Access to life-saving medicines is a critical concern for patients with severe health conditions, especially when such medicines are unavailable or not licensed in their country. In such situations, patients can import medicines for personal use. In India, the import of unapproved or unavailable medicines for personal use is regulated under the Drugs and Cosmetics Act of 1940 and the Drugs and Cosmetics Rules of 1945.
Legal Framework:
In India, the importation of drugs is regulated by the Drugs and Cosmetics Act of 1940 and the Drugs and Cosmetics Rules of 1945. Under these regulations, the import of unapproved or new drugs is prohibited due to public health concerns. Nonetheless, there are some exceptions where an individual requires the medicine for personal use, particularly when the medicine is life-saving and not available in India.
Relevant Provisions:
- Rule 36 of the Drugs and Cosmetics Rules, 1945: Allows the import of small quantities of drugs for personal use under specific conditions.
- Rule 122-A: Pertains to new drugs and the requirement for approval before importation and use in India.
- Rule 123: Provides exemptions for certain drugs from the provisions of Chapter III of the Act, which deals with import requirements.
Conditions for Importing Medicines for Personal Use:
To import life-saving drugs for which there is no approval or which are unavailable in India for personal use, the following conditions must be met:
- The medicine being imported must be for personal use only and not for commercial distribution.
- The quantity imported into the country should not exceed what is required for a registered medical practitioner’s three months of treatment.
- A valid prescription from a registered medical practitioner is required, specifying the necessity of the medicine.
- An import permit or No Objection Certificate (NOC) must be obtained from the competent authority, specifically the Central Drugs Standard Control Organization (CDSCO).
How to Get Import License or No Objection Certificate (NOC):
Individuals looking to import unapproved or unavailable medicines must obtain an NOC or import license from the CDSCO, the national regulatory body for pharmaceuticals and medical devices in India.
- Application Process:
Submission of Application: The form is to be filled out as prescribed. It is generally Form 12-A, as per the Drugs and Cosmetics Rules, 1945. - Supporting Documents: The application is to be submitted alongside other essential documents such as a prescription, the patient’s medical history, and reasons for importation.
- Processing by CDSCO: The CDSCO reviews the application to ensure compliance with legal and safety requirements.
- Issuance of NOC: After approval has been granted, the relevant CDSCO office issues an NOC or import license against the application which allows the importation of a prescribed quantity of the drug.
Documents Required:
The documents listed below are usually needed while applying for permission to import medicines that are not approved for use within the country.
- Application Form: Signed and completed application form (for example: Form 12-A).
Prescription: Obtained from a registered medical practitioner stating the necessity of the medicine. - Medical Report: Detailed medical history and/or medical report supporting the need for the medicine.
- Patient’s Identification: Copy of the patient’s identification documents like passport or Aadhaar.
- Justification Letter: A letter stating why the medicine is required, its unavailability in India, and the urgency.
Limitations and Restrictions:
Even though there are certain conditions under which the import of personal life-saving medicines is allowed, restrictions and limitations are also very key considerations:
- Quantity Restriction: The import of medicine is limited to a quantity sufficient for up to three months of treatment, as prescribed.
- Non-Commercial Use: The prescribed medicines are to be used only by the patient. Importation for sale and distribution is illegal.
- Prohibited Substances: Certain medicinal products and substances may still be prohibited from importation, regardless of personal need, under the Narcotic Drugs and Psychotropic Substances Act, of 1985.
- Compliance with Other Laws: The import of medicine must comply with other applicable laws and regulations, including customs requirements.
Steps to Import Unapproved Life-Saving Medicines:
The following steps outline the process for importing unapproved or unavailable medicines for personal use into India:
- Consultation with a Medical Practitioner: Secure a valid prescription and a detailed medical report from a registered medical practitioner stating the necessity of the medicine.
- Prepare Documentation: Collect all required documents, including the prescription, medical reports, patient identification, and justification letter.
- Submit Application to CDSCO: Fill out the prescribed application form and submit it along with supporting documents to the CDSCO.
- Await Approval: The CDSCO will review your application and may request additional information in case necessary.
- Get NOC or Import License: After successful approval, receive the NOC or import license specifying the allowed quantity and conditions.
- Arrange for Importation: Connect with a licensed importer like the Indian Pharma Network (IPN) to handle pharmaceutical products.
- Customs Clearance: Make sure that all the required documentations are provided to customs authorities to facilitate clearance upon arrival.
Role of Customs Authorities:
Customs authorities play an important role in regulating the importation of unapproved medicines. They verify the NOC or import license, assess the products, and ensure compliance with all regulations. It is crucial to provide relevant, accurate. and complete documentation to avoid delays or confiscation.
Regulatory Authorities Involved:
Several regulatory authorities are a part of the import processes of unapproved medicines into India for personal use:
- Central Drugs Standard Control Organization (CDSCO): The foremost regulatory authority that deals with drug approval and import licensing.
- Drugs Controller General of India (DCGI): The head of the CDSCO, overseeing the regulation and control of
- drug importation.
Customs Authorities: Policing Indian borders and controlling what comes in, these are the ones who implement border import laws.
Conclusion:
Importing unapproved or unavailable medicines into India is allowed. This is permitted under the Drugs and Cosmetics Act of 1940. Patients must meet all regulatory requirements. Following the guidelines is necessary to access these medicines. Permission from authorities must be obtained. Compliance with all laws is mandatory. Acting responsibly during the process is important. Ethical practices ensure public health safety. Legal integrity must be maintained throughout.
Can an individual import any unapproved medicine for personal use?
Unfortunately, you cannot import unapproved medicine very easily. Only medicines without substitutes in India can be imported after you gain CDSCO approval (Central Drugs Standard Control Organization).
Is there a fee for the import license application?
Yes, there is a fee. Import license fees are decided under the Drugs and Cosmetics Rules of 1945 which means that you have to pay this fee when you apply.
How long does it take to get an import license or NOC?
The time varies. It depends on how complete your application is. The workload of the authorities also matters. Apply early to avoid delays.
Can imported medicine be shared with others?
No. Imported medicine is only for a person’s use. So, you are not allowed to share it, trade, sell, or gift it to anyone.
Where can I buy unapproved or unavailable medicines in India?
You can buy unapproved or unavailable medicine in India with help from the Indian Pharma Network (IPN). Call us via WhatsApp or on +91 9310090915. If you have further inquiries, do not hesitate to get in touch.
