How To Apply For CDSCO License In India?

Apply For CDSCO License

If you are a manufacturer or seller, then you should know how to apply for CDSCO license in India. Companies and individuals involved in manufacturing, selling, import & export drugs/medical devices in India must ensure that businesses follow regulatory standards for pharmaceuticals or medical devices. This article consists of all the details anyone requires to know about CDSCO license in India.

About CDSCO

The CDSCO (Central Drugs Standard Control Organisation)  is the National Regulatory Authority for Indian pharmaceuticals and medical devices under the Directorate General of Health Services, Ministry of Health and Family Welfare in India. CDSCO is administratively incharge of approval of new drugs, conducts clinical trials, establishes drug standards, monitors the quality of drugs imported into the nation, and coordinates the efforts of State Drug Control Organizations by offering professional advice are all steps toward bringing uniformity to the enforcement of the Drugs and Cosmetics Act, 1940. 

How Can You Obtain CDSCO License In India?

Here are the tips you can follow to obtain a CDSCO License in India:-

  • Visit to CDSCO portal and click on the ‘Login/Sign up’ button
  • Sign up to apply for registration on the CDSCO portal
  • Fill in the details on the registration application form
  • Submit the required documents

This is how you can obtain a CDSCO License but it will be approved only after analysis. Always keep in mind whenever you apply for CDSCO license in India these are the steps individuals need to follow.

Who Can Apply For CDSCO License?

Any organization that works in Manufacturing, importing, Selling, or exporting drugs & cosmetics, organizes R&D activity concerning drugs, imports drugs with the aim of testing or performing Bioavailability (BA) & Bioequivalence (BE), and researching drugs for export purposes requires CDSCO license. That can be easily obtained by following the steps mentioned in the above answer.

List Of Documents Required To Get CDSCO License In India?

Here is the list of documents you will require to grant the CDSCO License in India (For info refer to guidance credentials):-

  1. Application with the mentioned reason for the letter
  2. Duly Authenticated – authorization from the manufacturer
  3. Part 1 of the second scheduled D
  4. Percentage of content with a list of ingredients
  5. Proposed product labels
  6. Testing methods and specifications
  7. Pack insert
  8. Manufacturing license
  9. Duly Authenticated – free sale certificate
  10. Non-Animal Testing declaration
  11. Testimonials for heavy metals and hexachlorophene content
  12. More papers (if needed)
  13. Form COS 1 application
  14. Bharatlosh fee receipt (original)

What Is The Eligibility Criteria For CDSCO License In India?

Enterprises registered under the Companies Act, 1956, or Companies Act, 2013. A proprietary firm registered under the Shop and Establishment Act. A society registered under the Society Act, of 1860. Partnership firm registered under the Partnership Act, of 1932.

All medical devices need a mandatory license for sale in India. Follow all the rules and you can apply for CDSCO license in India in a few easy steps.

What Is The Registration Fee Of CDSCO License In India?

The registration fee for a CDSCO license in India varies depending on different types of license. Registration fees must be subject to change with the times due to updates in regulation of the government.

That is why companies should check the latest fee schedule issued by the government or you can seek expert advice from CDSCO consultants. 

What Is CDSCO License?

CDSCO license refers to legal approval issued by the CDSCO. This is a primary regulatory authority of India to ensure that businesses ensure the safety and quality of pharmaceuticals, medical devices & drugs. In addition to this, a CDSCO license helps foster trust among customers as it assures that the product has undergone evaluation for safety and efficacy before reaching the market.

This License is compulsory for many activities like distribution, manufacturing, as well as import & export of medical devices or drugs. There are different types of CDSCO license required based on certain operations & activities. You can check out the list mentioned above in this article 

What Is Voluntary Registration Of CDSCO?

CDSCO voluntary registration is a procedure introduced for small-scale manufacturers of medical devices and drugs. This system is planned for small-level manufacturers of medical devices who may face troubles or cannot comply with regular manufacturing licenses. So, with Voluntary Registration of CDSCO, they can easily register their products.

What Are The Types Of CDSCO Licenses In India?

The Central Drug Standard Control Organisation in India offers various types of CDSCO licenses for the regulation and control of drugs and pharmaceuticals. CDSCO licenses are required for many activities that are associated with the sales, manufacturing, and import of drugs or medical devices. 

Here are the types of CDSCO licenses available in India:-

S.NOTypes Of CDSCO License
1.Import LicenseCDSCO Import License For Medical Devices & Drugs
2.Export LicenseExport License For Medical Devices & Drugs
3.Manufacturing LicenseManufacturing Loan LicenseBiological Manufacturing LicenseAPI – Active Pharmaceuticals Ingredients Manufacturing License
4.Clinical LicenseLicense For Clinical Trials
5.Testing Laboratory LicensePharmaceuticals license – Laboratories engaged in drug testing
6.Blood Bank LicenseBlood Bank Operating License
7.Loan LicenseLoan License For Manufacturing Arrangements
8.Retail LicenseDrug Retail License
9.Wholesale LicenseWholesale Drug LicenseDrug Importer License

These licenses are important to ensure that companies are following rules, and regulatory standards and protecting the public by maintaining the safety and quality of pharmaceutical products and medical devices.

What If You Violate The Law Of CDSCO?

If you violate the CDSCO law, there can be severe consequences for lawbreakers which include:-

  • Penalties – Businesses may face huge amounts of fines and other financial penalties imposed by CDSCO
  • Legal Actions – A legal action is taken against all the organizations found to be violating the law 
  • Suspension of license – Manufacturers, sellers, and importers can get their licenses suspended if they violate the CDSCO rules

Always follow the proper rules and regulations and never violate the law as it leads to major drawbacks.

Conclusion – Apply For CDSCO License

In conclusion, obtaining a CDSCO license is crucial. By following the information mentioned in the article above, anyone can easily know all the details about how to apply for CDSCO license in India, its steps, fee structure, types of CDSCO licenses available in India, and the eligibility criteria for a CDSCO license. 

What Is The Full Form Of CDSCO?

CDSCO full form is the Central Drug Standard Control Organization.

Who Approves CDSCO License?

The Central Drug Standard Control Organization (CDSCO) is accountable for approving drugs and pharmaceuticals in India.

How Long Is CDSCO Registration Valid?

CDSCO registration shall remain valid for a period of three years from the date of its issue, unless suspended or canceled.

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