**Summary:**
This office order, dated February 12, 2014, from the Drugs Controller General of India (DCGI), Central Drugs Standard Control Organization (CDSCO), addresses the import of small quantities of drugs for personal use. It reiterates the delegation of powers to all CDSCO port officers to permit such imports in Form 12B, as per the earlier order no. DCG 1MISC2013/34 dated May 23, 2013.
The order clarifies that the required documents for import permission are a filled and signed application in Form 12A, and a prescription from a registered medical practitioner (RMP) bearing their Medical Council of India (MCI) registration number. The prescription must clearly state the drug name, quantity, and duration of medication.
The DCGI directs all port officers to adhere strictly to the document requirements as prescribed on the CDSCO website and warns that demanding additional documents will be viewed seriously. Zonal and Sub-Zonal DDCIs are instructed to monitor compliance with these directions and ensure timely issuance of import permits.
The order is addressed to all DDCIs of Zonal Offices of CDSCO and all port offices of CDSCO. Copies are provided to all DDCIs of CDSCO HQ and DDA, CDSCO, H.Q, as well as the PPS to Secretary Health, PPS to DG, PPS to ASDG, and PPS to JS (AKP) for information. Dr. G.N. Singh, Drugs Controller General, is the issuing authority.
Key Entities Referenced
Directorate General of Health Services: An organization under which the Central Drugs Standard Control Organization functions.
Central Drugs Standard Control Organization: A national regulatory body for pharmaceuticals and medical devices in India.
Drugs Controller General India: The head of the Central Drugs Standard Control Organization (CDSCO).
Form 12 B: A form related to the import of small quantities of drugs for personal use, as per the office order.
Form 12 A: An application form required for importing small quantities of drugs for personal use.
Medical Council of India: A statutory body responsible for maintaining standards of medical education and registering medical practitioners in India.
Dr. G.N. Singh: The Drugs Controller General at the time of the order.
New Delhi: Location of FDA Bhawan, Kotla Road, the office of Drugs Controller General India
File No. DCG (1)/MISC/2013 (34)
Directorate General of Health Services
Central Drugs Standard Control Organization
(O/o Drugs Controller General India)
FDA Bhawan, Kotla Road
New Delhi-110002
Dated: - 12/02/2014
OFFICE ORDER
The undersigned has delegated the powers to all port officers of CDSCO to permit import of
small quantities of drugs for personal use in Form -12 B vide this office order no. DCG
(I)/MISC/2013 (34) dated 23.05.2013. In this regard the procedure for permission to import
small quantities of drugs for personal use was given in the CDSCO, website, under which
following documents are required:
- Filled and signed 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. It shall bear Medical
Council of India (MCI) Registration No. of the Physician. The name of drug, quantity of
the drug and duration of medication shall be clearly mentioned in the prescription.
It is brought to the notice of the Ministry that in addition to the documents mentioned above,
some more documents are asked by the Port Officers like affidavit, who would bear the cost of
drugs, photo Id of patient etc. All port officers are hereby directed to process the applications on
the basis of documents prescribed in our website. Any instances of demanding of any other
additional documents will be viewed seriously by this directorate. All Concerned DDC (I)’s of
Zonal, Sub-Zonal offices are also directed to keep vigil over this issue so that all the port officers
will adhere to the directions given by this directorate. Further it shall also be ensured that the
import permits are issued within the prescribed timelines
(Dr. G.NJ Singh)
Drugs Controller General (1)
To,
I. DDC (D of all Zonal Offices of CDSCO
2. All port office of CDSCO
Copy To:-
1. All DDC (1)s of CDSCO HQ
2. DDA (D) CDSCO, H.Q
Copy for information to:
1. PPS to Secretary (Health) / PPS to DG/PPS to AS&DG/PS to JS (AKP)