Industry Specific
Procedure to Obtain Licence for Sale of Homoeopathic Drugs
Introduction
Drugs are essential for ensuring the good health of a nation. Drugs are different from other commodities and because of that government has laid down stringent laws. Control is exercised over drugs from the raw material stage during manufacture, sale, distribution and up to the time it is passed-on to a patient or consumer by a pharmacist in retail Pharmacy, Hospital or Dispensary. A homeopathic medicine license is required to sell, market, manufacture and distribute homeopathic medicine.
Applicable Provisions
Rule 67A (2), 67D, 67E, 67GG of Drugs Rules 1945
Documents Required
- Form 19-B
- Declaration by the proprietor / Partner / Director / Competent Persons / Regd. Pharmacist with proof of residential address (Present and Permanent) for proof of residential address – Aadhar Card, Ration Card, Passport, Driving License, Voter ID.
- Attested copy of partnership deed (on Rs.500/- stamp paper) / Memorandum and Articles of Association.
- Copy of list of Directors downloaded from ROC website signed by Company Secretary / Managing Director (In case of company).
- In case of company an Affidavit under Section 34 of Drugs and Cosmetics Act, 1940 on Rs.20/- stamp paper duly notarized along with copy of its board resolution to this effect signed by company Secretary or Managing Director or Majority of the Directors of the company.
- Special declaration by Registered Pharmacist on Rs.20/- non-judicial stamp paper.
- Attested copy of Registered Pharmacist certificate (renewal up to date) affixed with latest original photograph and signature of the candidate / original to be produced to the Drugs Inspector at the time of inspection for endorsement.
- Original plan of the premises indicating the carpet area (specifying length and breadth in meters and area in Sq. m.) by the Licensed Draftsman / Planner along with the signature of the building owner and the applicant (Prop/ partners / Authorized signatory / Managing Director, etc.) in a legal size.
- Original declaration of building owner attested by Gazetted officer (Photograph of the building owner to be attested by the Gazetted officer).
- Attested photocopy of the document showing the proof of ownership of the building owner for the premises to be licensed (E.C / any other legal document showing the present ownership).
Procedure
Person shall obtain a license for sell, stock or exhibit or offer for sale or distribute Homoeopathic medicines by making an application in Form 19-B to licensing authority through portal e-AUSHADHI (www.eaushadhi.gov.in) accompanied by fees of rupees two thousand (Rs. 2000) which shall be valid for a period of five (05) years on and from the date on which it is granted.
License on Form 20-C is issued for sale of Homoeopathic medicines by retail license on Form 20-D is issued for sale of Homoeopathic Medicines by wholesale.
Renewal of License
Person shall obtain renewal license for to sell, stock or exhibit or offer for sale or distribute Homoeopathic medicines by making an application in Form 19-B to Licensing authority, within six months from the expiry of license, and such application shall be accompanied by a fee of rupees two hundred and fifty (Rs. 250) plus an additional fee at the rate of rupees fifty (Rs. 50) which shall be valid for a period of five (05) years on and from the date on which it is renewed.
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