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Wed, Jan 08 2025
Shubham Bansal
Obtaining a retail or wholesale drug license is a legal requirement for starting a pharmacy or distributing medicines in India. Beyond compliance, it assures customers and authorities that your business meets the safety and quality standards under the Drugs and Cosmetics Act, 1940.
This guide walks you through the eligibility criteria, documents, online application steps, and common challenges, along with professional support available to make the process easier.
A drug license is an official permit issued by the government to businesses or individuals dealing in medicines. It ensures that drugs are sold, stocked, and distributed only under authorized supervision, thereby protecting public health.
There are two main types of licenses:
Retail Drug License – Required for pharmacies and medical shops selling medicines directly to customers.
Wholesale Drug License – Required for distributors or suppliers who sell medicines to retailers or other wholesalers.
Running a pharmaceutical business without a license is a punishable offence. The license ensures that only qualified professionals handle medicines and that quality and safety standards are not compromised.
It also:
Prevents misuse of medicines
Promotes public safety
Ensures adherence to government regulations
The eligibility criteria for obtaining a drug license vary depending on the type of license, and these are as follows:
The applicant must hold a B.Pharm/D.Pharm degree or employ a registered pharmacist. The shop area must be at least 10 square meters, and ownership can be in the form of a sole proprietorship, partnership, or company.
Applicants must either be qualified pharmacists or employ a competent person with the required credentials. The premises should measure at least 15 square meters, and ownership can be individual, partnership, or corporate.
The process of obtaining a retail or wholesale drug license involves a series of online steps that applicants must carefully follow, which are as follows:
The first step is to access the official portal of your state’s Drug Control Department. Since licensing is a state subject, every state has its own dedicated platform where applications are submitted and tracked. For example, states like Delhi, Maharashtra, and Karnataka maintain independent portals. Choosing the correct portal ensures that your application goes to the right authority.
This is also the stage where you should familiarize yourself with your state’s specific rules, as some states may have slightly different documentation requirements or fee structures. Checking these in advance saves time during submission.
On the state portal, you must register by entering details like your name, mobile number, email ID, and business address. Once verified, you’ll receive login credentials to access the application dashboard.
This account is important because it will also be used later for tracking your application, uploading additional documents, and renewing your license. Keep your login details safe, as future compliance activities also happen through this account.
After logging in, choose the license type – retail drug license if you plan to sell directly to consumers, or wholesale drug license if you intend to supply to other businesses. The form will ask for details like business ownership, premises layout, and pharmacist/competent person details.
Be very careful at this stage. Any inaccurate information or mismatch with supporting documents can cause rejection or unnecessary delays. Double-check spellings, addresses, and qualification details before proceeding.
Document submission is the most crucial part of the process. You’ll typically need proof of premises, identity proof, qualification certificates, and an affidavit declaring compliance with the Drugs and Cosmetics Act.
To avoid delays, make sure that:
All documents are legible and scanned clearly.
File sizes match the portal’s requirements.
Information in documents matches what you entered in the application form.
Many applications face rejection at this stage because of blurry scans, missing affidavits, or inconsistencies. Taking time to prepare clean and correct files will save weeks of follow-up.
Once documents are uploaded, you will be redirected to the payment section. The application fee is usually ₹3000, but it can differ slightly depending on the state and the type of license applied for.
Payment can be made through net banking, debit/credit card, or other online modes provided on the portal. After payment, always download the receipt – it serves as proof of submission and is sometimes required during inspection.
After completing the form and payment, review all the details carefully before hitting “Submit.” The system will generate an acknowledgment number that you can use to track the progress of your application online.
At this stage, the department may also reach out if they need clarification or additional documents. Checking your portal dashboard and registered email regularly ensures you don’t miss any important notifications.
A drug inspector appointed by the state will visit your premises to verify compliance. They will check factors such as:
The size and layout of the premises
Storage facilities for medicines
Whether the pharmacist or competent person is present
Safety and hygiene standards
This inspection is often the deciding factor in the approval process. To prepare, ensure your premises meet all requirements and keep original documents handy for verification. Any shortcomings here can delay or even result in rejection.
If your documents are in order and the inspection is successful, the drug control department will issue the license. In most states, the license is emailed directly or made available for download from the portal.
This license must be displayed prominently at your business premises. It is proof that your operations are legal and compliant, and it reassures customers and suppliers that they are dealing with an authorized entity.
Generally, the approval process takes 30–60 days depending on the state and inspection backlog. Once granted, a license remains valid for five years and must be renewed before expiry. Failing to renew can result in penalties and even cancellation.
Applicants often face obstacles like:
Incomplete or incorrect documents, which cause delays
Premises not meeting minimum area requirements
Inspection backlogs that extend processing time
At PSR Compliance, we make the process Stress-free. From eligibility checks and documentation support to application submission and liaison with state authorities, we handle it all. Our experienced team ensures that your application is error-free and approved without unnecessary delays.
Securing a retail or wholesale drug license is the first step toward building a compliant and trusted pharmaceutical business. With the right preparation and expert support, you can complete the process efficiently and focus on growing your pharmacy or distribution network.
For quick and professional assistance, get in touch with PSR Compliance today.