Date: 2020-01-29Category: Not ApplicableState: Union GovernmentCountry: India
Office Memorandum regarding grant of permission for carrying out overprinting/stickering/stamping of imported drugs in certain cases under the provisions of Rule 104A
**Summary:**
This Office Memorandum, reference number F. No. X110262472019BD, issued on November 14, 2020, by the Directorate General of Health Services, Central Drugs Standard Control Organization (CDSCO), Biological Division, addresses the procedure for granting permission for overprinting, stickering, or stamping of imported drugs under Rule 104A of the Drugs and Cosmetics Rules, 1945.
The memorandum outlines a revised process designed to simplify the application procedure and reduce transaction time. Instead of submitting separate applications for each drug, importers can now seek comprehensive permission covering all products imported by them for overprinting, stickering, or stamping. This comprehensive permission applies specifically to labeling changes indicating:
* "For Hospital/Institution/Government Supply - Not to be Sold"
* "For Physician's Sample - Not to be Sold"
* "For Managed Access Program/Clinical Trial Use Only/For Post Trial Access only - Not to be Sold"
This labeling activity must be conducted at licensed manufacturing premises without concealing the original label, and subject to the satisfaction of the concerned State Licensing Authority (SLA).
The memorandum was approved by Dr. V. G. Somani, Drugs Controller General of India. Copies have been distributed to all concerned Pharma Associations, the PS to JSR, MoHFW, the Guard File, and the CDSCO Website.
Key Entities Referenced
Directorate General of Health Services: An organization under the Government of India.
Central Drugs Standard Control Organization: A national regulatory body for pharmaceuticals and medical devices in India.
Biological Division: A division within the Central Drugs Standard Control Organization.
FDA Bhawan, Kotla Road, New Delhi: Location of Central Drugs Standard Control Organization office.
Drugs and Cosmetics Rules, 1945: A set of rules governing the regulation of drugs and cosmetics in India.
Rule 104A: A specific rule within the Drugs and Cosmetics Rules, 1945 related to overprinting/stickering/stamping of imported drugs.
Dr. V. G. Somani: Drugs Controller General of India
MoHFW: Ministry of Health and Family Welfare
F. No. X-11026/247/2019-BD
Government of India
Directorate General of Health Services
Central Drugs Standard Control Organization
(Biological Division)
FDA Bhawan, Kotla Road,
New Delhi-110002
Dated: 1411) 20
Office Memorandum
This is with reference to the requests received for the grant of permission for
carrying out
overprinting/stickering/stamping of imported drugs in certain cases
under the provisions of Rule 104A of the Drugs and Cosmetics Rules, 1945 by the
CDSCO.
In this regards, presently applications are made separately for each drug for
the grant of permission under the provisions of the aforesaid Rules for making
alterations for various purposes.
The matter has been examined in detail and to further simplify the procedure
and to reduce the transaction time, it has been decided without prejudice to legal
provisions that for drugs imported into the country, the importer can seek a
comprehensive permission for all such products imported by him for
overprinting/stickering/stamping as per Rule 104A of the Drugs and Cosmetics
Rules, 1945 instead of seeking permission each time for the purpose of -
a) For Hospital/Institution/Government Supply — Not to be Sold
b) For Physician’s sample — Not to be Sold
c) For Manage Access Program/Clinical Trial Use Only/For Post Trial
Access only Not to be Sold
Provided such labeling activity shall be carried out at the licensed manufacturing
premises without concealing the original label, subject to satisfaction of concerned
SLA.
ye
a
(Dr. V. G. Somani)
Drugs Controller General (India)
To -
4. All concerned Pharma Associations
Copy to -
1. PS to JS(R), MoHFW
2. Guard File
3. CDSCO Website