What is FORM-42 and FORM-43?

FORM-42 and FORM-43
Ganesh Nair
| Updated: Sep 20, 2022 | Category: CDSCO

The Central Drugs Standard Control Organisation is the national regulatory governed by the Directorate General of Health Services. The organisation is responsible for making rules for clinical trials and approval of new drugs. The organisation has also laid down standards for creating and importing drugs and cosmetics into the country. Any manufacturer that imports/exports or conducts research & development must obtain CDSCO registration through the online portal. In this article, we shall discuss about Form-42 and Form-43.

What is the need to obtain Form-42 and Form-43?

Section 3(aaa) of the drugs and cosmetics act defines the term cosmetics. To summarise, it states that any article sprayed, sprinkled, rubbed or poured onto any part of the human body for cleansing, beautifying or promoting attractiveness will be called ‘cosmetics’.

Under the same regulations as per Rule 129, it is stated that no cosmetics shall be imported into India until it is registered under the rules as set by a licensing authority appointed by a Central Government. So, if any product falls under section 3 (aaa), they must register themselves.

What do Form-42 and Form-43 signify?

S.no Form Purpose
1. Form- 42 The application for the grant of import for cosmetics in India as per the Drugs and Cosmetics Act, 1945.
2. Form- 43 The Registration certificate is obtained in form 43 to import cosmetics in India as per the Drugs and Cosmetics Act, 1945.

Which entities need to obtain Form-42 and Form-43?

The application for registration under Form-42 and Form-43 can be made by:

  • Any manufacturer who has a registered office in India.
  • By an authorised agent appointed by the Manufacturer
  • Any subsidiary of the manufacturer
  • Any importer

What are the documents required to obtain Form-42 and Form-43?

The following documents are required to obtain Form-42 and Form-43

  • Covering letter
  • Form 42:once the applicant pays the online government fee, form 42 will be generated online. The applicant must complete the details of the form and submit a stamped copy of the same to the government.
  • Challan: This is the document that shows the proof of payment to the government.
  • Power of Attorney: the manufacturer/ importer needs to submit this document if an authorised agent is filing the application
  • Schedule D (III): These documents contain details of the manufacturer and the manufacturing plant.
  • A copy of the proposed label of the product
  • Free sale certificate (FSC): Free sale certificate of the products that the manufacturer intends to sell must be attached along with the application.
  • Specification of the product
  • Testing protocols of the product
  • Components of the package
  • Copies of documents showing information about manufacturers’ products and brands.

The process to complete cosmetics registration as per Form-42 and Form-43

  • The applicant must access the CDSCO portal[1], create a signup, and finalise login credentials.
  • The applicant must fill in the relevant details with an email id and valid mobile number and complete the signup procedure.
  • Once the signup is completed, then the applicant must login to the portal.
  • Next, go through the submission section, and select the department and the type of form.
  • Select the type of application
  • In the final submission view, the applicant can click on a preview of the page. The user can re-check all the information provided in the preview. If there are any errors, then click on the edit button and complete the modifications. Once done, click on save and continue to proceed further.
  • The user is now redirected to the checklist page. The applicant must go through the form and upload each document electronically.
  • Once the applicant is done uploading the documents, he should click on the submit button. The website will redirect the applicant to the payment portal.
  • The user needs to upload the challan of payment on the website. A total of five challans can be uploaded at once.
  • The user may now click on the ‘PDF’ button to generate the pdf of the entire form. The preview will consist of details done by the user. Click on the continue button then you will be redirected to the ‘upload form page.’
  • Here the applicant needs to upload Form 42, which was generated earlier.
  • The application shall be submitted successfully and then later forwarded to the designated officer.
  • At this point, the applicant must note down the reference number for the application.
  • The designated officer shall scrutinise the application for compliance with document registration.
  • If the application is found to be satisfactory the same can be forwarded for the approval of licensing authority. Once the licensing authority approves it, then an approval letter is made available for the applicant to download from the Sugam portal.
  • If any discrepancies are found in the application, the same shall be reflected on the Sugam portal. Once the discrepancies are rectified, then the application can be sent for approval once again.

Validity of the Certificate of registration issued under Form-42 and Form-43

The certificate of registration issued under Form-42 and Form-43 shall be valid for a period of three years from the date of issue.

Conclusion

The Central Drugs Standard Control Organisation, as per the guidelines laid down under the drugs and cosmetics act, has made it mandatory for manufacturers or importers to get their products registered with the government authorities. The registration of the product shall ensure that only good quality cosmetics are available in the Indian Market. The applicant needs to apply through Form-42 and Form-43 to get their products registered.

Read our Article:What is Forms MD-14 and MD-15

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Ganesh Nair

Ganesh Nair completed his graduation in law from IP university. He is an ardent researcher who has written various research papers and articles on contemporary legal issues. His keen interest in the field of research made him pursue a career in legal research. His core area of interest include Cyber, IPR and Finance laws.

 

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