Drug License Registration
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.
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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 & C (1).
Form 21-B is for wholesale of Allopathic drugs specified in Sch C & 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&C (1) (2) Drugs specified in Schedule C&C (1).
Document Required For Drug License Registration
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).
Process & Timeline for Drug License
Frequently Asked Questions
Drug License is an authorization from the government of India towards dealing with drugs. There are 2 types of license, the retail license and wholesale license for drug distribution or sale in India.
Yes, before you start any business dealing in drugs, whether it is Allopathic Drugs, Ayurvedic Medicine, Homeopathy or Unani, to manufacture, distribute or sell the drugs, it is compulsory to obtain a license as per the nature of business by applying towards the controller of the drugs and cosmetics
Licenses for the sale of drugs could be granted only at premises which are commercial premises or other premises independent of residence, also recognized as mixed land use. The State drug office issues guidance which may be referred for this purpose.
There are various licenses, for instance,
Drug Manufacturing License
Wholesale Drug License,
Retail Drug License,
Import of Drugs or Cosmetics
Import of Medical Equipment
Export of Medicines etc.
The main purpose of the Drugs and Cosmetic Act is to make sure the safety, efficiency, and conformity of the drugs as well as cosmetics sold in India towards the state quality standards for which certain restrictions have been provided under the Act.
You can submit the completed application with the following enclosures in the office of Drug Licensing Authority of your district within 15 days of online registration for renewal:
- Duly filled Form 19/19A/19AA/19C.
- Original Treasury challan after depositing the requisite fees.
- Original affidavit of proprietor/authorized partner/authorized director or authorized person of Pvt Ltd or Ltd Company or Trust or Society regarding no change in Name of the firm, Constitution(in case of Proprietorship or Partnership firm), premises since granting of the license.
- Documents related to Registered Pharmacist.
- Copy of Diploma Pharmacy; Registration Certificate from Pharmacy Council of a particular state; Copy of renewal of Registration; Copy of Appointment and Joining Letter.
- Original affidavit of Pharmacist.
- Documents related to a Competent Person (For wholesale licenses).
- Copy of Educational qualification certificate(s) including the High School Certificate.
- If the competent person is a registered pharmacist then all the documents as enlisted.
- Original affidavit of Competent Person.
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