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Drug License Apply

Wholesale or Retail Drug Business

A drug License is permission from the controller of the drug to deal with the drugs. Whether for wholesale or retail business, this drug license is issued subject to certain conditions attached to premises and the competent person. We assist pharmacies and pharma companies in obtaining the drug license.

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Pricing for Wholesale or Retail Drug License

None of Our Packs Include Govt Fee, Out of Pocket Expenses, Site Plan, Key Plan & Notary of Affidavits

Basic Pack

Pack includes Advisory and Drafting of Documents so that you may apply for Drug License Yourself.

₹ 4,999/-

Government Fee on Actual
Silver Pack

Everything From Basic Pack and filing of Drug License Application and Preparation of Inspection File

₹ 7,999/-

Government Fee on Actual
Gold Pack

Pack includes filing of the application and departmental follow-up. Available in select cities

₹ 24,999/-

Govt Fee & Out of Pocket Exp On Actual
* We offer our services in Gold Pack for Delhi, Noida, Gurugram, Ghaziabad, Mumbai, Bengaluru & Hyderabad. The Government Fee for Retail or Wholesale Drug License is Rs. 3000/- and for both the License the Government Fee is Rs. 6000/-
Basics of Drugs or Pharmaceutical Business License
The competent authority grants a drug license under the Drugs and Cosmetic Act of 1940 to carry out a business concerning drugs/medicines or cosmetics. In other words, no person can start or carry out a business dealing with drugs or cosmetics in India without a licence from the concerned authority. All types of drugs or cosmetics business fall under the Drugs and Cosmetics Act, 1940, including allopathic, homoeopathic, ayurvedic or unani drugs. To maintain the quality of medicines and cosmetics is the responsibility of all persons dealing with it.Suppose any person consuming or using a drug or cosmetic suffers any harm due to the negligence of the manufacturer or seller. In that case, the same is an offence, which is triable as an offence of grievous hurt under IPC. Hence it is essential to comply with conditions imposed on licence.
Understand Meaning of Drug
A drug licence is permission granted by the government authorities to the business to deal with drugs. It is mandatory to procure a drug licence before starting a drug business. The term drug is defined under section 3(b) of The Drugs And Cosmetics Act, 1940.
It includes the followings
Thus the drug comparises the all the medicines whether Allopathic, Homeopathic Ayurvedic, Siddha or Unani. For licencing purposes we could divide the medicines in two category

Drugs Regulated By Drug Controller

Medicines Licenced by Drug Controlling Authority (Functioning Under the Ministry Of Health). Following are the examples

Drugs Regulated Under Aayush

Aayush Drug Control Cell is one of the verticals of the Central Drug Standard Control Organisation (CDSCO), regulated by the Ministry of Ayush. Following is covered under Aayush.
Regulatory Authorities For Pharmaceutical Business
The drug regulatory authorities grant and renew the licenses to sell or manufacture Drugs and Cosmetics and to operate a blood bank. It grants approval for the laboratories to carry out tests and analysis on behalf of the manufacturers. They issue Free sale certificates and Good Manufacturing Certificates and Export registration documents, etc., for export registration if required. The business may also need a No conviction certificate, Performance certificate, a Market standing certificate granted by the regulatory authorities to participate in Government tenders. There are various regulatory authorities to regulate the business of Drug and cosmetic to ensure its safety and efficacy. Below is the list of licences and its regulatory authority:
S.No Type of License Regulatory Authority
1.
  1. Allopathic Drugs Licence
  2. Veterinary Medicines licence
  3. Cosmetic manufacturing licence
State Drug Controlling Authority
2.
  1. Blood Banks,
  2. Blood components &
  3. Blood Products like Vaccines, Sera and Parenterals,
State Drug Controlling Authority with an approval by the Central License Approving Authority
3.
  1. Ayurvedic Medicines
  2. Siddha Medicines
  3. Unani Medicines
  4. Homeopathic Drugs
  5. herbal Products For Medicinal Use
  6. Herbal Products For Cosmetic Use
Department of Ayush
4.
  1. New Drug Approval including investigational and subsequent new drug
  2. Clinical trial (test Licence)
  3. Import of Drug and medical devices
  4. Import of Cosmetics
Central Drugs Standard Control Organization (CDSCO)
5.
  1. Proprietary food like Herbal Powder and Churna where no Medicinal Use is claimed
Food Safety and Standards Authority of India (FSSAI)

