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Info - Patient Name Import
Import of new drug for personal use in India
In the medical practice in India, the new drugs which are not registered in the country are required exclusively for the treatment of patients to save their lives. In such cases, any person / Hospital based on doctor’s prescription can import new drugs under personal License (11A/ 11B) issued under Drugs and Cosmetics Act, 1940 and Rules 1945.

To facilitate import of such drugs in small quantities for personal use, it is provided under the Drugs and Cosmetics Rules, 1945, that a permit for import of small quantities of drugs for personal use in Form 12B could be obtained from the office of the Drugs Controller General (India), FDA Bhawan, Kotla Road, New Delhi or designated Port Offices of Central Drugs Standard Control Organization.

The applicant is required to make an application in Form 12A, which could be downloaded from the website, along with the prescription of the Registered Medical Practitioner (RMP) indicating the quantity of drug required for the treatment of the patient. The prescription should indicate registration number of RMP. The permission in Form 12B is issued on priority basis within one or two days. Further the rules also permit import of small quantities of drugs for exclusive personal use of the passenger as part of his bona-fide baggage. The quantities of any single drug so important shall not exceed 100 average doses and shall be declared to the customs authorities, if so directed.

The Port offices of CDSCO from where permissions for import of small quantities of drugs for personal use could be obtained are situated at the Air ports of IGI Air Port, New Delhi, Air Cargo Complex, Chennai, International Air Cargo Complex, Mumbai, New Integrated Cargo Terminal Building, Kolkata, RGI Airport, Hyderabad, Airfreight Terminal, Bengaluru, Aircargo Complex, Ahmedabad and Port offices at Custom House, Chennai, New Custom House, Mumbai, Nava Sheva Port, Navi Mumbai, Custom House, Kolkata.


Patient name import - How it works:
The process is simplified in the following steps:

  • A valid prescription from registered medical practitioner and address/id proof of patient
  • Submission of Form 11 for application of import license and obtaining the license as Form 12
  • Placing order with the documents in 1 and 2 and making the payment
  • Import of shipment from port
  • Product to be handed over to the patient along with commercial invoice


(CDSCO) Guidelines & Procedure

PROCEDURES TO IMPORT SMALL QUANTITIES OF DRUGS FOR PERSONAL USE


PREAMBLE
To facilitate the availability of small quantity of drugs for personal use for the needy patients of India. The procedure has been simplified which as follows:

PROVISIONS UNDER DRUGS & COSMETICS RULES
Rule 36 of Drugs & Cosmetics Rule provides Import of drugs for personal use. Small quantities of drugs, the import of which is otherwise prohibited under Section 10 of the Act, may be imported for personal use subject to the following conditions:

  • The drugs shall form part of a passenger’s bona fide baggage and shall be the property of, and be intended for, the exclusive personal use of the passenger;
  • The drugs shall be declared to the Customs authorities if they so direct;
  • The quantity of any single drug so imported shall not exceed one hundred average doses:
Provided that the licensing authority may in an exceptional case in any individual case sanctions the import of a large quantity:
Provided further that any drug, imported for personal use but not forming part of bona fide personal baggage, may be allowed to be imported subject to the following conditions, namely:

  • The licensing authority, on an application made to it in Form 12-A is satisfied that the drug is for bona fide personal use;
  • The quantity to be imported is reasonable in the opinion of the licensing authority and is covered by prescription from a registered medical practitioner ; and
  • The licensing authority grants a permit in respect of the said drug in Form 12-B.

PROCEDURE TO OBTAIN PERMISSION:

  • Download the application in FORM 12 A.
  • Prescription from Registered Medical Practitioner (RMP) in respect of the drug requirements for the purpose of patient use required to be attached. Prescription shall bear Medical Council of India (MCI) Registration No. of the Physician.
  • Fill and sign the application in Form 12A alongwith the Prescription and submit to ADC(I)/TO/DI of the respective port offices of Central Drugs Standard Control Organization (CDSCO). The list of such offices is at Annexure A
  • No fee is required under the Rule for said purpose.
  • The name of the drug, quantity of the drug and duration of medication shall be clearly mentioned in the Prescription.
  • Permission in FORM 12 B shall be issued to applicant on priority basis preferably in a day or two.
In case of delay or further clarification
following officer are designated at the Secretariat of DCG (I), CDSCO (HQ), FDA Bhawan, Kotla Road, New Delhi. 110002


Contact Officers:
Mr. Aseem Sahu, Deputy Drugs Controller (I)
Dr. V. Kasi Sankar, Drugs Inspector


Contact No.:
Ph. No.: 011-23236965;
Fax. No.: 011-23236973, Email id : dci@nic.in,


LINKS & REFERENCES

1. Submission of Form 11 for the Import Licence for personal medication can be applied online: