How to Open a Medical Store in India – Stepwise Guide

Drug stores, also known as pharmacies or chemist shops, are the primary points of access for consumers to purchase prescription and over-the-counter medicines.

This article aims to provide a step-by-step guide to help aspiring entrepreneurs establish a new successful drug store or pharmacy in India.

Step 1: Research Before Opening of Store

Before opening a drug store, it’s crucial to conduct thorough research and develop a comprehensive business plan.

This plan should include details such as the store’s location, target market, product range, pricing strategy, and marketing tactics. Additionally, analyze your competition and identify what sets your drug store apart.

Step 2: Identify the Regulatory Requirements

Compliance with legal and regulatory requirements is a fundamental aspect of opening a drug store in India. Here are some key steps to consider:

Registered Pharmacist: A registered pharmacist is required to oversee the operations of the drug store. Ensure that at least one qualified pharmacist is employed.

Pharmacy License: Obtain a license under the Drugs and Cosmetics Act, 1940. This involves submitting an application to the State Drugs Standard Control Organisation (SDSCO) or Central Drugs Standard Control Organisation (CDSCO) for Union Territories.

Premises: Choose a location that complies with the rules and regulations set by local authorities. For retail pharmacy the area should be 10 square meters and 15 square metres for a wholesale business. For combined wholesale and retail, the area should be 15 square meters. The premises should be well-maintained, have adequate storage facilities, and meet hygiene standards.

Good and Services Tax (GST): Register your business under the GST regime and understand the tax implications for pharmaceutical products.

Step 3: Keep Your Store and Inventory Ready

Establish Key Partnerships: Establish partnerships with reputable pharmaceutical distributors and manufacturers. Ensure that the products you source are genuine, comply with quality standards, and have the necessary approvals from regulatory bodies like the Central Drugs Standard Control Organization (CDSCO).

Store Organization: Medicines should be stored at the recommended temperature and humidity conditions to prevent deterioration.  It should also have dedicated areas for dispensing medicines, over-the-counter products, and storing items requiring refrigeration. Medicines must be displayed clearly and categorized appropriately, with proper labelling and pricing information.

Inventory Control: Ensure proper storage conditions for different types of pharmaceuticals, and implement a robust inventory management system to track product availability, expiry dates, and restocking needs.

Step 4: Apply for Drug Store License

Applying for a drug store license involves several steps that need careful attention and accurate documentation. Here’s a step-by-step guide to help you through the process:

1. Preliminary Research: Research and decide on the type of drug store license you wish to apply for, whether it’s retail, wholesale, or restricted.
2. Pharmacist Requirement: Ensure that a registered pharmacist is available for your store. A qualified pharmacist is a mandatory requirement for obtaining the license.
3. Application Form: Obtain the application form from the respective State Licensing Authority. This form can usually be downloaded from their official website or collected in person.
4. Documentation: Collect the necessary documents, which typically include:
   • Passport-sized photographs of the applicant and pharmacist
   • Identity proof (Aadhaar card, PAN card, etc.)
   • Address proof of the premises
   • Electricity Bill Of Pharmacist
   • Proof of ownership or lease agreement of the premises
   • Affidavit of the pharmacist’s appointment
   • Acceptance letter of the pharmacist.
   • Qualification certificates of the pharmacist
   • Partnership deed, LLP agreement in case of partnership and LLP.

• Cover letter with name and designation of the applicant.
• Pharmacist Self Declaration.

1. Fees: Pay the prescribed fee along with the application form. The fee structure varies based on the type of license and the state.
2. Submission: Submit the completed application form and all the required documents to the State Licensing Authority. Ensure that all documents are correctly filled and duly attested.
3. Inspection: Once the application is received, the drug Inspector will personally visit the drugstore for the verification of documents and correctness of facts stated in the application.
4. Verification: The documents and inspection report will be verified by the SLA. This process may take some time, so it’s essential to be patient.
5. Granting of License: If all requirements are met and the inspection is successful, the State Licensing Authority will issue the drug store license.

Documentation and Record-Keeping

Drug stores are required to maintain accurate and up-to-date records, including invoices, bills, prescriptions, and stocks. These records are subject to inspection by drug regulatory authorities and should be preserved for a specified period.

Conclusion

Opening a drug store in India requires careful planning, dedication, and a strong regulatory compliance. Providing safe and accessible pharmaceutical products is not only a business opportunity but also a service to the community. By following the steps outlined above in this guide and staying informed about industry trends, you can establish a successful and reputable drug store that meets the healthcare needs of your customers.

Resources

Below resources will be useful in process of opening a new drug store in India.  You can download required forms here.

Application Forms

For drug store application, forms can be downloaded from links given below as required.

Major Drug Control Authorities In India

For drug store application, you will be required to visit CDSCO or state Drug Control Authority.

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