CDSCO or Central Drugs Standard Control Organisation, it is the National Regulatory Authority for Indian pharmaceutical & medical devices under the Directorate General of Health Services and Ministry of Health & Family Welfare in India. It is the responsibility of CDSCO to approve new drugs & conduct clinical trials in India under the Drugs & Cosmetics Act, 1940 and Drugs & Cosmetics Rules, 1945. It also lays down standards for drugs & control the quality of imported cosmetics & drugs in the country to bring about uniformity in enforcing the Act & Rules. The Act & Rules entrust several responsibilities to the Central & State Regulators for regulating Cosmetics & Drugs in India. CDSCO is the Central Drug Authority that discharges the functions assigned to the Central Government under this Act. It is also provides expert advice to State Drug Control Organisations and coordinates their activities. CDSCO and State regulators are jointly responsible for issuing CDSCO licenses for specific specialised categories of critical drugs like vaccines, IV fluids, sera, blood, and blood products. In this article, we will discuss who can apply for CDSCO License in India.
A Brief on CDSCO SUGAM Portal
The CDSCO (Central Drugs Standard Control Organisation) introduced this portal in November 2015. To have up-to-date information on medications made in India, CDSCO created the module under the SUGAM portal for updating & uploading data on its website pertaining to the licenced Drug Manufacturing facilities & approved or licenced drug formulations. SUGAM’s deployment has improved the company’s accountability, dependability, transparency, and ease of use. It’s a significant overhaul for India’s pharmaceutical sector and specifically mentions the Government Digital India plan. An electronic governance system called CDSCO SUGAM is used to carry out various CDSCO tasks. It is software created for an online application portal used to request NOCs, permissions, licences, registration certificates, and approvals. This portal offers a web interface for following applications, answering questions, and downloading permissions granted by the CDSCO. Additionally, it assists CDSCO staff members with processing online applications, creating online permissions, and producing MIS reports.
Purpose to apply for CDSCO License
An applicant applies for CDSCO License for different objectives. The different objectives for which an applicant can register under the CDSCO portal are the following:
- Cosmetics Registration
- Export NOC (Zone);
- Ethics Committee Registration;
- Blood Bank Registration;
- Dual Use NOC (Trader);
- Blood Product Registration;
- Sponsors (BA/BE & CT)
- Manufacture or Import of Drugs;
- Test License;
- Formulation R&D Organisation;
- BA/BE Approved Sites.
Who are Eligible to Apply for CDSCO License?
Following is the list of applicants who can apply for CDSCO License:
- Authorised Indian Representatives (AIR);
- Foreign Enterprises were holding Indian Subsidiary.
Note: A manufacturing unit cannot register directly on the CDSCO portal. A corporate must create login credentials for the manufacturing unit by which they can log in on the CDSCO portal.
Documents required to apply for CDSCO License
Following are some essential documents to apply for CDSCO License:
- ID Proof Documents;
- Address Proof Documents;
- Undertaking granted by a Government Authority;
- Manufacturing License or Wholesale Licenses in case of manufacture or import of Drugs, blood product registration, test license registration.
- Copy of BA/BE Site Registration and approval from CDSCO in case of BA/BE Approved sites Registration.
Procedure to Obtain CDSCO License
Following are some essential steps to obtain CDSCO License in India:
Step 1: There are different kinds of drugs & cosmetic licenses, and the type of license required depends on products, services, activities and the nature of the business. The applicant has to apply in the requisite form according to the category mentioned on the site with fees and required documents.
Step 2: Documentation for obtaining a drug & cosmetic license is crucial in India’s licensing procedure.
Step 3: The applicant has to apply separate applications for all types of prescribed licenses via different forms.
Step 4: Scrutiny of application & inspection of factory location take place. The drug inspector visits the location and verifies the particulars of the application. A query is raised if there is any discrepancy/ shortcoming.
Step 5: Product Scrutiny also takes place. The Drug inspector verifies information of the product applied on the application, and in case they are found to comply with the norms and conditions, the application will be considered for grant of license. Inspector may raise any clarification in the application.
Step 6: After satisfactory verification, Drug Controller Department issues the license.
Step 7: The drugs control administration also provides the approval for technical staff according to Drugs & Cosmetics Rules, 1945, framed under the legislation abiding through the WHO & GMP inspection norms.
Under the Drugs & Cosmetics Act, CDSCO is responsible for approval of New Drugs, laying down the standards for Drugs, Conduct of Clinical Trials, control over the quality of imported Drugs, cosmetics, and medical devices in the country and coordinating the activities of State Drug Control Organizations by providing expert advice and a view of bringing about the consistency in the enforcement of the Drugs & Cosmetics Act.
Read our Article:Importance of CDSCO Certificate in Public Health Domain