**Policy Summary:**
This notice, issued by the Central Drugs Standard Control Organization (CDSCO) on March 3, 2016, addresses challenges encountered during the transition to the SUGAM online services for import licenses and registration certificates of drugs. While online applications were mandated from February 15, 2016, (Notice No. CDSCOIT20161 dated 16.02.2016), the CDSCO observed that importers were unable to apply due to missing historical data (details of Registration Certificates). To ensure a smooth transition to the e-governance system, all authorized Indian Agents and Registration Certificate (RC) holders are requested to upload details of their Registration Certificates and Import Licenses by March 11, 2016. This measure aims to generate a historical database, enabling importers to apply online. For assistance, a dedicated cell of officers is available:
* **User registration related queries:** Sh. Dinesh Kumar, 011-23216367 Ext. 331
* **Technical queries:** Sh. Navneet Pratap Singh, 011-23216367 Ext. 105; Sh. Virendra Singh, 011-23216367 Ext. 105
* **IT related queries:** Sh. Rahul Kumar Gautam, 011-23216367 Ext. 331
The CDSCO emphasizes the importance of stakeholder participation for the successful operation of the online system and requests that this matter be treated with top priority.
Key Entities Referenced
Indian Agents: Authorized representatives of Registration Certificate holders
SUGAM: Online portal initiated by Central Drugs Standard Control Organization for quick delivery of services.
Registration Certificate: A certificate required for registration of drugs.
Ministry of Health Family Welfare: A ministry within the Government of India.
Directorate General of Health Services: A directorate within the Ministry of Health and Family Welfare, Government of India.
Central Drugs Standard Control Organization: The national regulatory body for Indian pharmaceuticals and medical devices under the Ministry of Health & Family Welfare.
FDA Bhawan, Delhi: Location of Central Drugs Standard Control Organization office in Delhi, India
Import Licenses: Licenses required to import drugs.
IMP/Misce./27/2016
Government of India
Ministry of Health & Family Welfare
Directorate General of Health Services
Central Drugs Standard Control Organization
FDA Bhawan, Delhi,
Dated
NOTICE O03 MAR 2016
SUGAM on-line services have been initiated by Central Drugs Standard Control
Organization (CDSCO) for quick delivery of services and it is expected to receive all new
applications for obtaining import licenses and registration certificate of drugs by way of online
receipt from 15.02.2016 vide Notice No. CDSCO/IT/2016(1) dated 16.02.2016.
However it is observed that importers and applicants are not able to apply for import
license due to lack of uploading of historical data i.e details of Registration Certificate etc.
by the Registration Certificate holders. In the interest of smooth transition to the e-
Governance system applications, all the authorized Indian Agents (RC holders) are herby
requested to upload details of their Registration Certificates and Import Licenses owned on or
before 11/03/2016, so that historical data base can be generated and concerned importers can
apply online.
All stakeholders are desired to come forward for successful operation of online system.
For any clarification/assistance a cell of officers is created whose contact details are as follows:
For user registration related queries: _
Name _ Contact number
Sh. Dinesh Kumar 011-23216367 Ext. 331
For Technical queries
Sh. Navneet Pratap Singh 011-23216367 Ext. 105
Sh. Virendra Singh 011-23216367.Ext. 105
For IT related queries
Sh. Rahul Kumar Gautam | 011-23216367 Ext. 331
This may please be treated on Top Priority
(Dr.
Drugs Controller Ge
To
1. Concerned officials
2. PS to DCG (1)
3. DDC (RC)
4. All Pharmaceutical Associations _
5. Guard file