Retail Drug License Registration In Ladakh | Fees, Procedure & Documents

Updated on April 08, 2025 01:04:32 PM

Retail Drug license registration is a vital certification required by retailers engaged in selling or storing drugs, i.e., medicines in Ladakh. This license is a mandatory compliance for all retailers operating in Ladakh. The objective of issuing a Drug license to a retailer is to regulate the sale of generic and non-generic medicines in Ladakh and enhance consumer trust in the market.

Drug license registration is an obligatory and mandatory compliance in the retail business of medicines, as well as for other traditional drug-related businesses in Ladakh. It takes around 25-30 working days to complete the Registration process with central licensing authority.

Now, let's delve into the legal framework governing the retail drug industry and highlight the government's initiatives to support and regulate the retail sector in Ladakh.

Retailer Drug License Certificate Sample

  • Form-20B
  • Form-21B
Drug License Certificate Sample
Drug License Certificate Sample
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What is a Retail Drug License and its Importance?

The retail drug business is one of the traditional businesses in Ladakh, where individuals can conveniently purchase medicines for themselves. To regulate this industry, the government has made it mandatory for all retail businesses to obtain D&C permission to operate in Ladakh. Retailers need to obtain a retail drug license by filling out the 19A form as per D&C Rules.

Model for Retail Drug Business

Retail drug business typically operates on the following business models:

  • Physical traditional medical/pharmacy shops
  • Online Medical Shops
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Online Retail Business Models in a Glance

Online Retail Business can be categorized based on three models:

  • Stock-Based Models:Based on where merchandise and enterprise are both regulated by e-commerce entities, and the package is supplied to consumers directly.
  • Center-Based Models:In such business models, online entities act as mediators between consumers and retailers. All orders are verified and authenticated by retailers and dispatched to consumers.
  • Generic e-commerce Marketplace:Preexisting marketplaces, such as Flipkart, where consumers can directly purchase medicines that are not prohibited for sale under D&C rules.

Requirement to Establish a Retail Medical Store in Ladakh

  • Minimum space of at least 100 sq ft is required for a physical shop.
  • Must have a full-time qualified pharmacist or a competent person.
  • Proof of premises.
  • Blueprint of premises.
  • Invoice for all necessary types of equipment.

These are the prerequisites required to start a retail pharmaceutical business in Ladakh.

Classification of Products under Drug and Controller Act

Drugs are classified under the following categories for sale in the market:

  • Medicines
  • Health Supplements
  • Nutraceuticals

Documents Required For Retail Drug License Registration in Ladakh

The following documents are needed to be attached for a retail drug license application:

  1. Details of Applicant
  2. Proof of Business
  3. Affidavit from the Registered Pharmacist or Competent Person
  4. Proof of Qualification is Required
  5. Address Proof and Identity Proof of Applicant
  6. Key Plan and Site Plan of the Premises
  1. Affidavit of Non-Conviction Regarding Proprietor or Director
  2. FSSAI License (if required)
  3. Registration with Respective Pharmacy Council is Required
  4. Appointment Letter or Bio Data of Pharmacist
  5. Proof of Premises, such as Sale Deed, Utility Bills, or Rent Agreement if Rented
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Fee For Retail Drug License Registration In Ladakh

The professional fee for a Retail drug license in Ladakh is INR 34,999/- only. Applicants are required to pay a government fee during the registration process.

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Retail Drug License Registration Procedure in Ladakh

Given below is the complete registration process of One Person company in India:

Step 1 - Account Creation for users

An online login user ID and password are created on the portal to initiate the retail drug license registration process with the central licensing authority for drugs and cosmetics.

Step 2 - Documentation

After the creation of user login credentials, all the required documents for a retail drug license will be verified by our experts before filing a formal application with the central licensing authority for registration.

Step 3 - Filing Application

Once documentation is completed, a formal application will be filled under form 19A for a retail drug license along with other relevant forms in its entirety.

Step 4 - Issuance of Certification

A formal inspection will be held by licensing authorities for authorization for a retail license for medical shops. The registration process would take around 30 days to complete.

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Benefits of Drug license certification

There are several benefits of a registering One Person Company in India, which are discussed below:

  • Statutory Compliance: Ensures compliance with the Drugs and Cosmetics Act, 1940, demonstrating commitment to operating within the bounds of the law.
  • Quality Control:Involves a rigorous evaluation of products and facilities to meet specific quality standards, instilling confidence in consumers.
  • Consumer Trust:Legally approved and regulated products build consumer trust in terms of quality and safety, enhancing the brand's reputation.
  • Market Access:Many government tenders, hospitals, and medical institutions require suppliers to have a valid drug license, expanding market reach.
  • Export Opportunities:A prerequisite for exporting pharmaceutical products, facilitating entry into global markets.
  • Regulatory Support:Provides access to regulatory support and updates on industry best practices.
  • Business Credibility: Adds credibility in a competitive industry, assuring stakeholders of legitimacy.
  • Risk Mitigation:Reduces the risk of product seizures, legal penalties, and damage to the business's reputation.

Compliances for Retail Drug License Holder In Ladakh

  • There must be a pharmacist and registered chemist available with the entity.
  • Doctor's prescription is required to sell prescribed medicines.
  • Retail drug license is mandatory for medical shopkeepers.
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Conclusion

A Retail Drug License is an important certification for retailers of drug and cosmetic products in Ladakh. As the drug industry is highly regulated and deals with public health and safety, it is mandatory for all retailers of such products to obtain a retail drug license certification from CLA for their business in Ladakh.

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Frequently Asked Questions

What kind of drug license is required for a retail pharmaceutical business in Ladakh?

Applicants are required to get a retail drug license from the central licensing authority under the Drugs and Controller Act 1940 for their retail business.

What is the fee for a retail drug license?

The professional fee for a retail drug license in Ladakh is INR 34,999/-

How Much Time Does it Take to Get a Retail Drug License in Ladakh?

It takes around 30 working days to get a retail drug license in Ladakh.

Is having a drug license mandatory?

Yes, as per the guidelines of D&C rules 1945, any entity dealing in the list of scheduled drugs is required to have a retail drug license in Ladakh.

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