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  1. Pharma Approval: Stringent policy framework needed

Pharma Approval: Stringent policy framework needed

Patient safety is the cornerstone of all healthcare systems. That it must prevail over commercial interests of healthcare providers, healthcare professionals and the pharmaceutical firms is fundamental.

Published: March 14, 2018 3:13 AM
Pharma stocks, USFDA Today, India is witnessing a 22-25% growth in medical tourism, and healthcare providers expect it to be a billion industry this year. (Reuters)

Patient safety is the cornerstone of all healthcare systems. That it must prevail over commercial interests of healthcare providers, healthcare professionals and the pharmaceutical firms is fundamental. There must be zero tolerance for any compromise on patient safety, making it imperative to ensure the highest standard of treatment and quality of medicines. With recent media reports of several patients losing their vision due to the use of off-label drugs, especially biosimilars, to treat retinal disorders like age-related macular degeneration (AMD), we are faced with a grim reality today. Irresponsible treatment for retinal diseases is a textbook example of how off-label drugs and splitting of vials have been putting patients’ health in jeopardy for years. Yet, the use of medical products that don’t meet mandatory guidelines continue to exist in the healthcare supply chain of our country! This compels me to reinstate the debate for an imminent need to formulate stringent safety guidelines, to address the gross negligence of administering off-label drugs on innocent patients, who are completely ignorant of the consequences. That India is faced with a dichotomy of reducing the burden of out-of-pocket expenses while providing the highest standards of healthcare and medicines is certainly a burning subject. However, what remains sacrosanct is that lowering the cost of therapies must not compromise patient safety. It is the need of the hour to withhold the use of off-label/ unapproved drugs, and the blueprint for affordable healthcare access must be guided by stringent patient safety guidelines.

Today, India is witnessing a 22-25% growth in medical tourism, and healthcare providers expect it to be a $6 billion industry this year. The ministries of health, external affairs, tourism and culture are working in partnership to increase the number of medical tourists. The entire healthcare system revolves around patient’s well-being and improving health outcomes. However, if we fail to uphold the standards of patient safety in the country, and unethical off-label drug use continues to pose a threat to patient well-being, our reputation, both within and beyond the borders, is bound to be tarnished. There have been incidents where biosimilars have led to infections among retinal patients. Biosimilars are less costly imitations of drugs known as biologics but are different from generics—because they are not exact copies of the original ‘innovator’ drug. They are developed using living cells, and, thus, exhibit high molecular complexities, making them difficult to replicate. Consequently, even the smallest changes in the manufacturing process can highly affect the efficacy and safety of the drug.

This makes it necessary that biosimilars are thoroughly scrutinised based on robust clinical data, established efficacy and safety of the drug vis-à-vis the original product, along with consideration of any long-term adverse effect. Although, in a bid to ensure high-quality biologics, the Department of Biotechnology and the Central Drugs Standard Control Organization had released the ‘Guideline on Similar Biologics: Regulatory Requirements Marketing Authorization in India for Biosimilar Drugs’, the reality is that neither have these guidelines been followed, nor rightly implemented.

At present, clinical data for every potential indication is not mandatory to seek necessary approvals, leading to the recurring mishaps. Here pharmacovigilance can evolve as an important tool at every level—regulators, drug companies, medical practitioners, and above all, patients. Robust patient safety guidelines and stringent regulatory approval framework for biosimilars are definitely an impending need in order to truly benefit patients and safeguard their health outcomes. Let us adopt a multi-sectoral framework to develop and implement these guidelines so we put an end to these malpractices.

By Bejon Misra

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