Drugs License in Delhi

A drug license is an authorization granted by the authority under the Drugs and Cosmetic Act 1940 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 a Drug License and everything identified with drugs is directed by the Drugs and Cosmetics Act of 1940. Control is practised over drugs from the raw material stage amid manufacture, sale, and distribution and up to the time it is given to a patient or buyer by a Pharmacist in the retail drug store, hospital or dispensary. A 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 and hospital or dispensary utilization of drugs. The act covers the Ayurvedic and Unani drugs likewise in it.

Benefits of Drugs License in Delhi

In Delhi this license is issued by the Delhi Drugs Department, this department is also responsible for drafting the rules and regulations regarding the production and distribution of drugs and cosmetics.
Procuring a drug and cosmetic license serves the following benefits –

• Provides legal recognition to the manufacturer

• Helps ensure public health

• It paves the way for opportunities to establish a successful pharmaceutical business

• Improves the management and efficacy of drugs being circulated in the market

Forms for Drug License for sale and wholesale of Drugs:

Drugs have varieties of categories, and for various categories, the different licenses are 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 the wholesale of Allopathic drugs.

• Form 20-C is for the sale of Homoeopathic medicines by retail.

• Form 21 is for the Sale of Allopathic drugs specified in Sch C & C (1).

• Form 21-B is for the 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 the 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).

Drug License Fees in Delhi

The government fee for drug license fees in Delhi varies according to the type of license that an individual procures. For instance, the fees are different for wholesale and retail licenses. The professional fees also differ on the type of license that is being procured, whether the license is for manufacturing or importing drugs or cosmetics and so on.

Drug License Validity and Renewal

This license is valid for 05 years from the date of inception. It can be renewed further for the same amount of time i.e. 05 years.

Eligibility Criteria for Drug License in Delhi

The following persons are eligible to apply for a drug license in Delhi:

• A Registered pharmacist: Any registered pharmacist (registered under the particular State’s Pharmacy Council) can apply for a retail drug license.

• Graduate with experience in drug sales: Any graduate individual with experience (minimum of 01 year) in drug sales and marketing is also eligible to apply for a wholesale drug license.

• An individual who has passed SSLC: Any individual with a minimum of four years of experience in pharma marketing and who has passed S.S.L.C. is eligible to apply for a wholesale drug license.

• An Approved individual: A person who is explicitly approved by the Department of Drug Control to conduct drug business in India is also eligible to apply for a drug license.

Checklist for Drug License in Delhi

• Online fee deposit receipts.

• Application Form No. 19/19A/19B/19C as applicable (System Generated)

• Site plan and key plan of the premises.

• Constitution of the firm viz: Memorandum and articles of association and Copy of resolution Passed, in case of company. Partnership deed, duly attested by Notary Public, in case of partnership firm. Trust deed, in case of trust/society.

• Photo ID proof of proprietor/partner/director of the firm.

• Affidavit regarding non-conviction of Prop./Partner/Director as well as the firm under the Drugs & Cosmetics Act, 1940.

• Affidavit regarding compliance with MPD 2021, if the premises are located on a DDA residential flat / plot /building

• Conversion charge receipt issued by MCD with relevant documents in support of commercial use as per MPD 2021 viz; copy showing the Name of notified commercial/mixed use road/street.

• Affidavit from the Regd. Pharmacist/competent person (System Generated).

• Proof of qualification i.e. final degree certificate / provisional certificate with mark sheet.

• Experience Certificate

• Appointment Letter and Bio-data.

• Either Regd. Sale Deed / Regd. GPA / Conveyance Deed in the name of the owner, or Un regd. Sale Deed/unregd. GPA supported with Electricity Bill / Water Bill/property tax receipt.

• If Rented: Rent Receipt and either Regd. Rent Agreement, or Un registered Rent Agreement along with ownership documents of the landlord, as stated above. In the case of the village, Khasra Khatauni documents will be considered.

Document Required For Drug License Registration in Delhi

The list of documents required for a Drug License are:-

• The corporation’s constitution (AOA/MOA).

• The photograph identity proof of sole proprietor, partner or 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 are in use.

• An affidavit relating to compliance with MPD 2021 and if premises are situated on a DDA residential flat or building or a plot then their affidavit.

• An additional 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 depends 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).