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CDSCO’s National Single Window System Portal

calendar22 Apr, 2024
timeReading Time: 4 Minutes
CDSCO Single Window System Portal

The National Single Window System Portal is a revolutionary platform that the Central Drugs Standard Control Organization (CDSCO) has unveiled, intending to improve and expedite regulatory procedures in India’s pharmaceutical and healthcare industries. This cutting-edge digital system acts as a single point of contact for all regulatory application and approval submission, processing, and tracking—from clinical trial permissions to drug manufacturing licenses. The portal promotes transparency, expediency, and accountability in regulatory affairs by combining separate processes into a single interface. This allows for the adoption of strict quality and safety standards while simultaneously promoting an atmosphere that is favourable to pharmaceutical innovation. The National Single Window System Portal developed by the CDSCO is a significant step toward modernizing regulatory frameworks, facilitating corporate transactions, and eventually advancing the health of the public in the country.

Overview of CDSCO

The Central Drugs Standard Control Organization (CDSCO) is a national regulatory authority that is under the Ministry of Health and Family Welfare, Director General of Health Services, and the Government of India. CDSCO plays a vital role in the drug licensing field as it gives licenses for new businesses, approves drugs, and approves conducting clinical trials, as well as the quality of drugs and its standards. It ensures that the process is smooth and that all the drugs in the market have approval from the central government and related departments. It is a controlling authority in the nation that looks over the state and central drug agencies and makes sure that the drug testing and its quality are done following the stipulated rules.

National Single Window System Portal by CDSCO

The National Single Window System Portal by CDSCO is a single portal for all the necessary drug trials, license approvals, registrations, and clearances mandatory for doing business or conducting research in the medical field. There are so many advantages of the National Single Window System Portal, such as integrating all the necessities into one single portal as the process is streamlined and the approvals will come earlier and in compliance with the central government. It ensures that there are no formalities other than this, which makes it easy for investors and entrepreneurs to enter the market with a much less hectic registration process.

Objectives of the National Single Window System Portal

The Objectives of the National Single Window System Portal are as follows –

  • One of the main objectives is that it facilitates timely license approvals and streamlines the process for the people wanting the registration done.
  • It ensures that the application process is the same for everyone and that uniform approvals are given across the nation.
  • The other aim includes a reduction in costs and delays while applying for the license through other portals.
  • To be the direct source of contact between the authorities and the applying company to lessen the discrepancies.
  • To make sure that business commencement in the related sector is easy and license approval is done on time which makes sure that more and more investors and entrepreneurs are involved in this benefitting company’s economy and creating employment.  

Advantages of the National Single Window System Portal

The advantages of the National Single Window System Portal are as follows –

  • One of the most prominent advantages is that a single portal has been created for all the processes, making it easier for companies to get their licenses and complete the registration process.
  • The other advantage is that one portal has been created to monitor the activities and compliances, thereby reducing the chances of any discrepancies.
  • Other advantages include the establishment of more health and medical device manufacturing businesses, which aid India’s medical sector and reduce the import of these products.
  • The national portal ensured a direct point of contact between the authorities and the company, aiding in resolving the issues in much less time than through various portals.
  • It made it possible for businesses to set up in the country with ease, thereby increasing employment opportunities.

Features of the National Single Window System Portal

The National Portal is responsible for maintaining and granting approvals for licenses directly from the authorities and negating the interference of other departments, which makes the process of approval more accessible and faster. It is one of the main features of the National Single Window System Portal since earlier; the applicant had to do a lot of paperwork, which involved discrepancies and unsatisfactory responses by the department. Making it just a single window has made the process linear and less troublesome. The applicant can track the status of its approval, and the applicants planning to get the approval can look into the regulatory guidelines and the process involving all the paperwork and fee structure to get clear knowledge about what needs to be done at their end to avoid confusion while making the application.

Key services offered by the National Single Window System Portal

The essential services offered by the National Single Window System Portal are as follows –

  • Granting the pending approvals if they follow the necessary documentation and guidelines.
  • It serves as a digital repository for storing the documents that are pending to get approval.
  • Handling of the processing fee of approvals.
  • Granting renewal of the licenses.
  • Tracker and updates of application after it is done at the applicant’s end.
  • Any updates and information related to the approvals like the fee structure, time required, necessary documents, etc.
  • To lay the rules, procedures, and guidelines that is pre-requisite to the license approval to set up business in the country.

Conclusion

To conclude, the national portal launched by CDSCO represents a significant turning point in the development of India’s pharmaceutical regulatory environment. This platform aims to transform the way regulatory processes are carried out, promoting more efficiency, openness, and accountability by utilizing the power of digital technology. It is impossible to overestimate the portal’s importance in accelerating approvals, guaranteeing compliance, and encouraging innovation as the country moves closer to becoming a pharmaceutical powerhouse on the world stage. The portal symbolizes CDSCO’s dedication to supporting seamless operations and achieving public health objectives for the benefit of all stakeholders concerned, thanks to its extensive feature set and user-friendly interface.

Corpbiz is the platform where these investors can seek help to get the approval process done in time to start the medical business in the country. Our organization will give you ample support in establishing your business and complying with various laws, rules, and regulations attached to the nature of the company.

Frequently Asked Questions

  1. When did the National Single Window System Portal come into existence?

    The National Portal was established on January 1, 2024, by the Central Drugs Standard Control Organization (CDSCO) through an official notice.

  2. What are the key merits of the National Single Window System Portal to applicants?

    The applicant can also track status of its approval and the applicants planning to get the approval can look into the regulatory guidelines and the process involving all the paperwork and fee structure to get clear knowledge about what needs to be done at their end to avoid confusion while making the application.

  3. What are the primary necessary forms in the portal?

    The primary necessary forms in the National Single Window System Portal are as follows –
    Form MD-01 is used to apply for an entity's registration certificate.
    Form MD-12 is used for a license application for manufacturing medical devices for testing, research, inspection, training, and assessment.
    Form MD-16 is used for a license application for the import of medical devices used for testing, research, inspection, training, and assessment.

  4. Under which rules these forms were added?

    These forms were added under the Medical Devices Rules, 2017.

  5. Why was the National Single Window System Portal introduced?

    The National Single Window System Portal was introduced to facilitate smooth, seamless, and hassle-free business licenses, approvals, registrations, and clearances for investors and businessmen dealing with drugs and medical devices.

  6. What is the major objective of the National Single Window System Portal?

    The major objective of the National Portal is to reduce discrepancies in the application procedure for licensing by making a single portal for the same that is overlooked by the regulatory authorities.

  7. Who is required to register with CDSCO?

    Investors and entrepreneurs dealing with the manufacturing of medical equipment, drugs, research, testing, or import of medical products need to register with CDSCO for license approval.

  8. Is it mandatory to have the CDSCO License?

    Yes, all manufacturers, importers, and sellers need to attain a license from CSDSO to deal with the medical device business in the country. Manufacturers, along with the CDSCO, have to obtain a license from, Drug Controller General of India as well.

  9. What is the validity period of the CDSCO License?

    The validity period of the CDSCO License is three years from the date of its issuance. However, it can last for a lesser period if the license is revoked, suspended, or cancelled during the course by the authorities.

  10. By whom is CDSCO controlled?

    The Central Drugs Standard Control Organization (CDSCO) is a National Regulatory authority that comes under the Ministry of Health and Family Welfare, Director General of Health Services, and the Government of India.

Read Our Article: CDSCO Registration for Cardiovascular Medical Devices

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