Introduction:Your Path to Starting a Medical Store
Thinking about opening a medical store? That’s a great idea! It’s like starting a little health hub in your community. But, before you dive in, there are some important things to know.
First off, you’ll need to deal with paperwork – licenses, permits, and certificates. It might sound a bit boring, but these documents are like the keys to getting your medical store up and running. We’ll guide you through the essential documents so you can check all the boxes.
Now, let’s talk about the tricky part. Opening a medical store isn’t always a smooth ride. There are hurdles like getting the right licenses, figuring out how much money you need, and keeping up with all the rules. It can be a bit overwhelming.
But don’t worry! In this journey, we’ll tackle these challenges together in this blog. We’ll explore how to solve problems like getting the necessary licenses, dealing with the initial costs, and making sure you’re following all the rules.
Think of this guide as your roadmap to opening a medical store successfully. We’ll help you understand the paperwork, face the common challenges, and find smart solutions. So, let’s take the first step on this adventure – your dream of having a thriving medical store is closer than you think
First Step : Compliances
Opening a medical store in India involves obtaining various licenses and complying with regulatory requirements. Here is a list of essential documents needed for establishing and running a medical store in India:
Drug License:
- Application form for a drug license.
- Covering letter stating the purpose of obtaining a drug license.
- Site plan and key plan of the premises.
- Proof of ownership or rent agreement for the premises.
- Proof of educational qualification (for the registered pharmacist).
Goods and Services Tax (GST) Registration:
- PAN card of the business owner or partners.
- Proof of identity and address of the proprietor or partners.
- Passport-sized photographs.
- Rental agreement or proof of ownership for the business premises.
Shops and Establishment Registration:
- Application form for registration.
- Proof of identity and address of the business owner.
- Details of employees, if applicable.
- Lease agreement or ownership proof of the business premises.
NOC from Local Health Department:
- No Objection Certificate (NOC) from the local health department or municipal corporation.
Trade License:
- Application for a trade license.
- Property tax receipt or ownership proof of the premises.
Fire License:
- Application form for a fire license.
- Building plan and layout indicating fire safety measures.
FDA (Food and Drug Administration) Registration:
- Application for FDA registration.
- Details of the premises, including the layout and facilities.
- List of medicines to be stocked.
Wholesale Drug License (if applicable):
- Application form for a wholesale drug license.
- Proof of ownership or rent agreement for the premises.
- Details of the premises and storage facilities.
Pharmacist Registration:
- Proof of educational qualification.
- Passport-sized photographs.
- Application form for pharmacist registration.
Trademark Registration (optional):
- Application for trademark registration, especially if the medical store has a specific brand name.
Under “The Drugs and Cosmetic Act”, the Central Drugs Standard Control Organization (CDSCO) provides the approval for drugs, clinical trials, lay down of the standards of drugs, quality control of drugs etc., with the coordination of the authority.
In December 2020, The Ministry of Health and Family Welfare published the Cosmetic Rules 2020 that the licence is a must for the import of cosmetics into India.
“Drugs” – In pharmacology, a drug is a chemical substance, typically of known structure, which, when administered to a living organism, produces a biological effect.
ISSUING AUTHORITY FOR DRUG LICENCE
State Drugs Standards Control Organization (SDSCO) – State Authority with CDSCO is responsible for the grant of licence who deals in the business of Drugs & Cosmetics on the state level. The business operates in different states, and drugs are sold or stocked for sale in more than one state, and a licence is mandatory for each location.
TYPES OF DRUG LICENCE
A drug licence is permission granted by the Drug controller to deal in drugs. Kinds of the licence depend upon the type of business as follows.
1. Sales Drug Licence
Types of sales Licence are as follows
- Retail Sale Drug Licence(Chemist Shop) – Retail sale refers to the sale of the drugs to the end consumer. Retailers can sell drugs to a hospital, dispensary, medical, education, or research institute, etc. Under the Drugs and Cosmetic Act, a drugs licence is mandatory for the retailers of drugs or Chemist shops. And a retail licence is issued by the Drug Controller Authority of the State.
- In case any person sells drugs without the Licence, he shall be punishable with imprisonment for a term of not less than 1 year and may extend up to 3 years with a fine up to Rs. 5000.
Note –
- If a retailer is indulged in the drugs business in more than 1 state, then a different licence is required for the different state.
Basic requirements for obtaining Retail Drug Licence
- Applicant premises should have an area of not less than 10sqr.mtrs.
- A registered pharmacist shall always be present in the store throughout working hours.
- Premises should have a refrigerator and air conditioner.
Document requirement for obtaining Retail Drug Licence
- Rent agreement
- Affidavit of the proprietor on stamp paper
- Self-attested ID proof and educational certificate
- Affidavit and ID Proof of registered Pharmacist
- Plan the layout of premises in a blueprint
- Refrigerator Bill
- 5 Photographs of the proprietor and pharmacist
- Whole Sale Drug Licence – A wholesale licence is issued to the company/distributor/independent agent who can be an authorized Indian agent for the local or foreign manufacturer. Or we can say that the wholesale licence is issued to the manufacturer and authorized Indian representative. A whole Sale Drug Licence is issued by the CDSCO for those who deal in the wholesale distribution of Drugs.
Basic Requirements for obtaining a wholesale Drug Licence
- Applicant premises should have an area of not less than 15sqr.mtrs.
- Applicant premises must have an Air conditioner and refrigerator to store the vaccines, insulin injections, sera, etc.
- Licence issues to the person who has a degree or diploma in Pharmacy from a recognized university.
- A pharmacist shall be a Graduate with 1 year of experience in drug dealing.
- The licence shall be displayed on the premises.
