The CDSCO Sugam was introduced in November 2015 by the Central Drugs Standard Control Organisation. It is an online portal for filing applications for various services.
Brief on Central Drugs Standard Control Organisation
The Central Drugs Standard Control Organisation (CDSCO) works as per the directions of the Directorate General of Health Services, Ministry of Health and Family Welfare. CDSCO is a National Regulatory Authority (NRA) in India. Its head office is in New Delhi. It has six Zonal offices, four sub-zonal offices, thirteen port offices and seven laboratories. The Drugs & Cosmetics Act and the Rules made thereunder have put responsibilities on the CDSCO related to the following:
- To approve New Drugs.
- To conduct Clinical Trials.
- To lay down the standards for drugs.
- To control the quality of imported drugs in India.
- To coordinate the activities of the State Drug Control Organisation by providing expert advice to bring uniformity in the enforcement of the Act.
- To grant license of certain categories of critical Drugs along with the State regulators.
CDSCO Sugam Portal
The Central Drug Standards Control Organisation (CDSCO[1]) launched the module under the Sugam portal for updating and uploading the data on its website related to the licensed drug manufacturing facilities and approved or licensed drug formulations for having up to date information on drugs manufactured in India.
The Sugam is building a comprehensive database of the various licenses and permissions issued by the appropriate departments of a State. This includes details of manufacturers, manufacturing sites, and the drug’s formulations.
The implementation of Sugam has brought transparency, accountability, timeliness, reliability and simplicity to the business. It is a major reform in the Pharma Industry of India, and it directly refers to the Government Digital India initiatives.
Sugam for Online Licensing
CDSCO Sugam is an e-Governance system to discharge various functions of the CDSCO. It is a software system developed for an online web portal where an applicant applies for the followings:
- NOCs
- Licenses
- Registration Certificates
- Permissions
- Approvals
The Sugam provides an online interface to track the applications, respond to queries and download the permissions issues by the CDSCO. It is also helping the CDSCO officials in processing the online applications and generating the online permissions and the MIS reports.
Pre-Application: Registration
Sugam portal is a single-window interface for the stakeholders to access online services under the CDSCO. Before applying to any form, the applicant needs to register on the portal. The applicant fills in all the details in the registration form and submits it. The CDSCO administrator approves or rejects such submitted registration forms. After approval of the registration form, the applicant logins to the portal or if the form is rejected, then an email is sent to the applicant stating the reason for the rejection.
The registration form is filed by the authorised signatory or responsible person only. The hard copy of ID proof, undertaking, and address proof is submitted to the CDSCO office. The registration is approved by the CDSCO only after the evaluation of the documents submitted. After successful registration, the applicant can log in to the portal.
The applicant who can register on the CDSCO Sugam portal are:
- Corporate
- Indian Agent
- Importer
- Foreign Enterprises holding Indian Subsidiary
- Cosmetics
- Ethics Committee
- Formulation R&D Organisation
- BA/BE Approved Sites
- Sponsor (BA/BE & CT)
If the applicant has more than one manufacturing unit, then the applicant first registers its corporate on the Sugam Portal and then registers its sub-units on the portal. The Manufacturing units do not register directly; the corporate initiates the registration process for the manufacturing units.
Purpose of Registration
The applicant registers on Sugam Portal with different purposes with assigned roles and the Forms as given below:
| Purpose of Registration | Roles on Sugam | Forms Available |
| Cosmetics Registration | Applicant for Cosmetics | Form 42 |
| Ethics Committee Registration | Ethics Committee | Ethics Committee Registration |
| Formulation R&D Organisation | Formulation R&D Organisation | Form 44 Form 12 |
| Import of Drugs/Medical Devices/Test License | Corporate Importer (Form 8) Foreign Enterprise holding Indian Subsidiary Indian Agent | Form 40 Form 8 |
| BA/BE Approved Sites | BA/BE Approved Sites | Form 44 |
| Sponsors (BA/BE & CT) | Sponsors (BA/BE & CT) | Form 44 Form 12 |
Documents
The followings are the documents required as per the purpose of registration:
| Purpose of Registration | Documents Required |
| Cosmetics Registration | Details of ID Proof, Power of Attorney, Corporate Address Proof |
| Ethics Committee Registration | Details of ID Proof, Power of Attorney, Corporate Address Proof |
| Formulation R&D Organisation | Details of ID Proof, Power of Attorney |
| Import of Drugs/Medical Devices/Test License | Details of ID Proof, Power of Attorney, Corporate Address Proof and Manufacturing or Wholesale License (Form 20B & Form 21B) |
| BA/BE Approved Sites | Details of ID Proof, Power of Attorney, Corporate Address Proof |
| Sponsors (BA/BE & CT) | Details of ID Proof, Power of Attorney, Corporate Address Proof |
Application Form Submission
The applicant fills the application form with all required details and submits it to the portal. Then the applicant submits the documents accordingly. After uploading the documents, the applicant makes payment either online or challan.
