How to Apply for Drug License Online in India – Step-by-Step Guide (2025)

Starting a pharmacy, wholesale medicine business, or a manufacturing unit in India requires one crucial step — obtaining a Drug License. Under the Drugs and Cosmetics Act, 1940, it is mandatory for businesses to have a valid drug license before selling, distributing, or manufacturing drugs in India.

This guide will help you understand the eligibility, documents required, and the step-by-step process to apply for a drug license online in 2025.

What is a Drug License in India?

A Drug License is an approval issued by the State Drug Control Department or Central Drugs Standard Control Organization (CDSCO). It authorizes a business to legally manufacture, sell, or distribute medicines.

It ensures that only qualified professionals handle pharmaceutical products, protecting public health and preventing misuse.

Types of Drug Licenses

Depending on the nature of your business, you need to apply for the appropriate license:

  • Retail Drug License (RDL): For pharmacies and medical shops.

  • Wholesale Drug License (WDL): For businesses supplying medicines to retailers, distributors, and hospitals.

  • Manufacturing License: For drug and cosmetic manufacturers.

  • Loan License: For businesses using another manufacturer’s facility.

  • Import License: For importing medicines into India.

Eligibility Criteria for Drug License

Before applying, ensure your business meets these conditions:

  1. Qualified Pharmacist: A registered pharmacist is mandatory for retail licenses.

  2. Business Premises: Minimum 10 sq. meters (retail/wholesale) and 15 sq. meters (combined).

  3. Storage Facility: Refrigerator & air conditioning for medicines requiring cold storage.

  4. Registered Business Entity: Proprietorship, partnership, LLP, or company.

Documents Required

Here’s the checklist of documents needed for online application:

  • Identity proof of proprietor/partners/directors

  • Premises proof (rent agreement/ownership papers)

  • Pharmacist’s degree/diploma & registration certificate

  • Appointment letter of pharmacist

  • Business registration proof (Partnership deed/Company Incorporation)

  • GST registration certificate

  • Storage facility proof (Refrigerator & AC bills)

  • Premises layout/site plan

  • Affidavit of compliance under the Drugs and Cosmetics Act

Step-by-Step Process to Apply for Drug License Online (2025)

Step 1: Visit the Portal

Step 2: Select License Type

  • Choose between Retail, Wholesale, Manufacturing, or Import License.

Step 3: Fill the Application Form

  • Enter details such as business name, address, pharmacist details, and storage facilities.

Step 4: Upload Documents

  • Attach scanned copies of the required documents in PDF format.

Step 5: Pay Government Fees

  • Fees depend on license type & state (₹3,000 – ₹10,000 approx.).

Step 6: Inspection by Drug Inspector

  • A Drug Inspector will verify the premises, pharmacist, and compliance.

Step 7: License Issuance

  • If approved, the license will be issued online within 30–60 days.

Validity & Renewal

  • A drug license is valid for 5 years.

  • Renewal must be done at least 30 days before expiry.

  • Late renewal may lead to penalties or cancellation.

Penalties for Non-Compliance

Operating a medical or drug business without a valid license can result in:

  • Heavy fines

  • Business closure

  • Legal action, including imprisonment

Why Choose Professional Help?

Applying for a drug license requires technical knowledge and compliance with regulations. PSR Compliance helps businesses with:

  • End-to-end application support
  • Document verification & filing
  • Coordination with authorities
  • License renewal services

📞 Call us: (+91) 70658 83416
📧 Email: support@psrcompliance.com

FAQs on Drug License (2025)

Q1. What is the minimum shop area required?
👉 10 sq. meters (retail/wholesale) and 15 sq. meters (combined).

Q2. What is the validity of a drug license in India?
👉 5 years from the date of issue.

Q3. Can I apply for a drug license online?
👉 Yes, via CDSCO SUGAM portal or state drug control websites.

Q4. Is pharmacist qualification mandatory?
👉 Yes, a registered pharmacist is compulsory for retail licenses.

Q5. How long does the approval take?
👉 30–60 days depending on inspection and compliance.

Apply for Drug License Online in India – Complete Step-by-Step 2025 Guide

 If you are planning to start a pharmacy, wholesale medicine business, or manufacturing unit, the first thing you need is a drug license. Without it, operating in the medical sector is not just risky but also illegal.

With the government’s digital platforms, applying for a drug license is now easier than ever. Let’s break down the step-by-step process for 2025.

Why is a Drug License Important?

A drug license ensures that medicines are sold, distributed, or manufactured only by authorized and qualified individuals. This protects both public health and your business reputation.

Types of Drug Licenses You Can Apply For

  • Retail Drug License (for medical shops and pharmacies)

  • Wholesale Drug License (for bulk supply and distribution)

  • Manufacturing License (for producing drugs, cosmetics, or devices)

  • Loan License (to use another manufacturer’s facility)

  • Import License (for businesses importing drugs into India)

Who Can Apply?

