Wholesale Drug License in Telangana

Overview of Wholesale Drug License in Telangana

A Wholesale Drug License in Telangana is an official document issued by the state's Drugs Control Administration, under the Drugs and Cosmetics Act, 1940. This license is required for individuals or businesses that intend to sell or distribute medicines in large quantities. It is not permitted to sell or supply medicines without possessing this license. To obtain this license, the applicant must have suitable premises with adequate space and appropriate storage facilities.

Certain medications require refrigeration, so the necessary arrangements for storage must be in place. Additionally, the business must employ a qualified person, such as a registered pharmacist or someone approved by the regulatory authorities, to manage the pharmaceutical products effectively.

This license can be granted to various types of entities, including sole proprietorships, partnerships, private limited companies, or other organizations involved in the wholesale trade of drugs. The license typically has a validity period of five years and must be renewed after its expiration. The application process for the license is conducted through the online portal of the Telangana Drugs Control Administration.

Benefits of a Wholesale Drug License in Telangana

Pharmaceutical companies involved in drug-related activities must remain informed about new developments and comply with current regulations. Although this may seem like a demanding task, it ultimately benefits the company in a positive manner. A wholesale drug license enables pharmaceutical companies to maintain a smooth and efficient supply chain. It also allows wholesalers to conduct their business with fewer challenges and legal complications.

1. Maintaining proper hygiene for drugs is crucial, as they can become contaminated easily.

The Central Drugs Standard Control Organization (CDSCO) provides guidelines under the Drugs & Cosmetic Act of 1940 to ensure hygiene standards are met. These guidelines must be followed by wholesalers to maintain the highest level of drug safety.

A valid wholesale drug license ensures that drugs are stored in a safe manner and do not pose any health risks to consumers. Additionally, government authorities often provide official notifications to license holders regarding any changes in drug procurement processes.

2. Having a wholesale drug license helps build strong relationships with retailers.

It shows that the holder has adhered to all government requirements, promoting transparency in business operations. Retailers often have concerns about the quality, pricing, and storage conditions of the drugs they purchase. A wholesale license helps reduce these concerns.

3. A wholesale drug license also increases market exposure.

It allows the holder to sell, display, store, and distribute drugs, thereby expanding their market reach. With greater visibility, companies can explore new business opportunities and enhance their growth potential.

4. Boosts business credibility

A wholesale drug license shows the consumers that strict quality standards have been followed while distributing drugs. In addition, remaining compliant with the Drugs and Cosmetics Act,1940 helps develop credibility and creates numerous business opportunities for sustainable growth.

Fees for Wholesale Drug License in Telangana

Eligibility for Wholesale Drug License in Telangana

1. Applicant Type

The license can be obtained by proprietorship firms, partnerships, Limited Liability Partnerships (LLPs), private limited companies, public limited companies, or any other registered entity that intends to conduct the wholesale trade of medicines.

2. Premises Requirement

The business premises must have a minimum size of 10 square meters. The premises should be well-constructed and equipped with adequate storage space. If the medicines require cold storage, refrigeration and air-conditioning facilities must be available. The premises must comply with the hygiene and safety standards established by the Drugs Control Administration (DCA) in Telangana.

3. Qualified / Competent Person

A wholesale drug business is required to have at least one qualified and competent person responsible for managing sales and distribution.

This person may be:

• A registered pharmacist licensed by the State Pharmacy Council, or

• An individual who has completed graduation and has at least one year of experience in drug sales, or

• A person with a minimum of four years of experience in drug sales, who has been approved by the DCA.

4. Business Entity Registration

The applicant’s business must be officially registered and possess all necessary documents, including GST registration, incorporation certificate, or partnership agreement.

5. Compliance with Law

The applicant must not have any criminal records relating to the Drugs and Cosmetics Act or any laws concerning drug adulteration or misbranding. The business must commit to maintaining proper records, invoices, and bills for all drug-related transactions

Procedure for Wholesale Drug License in Telangana

Step 1: Prepare the Premises

Ensure that the business location has a minimum area of 10 square meters. Install refrigeration and air conditioning systems for storing medicines that require cold storage. Have storage shelves, a clean environment, and all required facilities prepared for inspection.

