & knowledgeable but are not aligned to build the Quality Culture then that is also not in favour of the organization’s success.

When Quality & Compliance is not the priority but the benefits are thought to be only commercial gain then problem of not having the Quality Culture takes place.

Although it seems the benefits of doing cost-cutting in long term, it’s a loss to the company.

I have discussed in details about this in my book with different examples & case studies.

Not Failing to adhere to the Quality Culture is the problem of many companies in India but there are companies that encourage Quality Culture. It is not only the problem of Indian companies but if you will read the warning letter then you will conclude that this problem is in other countries also.

The reasons of no-compliances are due to not having Quality Culture have been discussed in my book.

How do other countries fare when compared to India when it comes to USFDA approvals?

A comparison may be within our country India also. There are many companies who qualify the USFDA audit with Zero 483s. And there are companies that get warning letters.  USFDA Approval is the process of qualifying the Regulatory Inspection in which compliance of regulatory requirements is checked. It is a matter of following the guidance & manufacturing good quality of medicines to ensure the patient’s safety & health.

You will find non-compliance problems in every country.