  • Individuals with proper business premises and required area.

  • Pharmacists with B. Pharma/D. Pharma qualifications (retail).

  • Competent persons with experience (wholesale).

  • Companies with adequate storage and refrigeration facilities.

Required Documents

Before applying online, prepare these documents:

  • Identity and address proof.

  • Property proof or rental agreement of the premises.

  • Educational certificates of pharmacist/competent person.

  • Company incorporation or partnership deed.

  • Affidavit of non-conviction.

  • Proof of cold storage facilities.

  • GST registration certificate.

  • Premises layout and site plan.

Step-by-Step Application Guide (2025)

  1. Go to the State Drug Control Authority website or the CDSCO portal.

  2. Register online by creating an account.

  3. Choose your license type (retail, wholesale, manufacturing, etc.).

  4. Fill in details of your business, premises, and staff.

  5. Upload scanned documents in PDF/JPEG format.

  6. Pay the required application fees online.

  7. Wait for review and inspection scheduling.

  8. Drug Inspector will verify your premises.

  9. On approval, download your Drug License Certificate from the portal.

Fees and Timelines

  • Fees usually range between ₹3,000 – ₹10,000.

  • The approval process may take 30–60 days depending on inspection.

Renewal Process

  • A license is valid for five years.

  • Apply for renewal online before the expiry date to avoid penalties.

Key Tips for Faster Approval

  • Double-check documents before uploading.

  • Ensure your premises meet all requirements.

  • Keep proper refrigeration and storage facilities ready for inspection.

Conclusion

Applying for a drug license online in India is straightforward if you follow the official process. However, many businesses face delays due to documentation errors or inspection issues.

That’s where PSR Compliance helps – from documentation to approvals, we guide you at every step to secure your license quickly.

📞 Contact us at (+91) 70658 83416
📧 support@psrcompliance.com
🌐 https://psrcompliance.com/

How to Register a Company in India: Complete Process Explained

Starting a business in India in 2025 is an exciting opportunity, thanks to a simplified registration process and the country’s strong entrepreneurial environment. Company registration not only gives your business a legal identity but also opens the door to funding, credibility, and growth.

This guide walks you through every step of the process so you can register your company smoothly and in full compliance with the law.

Why Company Registration is Important ?

Registering your business establishes it as a separate legal entity from its owners. This offers several advantages:

  • Limited liability – Your personal assets are protected if the company faces financial issues.

  • Easier funding – Investors and banks prefer dealing with registered companies.

  • Credibility – A registered entity gains the trust of customers, suppliers, and partners.

  • Access to schemes – You can participate in government tenders, claim tax benefits, and use business-specific legal protections.

Choosing the Right Business Structure

Before starting the process, you must decide which type of business structure fits your needs:

Your choice will impact taxation, compliance obligations, and growth potential.

Pre-Registration Essentials

1. Obtain a Digital Signature Certificate (DSC)

A DSC is required for signing electronic forms. Each director must have one, and it is issued by authorized certifying agencies.

2. Get a Director Identification Number (DIN)

Every proposed director must have a DIN, which is applied for online with identity and address proof.

3. Reserve Your Company Name

Use the online name reservation service to check availability and book your preferred name. Ensure it is unique and complies with naming guidelines.


Steps to Register Your Company in 2025

Step 1: Draft the Memorandum of Association (MOA) and Articles of Association (AOA)

  • MOA specifies your company’s objectives, name, and scope of activities.

  • AOA outlines internal management rules, rights, and responsibilities of members.

Step 2: File the SPICe+ Form

The SPICe+ form integrates multiple services into one application, including name reservation, incorporation, and applications for PAN and TAN.

You will need to submit:

  • MOA and AOA

  • Identity and address proof of directors

  • Proof of registered office

  • Declaration forms and consent letters

Step 3: Pay Fees and Stamp Duty

The amount depends on your company’s authorized share capital and state-specific stamp duty rules.

Step 4: Receive Certificate of Incorporation

Once approved, you’ll get a Certificate of Incorporation with your Corporate Identification Number (CIN).

Step 5: Get PAN and TAN

These are essential for tax filings and financial transactions. They are often issued along with the incorporation certificate in the SPICe+ process.


Post-Incorporation Compliance

After registration, a few important steps remain:

  1. Open a Business Bank Account – Use your incorporation documents to set up a corporate bank account.

  2. Register for GST – If your turnover crosses the threshold or if you’re dealing in interstate goods and services, GST registration is mandatory.

  3. Maintain Statutory Records – Keep financial and statutory registers up to date.

  4. File Annual Returns and Taxes – Meet your compliance deadlines to avoid penalties.


Common Challenges and How to Avoid Them

  • Document errors – Ensure every form is complete and accurate before submission.

  • Name rejections – Check name availability in advance and avoid restricted words.

  • Delay in DSC or DIN – Apply early to prevent bottlenecks in the registration process.

