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Top 5 Myths about Named Patient Import in India

 When it comes to accessing life-saving or rare medicines that aren’t yet available in India, the process of named patient import often feels confusing. Many people hear bits and pieces, through friends, social media, or word of mouth, and end up with half-truths or misconceptions. These myths can create unnecessary confusion, stress, and even delay treatment for patients who need it the most.  

In this blog, we’re breaking down the top five myths about named patient import in India so you can see the process more clearly and confidently. 

Named Patient Import Is Illegal in India 

The idea that NPI is against the law is one of the most widespread misconceptions. In reality, there are clear provisions under the Drugs and Cosmetics Act 1940 and Rules 1945 that make it possible to import medicines when needed. Applications can be made to the Drug Controller General of India by patients, hospitals, or pharmaceutical companies. Globally too, similar programs, often called Compassionate Use (CU) or Expanded Access, ensure that patients are not left without hope when no approved therapy exists.1 

Any Patient Can Import Any Drug Freely 

Once people know that NPI is legal, the next assumption is often that it’s an open door, anyone can bring in any drug they want. But that’s not how it works. The Central Drugs Standard Control Organization (CDSCO), India’s top authority for regulating drugs and medical devices, allows such imports only in very specific circumstances. For example, this could be during national emergencies, epidemics, rare diseases needing orphan drugs, or when no other therapy exists. Even then, medicines can only be imported in small quantities with proper approvals, and only for patients facing life-threatening conditions or permanent disabilities.1 

Named Patient Import Is Only for Rare or Orphan Drugs 

Another misunderstanding is that NPI is restricted to rare or orphan drugs alone. The truth is broader. The concept of giving patients access to unapproved medicines has roots in the HIV epidemic of the 1980s, when investigational drugs were provided as a last hope for survival. Since then, what is often called “compassionate use” has expanded globally to cover more situations where patients face serious illnesses without satisfactory approved therapies. In India too, the CDSCO has provisions under the Drugs and Cosmetics Act, 1940 and Rules, 1945 that allow such imports, not only for rare diseases, but wherever there is an unmet medical need.1 

The Process Is Too Complicated to Be Practical 

Compassionate use (CU) may sound complicated, but in practice, it exists to make life-saving medicines accessible when no other options are available. The World Health Organization describes it as a program that gives patients access to potentially life-saving treatments if no approved therapy exists or they cannot join a clinical trial. 

In fact, drugs like bedaquiline and delamanid have already reached patients with drug-resistant tuberculosis through these provisions. While the process may seem long on paper, in reality, it can and does bring critical medicines to patients in need.1 

Imported Medicines Are Unsafe and Unregulated 

The fear that imported medicines under NPI are random or unsafe is another myth that discourages patients. In fact, there are strong safeguards in place. Globally, Compassionate Use and Expanded Access programs are recognized systems for providing treatments in exceptional cases. In India, the Drugs and Cosmetics Act, 1940 and Rules, 1945 contain provisions, including Rule 33A and 34A, that allow small quantities of medicines to be imported specifically for life-threatening conditions or where no treatment exists. These medicines are accessed through formal, legal, and regulatory channels, not through shortcuts or unsafe routes.1 

Conclusion 

Named Patient Import is not a loophole or a shortcut. It is a structured, regulated pathway that exists to give patients access to critical medicines when no approved alternatives are available. By clearing up common myths, patients and caregivers can approach the process with more clarity and confidence, knowing that it is backed by legal provisions, global practices, and regulatory oversight in India. 

Note 

This blog is for educational purposes only and should not be considered medical advice. The information provided here is based on published research and regulatory guidelines. Patients should always consult a qualified healthcare professional or their treating doctor before making any decisions about treatment or accessing medicines through Named Patient Import. 

Disclaimer: 

Rx4U procures prescribed medicines directly from manufacturers or authorized distributors. It does not claim ownership of any trademarks and complies with the provisions of the Trademark Act, 1999, particularly Sections 30 and 30(1) concerning ‘Fair Use’. It solely facilitates access to new launches through named patient import. 

Related Blog

References 

  1. Shetty YC, Brahma S, Manjesh PS. Compassionate drug use: Current status in India. Perspect Clin Res. 2020;11(1):3-7. doi:10.4103/picr.PICR_119_18 

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