Product Permission Documentation

Product Permission Documentation

Department of AYUSH and regulatory body are strengthening by new rules for product permission, as mentioned in the Drug & Cosmetic Act 1940, rule 158.

We (Ayurvedic Pharmacists) will prepare documentation for product permission to comply with regulatory requirements.

Checklist:

  • Annexure-1 (List of Product)
  • Annexure-2 (Draft of Label)
  • Annexure-3 (Master Formula Card)
  • Annexure-4 (Quality Control Specification)
  • Annexure-5 (Proof of Effectiveness)

Annexure-1 

List of Product:

Were actual formulation details with Latin name of ingredients, a form of ingredients with references.

Annexure-2 

Draft of Label:

Label content with pack details.

Annexure-3

Master Formula Card:

Formulation details, process SOP with production specifications.

Annexure-4 

Quality Control Specification:

Laboratory Testing Results will be provided by your Company or testing facility will be arranged as per requirement. On that basis setting up specification limits.

Annexure-5 

Proof of Effectiveness:

  1. Overview of Product with respect to their claimed indications.
  2. Overview of Disease – as per indications.
  3. Product Mechanism of Action
  4. Purpose of Excipients/ Inert / Any Other Material
  5. Conclusion
  6. Bibliography

Our experienced experts will prepare these documents only, and the company has to take product permission from state regulatory on their own.

Time of preparation: 5 Days 

Mode of Submission: Email – Set of Document along with reference documents.

Note:

If any documentation quarries raised by authority then we will resolve it with no extra cost but not responsible for any formulation quarries.

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