How to Obtain a Drug License in Uttar Pradesh
If you’re looking to start a pharmaceutical business or distribute medicinal products in India, acquiring a drug license is a crucial step. In Uttar Pradesh (UP), one of India’s most populous and economically diverse states, obtaining a drug license is not only legally required but also ensures the quality, safety, and efficacy of the medicines being distributed. This guide will walk you through the process of obtaining a drug license in UP, key requirements, and tips for ensuring compliance with the state’s pharmaceutical laws.
What is a Drug License?
A drug license is an official authorization granted by the Central or State Drug Control Authority to individuals or businesses for manufacturing, distributing, or retailing drugs and pharmaceutical products. The primary purpose of a drug license is to regulate and ensure that the drugs being manufactured and sold meet the necessary safety, quality, and efficacy standards.
In India, drug licenses are governed under the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945. The licensing authority varies based on the type of drug license and the business’s location, whether it is a manufacturing unit or a retail outlet.
In Uttar Pradesh, drug licenses are issued by the State Drug Control Authority, which operates under the Department of Medical Health and Family Welfare, Government of Uttar Pradesh.
Types of Drug Licenses in Uttar Pradesh
Depending on your business model, you may need one of the following types of drug licenses:
1. Retail Drug License
This license is required by pharmacies or retail drugstores that sell medicines directly to consumers.
The license is issued for dispensing over-the-counter (OTC) or prescription-based medicines to the public.
2. Wholesale Drug License
A wholesale drug license allows the holder to distribute medicines to other pharmacies, hospitals, or healthcare centers in bulk quantities.
This license is essential for businesses acting as intermediaries between manufacturers and retailers.
3. Manufacturing Drug License
If you’re planning to manufacture medicines or drugs (including generic and branded pharmaceuticals), a manufacturing drug license is required.
This license is highly regulated, and you must adhere to stringent guidelines to maintain the quality of the medicines being produced.
4. Import License
If you plan to import drugs into Uttar Pradesh, an import license is mandatory.
This license ensures that the imported medicines comply with the Drug and Cosmetic Act and Rules.
5. Blood Bank License
For establishments involved in the collection, storage, and distribution of blood and blood products, a specific license is required from the drug authorities
Who Needs a Drug License in UP?
The need for a drug license is mandatory for anyone involved in the following:
Pharmacy owners who sell medicines to the public.
Wholesale distributors who supply medicines to pharmacies, hospitals, or other medical facilities.
Manufacturers who produce pharmaceutical products, including tablets, capsules, syrups, injections, etc.
Importers who bring drugs and pharmaceutical products from other countries.
Blood banks and organizations handling medical devices and diagnostics.
If you are planning to establish a pharmaceutical business in Uttar Pradesh, it’s important to determine which type of license is applicable to your specific line of work. The requirements for each license differ, and each comes with its set of regulatory compliance guidelines
Key Steps to Obtain a Drug License in Uttar Pradesh
The process to obtain a drug license in Uttar Pradesh involves several critical steps. The exact steps may vary slightly based on the type of license you’re applying for, but the following is a general overview.
Step 1: Determine the Type of Drug License You Need
First, you must identify the specific type of drug license you require based on your business type:
Retail license if you are setting up a pharmacy.
Wholesale license if you are distributing drugs.
Manufacturing license if you are producing drugs.
Import license if you are importing pharmaceutical products.
Step 2: Meet the Eligibility Criteria
Each license has its set of eligibility criteria. The key requirements usually include:
For a Retail/Wholesale License:
You must have a registered business or legal entity (such as a private limited company, partnership, or sole proprietorship).
You need to have a qualified pharmacist to supervise the sale and distribution of medicines. The pharmacist must hold a diploma or degree in pharmacy from a recognized institution.
The premises should comply with the rules set by the Drug Control Department. The premises must have a proper storage facility for medicines, maintaining hygiene and adequate temperature control.
For a Manufacturing License:
A valid manufacturing facility with proper machinery and quality control measures in place.
Qualified technical staff such as chemists, pharmacists, and production specialists.
A licensed and registered address for the manufacturing unit.
For an Import License:
Valid import/export registration with the Directorate General of Foreign Trade (DGFT).
The importers must maintain a proper record of drug products.
Step 3: Submit the Application for a Drug License
Once you have prepared all the necessary documents and met the eligibility criteria, you can submit your application. In Uttar Pradesh, you can apply for a drug license online via the UP Drug License System (or the official website of the State Drug Controller).