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Common Types of License for Pharmaceutical Business in India
The kind of license your business needs can be determined based on your pharmaceutical business’s product or services. Here is the list of the most common licenses for the trading or manufacturing of drugs in India. Please don’t hesitate in contacting us to discuss your business so that our licensing expert can advise you appropriately.
Retail Sale Drug Licence: An applicant applies for a Retail Sale drug licence for the retail sale of drugs. The term “Retail Sale” means a sale to the consumption of the end consumer. It is not meant for resale by the purchaser. Thus the purchaser is not required to possess a drug licence. Retailers of the drug could sell it to a hospital, dispensary, medical, educational or research institute, or any other person.
Wholesale Drug Licence: A wholesaler of the Drug must possess a wholesale Drug licence. Wholesale means sale to a person to further sell it; thus, the purchaser of these drugs must have either a wholesale or retail sale drug Licence. Wholesale may opt for Third party manufacturing. Third-party manufacturing means the drugs manufactured by a licenced manufacturer per its client’s requirement, i.e. Wholesaler. Such a manufacturer will require a brand affidavit before manufacturing any medicine under the brand name of Wholesaler. The product package will bear the manufacturer( Marketed by) and the Wholesaler (Marketed by-). If a client places a requirement for which needs the approval of the Drug controlling authority, the manufacturer is to take such approval before manufacturing those drugs.
Manufacturing Licence for Drug: It is a licence for manufacturing of Drug. Manufacture in Drugs means any process or part of a process for making, altering, ornamenting, finishing, packing, labelling, breaking up, or otherwise treating or adopting any drug with a view to its sale or distribution.
Loan Licence: It is a licence for manufacturing the drug using the facility and premises of other manufactures. The manufacturer who provides its facility for the production of the drug must have a valid drug licence and surplus production capacity.
Import Licence: It is required to import drugs in India. The Central Drug Standard Control Organisation (CDSCO) grants import licences for drugs.
The Eligibility & Qualification of Pharmacist / Competent Person
The first requirement for a pharmaceutical business is to have a competent person or a qualified and registered pharmacist. Hence the first step is to check the basic eligibility requirements of the Competent Person / Pharmacist. The qualification or eligibility of a Competent Person for Retail and Wholesale Drug License is as under:
For Retail Drug License For Wholesale License
  1. B Pharma/DPharma Degree holder
  2. Registration with State Pharmacy Council
  3. No Prior Experience Required
  1. B Pharma/DPharma Degree holder Registered with State Pharmacy Council or
  2. A graduate with one year of experience of dealing in drugs or
  3. An undergraduate having four years experience of dealing in drugs
Notes on Competent Person:-

“Proprietor/Partner/Director Eligibility: Proprietor or any of Partner/Director must not be convicted under provisions of The Drugs and Cosmetics Act, 1940 and Rules framed there under.”

