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:
I. 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:
(i) 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;
(ii) the drugs shall be declared to the Customs authorities if they so direct;
(iii) 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:
(i) the licensing authority, on an application made to it in Form 12-A is satisfied that the drug is for bona fide personal use;
(ii) 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
(iii) the licensing authority grants a permit in respect of the said drug in Form 12-B.
II. 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.
III 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
1. Mr. Aseem Sahu, Deputy Drugs Controller (I)
2. Dr. V. Kasi Sankar, Drugs Inspector
Ph. No.: 011-23236965; Fax. No.: 011-23236973, Email id : firstname.lastname@example.org