CDSCO Sugam: An Overview

The Central Drug Standard Control Organisation (CDSCO) under the Directorate General of Health Services, Ministry of Health & Family Welfare, and Government of India are the National Regulatory Authority (NRA) of India. Moreover, CDSCO and State Drug Control Organisations are responsible for permitting certain specialised types of Critical Drugs licenses. This article will discuss the CDSCO Sugam in detail.

Under the Drug and Cosmetics Act, CDSCO has many responsibilities that include:

• Approval of Drugs to direct Clinical Trials
• Provide standards for Drugs
• Quality check of imported Drugs in the country and coordination with the State Drug Control Organisations for the activities by providing expert advice;
• Training keeping in mind the uniformity in implementing the Drugs and Cosmetics Act.

Role of Central Drugs Standard Control Organisation

Under the Drugs & Cosmetics Act, the arrangement of manufacture, distribution and sale of Drugs is the main priority of State Authorities. At the same time, Central Authorities are only responsible for permitting new drugs and clinical experiments in the country, providing standards for drugs, checking the quality of the imported drugs, and coordinating with the State Authorities.

Note: CDSCO is also a part of permitting specified categories of drugs such as blood & blood products, I. V. Fluids, and Vaccine.

CDSCO Sugam Portal

In January 2016, the Central Drug Standards Control Organisation (CDSCO) ^[1]launched the module under the Sugam portal for updating & 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  thorough database of the various licenses and permissions granted by the appropriate authorities of a State. This includes manufacturers, manufacturing sites, and the drug’s formulations.

The implementation of Sugam has brought transparency, timeliness, accountability,  reliability and simplicity to the business. It is a significant reform in the Pharma Industry of India, and it directly refers to the Government Digital India initiatives.

Pre-Application registration of CDSCO Sugam:-

CDSCO Sugam portal is a single-window interface for the stakeholders to access e-services under the CDSCO. Before applying to any form, the applicant must register on the sugam portal. The applicant fills in all the information in the registration form and submits it. The CDSCO administrator approves/rejects such submitted registration forms. Once approval of the registration form, the applicant logins to the sugam portal. If the form is rejected, the applicant is sent an email stating the reason for the rejection.

The authorised signatory or responsible person files the registration form only. The hard copy of ID proof, address proof and undertakings are submitted to the CDSCO office. The CDSCO approves the registration only after evaluating the documents submitted. Once successful registration, the applicant can log in to the portal.

CDSCO Sugam for Online Licensing

CDSCO Sugam is an e-Governance system to release various functions of the CDSCO. It is a software system successful for an e-web portal where an applicant applies for the following:-

• NGOs
• Licenses
• Registration Certificates
• Permissions
• Approvals

The CDSCO Sugam provide an online interface to track the applications, respond to queries and download the permissions granted by the CDSCO. It is helping the CDSCO officials in processing the e-applications and generating the online permissions and the MIS reports.

Objectives of CDSCO Sugam Portal

The prime objectives of the CDSCO Sugam portal are:

• Establishes a single window for several stakeholders related to the procedure of CDSCO.
• combine the Indian Drug Regulatory Framework by streamlining the CDSCO process
• Enables the paperless grant of various CDSCO License or NOC
• Enables transparency in the Drug Regulatory Process
• Enables facility in the pharmaceutical business and regulatory authority.
• Enables greater outreach of citizen-centric details related to India’s quality and standard of drugs.

Benefits of CDSCO Sugam Portal

The following are the benefits of the CDSCO Sugam Portal:-

• The CDSCO Sugam provides a single window for all stakeholders to access services by implementing role-based access control and actions.
• It has consolidated the whole Drugs Regulatory framework.
• It provides a centralised dashboard to observe all the regulatory permission in India.
• It provides high-level clarity as the applications’ status can be followed on the portal.
• It provides the project with the details to reduce delays in the regulatory process.
• It provides integrated workflows from making applications to obtaining permission.
• It also answers all the queries.