Specifications & Conditions for Premises for Drug License
The place where the drugs are stored is significant from the point of view of licensing. Most of the rejections of application for drug license are done mainly due to non-conforming specification or shortfalls in the measurement of premises. The Shop on which licence application is filed must be an independent and a pucca structure, wholly in control and possession of the applicant. The requirement of the premises for wholesale or retail drug license is different. Following is the tabular presentation on the specific condition for premises.
Eligibility criteria For Retail Drug License For Wholesale Drug License
Type of Premises
A retail pharmacy shop may be located in a Mixed Land Use Area or a Commercial Place.
A wholesale pharmacy store only at a Commercial Place.
Minimum Area
The carpet area of the retail store pharmacy must be a minimum of 10 square meters with a height of 2.75 meters.
The carpet area of the wholesale pharmacy must be a minimum of 10 square meters and height of 2.75 meters.
Approach Road
It must be facing a minimum road width prescribed by the municipality of the area for mixed land use.
The road/street on which it is located must be broad enough to facilitate loading and unloading of goods. It is suggestable to have a premises facing a minimum road width of 18 mts or more.
Furniture
The Retail Store requires
  1. Racks,
  2. Almirah for storage and
  3. table and chair.
The Retail Store requires
  1. Racks,
  2. Almirah for storage and
  3. table and chair.
Equipments
Following equipment/appliances is required for retail sale store
  1. Computer system
  2. Printer for printing of invoices,
  3. Refrigerator is essential for grant of a drug license in India since some drugs, particularly the vaccines, need to be stored in a low-temperature freezing zone
Following equipment/appliances is required for retail sale store
  1. Computer system
  2. Printer for printing of invoices,
  3. Refrigerator is essential for grant of a drug license in India since some drugs, particularly the vaccines, need to be stored in a low-temperature freezing zone
Notes:-
Area For Retail and Wholesale (Both): If the applicant wants to apply for retail and wholesale pharmacy at the same premises, the minimum area prescribed is 15 square meters.
How to Measure Carpet Area: While measuring the Shop or premises for drug license, the carpet area is calculated after excluding the open area, pantry area, and washroom area. It includes only the area used in dealing drugs.
What is meant by Mixed land use?: Mixed use essentially means provision of nonresidential activity in residential areas. Mixed use shops can only be on ground floor upto the maximum of ground floor coverage. There should be unconditional surrender of front setback, which should not have boundaries and shall be only used for parking.Permission of mixed use would be taken from the concerned local Authority and will be subject to payment of conversion charges.No encroachments shall be permitted on the street by these shops.
What is a Commercial Place: Commercial Place is a place where only commercial activity is carried out. The applicant must ask for the conversion charge receipt and parking fee receipt from the owner of the premises to confirm whether the premises is a commercial premise or not before taking it on rent for a wholesale drug licence.
Planning To Start a Pharmaceutical Business
If you are planning to start a drug business, you need to know the regulatory requirements. The stepwise process for a startup in the drug could be as under
List Of Document
A. Entity Documents
Certificate of Incorporation (COI), Memorandum of Association (MoA), Article of Association (AOA), Pan Card Copy of entity (in case of company)
COI, LLP Agreement and PAN card copy of Entity (in case of LLP)
Partnership deed and pan card copy of the entity (In case of Partnership)
Any establishment proof in case of proprietorship (Not mandatory)
C. Premises Related
Rental Agreement in the name of the entity. (Note*)
Ownership proof of the premises ie. Latest electricity bill, property tax paid receipt and sale deed(property papers) of the premises
Site plan and key plan of the premises with total area, dimensions, name of the firm, address mentioned on it.
E. Other documents
List or details of directors/proprietor/director.
Board resolution or Authorization Letter
B. Each Director/proprietor/partner Documents
Passport size Photograph
Pan card
Aadhar card
Address proof
Affidavits for directors/proprietor/partners
D. Technical person documents
Affidavit regarding non-conviction
All educational documents such as certificate and marksheet of graduation including 10th and 12th class documents.
ID proof & address proof including PAN , aadhar, and photo of the premises
Biodata and Appointment and consent letter in existing firm
Registration certificate and PPP card from state Pharmacy council in case of Registered Pharmacist.
Copy of experiences certificate of at least one year in case of experienced person.
Note:

Wondering How to Start a Business.

Our startup advisors are available to answer all your queries on the requirements, step-wise process, cost and the documents required to set up a business.

Step Wise Process For Drug License
  • Documentation

    Documentation is a crucial element in the whole licensing process. Correct documentation makes the process hassle-free and leads to a successful grant of licence. The list of documents required for the Wholesale /Retail sale drug Licence depends on the applicant's type and business activity.

