An Overview of CDSCO Registration
The CDSCO stands for Central Drugs Standard Control Organisation is the NRA or National Regulatory Authority under the Directorate General of Health Services, Government of India, and Ministry of Health and Family Welfare. The CDSCO is responsible for the regulation & approval of New Drugs and Clinical Trials in the country under the Drugs & Cosmetics Rules, 1945 and Drugs & Cosmetics Act, 1940. The CDSCO laid down the standards for Drugs, control over the imported Drugs’ quality, coordination of the activities of SDCO (State Drug Control Organisation) and facilitating expert advice with an outlook of the regularity in the enforcement of the Drugs & Cosmetics Act.
Any organisation that manufacturers or imports or exports drugs & cosmetics conducts Research & Development activities regarding drugs, imports drugs for the purpose of examining conducts BA (Bioavailability) & BE (Bioequivalence) studies in drugs for export purposes need to obtain CDSCO Registration through its online registration portal.
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Purpose behind CDSCO Registration
CDSCO Registration can be obtained for various purposes and the purposes for which an applicant can register under the portal of CDSCO:
Who can apply for CDSCO Registration in India?
Following are the applicants who can apply for online CDSCO Registration in India:
- Indian Agents;
- Foreign Enterprises holding Indian Subsidiary.
Remember: A manufacturing unit cannot register directly on the website or portal. A corporate must create login credentials for the manufacturing unit via which they can log in on the portal.
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What are the Different Divisions of CDSCO?
Following are the different divisions of CDSCO in India:
- Cosmetics: As per the Drugs & Cosmetics Act, Cosmetic means any item that is deliberately pat, sprayed, or used or applied to the human body or any part thereof for decorating, cleaning, glowing, or changing the appearance, includes any item intended for use as a component of cosmetic.
Under the Act & Rules made thereunder, the manufacturing of cosmetics is controlled under a system of examination & licensed by the State Licensing Authority assigned by the concerned State Governments, while the import of cosmetics is governed under a registration system by the authority appointed by the Central Government.
- DCC-DTAB: It gives suggestions on the matters raised out of the administration of the Act & Rules thereunder shall be done by changing the pertinent particulars of the Drugs & Cosmetics Act & Rules. DCC-DTAB also organises the meeting for effective checking of the rules. DCC-DTAB also organises the meeting for effective observing of the rules.
- BA/BE: BA or Bioavailability is defined as the respective amount of drug that reaches the instrinsic circulation and so able to have an active effect in the body. BE or Bioequivalence means if two drugs are said to be BE drugs if they function the same in all intent by providing in equivalent proportions.
- Import and Registration of Drugs: The import of rigs into India is governed under Chapter III of Act and Part IV of Rules. The Applications for registration and import license of drugs are processed as per the Drugs & Cosmetics Rules.
- New Drugs: Illustrations of safety & efficacy of the drug product for use in humans is vital before the drug product can be consented for manufacturing/import & making in the country. New Drugs as defined under the Rule 122-E of Drugs & Cosmetics Rules, new drugs comprising bulk drug substance or Phytopharmaceutical drug which has not been used in India to any remarkable extent under the conditions, suggested in the labelling thereof & has not been recognising as safe & effective by the authority mentioned under the Rule 21 of the concerned affirmation.
- Medical Devices and Diagnostics: In India, currently only notified medical devices are regulated as Drugs under Act & Rules of Drugs & Cosmetics made thereunder in 1945.
- Substances used for artificial insemination recognition and incision dressing stapes, sutures, bandages, ligatures, blood & its component collection bag with/without anticoagulant.
- Substances comprising prophylactic techniques, intrauterine devices, antiseptic & insect killer.
- Biological; Biological products are medical products, and most of the biological available on earth are made from a variety of natural sources. Like some medicine, some biological are aimed to treat diseases & medical conditions. Other biological items or products are used to prevent or diagnose diseases.
- Vaccines: Human organs/cell/tissue used for transplantation; Gene & Cellular therapies; Blood donor test; Allergic extracts from plants which are used for both treatment & diagnosis, etc.
Vital Necessary Papers Required for Online CDSCO Registration
Following are some vital necessary papers that should be submitted during online CDSCO Registration:
- Identity proof of the applicant;
- Address proof of the applicant;
- Upload the copy of BE or BA Site Registrations as issued by CDSCO in case of BE or BA approved sites Registration;
- Undertaking allotted by a Government Authority;
- Wholesale License or Manufacturing License in the case of Manufacture or Import of Blood Product registration or Drugs or Test License Registration.
Procedure for Online CDSCO Registration
The CDSCO Registration is completely online. Following are the steps by steps procedures for obtaining CDSCO Registration under the online portal of CDSCO:
- Applicant Type;
- User Name;
- Mobile Number;
- Email ID.
Fill out the Registered Indian Address Form, which contains details like:
- Organisation Name and Type;
- Contact Number;
- Upload the Corporate Address Proof.
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Frequently Asked Questions
The CDSCO is accountable for the CDSCO Registration in India of all drugs & medical devices in India.
For the licensing is regulated by the Ministry of Health & Family Welfare in the Central Government. The Ministry has verified the online CDSCO Registration portal via which the import license has to be made.
Medical devices are regulated or controlled by the Drug Controller General of India or DCGI with the CDSCO, part of the Ministry of Health & Family Welfare.
Form CT-16 for import of new drugs for CT, BE or BA or for examination, analysis, and test should be submitted in CDSCO.
On average, it takes a minimum of 10 years for a new drug or medicine to finish the journey from initial discovery to the marketplace, with clinical trials taking 6 to 7 years alone.
CDSCO is a Central Drug Regulator of India, and it's a statutory agency at the state level, reporting to the Ministry of Health & Family Welfare.
CDSCO is the National Regulatory Body of India for Pharmaceuticals, Cosmetics, and medical devices, whereas DCGI regulates medical devices and pharmaceuticals and its position within the Ministry of Health & Family Welfare.
It has 6 zonal offices in Mumbai, Ghaziabad, Kolkata, Hyderabad, Chennai, and Ahmedabad.