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.
- 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)
List of Product:
Were actual formulation details with Latin name of ingredients, a form of ingredients with references.
Draft of Label:
Label content with pack details.
Master Formula Card:
Formulation details, process SOP with production specifications.
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.
Proof of Effectiveness:
- Overview of Product with respect to their claimed indications.
- Overview of Disease – as per indications.
- Product Mechanism of Action
- Purpose of Excipients/ Inert / Any Other Material
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.
If any documentation quarries raised by authority then we will resolve it with no extra cost but not responsible for any formulation quarries.