What Is The Form 44 In CDSCO?

What Is The Form 44 In CDSCO?

In simple words, form 44 in CDSCO takes permission to import or manufacture new pharmaceuticals to conduct medical trials. This article covers various required documents for Form 44 and details regarding Form 44 in CDSCO. Check out the blog.

What Is The Process To Apply For Form 44 In CDSCO?

Here is the list of the processes you can read and follow to apply for Form 44 in CDSCO.

  1. Choose the form & category through the drop-down list
  2. Tap to proceed
  3. Fill in the package details, strength, & indication
  4. Enter application details
  5. Submit with proper documentation
  6. Now pay the required fee on the SUGAM Portal

What Documents Are Required For Form 44 In CDSCO?

The following documents are required for form 44 in CDSCO registration:-

  • Form 44 –  Fill the details in the application
  • Covering Letter – Concise introduction for the application
  • Fees Receipt – Payment slip as a proof of application fee
  • Product Details – All the details related to the pharmaceuticals that also includes its compounds
  • Manufacturing Details – Proper Info. about the pharmaceutical manufacturing “place where it made and everything”
  • Clinical Trial Data – Outcomes of all the pharmaceutical trials that are performed.
  • Regulatory Status – Approval reports of the drugs in the countries.
  • Label & Packaging – Sampling of the Packaging and label of the material.
  • Research Article – Related to pharmaceuticals blog that are published
  • Power of Attorney – Documents authorization
  • Declaration – Issuance Form

Here is the list of the documents that you required while filling form 44 in CDSCO.Z

Important Details About Form 44 In CDSCO

The important details about Form 44 in CDSCO are mentioned below:-

  • Brand Name 
  • Generic Name
  • Labeling Details
  • Name and address of manufacturers & Contract manufacturer
  • Risk classification (according to the country of origin as well as in 5 GHTF countries i.e USA, Japan, Canada, Australia, EU)
  • List of accessories or devices to be used in conjunction with the subject medical device 
  • Packaging description and include pack sizes
  • Physician manual and promotional literature (literature insert) in English 
  • Information on the sterility and stability of the product
  • Qualitative and Quantitative particulars of the constituents
    Variation in shape, style, or size of the device.
  • Indication w.r.t. Which clinical study to be carried out
  • Composition name 
  • Standards & Specification of device 

How To Fill Form 44 In CDSCO?

Check these steps and follow the correct order to fill out form 44 in CDSCO:-

  1. Information on Stamp duty and Payment (Check the instruction kit for more info and fill in details according to it)
  2. Main business premises address of India
  3. Details – Type of office/Primary division of business activity
  4. Registered office address 

Use these steps while filling out form 44 of CDSCO.

What Is The Cost Of Form 44 In CDSCO?

The cost of Form 44 in CDSCO varies and depends on the new updates and process time. As there are many more chances of system updations, so that’s why there is no fixed anyone can tell. But if still worried and want to know then directly talk to the expert and get to know everything related to it for free, another good thing is ELT’s special webinars. Join the webinar to learn all the aspects.

What Are The Benefits Of Form 44 In CDSCO?

There are so many benefits of Form 44 in CDSCO, as it works in the form of authorization to manufacture or import new drugs and avail clinical trials in the country. So, yeah this Form 44 of CDSCO has so many benefits that are mentioned below:-

  • Drug Import – Form 44 benefits you, because it allows enterprises to import fresh pharmaceuticals, lead to trials, & sell new drugs.
  • Drug Registration – CDSCO Form 44 helps in registering pharmaceuticals and permits to sell drugs in the market.
  • Streamlined Process – Presents a wide variety of systematic processes for regulatory permissions.
  • Permission for Trial – Form 44 in CDSCO helps get permits to perform pharmaceutical trials in India.
  • Research Promotion – It allows research & development in the pharmaceuticals sector by permitting them to study fresh drugs.

What Is the Validity Of Form 44 In CDSCO?

Form 44 in CDSCO is valid for six months. The Central Drug Standard Control Organization utilizes form 44 In short CDSCO. This Form 44 in CDSCO is used for the permission to import or manufacture new pharmaceuticals or to lead new pharmaceutical trials.

What Is The Timeline Period Of Form 44 In CDSCO?

It certainly takes approximately nine months to issue form 44 in the CDSCO license. It is liable to be changed according to the updation in the process. It’s suggested to clear your doubts directly with the service provider click here to get the direct solution to your problem “ medicaldeviceregistration.com.              

Why Does ELT Play an Important Role In Form 44 In CDSCO Registration?

ELT Services has been serving genuine services in the market for so long and made its name shine so early as compared to others in the market. With the affordable prices & top-notch services, there is no doubt why to choose ELT Corporate for your business. You can get all the solutions for your doubts and queries also if you are stuck in any process.

Which Authority Issues Form 44 In CDSCO?

The Licensing Authority issues the Form 44 in CDSCO.

What is Form 46 CDSCO?

Form 46/ Form 46-A in case of ‘New Drugs’ under Rule 122E of Drugs and Cosmetics Act and Rules Act and Rules made thereunder/NOC from CDSCO for specific amount commodity of New Medications


No comments yet. Why don’t you start the discussion?

Leave a Reply

Your email address will not be published. Required fields are marked *