Aleph Accreditation & Testing Centre Pvt Ltd.
CDSCO CERTIFICATION
CENTRAL DRUGS STANDARD CONTROL ORGANIZATION (CDSCO)
Central Drugs Standard Control Organization (CDSCO) is the drug regulatory agency under the ministry of health and family welfare, Government of India primarily vested in implementing the provisions of the Drugs and Cosmetics Act, 1940, which include approval of New Drugs, regulation of imported drugs, the conduct of their clinical trials, and coordinating the activities of the States to achieve uniformity throughout the country in the administration of the said Act.
WHAT IS CDSCO APPROVAL AND LICENCING?
The Central Drugs Standard Control Organization (CDSCO) under Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India is the National Regulatory Authority of India. It is responsible for the approval of Drugs, Cosmetics, Conduct Clinical trials, Laying down the Standards for Drugs, control over the quality of imported drugs in the country.
CDSCO is responsible for the approval of the license of specified categories of critical drugs such as blood and blood products, Vaccines, sera, I.V. fluid.
CDSCO is constantly working to bring out uniformity, transparency, accountability in its services to ensure the safety and quality of medical products imported, manufactured, and distributed in-country.
The drug controller general of India is responsible for the approval of licenses of specified categories of the drug.
FUNCTION OF CDSCO
The CDSCO is responsible for the following functions:
- Approval of new drugs and clinical trials
- Testing of new Drugs
- Grant of test license, Personal license, NOC for Export
- Import Registration and licensing
- License approving of blood banks, LVPs, Vaccines, and some medical devices
- Amendment to D and C Act and Rule
- Banning of drugs and cosmetics
- Oversight and mark surveillance through inspectorate of center
WHAT ARE THE REQUIREMENTS FOR CDSCO CERTIFICATION?
BASIC REQUIREMENTS
- Manufacturers are required to appoint an Authorized Indian Representative (AIR) to represent them in all dealings with the CDSCO authority in India.
- The AIR shall be an Indian national or entity registered in India. The AIR must have a valid wholesale license to be eligible to apply for an import license.
- Applicants who can register on the portal are Corporate, Indian Agent, Importer.
- If Applicant has more than one Manufacturing unit of his organization, then Applicant must register with its corporate organization.
- Department of Science and Technology Registration Number is mandatory to fill the Formulation Research and Development Registration Form.
We provide CDSCO services and extensive regulatory support for businesses. To know more, please visit at ALEPH INDIA CDSCO CERTIFICATION
REQUIRED DOCUMENTS
- ID proof details
- Power of Attorney
- Corporate address proof
- Manufacturing and Wholesale license
- Covering letter that signifies drug intent
- Duly signed undertaking
WHAT IS THE PROCEDURE TO GET CDSCO CERTIFICATION?
- An applicant is required to fill the registration form.
- Online portal generation on SUGAM by the authorized signatory/responsible person of the organization.
- Online submission of application with requisite documents by Authorized signatory
- Application received by Nodal Officer.
- Application forwarded to Reviewing Officer. Registration will be approved by CDSCO only after the evaluation of the submitted documents.
- After review forwarded to Deputy Decision Authority. If any deficiency in documents, the authority may require the applicant to submit additional information.
- Application forwarded by deputy decision authority to Licensing Authority
- Licensing authority grants the Approval of license
TIMELINE FOR PROCESSING AND APPROVAL OF APPLICATION BY CDSCO
If an examination or query is involved, the timeline will be from the date of receipt of the response from the applicant. The timeline varies as per the type of application.
PURPOSE WISE FEE’s REQUIRED TO BE PAID
Applicants can submit the payment through the online payment services of CDSCO. The fee will be as per the type of application and license required by the applicant.
WHY CHOOSE ALEPH INDIA FOR CDSCO LICENSE?
We “ALEPH INDIA GROUP” are a leading consultant in product testing and technical compliances for Indian Regulatory requirements. We aim to facilitate the consumers to get Certification & License under the various Schemes under Govt. of India.‘Aleph INDIA’ is a reliable service provider of PRODUCT CERTIFICATION, TESTING, TRAINING, INDIAN STANDARD ASSESSMENT like ISI Certification Services, REACH CERTIFICATION, CDSCO License, and many more. With the experience of more than a decade and expertise in various technical certifications, Aleph INDIA is offering a compliance partnership for CDSCO approval for 150+ drug companies.
To understand the CDSCO requirement for your product and get CDSCO CERTIFICATION.
Please visit to know more about us at www.alephindia.in
For more queries, feel free to contact us at inbox@alephindia.in, info@
Telephone: 9818571192, 9990136656