The Import of Drugs (Blood Products) into India is regulated through a system of registration by the CDSCO under the provisions of the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945. Any medicine (Drugs) falling within the definition of blood product is required to be registered along with manufacturing premises before import into the country. The Drugs Controller General (India) functions as the Central Licensing Authority who grants the Import Registration Certificate and regulates the import of Blood Products into India under the provisions of Drugs and Cosmetics Act. 1940.

The manufacture of blood products is regulated under a system of inspection and licensing by the State Licensing Authorities along with Central Licensing Authority under the provisions of Drugs and Cosmetics Act, 1940 and Rules made there under.

1. Application for Grant of permission to Import new drug for sale or for distribution under Form CT-18.
2. Application for Grant/ endorsement of Registration Certificate issued for Import of Drugs into India under Form 40.
3. Application for Grant/endorsement of additional product license to import the Drugs under Form 8.
4. Application for Grant of permission to manufacture new Active Pharmaceutical Ingredient (API) / Pharmaceutical formulation of New Drug for sale or for distribution under Form CT-21.
5. Application for Grant/Endorsement/ Renewal of Additional products license to manufacture the products under Form 27E.
6. Application for Grant of license to Import the Drugs for the purposes of examination, test or analysis under Form 12 (NSWS Portal).
7. Application for Grant of permission to conduct clinical trial of new drug or investigational new drug under Form CT-04.
8. Application for Grant of licence to import new drug or investigational new drug for the purpose of clinical trial or bioavailability or bioequivalence study or for examination, test and analysis under Form CT-16.
9. Application for Grant of Post Approval Changes as per PAC guidance for industry and all permissions issued by this directorate.
10. Application for Grant/re-issue of NOC for collection of excess/expired Human Plasma from the licensed Blood Centres for fractionation to manufacture the blood (plasma derived) products
11. Grant/re-issue of NOC for collection, storage and distribution of excess/expired Human Plasma from the licensed Blood Centres to the fractionation centre(Manufacturing site)
12. Any regulatory action (inspection/ investigation) as and when required.

The application submitted through various online portal (SUGAM/ NSWS) and          an e-receipt by the applicant will be processed by the Drugs Inspector (Reviewing Officer) and send to the ADC(I) (Nodal Officer) for further review. The Nodal Officer will send the application to DDC(I)/JDC(I)/DCGI for approval.