s the lack of sufficiently efficacious therapeutic products leaves some medical conditions untreated or undertreated (a problem compounded by the emergence of new disease manifestations), innovative therapeutic options are increasingly considered as alternative or additive therapies. The use of digital therapeutics, biological products, gene therapies, medical devices, cosmetics, and other products opens not only better opportunities for a cure but also opportunities for vigilance platforms and processes to monitor the safety of these products and ensure that patient safety is not compromised.

In an era defined by remarkable advances in medical science and technology, pharmacovigilance has emerged as a critical pillar in ensuring the safety of these emerging therapeutic products but has also raised questions about the appropriateness of this term. Under the theme Redesigning and Transforming PV for Augmenting Patient Safety, the tenth annual DIA India Pharmacovigilance Conference 2023 explored the growing scope of pharmacovigilance.

Biological Products

Biologics represent a category of medicinal products sourced from living organisms, including humans, animals, or microorganisms. Biologics can be administered via subcutaneous, intramuscular, or intravenous routes, and their distribution throughout the body is typically limited. However, one major challenge in their use in case of an adverse event involves accurately identifying the suspect product based on its specific utilization and batch number. Additionally, establishing the temporal relationship between the suspect product and the event, as well as conducting a thorough causality assessment, presents another significant hurdle. With biological products increasingly used for treating several conditions, monitoring the safety of such products becomes imperative. There is no doubt that the field of biovigilance deserves more attention.

Gene Therapy

Gene therapy involves modifying or manipulating an individual’s genes to prevent or treat diseases. It encompasses gene replacement, gene suppression, and gene editing as three distinct processes. Through 5,000 gene and cell therapy clinical trials conducted, one speaker noted, substantial research and development efforts have been dedicated to these groundbreaking treatment approaches, which have revealed common difficulties that both approaches share. Establishing the balance between achieving the desired effects of overexpressing the target gene while mitigating potential risks associated with genetic modifications remains a challenge. Additionally, the lack of uniform guidelines for cell and gene therapy presents a hurdle in establishing consistent standards and practices across different regulatory jurisdictions. It has become obvious that safety monitoring of gene and cell therapy is much more complex than any treatment monitoring known so far. Gene and cell therapy safety monitoring measures will evolve as significantly as these therapies will evolve in the future.

Development of Materiovigilance, or Medical Device Vigilance

A medical device encompasses instruments, apparatuses, machines, or implants utilized for medical purposes, including disease diagnosis, treatment, or prevention. The pandemic led to increased awareness and comprehension of medical devices among the general population.

However, an important challenge lies in the potential misuse of these devices, as no device can be deemed entirely risk-free or foolproof. Materiovigilance is dedicated to the surveillance and monitoring of medical devices, encompassing data collection, assessment, and analysis of their safety, performance, and quality across their lifecycle. However, the lack of safety data for medical devices is attributed to the challenge of testing them on healthy individuals. Additionally, it is worth noting that pre-marketing authorization is mandatory for medical devices such as cochlear implants, pacemakers, artificial heart valves, etc. However, certain medical devices like thermometers, surgical gloves, and stethoscopes are exempt from pre-marketing authorization in India.

Clinical Evaluation Reports (CER) meticulously evaluate and document clinical data and pertinent scientific literature pertaining to a medical device and are a crucial vehicle for regulators and clinicians to collaboratively ensure the safety of medical devices. Medical device companies in India also have the option to directly report adverse events associated with their products to the Indian Pharmacopoeia Commission (IPC).

One speaker noted that the absence of a compensation rule for injury due to a medical device defect in India is a major concern. Even if a company is willing to offer compensation, the lack of robust data on tracing and tracking of devices presents a significant challenge.

Submission of Medical Device-Related Cases

In the US, the submission of medical device-related cases has specific timelines: 7 calendar days for serious cases and 15 calendar days for nonserious cases. In India, on the other hand, serious cases must be reported within 15 calendar days. The Secretary of the Ministry of Health and Family Welfare has issued an order making it mandatory to report cases related to medical devices to the regulatory authority. Device reclassification entails the reassessment of a medical device’s classification, considering factors such as its intended use, inherent risks, and available scientific evidence.

Emerging Trends and Challenges in Cosmetovigilance

Cosmetovigilance is a specialized discipline dedicated to the surveillance and monitoring of cosmetic products, with a focus on identifying potential adverse effects or safety concerns. It involves the systematic collection, analysis, and evaluation of data pertaining to the safety, quality, and performance of these products. Some nutraceutical products, which are consumed orally, serve as ingestible alternatives to topical cosmetics, offering similar effects on the body. The limited active reporting of the safety of cosmetic products can be attributed to the lack of available data and analytics, which has also impeded the growth and advancement of the cosmetovigilance domain. However, many expect cosmetovigilance to become increasingly crucial in ensuring consumer safety and product quality.

The use of cosmetic products during pregnancy poses a challenge due to the limited availability of relevant data. Increasing awareness of the safety risks of using cosmetic products during pregnancy is significant for the global health market and healthcare practitioners. However, identifying the specific ingredient(s) in a product responsible for adverse drug reactions, especially when multiple ingredients are present, remains a challenge.

The International Nomenclature of Cosmetic Ingredients (INCI) plays a pivotal role in establishing uniformity among cosmetic ingredients worldwide. One speaker noted the lack of progress in developing specific guidelines to demonstrate efficacy in this context from a regulatory standpoint. Additionally, certain cosmetic companies in the EU and the US choose not to disclose all ingredients, labeling some as proprietary or confidential.

Cosmetic Act

Various governments, including the UK, the US, India, Japan, the EU, and several other countries in Asia, have implemented regulatory frameworks for the cosmetics industry. In the EU, the regulation of cosmetics underwent a transition from the Cosmetic Directive (1976-2009) to the introduction of the EU Cosmetic Regulation in 2013. The cosmetic product safety assessment report plays a crucial role in the product information file. Part A contains Section 9, which houses the safety report. Within this section, the responsible person is assigned the task of providing serious undesirable effects (SUE) information within 20 calendar days or less. Furthermore, implementation of the Modernization of Cosmetics Regulation Act in 2022 bolsters safety measures concerning cosmetic products in the US.

Conclusion

The word “pharmacovigilance” specifically refers to safety monitoring of pharmaceutical products, which traditionally have been the primary treatments for various medical conditions. However, due to the increasing variety of products and technologies deployed to address medical conditions, the use of the term pharmacovigilance has been unwittingly expanded to cover safety monitoring of all therapeutic products. This is not entirely appropriate.

The need to use specific terms like biovigilance, materiovigilance, and cosmetovigilance is now emerging due to the distinctly different approaches required to monitor the safety of the respective products. Even so, the core principles of safety monitoring and the ultimate goal of protecting patient safety remain the same. Therefore, going beyond the literal meanings and facilitating the growth of all these divisions is not only a matter of scientific interest but also an unavoidable responsibility for all stakeholders involved in exploring the growing scope of pharmacovigilance as custodians of global patient safety.