| 1 | Application A for the grant of No Objection Certificate (NOC) to manufacture for sale of Ayurveda/Siddha or Unani drugs, Drug License in Form No. 24-D | Pre Establishment | - Application Form
(Form 24-D). (placed at Annexure-I).- Sketch map of premises. Basis of possession of the premises (Conveyance deed) / Rent agreement and no objection from the owner (if rented).
| 30 days (Inspection reports within 15 days and License within next 15 days after inspection report received) | Nil |
| 2 | Application B for License to manufacture for sale Ayurvedic (including Siddha) or Unani drugs, Drug License | Pre Operation | - Copy of Form 24-D.
- Fee Receipt (Treasury challan ) under the Head of Account “0210-Medical and public Health, 04-Public Health, 104-Fees and Fines etc.
- Declaration Form. (placed at Annexure-II).
- NOC from Drugs Controller / Drug Licensing Authority.
- Municipality / Gaon panchayat certificate.
- Required Space (A minimum of 1200 Sq.feet space in conformed industrial area for initial one category).
- Key Plan (Blue print).
- Site Plan (Blue print) as per GMP under schedule T of D & C Act 1940.
- Proof of Constitution of firm (Certified copy).
- Letter of Authorized signatory.
- Two (2) Nos. Technical Persons :- (One Ayurvedic expert for manufacturing section & One Ayurvedic expert chemist for quality assurance.)
- Bio-data, Certificates, Appointment and joining letter, Affidavit registration certificate of Technical persons.
- List of formulation with reference, Process, Trial reports, Facsimile label, Trade mark Affidavit, Product proforma.
- Standard Operating Procedures (SOPs).
- List of necessary Machineries and Equipments.
- Non conviction Affidavit of the firm and Directors / Partner / Proprietor under Drug and Cosmetic Act 1940 and Drugs and Magic Remedies (Objectionable Advertisements) Act 1954.
- Analysis report of water.
- NOC for Pollution Control Board.
- Additional Form No. 19 or 19 A. (placed at Annexure-III).
| 60 days (Inspection reports within 30 days and License within next 30 days after inspection report received) | Rs. 1015/- |
| 3 | Application C for Certificate of renewal of license to manufacture for sale of Ayurvedic/Siddha or Unani drugs, Drug License | Post Commencement | - Copy of Form 24-D.
- Fee Receipt (Treasury challan) under the Head of Account “0210-Medical and public Health, 04-Public Health, 104-Fees and Fines etc.
- Two (2) Nos. Technical Persons :-(One Ayurvedic expert for manufacturing section & One Ayurvedic expert chemist for quality assurance.)
- Details of products.
| 60 days (Inspection reports within 30 days and License within next 30 days after inspection report received) | Rs. 1015/- |
| 4 | Application D for Certificate of Good Manufacturing Practices (GMP) to manufacture of Ayurveda/Siddha or Unani drugs, Drug License. | Fresh/Renewal | - Copy of Form-25-D/ 26-D issuing from Drug Licensing Authority.
- Copy of Previous Form-26-E-1
- Details of Products.
| 60 days (Inspection reports within 30 days and License within next 30 days after inspection report received) | Nil |