Step 2: Hire a Qualified Person

Employ a registered pharmacist or an individual with relevant experience in drug sales. The person should have at least one year of experience with a graduation or four years of experience without a degree. Keep all the necessary documents, such as qualification certificates, registration papers, and proof of experience, readily available.

Step 3: Register the Business

Register the business as a sole proprietorship, partnership, Limited Liability Partnership (LLP), or company. Prepare and submit documents like the Partnership Deed, Incorporation Certificate, or GST Registration.

Step 4: Gather All Required Documents

Collect the following important documents:

• Application form (Form 19 for a wholesale license under Form 20B/21B)

• Proof of premises (rental agreement or ownership documents)

• Proof of minimum area (10 square meters) with a site plan or layout

• Proof of refrigeration and air conditioning (invoice or photographs)

• Qualification and registration certificate of the pharmacist or a qualified person

• ID and address proof for the applicant, partners, or directors

• Business registration documents (Partnership Deed, Memorandum of Association, Articles of Association)

• GST certificate

• Affidavit confirming compliance with the Drugs and Cosmetics Act

Step 5: Submit an Online Application

Visit the Telangana Drugs Control Administration (DCA) website through TS-iPASS or ODLS. Create a login account, complete the application form, upload all required documents, and pay the applicable fees (approximately ?3,000 for government charges plus inspection fees).

Step 6: Inspection by a Drug Inspector

A drug inspector from the local area will inspect the premises. They will examine the physical setup, storage arrangements, refrigeration systems, and the documents of the qualified person. If all requirements are met, the inspector will submit a positive report to the Licensing Authority.

Step 7: Receive the License

Once the application is approved, the Licensing Authority (DCA Telangana) will issue the Wholesale Drug License in Form 20B or 21B. The license is valid for a period of five years and must be renewed after its expiration.

Documents Required for Wholesale Drug License in Telangana

1. Application Form 19: Is used for applying for a wholesale license and is referred to as Form 20B/21B.

2. Business Proof: This includes documents such as a partnership deed, company registration documents, or proof of proprietorship. If the business is a company, a board resolution is also required.

3. Identity and Address Proof: The applicant, partners, and directors must provide their Aadhaar and PAN cards.

4. Premises Proof: This includes the ownership deed or a rent agreement, along with a site plan, key plan, and a utility bill.

5 Documents for the Competent Person: These include a qualification certificate, pharmacy registration, experience certificate, ID proof, an appointment letter, and an affidavit.

6. Affidavits: These are required to confirm that the applicant and the competent person have no criminal convictions.

7. Infrastructure Proof: The premises must be at least 10 square meters in area. A purchase invoice for a refrigerator or air conditioner may also be required if applicable.

8. Photographs: Passport-sized photographs of the applicant and the competent person are needed.

9. Fee Payment Receipt: A government challan is required to show that the fee has been paid.

Conclusion

A wholesale drug license in Telangana is a mandatory permission that allows a business to legally buy and sell medicines in large quantities within the state. The process of getting this license is done online through the website of the Telangana Drug Control Administration, which makes the procedure more convenient, faster, and less dependent on physical documents. To apply, the business needs to gather all required documents, such as proof of ownership, details about the business address, and the name of a qualified person, like a registered pharmacist or someone with experience in drug distribution. The business location must meet certain space requirements and have suitable facilities, such as refrigeration, especially if it plans to store temperature-sensitive medicines. After applying, along with sworn statements, payment receipts, and other supporting documents, the authorities perform an on-site check to ensure that all regulations are followed before granting the license, which usually takes a few weeks to process.

This license also comes with important obligations, as the Drug Control Administration closely supervises the distribution of medicines and takes strict measures against any breaches of the rules, such as halting the license, imposing penalties, or taking legal action if the rules are violated. This monitoring helps ensure a safe and dependable medicine supply system for the public. In short, acquiring a wholesale drug license in Telangana not only gives the business legal status but also builds trust with both suppliers and customers, ensuring that medicines are distributed in a controlled and safe way across the state.

Author:

Maanyata Mishra
Delhi, India
Final Year Law Student (2021-2026)