The following documents are typically required for the application process:
Proof of Business Registration (Certificate of Incorporation or Partnership Deed).
Identity Proof of the applicant (Aadhaar card, PAN card, etc.).
Address Proof of the premises.
Qualification Certificate of the pharmacist or technical staff.
Layout Plan of the premises showing the location of the storage area and the area designated for drug handling.
Pharmacist’s Registration Certificate issued by the state pharmacy council.
No Objection Certificate (NOC) from the local municipal authority, indicating that the premises comply with local zoning laws.
Affidavit declaring compliance with the rules and regulations of the Drugs and Cosmetics Act.
Step 4: Inspection of the Premises
After submitting your application and required documents, an official from the Uttar Pradesh Drug Control Authority will visit your premises for an inspection. This step ensures that your business meets the necessary standards, such as:
Adequate storage space for drugs.
Clean and sanitized premises.
Proper safety measures and temperature control for storing medicines.
Availability of a qualified pharmacist or technical staff for drug handling and supervision.
Step 5: Receive the Drug License
If your application and premises pass the inspection, the Drug Control Authority will issue your drug license. The license typically includes the following details:
Type of license (retail, wholesale, manufacturing, etc.).
Name and address of the license holder.
Drug categories authorized for sale, manufacture, or distribution.
Validity period (usually 1-5 years, depending on the type of license).
Step 6: Renewal of the Drug License
Drug licenses are not permanent and need to be renewed periodically. The renewal process involves re-submitting your application and undergoing a re-inspection if required. Make sure to renew your drug license on time to avoid penalties or discontinuation of your business activities
Compliance with Regulations
Obtaining a drug license is just the beginning of your responsibilities as a pharmaceutical business owner. Once you have the license, you must adhere to the rules and regulations set by the Drug Control Authority. Some of the key compliance requirements include:
Maintaining proper records of drugs sold, manufactured, or distributed.
Following good manufacturing practices (GMP) and good distribution practices (GDP).
Ensuring that medicines are stored appropriately, especially temperature-sensitive products.
Regular audits and inspections by the Drug Control Authority to ensure adherence to quality standards.
Staff training on handling and dispensing drugs safely
Drug Licence Registration
Licensing is mandatory to do business in Drugs & Cosmetics in India. The provisions for this has been made in Drugs & Cosmetics Act, 1940, which is applicable to whole of India. It is an Act to consolidate all the laws relating to drugs & cosmetics, which established the Drugs Control Department. In 1964, the Act was amended to include Ayurvedic & Unani drugs. However, a particular business entity may require different types of drug license based on their business, you may contact SSGroup for consulting on it.
If a business is operating in more than two states, it has to obtain drug licence in every state in which business is being carried on. A drug license is location specific. If drugs are sold or stocked for sale at more than one place,application shall be made, and license shall be issued, in respect of each such place, except migrant vendors.
Once the licence is granted to the business, all such License must ensure that all the condition in the drug licence are complied at all times during the course of the business. All the records registers, and forms must be maintained in the manner specified by the licensing authorities and authorities shall be kept informed for all the changes or modification in the business activities.
Drug License Registration is done through silver star group
Documents Required For Registration Under Shops and Establishments
List of Documents for Applicant's Drug License
- The Certificate of Incorporation or Registration
- MOA & AOA or Partnership Deed/ LLP Agreement
- Pan Card and Cancelled Cheque
- Photo, ID and Address Proof of Director
- Affidavit from Directors
- Bio-data of Competent Person as per Proforma
- Appointment Letter of Competent Person (CP)
- Qualification and Experience Certificate of CP
- Photo, ID and Address proof of Competent Person
Documents of Shareholders/Directors
- In case the premises is owned, then registered Sale Deed / Registered GPA / Conveyance Deed in the name of the owner,
- In the case of unregistered Sale Deed / unregistered GPA, it must be supported with Electricity Bill / Water Bill/property tax receipt.
- In the case of a village, Khasra Khatauni documents are accepted
- If Rented: Registered Rent Agreement with Rent Receipt or,
- In the case of unregistered rent agreement, The Rent agreement must be supported with Electricity Bill / Water Bill/property tax receipt.
- No Objection Certificate from the owner of the premises
- Key Plan and Site Plan of the premises duly attested by an approved architect or mapmaker of the municipality