Drug license is an authorization granted by the authority under the Drugs and Cosmetic Act 1940 so as to perform the business of drugs/ medicines or cosmetics. The Drug license is issued through the State Drugs Standard Control Organization or the Central Drug Standard Control Organization.
The government has set down stringent laws and guidelines for the manufacturing and distribution of drugs and medicines within India. The registration of Drug License and everything identified with drugs is directed by the Drugs and Cosmetics Act 1940. Control is practiced over drugs from the raw material stage amid manufacture, sale, and distribution and up to the time it is given on to a patient or buyer by a Pharmacist in the retail drug store, hospital or a dispensary. Drug license is requisite to be taken for a wide range of drugs or cosmetics business which includes allopathic, homeopathic, ayurvedic or Unani drugs and so forth. The act also covers the Pharmacist s actions, hospital or dispensary utilization of drugs. The act covers the Ayurvedic and Unani drugs likewise in it.
Forms for Drug License for sale and wholesale of Drugs:
Drugs have varieties of categories, and for various categories, the different license is mandatory to obtain, by filing various forms as given underneath:-
FORM 20 is for the sale of Allopathic drugs.
FORM 20-A is for the sale of Restricted Allopathic drugs.
FORM-20-B is for wholesale of Allopathic drugs.
Form 20-C is for the sale of Homoeopathic medicines by retail.
Form 21 is for Sale of Allopathic drugs specified in Sch C and C (1).
Form 21-B is for wholesale of Allopathic drugs specified in Sch C and C(1).
Form 21-A is for the retail sale of restricted Allopathic drugs specified in Schedule C (I).
Form 20-F is for the retail sale of drugs specified in Sch. X
Form 20-G is for wholesale of drugs Specified in Sch. X
Form 20 BB & Form 21 BB R-62- D R is for Sale of Drugs from motor vehicles (1) Drugs other than those specified in Schedule C and C (1) (2) Drugs specified in Schedule C and C (1).
Document Required For Drug License Registration In Delhi
The lists of documents required for Drug License are:-
The corporation’s constitution (AOA/MOA).
The photograph identity proof of sole proprietor, partner or their director.
The papers of the owned property where the commerce would be carried out.
For rented property, a copy of the rent agreement is required.
The key plan and the site plan of the particular premises.
Drug storage sometimes needs to be in the cold chain, therefore the particulars and invoice of the refrigerator in use.
An affidavit relating to compliance with MPD 2021 and if premises are situated on DDA residential flat or building or a plot then their affidavit.
An additionally exhaustive document is required for a registered pharmacist.
Qualification proof in the form of degrees as well as certificates or mark sheets ( wholesale license).
The certificate of registration with the state pharmacy council depending on the region.
An appointment letter as well as biodata ( wholesale license).
Any other additional wholesale documents for wholesale Drug License competent person.
Any type of experience certificate ( wholesale license).
Documents Required
Registration Process
Drug License Registration in Delhi Process:
The standards and guidelines relating to drug licenses are governed by the Food Safety and Drug Administration Department of the respective State Government.
The process for obtaining a Drug license is-
Step-1: Online application filling for the drug License, with the payment of a government fee. The scanned copy of each and every document is uploaded at the time of filing the application.
Step2: On receipt of the application, the drug inspector would visit personally the shop for verifying the documents and the accuracy of the information provided.
Step3: On successful completion of the Inspection personal interview for by the inspector or such competent individual and depending on verification of every information and documents provided is correct the controller of drugs issues the Drug License.
The Drug Regulatory Body has made it compulsory for its authorities to attend as well as grant the licenses, whether retail or wholesale, within a period of 30 days, in the event that they satisfy all the necessary eligibility criteria.
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