Quality drugs through Regulatory compliance: Akums ensures Regulatory Compliance to Improve Drug Quality
The pharmaceutical industry is subject to rigorous regulation globally to ensure the safety of medicines. To improve the delivery of pharmaceutical products, quality improvement measures should be applied at every level of the manufacturing process and the products should undergo comprehensive testing to confirm their safety and effectiveness.
Regulatory compliance is critical in quality management as it ensures that a company’s products comply with legal and regulatory regulations. Noncompliance can result in product recall, a tarnished brand name, and difficulties acquiring consumers. Product failures, safety difficulties, and other issues that might hurt customers or the business can be reduced through compliance. It aids in the development of consumer trust, the protection of brand reputation, and the avoidance of costly legal and commercial challenges.
Akums is a company that prioritizes quality in every step of manufacturing. Akums have implemented global standards in quality control (QC) laboratories and documentation processes ensuring that products meet the highest standards of quality and regulatory compliance. By adhering to these standards, Akums continually improve its product quality and ensure that they comply with the regulations set forth by regulatory bodies.
Regulatory compliance is essential in the pharmaceutical sector as it ensures that medicines are safe, effective, and of high quality. These regulations serve to reduce the hazards of medication usage while optimizing the therapeutic advantages. Pharmaceutical companies must enhance the quality of their medicines, maintain customer trust, and avoid drug recalls by conforming to regulatory guidelines.
A centralized QC lab can assist to streamline the drug testing process, decrease time, and assure drug quality uniformity. This assists pharmaceutical businesses in meeting regulatory standards, which differ by nation. Companies that adhere to global standards can avoid costly delays and drug recall as a result of noncompliance. The QC laboratory at Akums is the largest in Asia in terms of batch and volume for assessment and is outfitted with state-of-the-art QC equipment such as an Atomic Absorption spectrometer, Raman Spectroscopy, and polarimeter, among others. Akums also has a dedicated Compliance unit solely focused on conducting quality audits.
A centralized QC lab can assist to streamline the drug testing process, decrease time, and assure drug quality uniformity. This assists pharmaceutical businesses in meeting regulatory standards, which differ by nation. Companies that adhere to global standards can avoid costly delays and drug recall as a result of noncompliance. The QC laboratory at Akums is the largest in Asia in terms of batch and volume for assessment and is outfitted with state-of-the-art QC equipment such as an Atomic Absorption spectrometer, Raman Spectroscopy, and polarimetry, among others. Akums also has a dedicated Compliance unit solely focused on conducting quality audits.
A Compliance Management System (CMS) can streamline compliance tasks by identifying, managing, and documenting their status to meet various reporting requirements. Automated documentation eliminates human error and ensures data accuracy, reducing the risk of errors that could compromise drug quality.
Nowadays, it is crucial for pharmaceutical facilities to establish documented preventive measures against contamination and cross-contamination. To identify potentially dangerous drugs and materials, numerous pharmaceutical companies opt to use color coding. The effectiveness of color coding is maximized when it is done simply. Akums enforces SAP color-coding system for all tools, including scoops and cleaning equipment, to ensure proper zoning and prevent contact with improper materials.
Compliance with regulatory standards is crucial in handling and storing raw materials to avoid contamination and ensure quality. Regulatory agencies like the FDA have specific requirements for storage conditions, temperature, and humidity ranges. Proper handling practices also aid in regulatory compliance. Akums maintains detailed documentation of the API from the point of unloading and the excipient to ensure precision and prevent errors. The API is put under quarantine for 14 days to undergo rigorous quality control and physical examination to detect any signs of contamination.
Akums ensures regulatory compliance and improves product quality through a strong system that includes risk assessment and measures for enhancing quality, leading to recognition for excellence in the pharmaceutical industry.
Satwinder Singh is an Independent Director of our Company. He holds a bachelor’s degree in commerce and a bachelor’s degree in law from Guru Nanak Dev University, Punjab. He is a fellow member of the Institute of Company Secretaries of India (‘ICSI’).
He was the past Chairman of Expert Group on Secretarial Standards and Secretarial Standards Committee for the years 2021 and 2022. He has also held the chairmanship of the Secretarial Standards Board for the years 2019 and 2020. He was also the Chairman of the Task Force on NCLT/NCLAT for the year 2023.
Sanjay Sinha is a Whole Time Director of our Company. He holds a bachelor’s degree in pharmaceutical sciences from Ranchi University and a master’s degree in pharmacy from the University of Delhi. He was previously associated with Ipca Laboratories Limited and Famy Care Limited.
He joined our Company with effect from November 26, 2022 as President of Operations.
Ms. Gowrishankar comes with a wide range of experience across different domains.
Besides Akums, she is currently an independent director on the boards of several prominent companies including Cyient, Gabriel India, Greenlam Industries, Arohan Financial Services, Ashv Finance, Intellecap Advisory Services, Altum Credo Home Finance and Premium Transmission.
In the past, Ms. Gowrishankar has served on the boards of BP India Services, the holding company of oil and gas major BP in India, and subsidiaries of Cummins India.
