CDSCO Registration for Drug Manufacturing in India | Process, Documents, Fees

Updated on November 24, 2023 10:55:07 AM

The Central Drugs Standard Control Organisation is India’s National Regulatory Body for Cosmetics, Pharmaceuticals and Medical Devices.

Under the Drugs and Cosmetics Act 1940 and Rules 1945, CDSCO is responsible for approval of Drugs, Conduct of Clinical trials, Laying down the standards for drugs, Control over the quality of imported drugs in the country, Coordinating the activities of the state drug control organization by providing expert guidance advice.

Registration for Drugs Manufacture

Drug Manufacturing in India.

Drugs are the Medicines consumed for Internal or External use, the medicines for diagnostics, treatment, mitigation, prevention etc. In India, import, manufacturing, sale and distribution of drugs is regulated under the Drugs and Cosmetics Act 1940 and Rules 1945.

The Drugs and Cosmetic rules, 1945 are the rules which the government of India established through the Drugs and Cosmetics Act, 1940. These rules classify drugs under given schedules and present guidelines for the storage, sale, display and prescription of the schedule.

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What is CDSCO Registration for Drug Manufacturing in India?

CDSCO, the Central Drugs Standard Control Organisation is one of the most powerful organizations of India. It is responsible for the approval of new drugs, conduct of clinical trials, granting of the license of certain specialized categories of critical drugs such as Blood and Blood Products, I.V Fluids, Vaccine and Sera.

In India, import, manufacturing, sale and distribution of drugs is regulated under Drugs and Cosmetics Act 1940 and Rules 1945.

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Process for doing CDSCO Registration for Drug Manufacturing in India

Process for doing CDSCO Registration for Drug Manufacturing in India is as follows;

Step 1:Signing up for the application

Visit the official website of CDSCO, Sign Up in the ‘SUGAM’ Portal for the registration application.

Step 2:Fill up the Details

Fill all the necessary details in the form. The form is divided into two parts, the applicant needs to fill all his/her personal and organizational details.

Step 3:Documentation

Required documents are mandatory to submit for the verification process for authorizing the CDSCO License.

Step 4:Verification of the registration

Click on the verification link sent to the registered email Id to activate the account in the ‘SUGAM’ portal for the CDSCO Test License.

Step 5:Approval from the Authority

After the confirmation, the registration application will be sent to the concerned authority for the approval of the license. If the application got approved by the CDSCO officials, an email of approval will be sent to the registered email Id, vice versa for the case of rejection.

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Benefits of CDSCO Registration for Drug Manufacture in India.

Cdsco Registration gives access to numerous benefits as:

  • Ensuring Compliance with Laws and Regulations: CDSCO registration is a mandatory process to ensure that an organization follows relevant laws, regulations, and business rules, allowing for approval from the regulatory authority to maintain the efficiency and quality of Cosmetic Products.
  • Safety & Quality Assurance: CDSCO registration ensures that cosmetic products are free from harmful ingredients and are suitable for all, guaranteeing the safety and quality of these products for consumption by the general public.
  • Public Health Safeguard: The vision and mission of the Central Drugs Standard Control Organisation is to protect, promote, safeguard, and enhance public health by ensuring the safety, efficacy, and quality of medical devices and products intended for mass consumption.
Benefits for Drugs Manufacture
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CDSCO Fee for Product

The Professional Fee For CDSCO import Certficate for Cosmetic products is INR 99,999/- only with Professional Utilities.

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Documents required in the CDSCO Drug Manufacturing process in India.

Documents for Drugs Manufacture

Documents required in CDSCO Registration are as follows:

  • Form 24/24A
  • Attested copies of education
  • List related to machinery and lab equipment
  • Description of the Product
  • Details of the approval of the New Drug in the Drug
  • Fee Challan
  • Copy of Valid Test License
  • Consent Letter from the supplier of the Drug
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Conclusion

Registering for Drug Manufacturing in India under CDSCO will access several benefits as it majorly acts as a legal and formal approval to work with Drugs in the domain for various activities. As the Indian government has announced its plan to bring all the medical devices,drugs and cosmetics to work under a review of CDSCO.

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Frequently Asked Questions

What can be labeled as a drug?

A drug is a medicine that is consumed for external or internal use. As in medicines used for treatment,mitigation,prevention etc.

What benefits can be obtained by CDSCO Registration?

Improving customer confidence,increasing revenue and turnover,safety and quality of products etc.

Where to start the process of CDSCO Registration for Drug Manufacturing in India?

You can contact Professional Utilities for the whole procedure.

What documents are mandatory for CDSCO Registration of Drug Manufacturing in India?

Application Form,Description of the Product,Consent Letter from the supplier of the Drug etc.

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