**Policy Summary:**
This Office Order, Immediate No. D.21013752017DC, issued on January 2, 2018, by the Directorate General of Health Services, Central Drugs Standard Control Organisation (CDSCO), Government of India, delegates the authority to issue import licenses for drugs under Form 11A to Zonal Offices, Sub-zonal offices, and all Port Offices of CDSCO. This delegation applies specifically to import licenses requested by Government Hospitals or Autonomous Medical Institutions for the treatment of their patients. The decision is made in accordance with Rule 33 A of the Drugs and Cosmetics Act, 1940, and its associated Rules. The order has been approved by the competent authority, as stated by Director Admn., Arun Sharma. The order is disseminated to all Zonal/Sub-zonal/Port Laboratories of CDSCO, all JDCs/DDCIs/ADCIs at CDSCO HQ, PPS to JSR, MoHFW, Nirman Bhavan, New Delhi, the CDSCO web portal, and the DDAs/DOs to DCG(I) Guard file.
Key Entities Referenced
Drugs Cosmetics Act, 1940: An act of the Indian Parliament that regulates the import, manufacture, distribution and sale of drugs and cosmetics.
Central Drugs Standard Control Organisation: National Regulatory Authority (NRA) of India under the Ministry of Health & Family Welfare, responsible for regulation of drugs, cosmetics, and medical devices.
New Delhi: The location of the Directorate General of Health Services and Central Drugs Standard Control Organisation office issuing the order. New Delhi is a city and a union territory of India.
Form 11 A: A form related to the license for import of drugs by a Government Hospital or Autonomous Medical Institution for the treatment of patients.
Arun Sharma: Director Admn. issuing the office order.
Ministry of Health & Family Welfare: A ministry of the Government of India.
Nirman Bhavan, New Delhi: Location of the Ministry of Health & Family Welfare in New Delhi.
Government Hospital: A hospital run by the government.
Immediate
No. D.21013/75/2017-DC
Government of India
Directorate General of Health Services
Central Drugs Standard Control Organisation
New Delhi, dated the 2" January, 2018
Office Order
In terms of Rule 33 A of the Drugs & Cosmetics Act, 1940 and Rules
made thereunder, it has been decided to delegate the power to Zonal
Offices/sub-zonal offices and all Port Offices of CDSCO to issue license for
import of drugs by a Government Hospital or Autonomous Medical Institution for
the treatment of patients under Form 11 A.
This issues with the approval of the competent authority.
(Arun Sharma )
Director (Admn.)
1. All Zonal/sub-zonal/Port/Laboratories of CDSCO.
2. All JDC(!)s/DDC(1)s/ADC(I)s at CDSCO (HQ).
3. PPS to JS(R), M/o H & FW, Nirman Bhavan, New Delhi.
4. Web portal of CDSCO.
5. DDA(D)/O/o to DCGI/Guard file.