Not only has she led teams both in India and outside, she has also been an executive coach to the top leadership at BP plc and other companies.
Ms. Gowrishankar has been a strategic human resources advisor to companies like Safari Industries, FlyNava Technologies, Quantum Consumer Solutions, BP Global Solutions India and Cornerstone India, to name a few. She was also heading the group HR council for the Aavishkaar Group.
She holds a postgraduate degree in personnel management and industrial relations from the prestigious XLRI, Jamshedpur, and a bachelor of arts in sociology from Stella Maris College, Chennai.
A former career bureaucrat, Mr. Kalra spent 36 years in the elite Indian Revenue Service (IRS), and held various important positions. He now heads the audit committee of the company, as its chairman.
From 2005-12, Mr. Kalra was a member of the Income Tax Appellate Tribunal, where he delivered several landmark judgements. Before that, Mr. Kalra served as the assistant commissioner, deputy commissioner, joint commissioner and additional commissioner in the income tax department and has served across the country.
Mr. Kalra, who has worked actively to extend financial help to underprivileged children, has an excellent academic record. He earned a Bachelor of Science degree from Kurukshetra University with a gold medal. He holds a masters in science from Panjab University and a law degree from Jodhpur University.
Mr. Handa is a veteran of the pharmaceutical industry in India. He headed Pfizer India as managing director and country manager from 2005 to 2012. Before Pfizer, he was also the managing director at Wyeth Ltd.
After leaving Pfizer, Mr Handa joined Samarth Life Sciences as President. He went on to serve as the non-executive chairman on the board of Union Bank of India, one of the most prominent government-owned lenders. Mr. Handa recently also joined the board of merchant payments firm BharatPe as an independent director.
Mr. Handa has diverse experience in finance, commercial, strategy, business development, M&A, banking, corporate affairs. He is also experienced across sectors like engineering and consumer in companies
like Schrader Scovill, Hindustan Unilever Limited, and State Industrial Investment Corporation of Maharashtra. Mr. Handa has wide experience in markets like the US, Southeast Asia, Africa, Bangladesh, and Sri Lanka.
One of Mr. Handa’s key focus areas is building a diverse organisation. He has driven various teams to hire and retain women colleagues in management and most importantly in sales positions – an initiative unheard of in the Indian pharmaceutical industry. He has managed this by sensitization and by developing women-friendly policies. These initiatives are now case studies and were showcased at a ministerial roundtable held in Turkey.
Mr. Handa is a qualified management accountant and company secretary, and has a master’s degree in commerce
Sunil Kumar Thakur is a Non-Executive Director of our Company and is a nominee of Ruby QC Investment Holdings Pte. Ltd. on our Board. He holds a bachelor’s degree in business administration from Thames Valley University and a master’s degree in international business from the University of Delhi.
He is currently associated with Quadria Capital Advisors Private Limited as a partner, where he leads the investments, portfolio management and divestment activities across South-Asia and also serves on the investment committee of the Quadria Capital Fund II GP.
Mr. Rathore is a three-decade old veteran of the pharmaceutical industry. He is an accomplished, outcome-driven executive with a proven track record in leading challenging initiatives, with emphasis on strategic planning, manufacturing, engineering, quality assurance, project development, budget management and human resources.
Mr. Rathore has, over the years, shown tremendous leadership ability and has extensive experience in managing pharmaceutical plants as per international standards.
Mr. Rathore holds a master’s degree in pharmacy and a postgraduate diploma in management from Rajasthan University.Before Akums, Mr. Rathore worked with companies like Bal Pharma, Tirupati Zion Medicare, Micro Labs, Scott-Edil Pharmacia, Nicholas Piramal, Lupin and Torrent Pharma.
Mr. Sandeep Jain has been the force behind setting up Akums’ state-of-the-art world-class facilities. He has had a key role in making contract manufacturing the most viable industry model.
He has been associated with several leading trade and industry bodies and has advocated the cause of the Indian pharmaceutical sector. In 2013-14, he was the president of the Uttarakhand state council of the Confederation of Indian Industry (CII). The same year, he also headed the state’s Association of Pharmaceutical
He has also served as the chairman of the Chamber of Commerce and Industry, Uttarakhand and has been a member of the managing committee of the PHD Chamber of Commerce and Industry and the vice-chairman of the Foundation of Pharma Entrepreneurs (FOPE)
Mr. Sanjeev Jain was the principal force behind founding Akums, and ranks among the pioneers of the Indian pharma sector. Mr. Jain is known as a visionary leader and mentor. He has been guiding not just Akums but the industry as a whole to greater heights over the last decade and a half.
A people person, he has more than three decades of experience in the field of pharmaceuticals sales and marketing. He has received multiple industry awards, including the prestigious Dynamic Entrepreneur Award at the 6th Annual Pharmaceutical Leadership Summit & Business Leadership Awards in 2014.
Under his leadership, Akums has made several national and foreign collaborations. His innovative ideas in product development, patents, and customer retention have helped the company chart new growth paths over the year