Enhancing herbal, supplemental and OTC product regulatory compliance | HCLTech
Life Sciences and Healthcare

Enhancing regulatory compliance for herbal and OTC products

Rising demand for natural and alternative health products spurs market growth and calls for strict regulatory oversight to ensure safety and compliance
4 minutes read
Kiran Singh J


Kiran Singh J
Group Manager
4 minutes read
Enhancing herbal, supplemental and OTC product regulatory compliance

A comprehensive solution for pharmacovigilance 

The global market for herbal, supplemental and over-the-counter (OTC) products has seen remarkable growth in recent years, driven by the increasing demand for natural and alternative healthcare options. However, this growth has also brought about heightened regulatory scrutiny and the need for robust pharmacovigilance systems to ensure product safety and compliance. This blog presents an overview of our comprehensive suite of designed to help companies navigate the complex landscape of herbal, supplemental and OTC product regulation to foster consumer trust and confidence.

The need for product regulatory compliance 

Herbal, supplemental and OTC products play a significant role in the global healthcare market, offering consumers a wide range of options for maintaining and improving their health and well-being. However, the regulatory framework governing these products is often complex and subject to frequent updates, posing challenges for manufacturers and marketers seeking to ensure compliance while bringing innovative products to the market.

The safety of these products is of utmost importance, as adverse events or interactions can have grave consequences for consumers. Pharmacovigilance, the science of monitoring and assessing the safety of pharmaceuticals, is equally critical for herbal, supplemental and OTC products to identify and mitigate potential risks promptly.

Amid the complexity of regulatory standards, it is morally and legally necessary to maintain compliance. Each new product that hits the market has the potential to affect customers' health and well-being. Stakeholders in the sector are responsible for protecting public health by adhering to the strictest regulations and prioritizing product safety, effectiveness and openness.

Strategies for regulatory excellence

In the world of herbal, supplementary and OTC products, regulatory excellence necessitates a multi-dimensional strategy that includes proactive compliance measures and ongoing improvement projects. Important strategies consist of:

  1. Regulatory intelligence: Keep up with the constantly changing regulatory environment and foresee changes in advance to guarantee timely compliance
  2. Risk-based approach: Align resources according to risk assessment to concentrate efforts where they will have the biggest influence on the safety of consumers
  3. Collaborative relationships: Share best practices, jointly address regulatory obstacles and establish collaborative relationships with stakeholders, industry peers and regulatory bodies
  4. Technology investments: To improve data integrity and expedite compliance procedures, use technology-driven solutions like digital documentation systems and regulatory software platforms
  5. Employee education and training: Make continuous educational and training investments to provide staff members with the know-how and abilities needed to handle complicated regulatory obligations successfully

Handling regulatory complexity

Regulatory compliance is critical when it comes to herbal, supplementary and OTC products. To navigate this terrain, one must be knowledgeable and alert.

Regulatory nuances such as product categorization and labeling requirements are essential to ensure consumer safety and market access. Product integrity is guaranteed when Good Manufacturing Practices (GMP) are followed.

Maintaining product integrity

Quality assurance procedures, including compliance audits and post-market surveillance, protect consumer health by detecting and reducing hazards.

A comprehensive range of regulatory services plays a crucial role in this class of products. These services include:

  1. Regulatory consulting: Providing expert guidance on regulatory requirements and helping clients develop strategies for product development, registration and compliance
  2. Product classification and labeling: Assisting clients in determining the appropriate regulatory classification for their products and ensuring compliance with labeling requirements, including ingredient lists, warnings and claims
  3. Registration and submission support: Facilitating the registration and submission process by consulting with regulatory authorities to obtain approvals and licenses necessary for market entry
  4. Quality assurance and GMP compliance: Offering support in implementing GMP to ensure product quality, safety and consistency throughout the manufacturing process
  5. Post-market surveillance: Monitoring regulatory updates and changes, conducting compliance audits and assisting with post-market surveillance activities to identify and address emerging safety concerns

Pharmacovigilance solutions

In addition to regulatory services, pharmacovigilance solutions will help clients monitor and assess the safety of their herbal, supplemental and OTC products. These solutions include:

  1. Adverse event reporting: Establish systems for capturing and reporting adverse events associated with client products, ensuring compliance with regulatory reporting requirements
  2. Signal detection and risk management: Employ advanced data analysis techniques to detect potential safety signals and develop risk management strategies to mitigate identified risks
  3. Risk communication: Assist clients in communicating safety information to healthcare professionals and consumers through labeling updates, educational materials and public awareness campaigns
  4. Post-market surveillance studies: Design and conduct post-market surveillance studies to monitor client products' long-term safety and effectiveness and identify any emerging safety issues


The regulatory landscape for herbal, supplemental and OTC products is complex and evolving. This requires companies to adopt proactive strategies to ensure regulatory compliance and product safety. Our comprehensive suite of regulatory services and pharmacovigilance solutions are designed to help companies meet their regulatory requirements, foster consumer trust and ultimately improve public health outcomes. By partnering with HCLTech, manufacturers and marketers can navigate the regulatory challenges more effectively while demonstrating their commitment to product quality and safety.


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