Gaurang Bhavsar on Driving DSCSA Compliance at Micro Labs USA

I hold a Master of Science in Industrial Pharmacy and bring over two decades of experience in regulatory affairs within the pharmaceutical industry. Currently, I serve as the Associate Director of Regulatory Affairs at Micro Labs USA, Inc., where I lead critical regulatory and compliance strategies to ensure alignment with FDA standards throughout the product lifecycle.

I am proud to hold the Regulatory Affairs Certification (RAC), which reflects my comprehensive expertise in regulatory processes. Over the years, I have been recognized as a "RegEx Pro," “RAPS Platinum Most Valuable Contributor,” and "RAPS Mentor" by the Regulatory Affairs Professional Society (RAPS) for my knowledge-sharing contributions. Additionally, the American Association of Pharmaceutical Scientists (AAPS) has named me a “Silver Contributor” in recognition of my leadership in pharmaceutical and regulatory science.

My research interests include Regulatory Compliance, Regulatory Requirements, DSCSA, Validation, Nitrosamine Impurities, Microdialysis, Anti-fungal Activity, Product Development, and Patient Safety—areas where I have contributed significantly to advancing the pharmaceutical industry. I have also had the opportunity to help shape industry standards by serving as a panelist on DSCSA compliance alongside wholesalers and dispensers.

Through my leadership, expertise, and dedication, I continue to drive advancements in regulatory science, product development, and patient safety, and I am committed to solidifying my role as a thought leader in the pharmaceutical industry.

I come from a family that believes in public service and has always been engaged with various organizations to support the community. The pharmaceutical industry produces medicines, which are key products that we need throughout our lives—from birth until death. I chose to pursue a Bachelor of Pharmacy after high school in India, and through a campus interview, I got my first professional break in the Regulatory Affairs department.

Although I worked there for only six months, I learned a lot and made the determination that regulatory affairs should be my primary career focus. Later, I realized that a bachelor’s degree was not enough to fulfill my dream job, so I decided to move to the USA to pursue a master’s degree in industrial pharmacy.

Micro Labs USA, Inc. is a wholly owned subsidiary of Micro Labs Limited, India, which is among the top twenty pharmaceutical companies in India and was founded in 1973. The US headquarters markets high-quality, affordable generic medicines that are trusted by patients and healthcare professionals. As our motto states, it is Micro Labs' attention to “health in the small details” that allows us to provide best-in-class service and supply to our customers. These products are manufactured in three state-of-the-art USFDA-approved facilities—one in Goa and two in Bangalore, India—focusing on oral solid tablets and capsules, injections, ophthalmic, and oral solutions.

I have been working as Associate Director – Regulatory Affairs since May 2019.

My key responsibilities are as follows:

• Act as the US Regulatory and Compliance leader, responsible for the development, implementation, and maintenance of regulatory strategies at various stages, from product development through the entire lifecycle.
• Manage generic product (ANDA) submission documents and communications with the FDA and Micro Labs Limited, India, for the development and approval of generic pharmaceutical products.
• Share regulatory intelligence with all stakeholders in the company to assess the impact on products and adapt to regulatory changes to avert business disruption.
• Work closely with the AVP (Associate Vice President) and managers to ensure compliance and completion of assigned projects, providing regulatory strategic options and recommendations to expedite the path to market as per FDA regulations.
• Review all generic product submissions including original submissions, PAS, CBE-0, CBE-30, post-marketing requirements, annual reports, REMS (Risk Evaluation and Mitigation Strategy), etc., and maintain all communications pertaining to ANDAs in the RA server.
• Manage Certificate of Pharmaceutical Product (CPP) submissions to the FDA to obtain marketing approval in the Rest of the World (ROW) market.
• Plan and implement PLAIR and launch-related activities for seamless distribution in the US market.
• Manage all state licenses for distribution in the US market and provide strategic recommendations to stay in compliance with state-specific regulatory requirements.
• Manage specific Drug Price Transparency reporting and Drug Take Back programs.
• Review drug listing and SPL-related activities for current approved products and ANDA applications under review, adhering to relevant labeling regulatory requirements.
• Monitor and address product-related quality and safety complaints under the pharmacovigilance system.
• Manage field alerts, product recalls, and drug notifications pursuant to the DQSA (Drug Quality and Security Act) with the FDA.
• Manage ATPs (Authorized Trading Partner) EPCIS connections, seamless data exchange, and exception handling for shipped products pursuant to the DQSA.
• Execute and manage Quality Agreements and Pharmacovigilance Agreements with CMOs.
• Monitor and perform quality audits with vendors, distribution centers, return processors, CMOs, and relevant service providers located in the US.

