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:
- Preliminary Research: Research and decide on the type of drug store license you wish to apply for, whether it’s retail, wholesale, or restricted.
- Pharmacist Requirement: Ensure that a registered pharmacist is available for your store. A qualified pharmacist is a mandatory requirement for obtaining the license.
- 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.
- 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.
- Fees: Pay the prescribed fee along with the application form. The fee structure varies based on the type of license and the state.
- 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.
- 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.
- 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.
- 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.
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.
Below resources will be useful in process of opening a new drug store in India. You can download required forms here.
For drug store application, forms can be downloaded from links given below as required.
|Form 19 Download|
|Application for grant or renewal of a licence to sell, stock, exhibit or offer for sale, or distribute drugs other than those specified in Schedule X|
|Form 19A Download|
|Application for grant or renewal of a restricted licence to sell, stock or exhibit or offer for sale, or distribute drugs by retail by dealers who do not engage the service of a qualified person.|
|Form 19AA Download|
|Application for grant or renewal of a licence to sell, stock or exhibit or offer for sale by wholesale or distribute drugs from a motor vehicle.|
|Form 19B Download|
|Application for licence to sell, stock or exhibit or offer for sale, or distribute Homoeopathic Medicines.|
|Form 19C Download|
|Application for grant or renewal of a [ licence to sell, stock, exhibit or offer for sale, or distribute] drugs specified in Schedule X|
|Form 24 Download|
|Application for the grant of or renewal of a licence to manufacture for sale or for distribution of drugs other than those specified in [Schedule C, C (1) and X]|
|Form 24A |
|Application for grant or renewal of a loan licence to manufacture for sale or for distribution of drugs other than those specified in Schedule C, C (1) and X|
|Form 24B |
|Application for grant or renewal of a licence to repack for sale or distribution of drugs, being drugs other than those specified in Schedule C and C (1) excluding those specified in Schedule X|
|Form 24C |
|Application for the grant or renewal of a licence to manufacture for sale [or for distribution] of Homoeopathic medicines or a licence to manufacture potentised preparations from back potencies by licensees holding licence in Form 20-C|
|Form 24F |
|Application for grant or renewal of a licence to manufacture for sale or for distribution of drugs specified in Schedule X and not specified in Schedule C and C(1).|
|Form 27 |
|Application for grant or renewal of a licence to manufacture for sale or for distribution of drugs specified in Schedule C and C (1) excluding those specified in part XB and Schedule X|
Major Drug Control Authorities In India
For drug store application, you will be required to visit CDSCO or state Drug Control Authority.
Central Drugs Standard Control Organization Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India FDA Bhavan, ITO, Kotla Road, New Delhi -110002
DIRECTOR GENERAL, DRUGS AND COPY RIGHTS, Siddhartha Medical College Campus, Gunadala,Vijayawada – 520 004, Andhra Pradesh
| Government of Andhra pradesh ఔషథ నియంత్రణ పరిపాలన (DCA)|
Drugs Controller, Dte. Of Health Services Hengrabari, Guwahati ( Assam ) – 38
Drugs Controller Bihar, Dte. of Health Services, 4th Floor, Vikas Bhavan, New Secretariat, Patna 800001
|:: DCD :: (bihar.gov.in)|
Drugs Controller and Licensing Authority, Chandigarh Administration, Sector 16, Chandigarh-160016
Drugs Controller, Food and Drugs
Admn.Chattisgarh, Old Nursing Hostel Campus,Near Mantralaya, Raipur- 492001
Government of Nct of Delhi,
Drugs Control Department, F-17,
Commissioner, Food and Drug Control Admn., Gujarat, Block-8, Dr. Jivraj Mehta Bhavan, 1 st Floor, Gandhi Nagar 382010
Drugs Controller of Haryana, Dte. of Health Services, Civil Dispensary, Sec – 20, Panchukla
State Drugs Controller,
Nagar Panchayat Bhawan, Sai Road Baddi , Distt. Solan, Himachal Pradesh
01795 – 244288
Director in Chief (Drugs) Ministry of Health & Family Welfare
MCH Building, RCH Campus, Namkum, Ranchi – 834010
|Jammu & Kashmir|
Controller drugs & food control organisation, J&K,Patoli Magotrian, Jammu Tawi -180007S
Drugs Controller, Drug Control Department, PB No.5377, Palace Road, Bangalore – 560001
Drugs Controller and Licensing Authority, Public Health Laboratory Campur, Red Cross Road, Thiruvananthapuram – 695035
Drugs Controller, Food & Drugs
Administration, Idgah Hill, Bhopal 462001
Food and Drugs Admn., 341, Bandra Kulra Complex, Opp. RBI Building, Bandra (East) Mumbai- 400 051
Directorate of Drugs Control, Odisha,PoManeheswar Railway Colony, Bhubaneswar- 17
0674-2300494 , 2302624
Drugs Controller, Sector 34 A, Chandigarh -160016
Drugs Controller, 259/261, Anna Salai, Chennai – 600006
Drugs Control Bhavan,
Drugs Control Administration,
Vengalrao Nagar, Hyderabad – 500 038
Contact No. +91-40-23814357, +91-40-23713563
e-mail: email@example.com, firstname.lastname@example.org
Dy.Drugs Controller and Licensing Authority, Aushadh Niyantran Bhawan, Pt.Nehru Office Complex, PO – Kunjaben, Agartala – 799006
Drugs Controller, Swasthya Sewa Mahanideshalaya, Swasthya Bhawan, Aushadhi Kaksha, Lucknow-226006
Drugs Controller, Swasthya Sewa Mahanideshalaya, Swasthya Bhawan, Aushadhi Kaksha, Lucknow-226006
Director, Drugs Control, P-16, Building, India Exchange Place Extension, Kolkata-700013
You May Also Like: