A Comprehensive Guide to Opening a Medical Store in India

How to Open a Medical Store or Pharmacy in India?

India’s pharmaceutical and healthcare sectors have been experiencing significant growth in recent years, driven by the proliferation of corporate and multi-speciality hospitals. Establishing a medical store can be a promising venture for aspiring entrepreneurs with limited capital looking to invest in the healthcare industry. However, opening a medical store involves multiple registrations and adherence to legal procedures. This article will explore the various types of medical stores, the requirements for opening one, the registration process, and the necessary licenses and registrations.

Types of Medical Stores

1. Hospital Medical Store: These are stores located within hospitals, primarily catering to the needs of the patients receiving treatment at the hospital.
2. Standalone Medical Store: These are the most common type of medical store in residential areas. They serve as small to medium-sized outlets where residents purchase essential medicines.
3. Chain Pharmacy or Franchise Outlets: Located in malls and shopping complexes, these stores are part of a larger pharmacy chain with branches in multiple areas. They are usually larger and offer a wide range of pharmaceutical products.
4. Township Medical Stores: These stores are established in townships to meet the requirements of the residents.
5. Stores in Government Premises: Operated under various government policies and schemes, the government directly controls these medical stores and is often located within government offices and buildings.

Hospital medical stores, chain pharmacies, and township medical stores are typically established under larger corporate entities. In contrast, single proprietors or partners often set up standalone and township medical stores. The choice of the medical store type plays a crucial role in the registration and licensing process.

Requirements for Opening a Medical Store

Several key requirements must be met when opening a medical store in India:

1. Area Specification: The minimum area required for a retail medical store is 10 square meters, while a wholesale medical store should have a minimum area of 15 square meters.
2. Storage Facility: Medical stores must be equipped with air conditioning or refrigeration units as certain drugs, such as insulin injections and vaccines, require storage in a controlled environment.
3. Technical Staff: The presence of registered pharmacists is essential for both retail and wholesale medical stores. As approved by the Department of Drug Control, a registered pharmacist with at least one year of experience or an individual with four years of relevant experience is required for wholesale operations. Retail, medical stores must have a registered pharmacist present during working hours.

Medical Store Registration

The structure of your medical store plays a vital role in the registration process. Here are the different business structures available for opening a medical store in India:

1. Proprietorship Registration: In a sole proprietorship, a single owner runs and manages the medical store. While specific registration is not required, the proprietor should obtain a PAN card and open a bank account for the business.
2. Partnership Registration: A partnership firm involves two or more partners who jointly manage the business based on a partnership deed. This structure must be registered with the Registrar of Firms.
3. One-Person Company (OPC) Registration: An OPC is registered by a single person as the sole company member. It offers benefits such as limited liability and a separate legal entity. OPC registration is completed with the Registrar of Companies (ROC).
4. Private Limited Company Registration: A private limited company requires a minimum of two members and two directors. It is registered with the Registrar of Companies but cannot issue a prospectus inviting public share subscriptions.
5. Limited Liability Partnership (LLP) Registration: LLPs have become popular among medical store owners. Similar to a partnership, they offer the features of a company. Registration is completed with the Registrar of Companies.

Documents Required for Medical Store Registration

To register your medical store, you’ll need the following documents:

1. Pharmacy licence application.
2. Drug licence fee payment receipts.
3. Blueprint or floor plan of the premises.
4. Proof of ownership or possession of the premises.
5. Identity and address proof of the owners or partners.
6. Ownership proof of the premises.
7. Appointment letters of registered pharmacists or competent personnel.
8. Affidavit confirming the full-time working status of registered pharmacists or competent personnel.
9. Non-conviction affidavit of proprietor, partners, or directors under the Drugs and Cosmetics Act, 1940.

Other Registrations Required for Medical Stores

In addition to the medical store registration, several other essential registrations and licenses are required:

1. Pharmacy Licence: This is a critical license to operate a medical store, and it requires the owner or appointed pharmacists to be qualified pharmacists with degrees in pharmacy (B. Pharm or M. Pharm).
2. Shop and Establishment Registration: Under the respective state’s Shop and Establishment Act, all medical stores must obtain this registration in compliance with municipal rules.
3. GST Registration: Any business, including medical stores, must obtain a Goods and Services Tax (GST) registration if the turnover exceeds the threshold limit prescribed under the GST Act.
4. Drug Licence: To procure and sell drugs, medical stores must obtain a drug license from the Central Drugs Standards Control Organisation (CDSCO) and State Drugs Standard Control Organisation (SDSCO). Depending on the store type, a retail or wholesale drug license is required.

Conclusion

Opening a medical store in India can be a rewarding venture, given the growth in the healthcare sector. However, it’s essential to understand the registration process and adhere to legal requirements. Whether you opt for a proprietorship, partnership, LLP, or company structure, obtaining the necessary licenses and registrations is crucial. This includes the pharmacy license, shop and establishment registration, GST registration, and drug license. Complying with the Drugs and Cosmetics Act, CDSCO, and SDSCO regulations ensures your medical store’s smooth and legally compliant operation.