CEO Insights India

The Indian pharmaceutical industry has shown promising growth over the last few decades. With a strong base of pharmaceutical third-party manufacturing in India and the resilience shown especially during the pandemic, as India’s pharmaceutical industry reflects a considerable strength and growth potential, there are many issues still pertinent to regulations and quality standards that are challenging the industry. It needs to be overcome to become at par with the stringent US and European Pharma markets. Here, Acesst Pharmatech (formerly Swami Samarth Pharmatech), a Mumbai-based company takes the lead by serving as the Lead Quality Auditor to help companies who want to improve their quality and supply their products like pharmaceuticals, medical devices, dietary supplements, food ingredients, and food supplements to the US and European markets. Acesst Pharmatech strives to lead the Indian industry with ethics and abiding globally set industry regulations, under the able leadership of Nitin Ramesh Parab, CEO of the company for the last six years now.

Recently, CEO INSIGHTS engaged in a one-on-one interaction with Nitin to know about his exclusive and inspiring professional journey in Pharma. Let’s read on!

Give a brief account of your professional background and experiences.
I have done Chemical Engineering with MBA in International Business Management. Since I wanted to become a Scientist, I initially started my career with German Remedies, and there got exposed to Quality Control profile working on various products R&D over there for almost 23 pharma products in the production area doing developmental and troubleshooting & testing on new molecules (Fluoxetine Hydrochlorides, Xanthinol Nicotinate, and several antibiotics), which was under development at that time. Later when I shifted to Cipla, I gained complete Quality Assurance profile exposure looking after the audits, internal qualifications validations, and regulatory affairs. There only, I also got an opportunity to work with Dr. Norman Franklin who was a trainer of the Pharma guidelines ICH Q7 there. Following, I also worked with Charak Pharma.

Eventually, thinking of starting off

my own, I began my auditing career as an Independent Auditor in 2010,performing quality system audits for US-based companies. There are some regulatory standards (21 CFR Part 211, 210, Part 820, and Part 111, ICH Q7), that the US follows to qualify their suppliers or third-party manufacturers. I have worked with the US certification bodies, which certify all the companies in India who want to export their products to retailers in the US. I serve all such Indian suppliers as the Quality Lead Auditor. The journey that began in 2010 was a struggle, but improved a lot since 2015 when USFDA become very rash on the Indian industry to qualify for the supplier, supplier management, and supplier audits. Since then, having never looked back I moved on as an Independent Auditor and then the proprietorship firm Swami Samatha Pharmatech which in 2017 turned into Acesst Pharmatech. Until the time, I have worked as an independent consultant and auditor for numerous US-based certification bodies and larger companies in the US like Pfizer, and others.

What is the motivation that fuels your daily life & career? How has been your path to success and what is your success mantra?
So, I have two passions. One is the travel passion (since childhood), and the second is Auditing. However, my two passions are interrelated and were driven when I came into cognizance with Dr. Norman Franklin, and his travel tours for Auditing across the globe. I chose to become an Auditor and am really happy today traveling around Auditing and exploring the world.

Well, the path to success was challenging for me, especially, during my struggle period from 2010-2015. I used to get only one audit once in three months or like some of the job books for the drug master file submissions and more. But, that made me go on continuously keeping my tracks and focus areas on the audits, aspiring to be in the auditing field and become an internationally qualified auditor to be able to audit numerous US and European-based companies, including the US authorities audits. Well, it's only the dedication to the work and the commitment to timelines, and the ethics that I’ve been maintaining that are my success mantra.

How would you define Swami Samarth Pharmatech as an organization and its position in the market?
Acesst Pharmatech (formerly Swami Samatha Pharmatech)started in 2017 is a Pharmatech firm that conducts

Audits throughout the globe providing businesses services like Third Party Audits of Pharmaceutical (21CFR 211,210, 111, ICH Q7A, EUGMP) and Medical Devices (Part 820 & ISO13485) manufacturers, including advising on compliance with cGMP, conducting mock Audits for US, EDQM and other Authorities. It also supports Supplier Qualification, Mock audits, GAP Analysis, and QMS Consulting.

We strive to strengthen the Indian Pharma Industry’s quality standards. Also, ethics is very important in this field. It is only the ethics which we have maintained, showing dedication and commitment to timelines that has brought us here today.

Tell us about your leadership approach.
Well, whenever I get a project, I do confirm which of the expertise I hold, and deploy ICs (Individual consultants) to distribute the other works regarding the project realizing their expertise individually. So, roles are segregated as per individual IC capabilities and are initiated by holding project meetings and discussions with all. Nobody is the leader but it's teamwork where we work all together to meet the client’s needs and make them happy & satisfied.

What is the future destination you are heading towards?
I have more than 12 clients and I am looking forward to growing further in Pharma Consulting and Auditing field. While my future approach is to enter into pharma manufacturing as well as into the supporting functions of Pharma manufacturing in the near future maybe within two to three years from now.

Any advice for budding industry leaders?
Well, to newcomers in the industries who want to try Auditing and pursue it as a career, I would say, Auditing may look good on the outside but entails several sleepless nights (because of the report writing) and continuous travels. So only think of becoming one, if you are really passionate about Auditing in Pharma and have that dedication, ethics standards and commitments you need to possess to complete the work on time.

Nitin Ramesh Parab, CEO, Acesst Pharmatech
A dedicated Pharma Leader, equipping the Indian Pharmaceutical & Manufacturing Quality Standards offering quality audits and consulting services at par with US & European Standards.

•Hobbies:Painting, Cooking, and Traveling
•Favorite Cuisine:My hand-prepared Chicken & Lamb Biryani. My son just loves it.
•Favorite Book:Spiritual and old mythological books.
•Favorite Travel Destination:I have traveled 29 countries, but my favorite still is India.