Drug License

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    It is applicable to drug or pharmaceuticals trading, manufacturing and distribution business. Bizzonns have experience of providing service for drug license in most of the States of India like Maharashtra, Karnataka and Delhi.

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    Drug license is valid for 5 years of tenure and need to renewed before 60 days of expiry.

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    Professional Fess Starting at Rs 6,999/- Onwards

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100% Online, Easy & All India Services

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12+ Years Experienced Team of Professionals

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Total Number of Served Clients

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Availability in Major Indian Cities

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Overview

Drug and cosmetic act 1940 regulate the Import, Manufacture, Distribution, Storage and Sale of drugs & cosmetic in India. Before commencing any commercial activities of drugs and cosmetics the business owner should obtain appropriate license from the food and drugs administration. The act is applicable to storage, transpiration, retail, wholesale, import and manufacturing activities of drugs and cosmetics. Business entities cannot even transport and store the drugs without taking drug license.

This act includes all types of (Allopathy, Homeopathy, Siddha or Unani) Drugs and devices used as medicines for internal or external use or in the diagnosis, treatment, Mitigation and for prevention of diseases or disorder in human beings or in animals.

Drug license is premise specific license and is required to each premises of an business entity where Medicine and medical devices are stored.

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Eligibility for Drug License

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    Office premise should be more than 10sq/ Mtr or 110 Sq/ft.

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    For retail license “registered pharmacist” under state pharmaceutical council is required.

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    For wholesale an experienced Competent person is required having education qualification above 12th with 4 years of Job experience or Graduate with 1 hour of job experience in pharmaceuticals field.

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    Office premises should be commercial and in case of retail it should be easily accessible by public.

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    For retail and wholesale both license at one premises, then office premises should be more than 15sq mtr and Registered Pharmacist is mandatory.

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    If office will open all 7 days in week, then minimum two competent person/ registered Pharmacist is required.

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    If office will open for 24 hours, then minimum 3 pharmacist is required.

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Types of Drug Licenses

Drug license is categorised into three categories applicable as per the nature of business. Each license has specific requirements and rules & regulation also differs. Like retail drug license is applicable to those business entities who intends to sale drugs to end consumer.

1. Wholesale drug license

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    It is B2B sales, Whole sellers cannot sale medicine to end consumer directly.

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    To get whole sale license business entity need to hire competent person.

2. Retail drug license

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    Retailers are allowed to sale medicine to end consumers. To sale medicine retailers requires only doctors’ prescription.

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    Registered Pharmacist is required

3. Manufacturing drug license

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    This license holder can manufacture medicine and can sale medicine to whole seller or retailers both. But cannot sale to end consumers.

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    Technical staff is required who have education in field of chemistry

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    License issued to a business that manufactures drugs inclusive of allopathic/homoeopathy medicines

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Documentation of Drug License

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    Site plan and key plan of office premises (In some states it should be attested by architect)

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    Commercial Electricity bill and rent agreement of office premises valid for five years

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    Noc from the owner of office premises

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    Identity and address proof of applicant

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    Company formation documents

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    Invoice of cold storage

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    Documents of Registered Pharmacist for retail and of Competent person for whole sale

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Registered Pharmacist ( For Retail license)

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    Certificate of pharmaceutical council of state.

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    B.Pharma/ D.Pharma certificate/ degree.

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    Photo, Pan card and aadhar card

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    Bio data in prescribed format by drug dept

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    Applicant can hire registered Pharmacist (Not mandatory for applicant to have the Pharmacy background education qualification)

Competent person (For Wholesale licenses)

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    Education qualification certificate

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    Experience certificate in case 12th pass then 4 years and if graduate than 1 years of drug sales and purchase

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    Photo, Pan card and aadhar card

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    Applicant can hire competent person

Process

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Login creation at FDA.

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Online Form filing and documents uploading at FDA.

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Payment of prescribed Govt fees and verification of fees.

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Office premises verification by drug inspector

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Online response to queries raised by inspector.

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License Issue/reject.

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FAQ

Any Questions? Answered

Our FAQ section addresses common inquiries to help you find the information you need quickly. If you have further questions, feel free to reach out!

A drug license is a legal authorization granted by the regulatory authority in India to individuals or entities to carry out activities related to the sale, manufacture, distribution, or storage of drugs and pharmaceuticals.
In India, drug licenses are issued by the Central Drugs Standard Control Organization (CDSCO) at the central level and the Food and Drug Administration (FDA) of the concerned state at the state level.
There are several types of drug licenses, including: Retail Drug License, Wholesale Drug License, Manufacturing Drug License, Loan License, Restricted License.
The eligibility criteria vary based on the type of drug license. Generally, applicants must: Be an Indian citizen or a registered entity in India., Have adequate premises and facilities as per the requirements., Employ a qualified pharmacist or a competent person as specified.
To apply for a drug license, you need to: 1. Prepare the required documents, such as application forms, site plan, layout, etc., 2.Submit the Online application along with the required fee to the appropriate authority, 3. Undergo inspections and fulfil any additional requirements specified by the authority., 4. Once approved, you will receive the drug license.
Yes, drug licenses need to be renewed periodically. The duration of the license and the renewal period is 5 years. It is important to ensure timely renewal to avoid any legal complications.
Operating without a valid drug license is a serious offense and can lead to legal consequences. Penalties may include fines, imprisonment, suspension, cancellation of license, or other actions as prescribed by the relevant drug control authority.
Complete procedure may take 25 to 30days of time after successful filing of online application and payment verification.