DSCSA (Drug Supply Chain Security Act) compliance has been under discussion for the past few years, and companies that are non-compliant with this requirement cannot conduct business in the United States, as it violates federal regulations designed to ensure patient safety. I began working in this area in depth in 2020 and provided strategy to our operations and IT teams on how we, as a company, can attain and maintain compliance to remain in business, especially since many pharmaceutical companies still struggle to meet this obligation.

As of today, Micro Labs USA, Inc. has successfully connected with all downstream wholesalers and distributors to send EPCIS data and has received satisfactory scorecards from major wholesalers. This certifies that we are DSCSA compliant, which not only provides us with additional business opportunities but also grants the company marked recognition as a DSCSA-compliant organization.

I believe in and follow the FDA's guiding principle: right the first time. I always thoroughly read the requirements, consult multiple resources to ensure accuracy, prepare the document or response carefully, review my work at different times or on different days, and then finalise the activity.

I also believe that each professional should have enough time to complete their tasks to ensure quality and positive outcomes. I work closely with colleagues and partners in the US, India, and other locations around the world. I always respect their time zones and clearly communicate expectations for their deliverables, keeping in mind the FDA’s strict deadlines. Thankfully, they have never disappointed me.

Many pharmaceutical companies face challenges in complying with the FDA’s DSCSA (Drug Supply Chain Security Act) requirements. Based on multiple customer feedbacks, I am proud to say that Micro Labs USA, Inc. is one of the few companies successfully connected with all downstream customers for EPCIS data exchange and is regarded as a role model for handling exceptions in DSCSA compliance.

For any project, whether short- or long-term, and even daily tasks, I believe it’s important to include two people from my company and two people from the partner company in all communications. This approach ensures that everyone stays on the same page and significantly reduces the risk of miscommunication, helping us complete work within the desired timeframe.

Most pharmaceutical companies face challenges in complying with the FDA’s DSCSA (Drug Supply Chain Security Act) requirements. Based on multiple customer feedbacks, I am proud to say that Micro Labs USA, Inc. is one of the few companies connected with all their downstream customers for EPCIS data exchange and serves as a role model for handling exceptions in DSCSA compliance.

The DSCSA was implemented to prevent fraudulent drug products from entering the United States, ensuring patient safety. Every pharmaceutical company must meet this requirement, but many struggle due to a lack of specific skills, the importance of the regulation, and financial burdens. With over five years of hands-on experience in serialization, I have a thorough understanding of the processes, potential errors, and mitigation strategies. Because of this, I can confidently say that Micro Labs has strong DSCSA processes in place to maintain compliance.

I have also served as a panelist on DSCSA compliance, sharing best practices at industry conferences. If invited by the government to share these practices, I would be happy to contribute to benefiting other industry peers and the generic pharmaceutical sector as a whole.

DSCSA (Drug Supply Chain Security Act) compliance has been a topic of discussion for the past few years. Companies that are not compliant with this requirement cannot do business in the United States, as it is a violation of federal regulations designed to ensure patient safety. I began working in this area in depth in 2020 and have provided strategies to our operations and IT teams on how we, as a company, can attain and maintain compliance to continue operating. Even today, many pharmaceutical companies struggle to meet this compliance obligation.

• Regulatory Compliance
• Patient Safety
• Mentorship
• Affordable generic drugs

Through its leadership, significant investment, and targeted programs, the U.S. has contributed to enormous progress:

• Contributed to a significant drop in global poverty rates
• Helped found and served as a key donor to multilateral health organizations, including the Pan American Health Organization, WHO, GAVI, and The Global Fund
• Allocated over $9 billion in global health programs, in addition to almost $16 billion in emergency supplemental funding for COVID-19 in 2021
• Saved more than 21 million lives through the President’s Emergency Fund for AIDS Relief (PEPFAR)
• Invested $770 million in the President’s Malaria Initiative (PMI) in 2020, reaching nearly 60 million people with malaria treatment
• Contributed to over 400 million children being vaccinated against polio each year
• Committed up to $11 billion over three years toward global malnutrition
• Worked with partners on key global health priorities including childhood immunization, nutrition, and human resources for health
• Worked with partners to develop equitable health systems that deliver for the most vulnerable and hardest-to-reach

The U.S. healthcare industry is on the cusp of significant transformation over the next decade, driven by technological advancements, evolving patient expectations, and persistent financial and operational challenges. Here's a breakdown of what to anticipate:

1. Growth Areas and Opportunities

• Market Expansion: The U.S. health and medical insurance market is projected to grow from $1.59 trillion in 2025 to $2.13 trillion by 2030, demonstrating a CAGR greater than 6%. This growth is fueled by rising chronic disease incidences and an increasing demand for health insurance.

