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 The Indian pharma and medical devices sectors are emphasising the need to address misinformation in labelling as the US FDA has issued related norms. The US FDA draft guidance responds to common queries firms have when voluntarily addressing misinformation about approved products.
This, according to Indian industry, gains particular importance in an age where robotics, artificial intelligence, blockchain and 3D printing take centrestage. Recognised as a dependable contract manufacturing base by global majors because of capability and cost-effectiveness, Indian pharma and medical devices sectors noted that with high sales generated for over-the-counter purchases, the US FDA guidance is much-desired.
From an India standpoint, the draft guidance on Good Distribution Practices (GDP) issued by CDSCO in April aligns with global standards for labelling. It aims to prevent the entry of spurious, adulterated, misbranded, and not-of-standard quality (NSQ) products into the market.
The pharma and medical devices labelling is not just a legal requirement but a vital communication tool to ensure safe and effective use of pharmaceuticals and medical devices. It bridges the gap between manufacturers, healthcare providers, and patients, facilitating informed decision-making and enhancing overall medical care delivery. There have been labelling issues and there is a need to reinstate mandatory stringent adherence, stated industry officials from the junior cadre who were not authorised not to disclose their names.
For the global regulator, this guidance replaces the draft guidance for industry Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices issued in June 2014.
The current guidance titled ‘Addressing Misinformation About Medical Devices and Prescription Drugs’, US FDA has delved into the existing avenues for communications companies. Yet it sets out an enforcement policy for certain kinds of internet-based communications that firms might choose to handle for their products disseminated by an independent third party.
The label's content represents the formal, legal representation of what the drug can and cannot do, including side effects and potential hazards or toxicities. The label establishes the legal boundaries of what the medicine's manufacturers can promote or claim about its effects.
The primary purpose of medicines and devices labelling and packaging is to clear unambiguous identification to ensure patient safety and appropriate medication and medical device usage. Misinformation about an approved medicine or device can cause harm to both individuals and the public health in general. Basing medical decisions on misinformation can lead patients and health care providers (HCPs) to choose treatments that are not safe and effective, or to forgo treatments that are, which can have adverse consequences, said the global regulatory authority.
Internet-based forms of communication via e: commerce and social media platforms are viewed as sources of misinformation that travel quickly and reach more people who otherwise might not be exposed to such wrong evidence. This the global regulatory authority has viewed it to be rapid and harmful going by the large follower base on social medial and ecommerce sections. The conviction and trust have created a higher degree of influence.
The guidance, when finalized, is intended to advance US FDA’s efforts to help the public get the accurate, up-to-date, science-based information they need to inform their decisions about medical products to maintain and improve their health.
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