  • Ignoring post-registration compliance – This can lead to penalties or even company strike-off.

Benefits of Proper Registration

When you follow the correct registration process, you gain:

  • Legal recognition for your business

  • Better access to funding and investors

  • Stronger brand image and trustworthiness

  • Eligibility for government incentives and tenders


Final Thoughts

Registering a company in India is a crucial step in turning your business idea into a fully recognized entity. While the process involves multiple steps—right from obtaining a DSC to completing post-incorporation compliance—proper planning and attention to detail make it smooth and stress-free.

By following this guide, you can ensure your business is set up on a solid legal and operational foundation, ready for growth in 2025 and beyond.

https://www.psrcompliance.com/blog/company-registration-steps-2025


BIS Certification for Home Appliances in India – Complete 2025 Guide

 In India, the Bureau of Indian Standards (BIS) plays a crucial role in ensuring the quality, safety, and reliability of consumer products. When it comes to home appliances, BIS certification is not just a legal requirement for certain products—it is a mark of trust that assures customers of the product’s compliance with national standards.

Whether you are a manufacturer, importer, or distributor of home appliances, obtaining BIS certification can significantly enhance your brand image and market reach. In this article, we will cover the importance, process, requirements, and benefits of BIS certification for home appliances.


What is BIS Certification?

BIS certification is a conformity assessment provided by the Bureau of Indian Standards under the BIS Act, 2016. It ensures that the product meets specific Indian standards (IS) related to quality, safety, and performance. For home appliances, this certification guarantees that the product has undergone rigorous testing and complies with the safety norms prescribed by BIS.

Some common home appliances that may require BIS certification include:

  • Refrigerators

  • Washing machines

  • Air conditioners

  • Electric irons

  • Microwave ovens

  • Electric water heaters

  • Ceiling fans


Why BIS Certification is Important for Home Appliances

  1. Legal Compliance – For certain home appliances, BIS certification is mandatory as per the Government of India’s regulations. Selling uncertified products can lead to legal action, penalties, or product seizures.

  2. Consumer Safety – Certified products undergo strict testing to ensure they are safe for everyday use, reducing the risk of accidents, electric shocks, or fire hazards.

  3. Market Acceptance – Retailers, e-commerce platforms, and distributors prefer certified products because they are reliable and compliant with safety standards.

  4. Brand Trust & Reputation – BIS certification enhances customer confidence, making your brand stand out from competitors.


Types of BIS Certification Schemes for Home Appliances

BIS offers certification under different schemes depending on the nature of the product:

  1. ISI Mark Certification – Applicable to domestic manufacturers, this scheme ensures that the product meets Indian standards.

  2. Foreign Manufacturers Certification Scheme (FMCS) – For overseas manufacturers who want to sell their home appliances in India.

  3. Compulsory Registration Scheme (CRS) – Covers certain electronic products, including some categories of home appliances, under mandatory registration.


BIS Certification Process for Home Appliances

The certification process generally involves the following steps:

  1. Application Submission – The manufacturer or their authorized representative submits an application to BIS with the required documents and product details.

  2. Product Testing – Samples of the appliance are sent to a BIS-recognized laboratory for testing as per the applicable Indian standards.

  3. Factory Inspection – BIS officials conduct an inspection of the manufacturing unit to verify production processes, quality control measures, and compliance with standards.

  4. Grant of License – Upon successful verification and test results, BIS issues the certification, allowing the manufacturer to use the BIS Standard Mark (ISI mark) or CRS registration.


Documents Required for BIS Certification

  • Application form

  • Manufacturing license or company registration documents

  • Product specifications and drawings

  • Test reports from BIS-recognized labs

  • Quality control plan

  • Details of manufacturing facilities and processes


Validity and Renewal

BIS certification is usually valid for two years and can be renewed by submitting a renewal application before expiry. Renewal requires proof of continued compliance, including updated test reports and inspection results.


Benefits of BIS Certification for Home Appliances

  1. Compliance with Legal Standards – Avoids penalties and ensures hassle-free operations in the Indian market.

  2. Enhanced Market Reach – Many retail outlets and online platforms mandate BIS-certified products.

  3. Customer Confidence – Builds trust in your brand and assures buyers of product safety and quality.

  4. Reduced Product Liability Risks – Certified products are less likely to cause harm, reducing the chances of legal disputes.

How PSR Compliance Can Help

Navigating the BIS certification process can be complex, especially for first-time applicants. PSR Compliance offers complete assistance, from identifying applicable Indian standards to preparing documents, coordinating with BIS, and ensuring timely certification. With expert guidance, manufacturers can save time, reduce costs, and ensure compliance without unnecessary delays.

If you are planning to manufacture, import, or sell home appliances in India, BIS certification is your gateway to market credibility and consumer trust.


🔗 Read the full detailed guide here: https://www.psrcompliance.com/blog/bis-certification-for-home-appliances


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