Retail Drug License Registration in Haryana - Process & Fees

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

• Details of Applicant
• Proof of Business
• Affidavit from the Registered Pharmacist or Competent Person
• Proof of Qualification is Required
• Address Proof and Identity Proof of Applicant
• Key Plan and Site Plan of the Premises
• Affidavit of Non-Conviction Regarding Proprietor or Director
• FSSAI License (if required)
• Registration with Respective Pharmacy Council is Required
• Appointment Letter or Bio Data of Pharmacist
• Proof of Premises, such as Sale Deed, Utility Bills, or Rent Agreement if Rented
• Online fee payment receipt / challan issued by Haryana Drug Control portal
• 3 copies of layout plan (As per Haryana govt. Norms)

The retail drug business is one of the traditional businesses in Haryana, enabling consumers to purchase medicines and pharmaceuticals directly from licensed pharmacies and medical stores. To regulate this industry, the government has made it mandatory for all retail businesses to obtain requisite permission under the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945 before commencing operations in Haryana.

Operating a retail pharmacy without a valid license may attract regulatory action, including penalties and suspension of business activities. Businesses engaged in the distribution and supply of medicines to pharmacies, hospitals, clinics, and other licensed entities are required to obtain a Wholesale Drug License in Haryana. The nature of the business activity determines whether a retail license, wholesale license, or manufacturing license is required.

Model for Retail Drug Business

Retail drug businesses in Haryana generally operate under the following business models:

• Physical Traditional Medical/Pharmacy Shops: Physical traditional Medical/pharmacy shops that sell medicines and healthcare products directly to consumers through a retail outlet.
• Online Medical Shops: Digital platforms such as Tata 1mg, PharmEasy and other e-pharmacies that facilitate the sale and delivery of medicines to consumers while complying with the applicable regulatory requirements governing drug sales and distribution.

There are several benefits of retail drug license registration, 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 Haryana

Drug license holders in Haryana must comply with the Drugs & Cosmetics Act, 1940. Non-adherence with the laws may lead to penalities or even seizure of products.

• 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
• License must be displayed prominently at the premises
• Separate register must be maintained for Schedule H and Schedule X drugs

• Retail Drug License:Retail drug license in Haryana authorizes the sale of medicines directly to consumers through physical medical stores or pharmacies. The license is mandatory for businesses engaged in the retail sale of drugs and pharmaceutical products in Haryana.
• Wholesale Drug License:Businesses involved in the wholesale trade and supply of pharmaceutical products in Haryana are required to obtain a wholesale drug license. The license permits the sale and distribution of drugs to retailers, hospitals, clinics, and other licensed entities.
• Manufacturing Drug License:A Manufacturing Drug License authorizes the manufacture of drugs and pharmaceutical products in Haryana. Applicants must have premises in an approved industrial area and comply with the prescribed Good Manufacturing Practices (GMP) requirements before applying for manufacturing drug license in Haryana.
• Loan License:A Loan License allows an applicant to manufacture drugs using the facilities of an existing licensed manufacturer. It is commonly used by startups and pharmaceutical businesses that do not possess their own manufacturing premises.

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.

Applicants must fulfill the eligibility criteria before applying for retail drug license in Haryana:

• Minimum space of at least 100 sq ft (approximately 10 sq.m)is required for a physical shop.
• A registered pharmacist holding a B.Pharm or D.Pharm degree from a recognised university, registered with the Haryana State Pharmacy Council, must be available full-time
• Proof of premises.
• Blueprint of premises.
• A working refrigerator (for temperature-sensitive drugs), deep freezer (for vaccines), and air conditioner are mandatory.
• Purchase invoices or receipts for each must be submitted as part of the application

Retail Drug License registration is an important step in setting up a drug retail drug business in Haryana and its major cities such as Gurugram, Faridabad, Ambala, & Hisar. Retail drug license ensures that the business follows the laid-down standards of safety, quality, and operation.

Getting the license at the appropriate time will help you avoid complications with the law, delays in production, and financial losses. With expert support from Professional Utilities, you can smoothly register your retail drug store and run your business with complete confidence.