2. Technological Integration:

• Digital Transformation: The industry is undergoing rapid digitalization, catching up with sectors like retail and finance. Approximately 90% of healthcare executives anticipate an acceleration in the use of digital technologies.
• Artificial Intelligence (AI): AI is expected to revolutionize healthcare through improved workflows, enhanced clinician training, and increased patient safety. Generative AI will likely streamline administrative tasks, improve health equity, and reduce wait times. AI-powered tools can also simplify complex diagnostics and personalize treatments.
• Telehealth and Remote Patient Monitoring (RPM): Telehealth adoption, which significantly increased during the pandemic, will continue to expand, accounting for a larger share of outpatient visits. RPM, utilizing IoT-powered wearable devices, will enable remote communication and monitoring, facilitating virtual hospitals and personalized care.
• Virtual and Augmented Reality (VR/AR): VR and AR are poised to transform patient care through pain management, rehabilitation, surgical visualization, medical simulations, and mental health treatments.
• Data Analytics and Interoperability: Advanced data analytics, including big data and predictive models, will lead to better patient outcomes and improved efficiencies. Enhanced data sharing and interoperability between healthcare systems will be crucial.
• Other Emerging Technologies: Expect increased adoption of 3D printing for personalized medical devices, blockchain for secure data management, and nanomedicine for targeted therapies.
• Value-Based Care (VBC): The shift from fee-for-service to VBC models will accelerate, with a growing percentage of payments tied to quality outcomes. By 2027, it's estimated that 90 million lives will be under VBC arrangements.
• Growth in Specific Sectors: Ambulatory surgery centers (ASCs) and home healthcare are projected to grow by 7% annually through 2028, aligning with patient preferences for lower-acuity settings and broader reimbursement options. The Medicare Advantage market, including the dual-eligible population, will also continue to expand.

Key Challenges

• Rising Healthcare Costs: Healthcare spending in the U.S. reached $4.9 trillion in 2023, a 7.5% increase from the previous year. This trend is driven by factors like rising drug prices, increased utilization, and the cost of new technologies. Managing these escalating costs will be a significant challenge.
• Workforce Shortages and Burnout: Shortages of nurses, physicians, and other healthcare professionals are expected to persist, leading to increased labor costs and potential strain on service delivery. Addressing clinician burnout and improving workforce retention will be critical.
• Aging Population and Eldercare: With an increasing number of older adults, the demand for eldercare services will rise significantly, placing additional pressure on the healthcare system.
• Health Equity: Addressing disparities in healthcare access and outcomes across different populations will remain a crucial challenge. Technology can play a role in tackling these disparities.
• Cybersecurity: As healthcare becomes more digitalized, safeguarding patient data against increasingly sophisticated cyber threats will be paramount.
• Integration of Advanced Technologies: Effectively integrating new technologies like AI and VR into clinical practice and ensuring equitable access will require careful planning and investment.
• Policy and Regulatory Changes: The healthcare industry will continue to be shaped by evolving federal and state regulations, including those related to cost management, payment models, and the oversight of new technologies like AI.
• Financial Pressures: Hospitals and health systems face financial pressures from slow reimbursement growth, rising operating costs, and potential increases in payer denials.

Strategies for the Future

• Focus on Efficiency and Cost Management: Healthcare organizations will need to focus on improving operational efficiency, leveraging technology to reduce costs, and exploring alternative care delivery models.
• Investment in Workforce Development and Retention: Strategies to attract, train, and retain healthcare professionals will be essential to address workforce shortages.
• Enhanced Patient Engagement: Engaging patients through digital platforms, personalized communication, and convenient access options will be crucial.
• Strategic Partnerships and Consolidation: Collaborations and mergers may help organizations navigate financial challenges and expand service offerings.
• Emphasis on Preventive Care and Wellness: Programs aimed at promoting healthier lifestyles and preventing chronic diseases will become increasingly important.

In conclusion, the U.S. healthcare industry over the next decade will be characterized by significant growth and innovation, driven by technological advancements and a growing market. However, it will also face substantial challenges related to cost, workforce, equity, and regulation. Success will depend on the industry's ability to adapt, embrace new technologies, and implement strategies that improve efficiency, access, and patient outcomes.

• Become a member of professional organizations and volunteer your time.
• Take competitive exams to continue learning and stay updated in your profession.
• Attend professional conferences for networking and to stay up to date with industry trends.

• Consistency, planning, punctuality, and continuous learning are my keys to success.
• Challenges are part of life, so face them with a positive spirit. Stay strong and have faith in God. Remind yourself: "I overcame past challenges — this one is no different, and I will handle it."