written by | October 11, 2021

Medical Store License

WHAT IS A MEDICAL STORE LICENSE/ DRUG LICENSE AND HOW TO GET IT

When we entered 2020, we were hoping for a brand-new start and the resolutions about earning more getting fit were made but destiny had some other plans for us and the globe was hit by coronavirus and COVID-19. The ambitions were knocked down and the world was locked-down. The schools shut and businesses were lost. The only sector the world saw rising was the ‘Essential Service Sector’ where healthcare and sanitation workers were of prime importance and we were allowed to leave our houses only for food and medicines. We saw our local medical store owners at the frontline beating the COVID-19 pandemic, helping us during this delirious time, and… earning profit. It was the business that was running when everything else was shut and more likely so because when it comes to essentiality pharmacy takes to spot number 1. 

Pharmacy is not a sector that changes with time. The drugs that were consumed to treat headaches long ago are being used even now. Brands of these medicines may change and there can be an advancement in the drug components, but you always need a medical store to distribute those drugs to you. The medical store business has always been big but after the pandemic, it is being noticed even by the common people that investing in it is a good idea but not everyone can open up a pharmacy. But there are certain prerequisites and permissions that you have to arrange for in advance. One such is the Drug License. A Drug license is a permission granted by the competent authority under the Drugs and Cosmetic Act, 1940 to carry out a business concerning drugs/medicines or cosmetics.

Let us learn a little more about it and how you can apply for it:

DRUG LICENSE

Getting Drug License is required for all the retailers who want to start a business of Drugs and Cosmetics in India. Provisions identified with getting a Retail Drug License are characterized in the Drugs and Cosmetics Act, 1940. These provisions are applicable in each state and area of India. In 1964, the government of India had rolled out several changes in the Act, the reason behind the correction was to incorporate Ayurvedic and Unani drugs.

We can say it isn’t lawfully possible to venture into a business that deals with drugs or cosmetics if you have not gotten the license under the Drugs and Cosmetics Act, 1940. The Act covers all the territories of medication, for example, allopathic, homeopathic, ayurvedic, or Unani. If any individual endures any damage while consuming medications then negligence falls on to the manufacturer or dealer and both of them are chargeable for offense and are harmed under IPC.

Important details about Drug License

  • In the event that a businessman has more than one drug retail shop in multiple states then it is compulsory for the businessman to acquire the drug license in each state in which the business is being operated.
  • It is mandatory for the business who is managing the business of drugs and cosmetics to follow all the standard rules and regulations of such licenses constantly at all times over the span of their business. It is mandatory to keep up all the records/registers/forms in a specific way and authorities must be informed regarding all the changes made in the business activity.
  • It is essential for all the drug stores to get a drug permit. State Drug Control Organization is mindful to give the permit to the wholesale drug stores just as to the retail drug stores. However, the rate of approval for retail licenses is very low in contrast with wholesale licenses. 
  • Generally, a specialist deals with drugs and cosmetics, and thus a need for qualified pharmacists emerges for obtaining a retail drug license. 
  • For opening a medication retail business, the floor covering the area of the medication store must be a minimum of 10 square meters, and if the application is for both retail and wholesale drug stores the base zone is suggested in 15 square meters. You must make sure that the premises must be sufficiently ventilated. 
  • It is important to keep medications at a low-temperature freezing zone since it is the prerequisite for all the drugs and medicines to be kept in a perfectly clean, ventilated, and cool storage space, especially vaccines and injections since they can’t endure the rage of high-temperature. Thus, ensure that you have a cooler or air conditioner before you apply for a drug permit in India. 
  • Before accepting a medication permit, the inspector has the authority of the region visits the premises where a drug license is required and affirms the interest of the focal point with the application, and meets the capable person.

Procedure

Step. 1: Apply for Grant/Renewal of Drugs Sale Licence Application

Using the form available on the site stating New Drug Sale License Application you can apply for the drugs sale license. The form will ask you to about your personal details, address proof if and it is a partnership, if yes then information related to that. 

Step. 2: Document Uploading Form 

Based on the license form(s) selected by the applicant a list of documents will appear on the screen if it is a partnership or individual. All the documents that are marked as mandatory need to be uploaded.

The list of documents may include:

  • Constitution of the firm (MOA/AOA)
  • Identity proof of partner/ proprietor/director
  • If you own a property then a copy of the property paper
  • In the case of a rented property a copy of the rent agreement
  • Site plan and key plan of the premises
  • Refrigerator invoice details
  • Affidavit regarding the compliance of MPD 2021 (if premise are situated on DDA residential flat/plot/building)
  • Additional Documents for Retail Sale Registered Pharmacist
  • Proof of qualification
  • Registration of local pharmacy council
  • Appointment letter

List of Documents retailer requires at the time of obtaining drug license

  • Proof of qualification
  • Registration of local pharmacy council
  • Appointment letter

Step. 3: Fill the Application form

After uploading relevant documents, the next step applicant is asked to sign the system-generated Application form. This is the main form that you will be required to fill. Make sure to fill the form correctly and cross-check that there is not any mistake.

Step. 4: View Application Detail form 

After successfully digital signing the application form, the applicant can make payment. Make sure you are using a government portal and have a strong internet connection to avoid any payment failure. Also, before making payment applicant must verify all the details filled in the application as a wrongly filled application can lead to cancellation of the application and to get the license you’ll have to register again. 

Step. 5: Receipt 

After making a successful payment, a system-generated receipt will appear on the screen. If the receipt doesn’t appear and the amount is deducted from your account, please go to the FDA home and click on Duplicate Receipt. If you are still unable to get your receipt that means your payment is not completely successful. Please go to FDA Home and fine Pay for Unpaid Application link and repay, this way you don’t have to fill your application again.

Once you have successfully submitted the form, after reviewing your application and doing the site inspection, the concerned authority of the state will issue a drug license in your name. 

Duty enrollment The GST registration process is a compulsory procedure to finish as a drug store business is the trading of medicines that come under the jurisdiction of goods and service tax. Along with this Registration for the type of business, whether sole or in partnership is an important process as this will additionally assist you with getting a drug license. It all relies upon the individual who is opening a medical store what method of the organization they need to operate. The medical store business is very popular but you have to understand that it comes with a lot of accountability. You have to be qualified enough and have the minimum education required to open up a pharmacy. You cannot leave your shop in the hands of an underqualified person. You must understand the responsibilities that come with operating this business that involves taking care of a person’s life. Be responsible! All the best!

 

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