The details of departments and their forms are as follow:
| CDSCO Departments/ Stakeholders | Processes | Forms |
| Import & Registration | Fresh Registration Certificate, Endorsement & re-registration, Post submission & Post Approval changes (PAC) | Form 40/41 Form 8/10 Form 12AA 17 cases of PAC |
| Medical Devices & Diagnostics | Fresh Registration Certificate, Endorsement & re-registration, Post submission & Post Approval changes (PAC) | Form 40/41 Form 8/10 17 cases of PAC |
| Cosmetics Registration | Fresh Registration Certificate, Endorsement, Re-registration | Form 42/43 4 cases of PAC |
| Ethnic Committee Registration | Ethnic Committee Registration and Re-registration | |
| Global Clinical Trials | NOC to conduct clinical trials Import license for test and analysis | Form 44/NOC Form 12/11 11 Cases of PAC |
| BA/BE | NOC to BA/BE studies Import license for test and analysis | Form 44/45/46 NOC |
| Biological- New Dug- Vaccines | Permission to Market/Import/Conduct Clinical Trials | Form 44/45/46 NOC |
| New Drugs/SND/FDC | Permission to Market/Import/Conduct Clinical Trials | Form 44/45/46 NOC |
| CLAA Processes | Grant & Renewal of Licenses for: Blood BankAnti-Sera Stem Celles | Form 27C/28C Form 26G Form 27F/Form 28F |
| Port Offices (7 locations) | Permission to import drugs in small quantity for personal use | Form 12A/12B |
| Zonal/Sub Zonal Offices | Import License for Test & Analysis for Drugs more than 4 years (old drugs) | Form 12/11 |
| Zonal/Sub Zonal Offices | Export NOC for manufacturing (5 cases): Export purpose- BD, FF, material transfer, Exhibit Batches- BD, FF | Application Form/NOC |
CDSCO Sugam Login and Sub-Login Guidelines
After the CDSCO approves registration, the applicant can log in to the Sugam portal. The applicant files the application with all mandatory details. The application is further approved, rejected, suspended or withdrawn by the authority.
An applicant from the pharmaceutical industry can possess roles of the corporate, Indian agent, sponsors, etc. This function of the Sugam portal is known as Switch Role. An applicant can also have an additional role, and at the Sugam portal, he can request additional roles. The applicant provided the required documents to the CDSCO Sugam portal for this additional role.
The Sugam portal allows corporate applicants to create a sub-login account for filing independent applications by manufacturing unit, R&D unit or any other unit. The sub-login can be created for the following:
- Branch Office
- CRO
- Manufacturing Site
Objectives of CDSCO Sugam Portal
The prime objectives of the Sugam portal are:
- Establishes a single window for a number of stakeholders related to the process of CDSCO.
- Consolidates the Indian Drug Regulatory Framework by streamlining the CDSCO process
- Enables the paperless grant of various CDSCO licenses, or NOC
- Enables transparency in the Drug Regulatory Process
- Enables the ease in the pharmaceutical business and regulatory agency.
- Enables greater outreach of citizen-centric information related to India’s quality and standard of drugs.
Benefits of CDSCO Sugam
The following are the benefits of the Sugam Portal:
- The Sugam provides a single-window for all stakeholders to access services provided by implementing role-based access control and actions.
- It has consolidated the whole Drug Regulatory framework.
- It provides a centralised dashboard to monitor all the regulatory clearances in India.
- It provides high-level transparency as the status of the applications can be tracked on the portal.
- It provides the project with all the information to reduce delays in the regulatory process.
- It provides an integrated workflow from making applications to obtaining permission.
- It also answers all the queries.
Conclusion
CDSCO Sugam is an online portal for CDSCO licensing. It was launched by the Ministry of Health and Family Welfare. It is an e-governance system which is launched to perform different functions of the CDSCO. These functions are provided under the Drugs and Cosmetics Act as approval of new drugs, Clinical Trials, etc. Implementation of Sugam has brought simplicity, transparency, reliability, accountability, etc. Sugam has multiple benefits, such as providing a single window for all stakeholders to access services.
Read our Article:CDSCO Medical Devices Manufacturing Registration Requirement
