CDSCO Online Registration

The Controller of Drugs and Cosmetics (CDSCO) is a statutory body under the Ministry of Health & Family Welfare. It was established in 1958 under the Drugs and Cosmetics Act 1940.

CDSCO has been entrusted with the responsibility of ensuring the availability of safe, efficacious, and quality medicines for human use at affordable prices. The objective is to protect public health by ensuring that drugs are not sold or distributed for unauthorized purposes, that the composition of drugs is accurately stated, and that the labeling and packaging are not false or misleading. The CDSCO has made it mandatory for all drug manufacturers to register themselves with them in order to ensure that they are following all regulations set by the government. This helps reduce the number of fake drugs that are sold in India and protects consumers from unsafe products.

Product Registration Guidelines CDSCO

Product Registration Guidelines provides guidance to manufacturers, importers, exporters and distributors on various aspects related to compliance with regulations governing drugs and cosmetics. It also contains information about the requirements for registration/licensee under D&C Act.

The main areas covered in this document are:

1. Role and functions of Drug Controller General of India (DCGI);

2. Authority of DCGI over drugs;

3. Powers and functions of State/UT Director General of Health Services;

4. Licensing & Registration;

5. Inspection;

6. Disciplinary action against erring parties;

7. Complaint redressal mechanism at all levels i.e., District level, State level and National level;

8. Appointment of Board members by Union Ministry of Health & Family Welfare on recommendation made by State Government through their nominee Secretary, Health & Family Welfare Department as per Section 2 (f)(i)(a) under CDS

CDSCO Registration Process

The following documents must be attached to the registration application on the CDSCO portal:

• Undertaking issued by a Government Authority

• ID Proof Document

• Address Proof Document

• Copy of BA/BE Site Registration

• Manufacturing License or Wholesale Licenses in case of Import or Manufacture

List of new drugs approved in the year 2022 till date

Here is the new drugs approved list

CDSCO Online Registration Guidelines

Here is the guidelines of CDSCO Online Registration

• Authorized Signatory / Responsible person of the organization should fill the form.

• After submitting the Registration Form, Check Registered email for E-mail Verification

• Submit ID proof, Undertaking, Address Proof Document in hard copy to CDSCO office.

• Registration will be approved by CDSCO only after evaluation of the submitted documents. Check  your registered email id for all communications.