Types of Applications Allowed In theCDSCO Sugam

CDSCO Sugam allows applicants to file the following type of applications:

1. Certificate of Registration – Form 41 for Drugs
2. Certificate of Registration – Form 41 for Medical Devices
3. Certificate of Registration – Form 41 for Diagnostic Kit
4. Certificate of Registration – Cosmetics
5. The license of Import – Form 10 for Drugs
6. The license of Import – Form 10 for Medical Devices
7. The license of Import – Form 10 for Diagnostic Kit
8. Clinical Trial Test License
9. BE NOC for Clinical Trial for importing/manufacturing a New Drug
10. Permission to conduct GCT

Entities allowed to register on the CDSCO Sugam portal

The following applicant can register on the CDSCO Sugam portal-

• Corporate
• Indian Agent
• Importer
• Foreign Enterprises holding Indian Subsidiary
• Cosmetics
• Ethics Committee
• Formulation R&D Organisation
• BA/BE Approved Sites
• Sponsor (BA/BE & CT)

Note: if the applicant has more than one manufacturing unit, the applicant first registers its corporate on the Sugam Portal and then registers its sub-units on the sugam portal. The manufacturing units do not register straight; the corporate initiates the registration process for the manufacturing units.

Purpose of Registration on CDSCO Sugam

The users register on CDSCO Sugam Portal with different objectives with assigned roles and the Forms as mentioned below:

• Cosmetics Registration: The applicant can register for cosmetics on the CDSCO Sugam Portal through available Form 42.
• Ethics Committee Registration: The applicant can register for Ethics Committee on the CDSCO Sugam Portal through the available Form CT-01.
• Formulation R&D Organisation: The applicant can register for Formulation R&D Organisation on the CDSCO Sugam Portal through the available Form 44 & Form 12.
• Import of Drugs/Medical Devices/Test License: The applicant can register for Corporate Importer Foreign Enterprise holding Indian Subsidiary Indian Agent on the CDSCO Sugam Portal through the available Form 40 & Form 8.
• BA/BE Approved Sites: The applicant can register for the BA/BE Approved Sites on the CDSCO Sugam Portal through the available Form 44.
• Sponsors (BA/BE & CT): The applicant can register for the Sponsors (BA/BE & CT) on the CDSCO Sugam Portal through the available Form 44 & Form 12.

Documents

The following are the documents required according to the purpose of registration:-

1. Cosmetics Registration: detail of ID Proof, Corporate Address Proof, Power of Attorney.
2. Ethics Committee Registration: Detail of ID Proof, Corporate Address Proof, Power of Attorney.
3. Formulation R&D Organisation: Detail of ID Proof and power of Attorney
4. Importer of Drugs/Medical Devices/Test License: Details of ID Proof, Corporate Address Proof, Power of Attorney, and Manufacturing or Wholesale Certificate (Form 20B & Form 21B).
5. BA/BE Approved Websites: Details of ID Proof, Corporate Address Proof, Power of Attorney.
6. Financer (BA/BE & CT): Details of ID Proof, Corporate Address Proof, Power of Attorney.

Sub-Logins

Sugam allows corporate applicant accounts to create Sub-Login accounts for the following:-

• Branch Office
• CRO
• Manufacturing Site
• R&D Site

Note: To create sub login credentials, applicants must first add the details of the other offices under the user Profile section in the ‘Add Manufacturing License details’/Add R&D Sites/Add Branch Officers. Once you add these details, the list of officers will be available for you to create sub-login accounts under creating Sub-logins section.

Conclusion

CDSCO Sugam is an e-portal for CDSCO licenses. It was initiated by the Ministry of Health and Family Welfare. The Drug & Cosmetics Act provide these functions as approval or rejection of new drugs, clinical trials, etc. Implementation of CDSCO Sugam has brought simplicity, transparency, reliability, accountability, etc. CSDCO Sugam has multiple benefits, such as providing a single window for all stakeholders to access services.