Documents required for obtaining wholesale Drug Licence
- Incorporation certificate, MOA or AOA, Partnership deed as applicable
- Proof of the ownership
- Cover letter with name and designation of the applicant
- Challan of fees deposited for the license
- Declaration form in a given format
- Key plan and site plan of the premises (Blueprint)
- The documents of possession of the premises
- Affidavit regarding non-conviction under the Drugs and Cosmetic Act 1940, signed by proprietors, partners, and directors as the case may be
- Appointment letter on being appointed as a full-time registered pharmacist
- Restricted Licence for Drugs – Under Form 20A and 21A, this licence is issued to those applicants who want to sell drugs without the supervision of a competent individual.
2. Manufacturing Licence for Drug
A manufacturing licence is granted to the manufacturer of Allopathic and Ayurvedic drugs and cosmetic products; a licence is granted by the concerned State government of the manufacturer.
Types of manufacturing licence
- Test Licence for Manufacturing – Form -29, this licence is issued by the Zonal Office and State licencing authority for the purpose of examination. Testing and analysis of drugs in small quantities and also given for the import of small quantities of drugs for examination, testing and analysis.
- Post successful clinical trial manufacturing licence – Form -46, Licence permitted to manufacture for sale of medical devices which are new in the market, and a clinical trial is not done.
- Notified medical devices manufacture licence – Form -28 Form – 27This licence is issued to the manufacturer of disposable hypodermic syringes and needles, cardiac stents, catheters, IVD Devices for HIV, HBsAg, HCV, etc.
Basic Requirements for obtaining a manufacturing Licence
- Factory premises should be according to the standard schedule M.
- The factory should be well-equipped, and have adequate space for machinery.
- Should have been well qualified to carry out the analysis at the testing centre.
- Should have adequate laboratory equipment for testing.
- Adequate drug storage arrangements should be made.
- Conform to Good Manufacturing Practices standards.
Documents required for obtaining manufacturing Licence
- Constitution of the Firm (MOA/AOA)
- ID Proof of the partner/director/proprietor
- Address proof of the owners
- Copy of Property paper/Rent agreement
- The site and key plans of the premises (Blue Print)
- Invoice and details of Refrigerator and Air Condition Purchased for business use
- Mention the purpose of the application on Cover Letter
- Self Attested of registered plant layout
- List of technical staff with ID Proof, qualification, experience letter, appointment letter, and 3 photographs
- Machinery list
- Laboratory equipment
- NOC of pollution control and fire fighting
- Nominate an authorized Indian Representative
3. Loan Drug Licence
According to the Drug and Cosmetic Act,” A loan license means a license which a licensing authority may issue to an applicant who doesn’t have its own arrangement of manufacturing but who intends to avail himself of the manufacturing facilities of a licensee.
4. Import Licence
Under Schedule X, Drugs & Cosmetics can be imported to India only after obtaining a Licence. Not only drugs be registered, but the manufacturing unit should also be registered for import purposes.
5. Multi-licence for Drug
This licence is for those applicants who operate their business in more than one state. Without a multi-drug licence, you cannot sell drugs in more than one state.
THE PROCESS TO OBTAIN DRUG LICENCE
- Documentation – Its process starts with the documents, as documentation depends upon the region and type of business like a retailer, wholesaler, manufacturer, and importer. Without documents, no application can be filed, or we can say without complete documents, no licence will be granted.
- Submit application – After compiling the documents, submit the complete application with appropriate information to the Drug Control Authority.
- Inspection of the Premises – the Drugs inspector appointed by the authority conducts the audit to inspect the premises in order to check whether the details provided by the applicant are correct or not.
- Scrutiny of application – Drugs inspector will verify the details of the application. If he finds everything satisfactory, then Licence will be granted. In case he raises the query applicant must reply within 3 days in an appropriate manner. An unsatisfactory reply can lead to the cancellation of the licence.
- Grant of Licence – After getting satisfied with the documents, the Drug Control Department issues the Drug Licence.
TIMELINE
30 working Days
VALIDITY
Issued Licence is valid for 5 years
RENEWAL
The licence can be renewed by providing requisite documents for renewal, and the authority will renew the licence for a particular time period.
Any business, including a medical store, requires a Goods and Service Tax (GST) registration if the aggregate turnover of the business exceeds the threshold limit in a financial year as prescribed under the GST Act. Under the GST Act, any business supplying goods having a turnover beyond the threshold limit of Rs.40 lakhs for normal category states and Rs.20 lakhs for special category states in a financial year must obtain GST registration.
Document will be same as DL and it must include Drug License.
General Problem Faced By Medical Owner's
1. Inventory Management:
Pharmacies need to maintain an accurate inventory of their drugs, supplies, and equipment. One simple solution is to implement an automated inventory management system that tracks stock levels and alerts you when it’s time to order more.
2. Prescription Errors:
Mistakes can occur when filling in prescriptions, which can lead to serious consequences for patients. To reduce the risk of errors, consider using electronic prescription systems and double-checking prescriptions before filling them.
3. Insurance and Reimbursement Issues:
Dealing with insurance companies and getting reimbursed for prescription drugs can be time-consuming and frustrating. To simplify this process, consider using a pharmacy benefit management (PBM) system that automates the insurance and reimbursement process.
4. Customer Service:
Poor customer service can lead to unhappy patients and a decrease in business. To improve customer service, consider investing in training for your employees, as well as implementing an automated patient management system that streamlines the process of scheduling appointments and handling customer inquiries.
5. Data Management:
Keeping track of patient information, prescription records, and other sensitive data can be a challenge for pharmacies. To solve this problem, consider using a secure, cloud-based system that allows you to store and access data from any location.
By implementing these simple solutions, pharmacies can solve common problems and improve their operations, helping to ensure the health and well-being of their patients
