Ikris Pharma

Medicine Safety

Medicine safety is our fundamental responsibility, which is embedded across every stage of the Named Patient Program supply chain. Specialty, rare disease, oncology, biologic, and critical medicines often require strict environmental controls and validated handling procedures to maintain their quality, efficacy, and safety for patients.
Medicine Safety
Temperature Control and Handling: Many medicines supplied under Named Patient Programs are temperature-sensitive and can lose effectiveness or become unsafe if exposed to conditions outside the manufacturer's specifications. We ensure that medicines are: Stored and transported strictly within manufacturer-recommended temperature ranges Maintained under controlled room temperature (15–25°C) or cold chain conditions (2–8°C), as applicable Monitored using validated temperature-monitoring devices during storage and transit Temperature data is reviewed at key points in the supply chain. Any temperature excursion is documented, assessed, and managed according to defined procedures aligned with Good Distribution Practices (GDP) and applicable Indian regulatory expectations. Medicines are supplied only when quality integrity is assured. All handling activities are performed by trained personnel following established standard operating procedures to minimize risk and ensure patient safety. Use of Temperature Data Loggers: To ensure continuous temperature monitoring, we use validated electronic temperature data loggers during the storage and transportation of temperature-sensitive medicines. These data loggers: Continuously record temperature throughout transit and storage Provide objective, time-stamped temperature data Enable identification of any temperature excursions Support documented review and quality assessment upon receipt Temperature data is reviewed at defined checkpoints in the supply chain. Any temperature excursion is documented, assessed, and managed according to predefined procedures aligned with Good Distribution Practices (GDP) and applicable Indian regulatory expectations. Medicines are supplied to patients only when temperature integrity and product quality are assured. All handling activities are performed by trained personnel following established standard operating procedures to minimize risk and ensure patient safety. Combatting Counterfeit Medicines: The Global Threat of Counterfeiting: Counterfeit medicine is fake medicine, and it poses a serious threat to patient health and safety worldwide. According to the Pharmaceutical Security Institute (PSI), global law enforcement agencies uncovered 6,424 incidents of pharmaceutical counterfeiting, illegal diversion, and theft across 136 countries in 2024. These incidents involved more than 2,428 different medicines across all therapeutic areas. Criminal organizations targeted 638 products in 16 therapeutic areas, including oncology and biologics, and 3,658 arrests were recorded for pharmaceutical-related crimes. In Interpol’s Operation Pangea XVI (2025), authorities from 90 countries seized 50.4 million doses of counterfeit and unapproved medicines, dismantled 123 criminal groups, arrested 769 suspects, and shut down approximately 13,000 digital channels used to sell illegal medicines. These figures highlight that no country, product, or therapeutic area is immune to counterfeiting. Why Counterfeit Medicines Are Dangerous? Counterfeit medicines are dangerous by their very nature: They are not manufactured under regulated conditions They are not inspected or approved by regulatory authorities Their ingredients, strength, and purity are unknown Sophisticated counterfeiters may include some active ingredient and replicate packaging, making fake medicines appear legitimate. However, the medicine may be ineffective, incorrectly dosed, contaminated, or toxic. The primary risk is that patients may consume a product that: Does not treat their condition Delays proper medical treatment Causes unexpected or harmful side effects Poses serious or life-threatening health risks Each year, hundreds of thousands of deaths worldwide are linked to the use of falsified or substandard medicines. Risks of Unverified Online Sources: Medicines sold through uncertified or illegal online sources often bypass regulatory oversight. Such sellers may: Not require a valid prescription Fail to provide safety information or warnings Distribute counterfeit or diverted products Reputable pharmacies and authorized supply channels require prescriptions issued by registered healthcare professionals and follow regulatory safeguards. Our Approach to Supply Chain Integrity: We works exclusively with authorized manufacturers, licensed wholesalers, and regulated logistics partners worldwide. Medicines supplied under Named Patient Programs are: Procured from legitimate, traceable sources Supplied in original manufacturer packaging Distributed strictly against valid prescriptions for named patients Handled under documented quality and safety procedures Our approach is designed to reduce risks associated with diversion, counterfeiting, and improper handling. Frequently Asked Questions (FAQs) What is a counterfeit (fake) medication? A counterfeit medication is a falsified product that may contain incorrect, insufficient, or harmful ingredients and is intentionally misrepresented as a genuine medicine. What are the dangers of taking counterfeit medicine? Counterfeit medicines may not treat the condition, may worsen illness, cause adverse reactions, or lead to serious health complications due to unknown ingredients or incorrect dosage. Why is it dangerous to order medicines from uncertified online sources? Uncertified sources often bypass regulatory checks, do not require prescriptions, and may supply counterfeit or illegally diverted medicines. How serious is the problem of prescription medicine counterfeiting? Counterfeiting is a global public health issue affecting all therapeutic areas, including life-saving treatments such as oncology, diabetes, and biologics. How can you tell if you have purchased a counterfeit medicine? Signs may include unusual packaging, spelling errors, unexpected appearance, lack of proper labeling, or absence of regulatory information. However, many counterfeit medicines closely resemble genuine products, making professional verification essential. What can you do to help reduce the risk? Patients should obtain medicines only through authorized healthcare providers and regulated supply channels and report any suspected adverse events or quality concerns to their doctor. How does the Named Patient Program secure its people, facilities, and supply chain? The Named Patient Program implements controlled sourcing, GDP-aligned handling, temperature-monitored logistics, documentation review, and collaboration with authorized partners to maintain supply chain integrity.
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