  • Generation of User ID and Password

    The applicant is to register for user ID and password. Once The User ID and password once generated is sent to the registered mail ID of the applicant. The applicant can apply to the generation of user ID and password.

  • Application Filing

    The applicant applies for the grant of a Drug licence to the respective Drug Controlling Authority of the state. For each type of licence, a separate application is filed via different forms prescribed for it. There is no provision for one central certificate/license covering all states. The applicant is to file separate applications for each store.

  • Inspection of the premises

    Before the grant of a drug license, the drug inspector having jurisdiction of the area visits the premises where the drug license is required and verifies the particulars furnished with the application and takes a measurement of the premises. He also checks the area of the premises, whether it is on mixed land use or in a commercial.

  • Scrutinization of Application

    The concerned Drug Inspector verifies the details and the documents uploaded in the online application with his observations on his visit. He may raise a clarification in the application. The applicant must reply to the clarification within 3days of it. Non-furnishing a satisfactory reply may lead to the cancellation of the application.

  • Issue of License

    After satisfactory verification of the documents and the details, the Drug Control department issues the Drug License. The issued licence is valid for five years and is valid after that, subject to its renewal.

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Validity of Drug License
A drug licence, once granted, is valid for five years unless suspended and cancelled by the Drug department. The licence imposes certain conditions on the licensee. A wholesale / Retailer of drug having a drug licence shall

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Frequently Asked Questions
No one can deal with drugs without a licence in any manner. So, a drug licence is compulsory to do pharmacy business.
Drug controlling authority specified under Drugs and Cosmetic Act,1940 and rules made thereunder provides the drug Licence.
Drug and Cosmetic Act is an Act to regulate the pharma sector, be it sale, distribution, transport, storage, import, export, manufacturer of drugs in India. This act was passed in 1940 with the primary objective to ensure the provision of safe, effective and quality drugs to the people of India.
Yes, the licensee should display the original license s in a prominent place in a medical store. The medical store should display the Registration Certificate of the registered pharmacist and the licence.
No, A cosmetic trader does not require any licence from the drug controlling authority. Cosmetic manufacturers require a licence from the drug department, but if they are manufacturing ayurvedic/herbal cosmetic products, they need an Ayurvedic cosmetic manufacturing licence from AYUSH.
Yes, a separate licence is required for the sale of drugs through motor vehicles. At the time of applying, applicants need to opt for it.
Pharmacy stores running 24X 7 do not require any special licence. They need to get the retail sale licence, but they have to appoint three pharmacists to operate three shifts continuously. Each pharmacist will do a shift of 8 hours.
The minimum area required to sell drugs are as under:-
  1. Retail sale Pharmacy Store- 10 sq.m
  2. Wholesale Pharmacy store- 10 sq.m.
  3. Retail & Wholesale Pharmacy Store at a single premise- 15 sq. m
The wholesaler or retailer of drugs compulsorily requires a refrigerator at his medical Store.
No, as we all know, some medicine must be stored between 2ºC and 8ºCparticularly vaccines, insulins, sera, eye drops, etc. Thus the pharmacy store cannot switch off the fridge at any point in time. It should be on & in working conditions even after working hours at a medical shop/store.
No, Drug dealers do not have a separate license for veterinary drugs. Still, he needs to make a separate provision for storage in the medical Store marked as VETERINARY DRUGS, NOT FOR HUMAN.
Yes, A medical store can store and sell general items like cosmetics, chocolate, mineral water etc.
The applicant has to surrender the drug licence granted for the old premises and apply for a new licence if there is any change in the firm’s premises..
Licensee needs to report any change in the competent person / registered pharmacist and submit relevant documents of the newly appointed competent person / registered pharmacist to the concerned licensing authority. The licencing authority does the necessary endorsement on the license after verification of the document to its satisfaction.
Yes, the importer of a drug must possess both an import License and a wholesale licence to sell imported drugs within the country.