Date: 2014-02-26Category: Not ApplicableState: Union GovernmentCountry: India
Office Order Dated 26.02.2014 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 26, 2014, from the Directorate General of Health Services, Central Drugs Standard Control Organization (CDSCO), and issued by the Drugs Controller General of India, delegates specific powers to Dr. K. Bangarurajan, Deputy Drugs Controller of India (DDCI), CDSCO West Zone, Mumbai. This delegation, under Rule 22 of the Drugs and Cosmetics Rules, transfers the authority to issue No Objection Certificates (NOCs) for the following: (1) the grant of licenses to manufacture drugs for examination, testing, or analysis (Rule 89); (2) permissions for manufacturing for export only of unapproved/approved new drugs and drugs banned under sanction 26A of the Drugs and Cosmetics Act; and (3) permissions for import of dual-use items not intended for medicinal use. This order is a continuation of a previous order of the same number dated February 10, 2014. The order is addressed to all Zonal Officers of CDSCO, IDMA, OPPI, FOPE, Pharmexcil, and SPIC. The issuing authority is Dr. G.N. Singh, Drugs Controller General of India.
Key Entities Referenced
Directorate General of Health Services: A department of the Government of India responsible for public health.
Central Drugs Standard Control Organization: The national regulatory body for Indian pharmaceuticals and medical devices.
Drugs Controller General of India: Head of the Central Drugs Standard Control Organization (CDSCO) in India.
FDA Bhawan, New Delhi: Headquarters of the Drugs Controller General of India (DCGI), located in Delhi.
Drugs Cosmetics Rules: A set of rules in India regulating the import, manufacture, distribution, and sale of drugs and cosmetics.
Dr. K. Bangarurajan: DDCI (Deputy Drugs Controller of India), CDSCO West Zone, Mumbai.
CDSCO West Zone, Mumbai, Maharashtra: A zonal office of the Central Drugs Standard Control Organization (CDSCO), located in Mumbai.
Drugs Cosmetics Act: An act to regulate the import, manufacture, distribution and sale of drugs and cosmetics.
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: 26" 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 continuation to this office earlier order of even number dated 10.02.2014, It has been decided
to delegate the following powers to Dr. K. Bangarurajan, DDC(I), CDSCO West Zone, Mumbai
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 uad provided under Rule 89 of the Drugs & Cosmetics Rules
2. 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.
3. No Objection certificates for grant of permissions for import of dual use items, not for
medicinal use.
(Dr. GJN. Singh)
Drugs Controller Geweral (India)
To,
1. All Zonal Officers of CDSCO
2. IDMA/OPPI/FOPE/Pharmexil/SPIC