Date: 2014-02-13Category: Not ApplicableState: Union GovernmentCountry: India
Office Order Dated 13.02.2014 Regarding Transfer of Certain Functions and Delegations of Powers to Zonal Office to CDSCO Under Rule 22 of Drugs and Cosmetics Rules
**Summary:**
This office order, dated February 13, 2014, issued by the Drugs Controller General of India (DCGI), Central Drugs Standard Control Organization (CDSCO), delegates specific powers previously held by the DCGI to zonal officers, effective immediately. This order supersedes the previous order of even number dated 10.02.2014. The delegated powers include the authority to issue:
1. No Objection Certificates (NOCs) for licenses to manufacture drugs for examination, test, or analysis as outlined in Rule 89 of the Drugs & Cosmetics Rules.
2. NOCs for permissions to manufacture unapproved/approved new drugs and drugs banned under Section 26A of the Drugs & Cosmetics Act, exclusively for export purposes.
3. NOCs for permissions to import dual-use items that are not intended for medicinal use.
The following zonal officers are authorized to exercise these powers within their respective jurisdictions:
* Sh. P.B.N Prasad, Deputy Drugs Controller (India), Central Drugs Standard Control Organisation, Hyderabad Zonal Office, Hyderabad.
* Sh. A.K. Pradhan, Deputy Drugs Controller (India), Central Drugs Standard Control Organisation, North Zone, Ghaziabad-201002, U.P.
* Sh. Manivanan, Deputy Drugs Controller (India), Central Drugs Standard Control Organisation, South Zone, Chennai-600006.
* Sh. S.P. Shani, Deputy Drugs Controller (India), Central Drugs Standard Control Organisation, East Zone, Kolkata-700020.
* Dr. S. Eswara Reddy, Deputy Drugs Controller (India), Central Drugs Standard Control Organisation, Ahmedabad Zone, Ahmedabad.
This order is addressed to all Zonal Officers of CDSCO, IDMA, OPPI, FOPE, Pharmexcil, and SPIC. Dr. G.N. Singh is the Drugs Controller General of India.
Key Entities Referenced
Central Drugs Standard Control Organization: A national regulatory body in India responsible for the regulation of pharmaceuticals and medical devices.
Drugs Controller General of India: The head of the Central Drugs Standard Control Organization (CDSCO) in India.
Drugs Cosmetics Rules: A set of rules and regulations governing the import, manufacture, distribution, and sale of drugs and cosmetics in India.
Hyderabad Zonal Office, Hyderabad, Telangana: A regional office of the Central Drugs Standard Control Organisation located in Hyderabad.
North Zone, Ghaziabad, Uttar Pradesh: A regional zone of the Central Drugs Standard Control Organisation with office in Ghaziabad, Uttar Pradesh.
South Zone, Chennai, Tamil Nadu: A regional zone of the Central Drugs Standard Control Organisation with office in Chennai, Tamil Nadu.
East Zone, Kolkata, West Bengal: A regional zone of the Central Drugs Standard Control Organisation with office in Kolkata, West Bengal.
Ahmedabad Zone, Ahmedabad, Gujarat: A regional zone of the Central Drugs Standard Control Organisation with office in Ahmedabad, Gujarat.
File No. DCG(D/Mise/2014/(12)
Directorate General of Health Services
Central Drugs Standard Control Organization
(O/o Drugs Controller General of India)
FDA Bhawan Kotla Road,
New Delhi-110002
Dated: 13" February 2014
OFFICE ORDER
Subject: Transfer of certain functions and delegation of powers to zonal office to CDSCO under
Rule 22 of Drugs & Cosmetics Rules
In supersession of this office earlier order of even number dated 10.02.2014, It has been decided
to delegate the following powers which were exercised by the undersigned to the zonal officers as
stated below:
1. No Objection certificates for grant of license to manufacture drugs for the purpose of
examination, test or analysis and provided under Rule 89 of the Drugs & Cosmetics Rules
to No Objection certificate for grant of permissions for manufacture for export only of
unapproved/approved new drugs and drugs banned sanction 26-A of the Drugs & Cosmetics
Act.
12 No Objection certificates for grant of permissions for import of dual use items, not for
medicinal use.
Following officers of the respective zone will exercise the above powers within the
jurisdiction with immediate effect.
Name of the Officer & Designation Name of the Zone
Sh.P.B.N Prasad Dy. Drugs Controller(India) Central Drugs Standard Control Organisation,
Hyderabad Zonal Office, Hyderabad.
Sh.A.K.Pradhan Dy. Drugs Controller(India) Central Drugs Standard Control! Organisation,
North Zone, Ghaziabad-201002,U.P
Sh. Manivanan Dy. Drugs Controller(India) Central Drugs Standard Control Organisation,
South Zone, Chennai-600006
Sh.S.P.Shani Dy. Drugs Controller(India) Central Drugs Standard Contro] Organisation.
East Zone, Kolkata~700020
Dr.S.Eswara Reddy, Dy. Drugs Controller(India) Central Drugs Standard Control Organisation,
Ahmedabad Zone, Ahmedabad
(Dr. G{N. Singh)
Drugs Controller Gengral (India)
To,
1. All Zonal Officers of CDSCO
2. IDMA/OPPI/FOPE/Pharmexil/SPIC