Retail Drug License Registration | Fees, Procedure and Documents Required

Online Retail Business can be categorised based on threse models.

• Stock Based Models: It is based on where merchandise and enterprise both are regulated by e-commerce entities and the package is supplied to consumers directly.
• Center Based Models: In such business models online entities act as a mediator between consumers & the retailers. Where all orders are verified and authenticated by retailers and dispatched to consumers.
• Generic E-commerce Marketplace: They are preexisting marketplaces such as Flipkart from where consumers can directly purchase their medicines which are not prohibited for sale under D&C rules.

• Minimum space of at least 100 sq ft is required for the physical shop.
• Must have a full-time qualified pharmacist or a competent person.
• Proof of premises is required.
• Include a blueprint of the premises, outlining the layout and design.
• Keep invoices for all necessary types of equipment required for the pharmacy shop.

These are the prerequisite that is required to start retail pharmaceutical business in India.

Classification of products under drug and controller act

Drugs are classfied under the following categorie for sale in market

• Medicines
• Health Supplements
• Nutraceuticals

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

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

• Legal Compliance: One of the primary benefits of acquiring a drug license in India is that it ensures legal compliance. The Drugs and Cosmetics Act, 1940, mandates that anyone involved in the manufacturing, distribution, or sale of drugs and pharmaceutical products must hold a valid drug license. Failing to do so can result in legal consequences. By obtaining the necessary license, you demonstrate your commitment to operating within the bounds of the law.
• Quality Assurance: A drug license registration in India involves a rigorous evaluation of the products and the facilities where they are manufactured or stored. This scrutiny ensures that the drugs being produced meet specific quality standards. As a result, consumers can have confidence in the safety and efficacy of the pharmaceuticals they purchase, which is vital for any healthcare-related business.
• Consumer Trust: Consumers tend to have more trust in products that are legally approved and regulated. Having a drug license displays a commitment to quality and safety. It can significantly enhance your brand's reputation and help you build trust with your customers, which is especially important in the pharmaceutical industry.
• Market Access: Many government tenders, hospitals, and medical institutions require suppliers to have a valid drug license. Without it, you may miss out on lucrative business opportunities. By obtaining a drug license, you can expand your market reach and access a broader customer base, including government and institutional buyers.
• Export Opportunities: If you have aspirations to export pharmaceutical products, a drug license is often a prerequisite. International markets demand strict compliance with quality and safety standards. A drug license can facilitate your entry into global markets, making your business more competitive.
• Regulatory Support: Obtaining a drug license means you are part of a regulated industry. This can provide you with access to regulatory support and updates on industry best practices. Staying informed about changing regulations is crucial in the pharmaceutical sector, and a drug license keeps you in the loop.
• Business Credibility: In a highly competitive industry like pharmaceuticals, credibility is everything. Having a drug license adds a layer of credibility to your business. It assures partners, investors, and stakeholders that you are a legitimate player in the market.
• Risk Mitigation: Operating without a drug license carries the risk of product seizures, legal penalties, and damage to your business's reputation. By obtaining a license, you reduce these risks and ensure the smooth operation of your pharmaceutical business.

Compliances for Retail Drug License holder

• 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.