How to Obtain a Pharmacy Business License in India

How to Obtain a Pharmacy Business License in India

Indian pharmaceutical market has been one of the largest markets in the world in terms of volume as well as value. Also, India is the largest provider of generic drugs with around 20% to 25% of global exports in volume. Since the business in the pharmaceutical industry of India is great, one can have a decent opportunity to start it in the local market.

If you are someone who is interested to open a medical store or obtain a pharmacy license in India, this write-up is for you. Pharmacy business has been eternal in our country. Even when all other businesses suffered huge losses due to the Covid-19 pandemic, pharmacy businesses kept on growing and flourishing and will continue the same in the future as well.

In India, the pharmacy business doesn’t get affected by economic cycles or financial hiccups. With minimum investment and space you can set up your pharmaceutical business is it a franchise or your own store. Read this article to know more about how to get a pharmacy license in India.

Types of Pharmacy Business in India
Types of Drug License
Prerequisites of obtaining a pharmacy business license in India
Documents required for starting a Pharmacy Business
List of Application Forms
FAQ

Types of Pharmacy Business in India

When you decide to obtain a pharmacy license in India, you should first decide the type of pharmacy that you would want to run as there are different types of pharmacy businesses in India.

In our country mostly all the pharmacy businesses fall under the category of standalone pharmacies who operate their business in the unorganized sector. However, the popularity of township pharmacies has been growing in recent years. It is observed that the majority of the standalone pharmacies are set up under a partnership or sole proprietorship.

These days pharmacies can now register themselves as LLP or a Private Limited Company for around Rs. 8000/-

Types of Drug License

Since there are various types of dealings and businesses in India in the pharmacy sector, there are various types of drug licenses. As mentioned below

Sales License

This license is to be obtained by the businesses that plan to make sales of drugs. These include Wholesale Drug License, Retail Drug License, and Restricted Drugs Sale License.

Manufacturing License

Those businesses who plan to manufacture drugs allopathic and homeopathic need to obtain a manufacturing license.

Loan License

A business that uses manufacturing facilities of some other license and does not own a manufacturing unit, requires a loan license.

Import License

When one wishes to deal in the import of drugs, an import license is issued.

Multi-Drug License

If one places to operate the pharmacy business in multiple regions with the same name, he/she a multi-drug license will be issued.

Revenue of Indian Pharma Sector
Revenue of Indian Pharma Sector

Prerequisites of obtaining a pharmacy business license in India

There are a few essential things that are to be acknowledged before obtaining a pharmacy license in India.

1. Qualification

If you are planning to have your own pharmacy business, you must be qualified. If your business operations are in wholesale it is imperative that you have completed your post-graduation with one year of experience or have an under graduation degree with four years of experience.

2. Place

When you wish to have a pharmacy business, it is important that you have adequate space too.

Pharmacy License
Pharmacy License
  • To obtain a wholesale or retail pharmacy business license you must have a minimum 15 square meter space.
  • In all other types, you would have to have a minimum of 10 square meters of space.
  • Also the National Building Code of India, 2005 has laid a few guidelines on the clear height of the premises of the sale which are to be followed accordingly.

3. Storage

There are many drugs that are required to be stored in low temperatures, refrigerators, or under air conditioners. You must have such important storage facilities for the same.

4. Tax registration

In our country, all pharmacy businesses are required to obtain GST tax and pay GST timely. Since these businesses will be selling drugs and medicines, they are going to be registered under GST 2017.

Documents required for starting a Pharmacy Business

Starting a pharmacy business in India comes with certain formalities and responsibilities that vary from state to state. It is suggested that whenever you apply for a pharmacy business license, keep the following documents ready with you.

1. Application form for the pharmacy license which is in the prescribed manner.

2. A covering letter would be required with the intent of the applicant. It should be signed by the applicant along with his/her name and designation.

3. For obtaining the drug license, you would be required to produce the receipt of challan fees.

4. A declaration in the prescribed format mentioned in the form.

5. The blueprint of the premises regarding the key plan and the site plan.

6. The grounds or basis of possession of the premises.

7. Any authorized Identification proof and photo of the owner/s of the pharmacy.

8. If the premise is taken on rent, then you would be required to show proof of the ownership of the premises.

9. Proofs of the constitution of a company like an Incorporation Certificate or Memorandum of Association or Article of Association or Partnership Deed are to be presented while obtaining the drug license.

10. An affidavit of non-conviction of proprietor or partners of the pharmacy business under the Drugs and Cosmetics Act 1940 is essential.

11. Along with the above-mentioned affidavit, you also need to produce an affidavit of a registered pharmacist or a competent person working full time.

12. If the person is employed, an appointment letter of a registered pharmacist or a competent person is required.

All these documents are required to be produced in order to become eligible for obtaining a medical store license. Once you complete all these formalities, you will be required to file the application for granting the pharmacy business license. For the same, you will have to visit the drug inspector's office where all the proceedings would be taken ahead.

List of Application Forms

Sr. No

Form No.

Purpose

1.

Form 19

Application for grant or renewal of a license to sell, stock, exhibit or offer for sale, or distribute drugs apart from those specified in Schedule X.

2.

Form 19A

Application for granting or renewing a restricted license to sell, stock, exhibit or offer for sale, or distribute drugs by retail via dealers who don’t engage the service of a qualified individual.

3.


Form 19B

Application for license to sell, stock or exhibit or offer for sale, or distribute Homoeopathic Medicines.

4.

Form 19C

Application for grant or renewal of a [license to sell, stock, exhibit or offer for sale, or distribute] drugs specified in Schedule X.

5.

Form 24

Application for either the grant of a license or for the renewal of a license or to manufacture for sale or for distribution of drugs other than those which are specified in [Schedule C, C (1) and X].

6.

Form 24A

Application for either the grant of a loan license or renewal of a loan license to manufacture for sale or distribution of drugs other than those specified in Schedule C, C (1) and X.


7.

Form 24B

Application for grant or renewal of a licensee 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.

8.

Form 24C

Application for the grant or renewal of a license to manufacture for sale [or for distribution] of Homoeopathic medicines or a license to manufacture potentized preparations from back potencies by licensees holding a license in Form 20-C

9.

Form 24F

Application for grant or renewal of a license to manufacture for sale or for distribution of drugs specified in Schedule X and not specified in Schedule C and C(1).

10.

Form 27

Application for grant or renewal of a license 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

FAQ

How much does it cost to open a pharmacy in India?

A pharmacy franchise requires an initial investment starting from INR 8 – 10 lakhs, which includes licensing and documentation.

How long does it take to become a pharmacist in India?

To practice pharmacy in India one atleast requires a diploma in pharmacy, which is awarded after only 2 years and 3 months of pharmacy studies.

Which is the number 1 pharmaceutical company?

Sun Pharmaceutical Industries Ltd is the number 1 pharmaceutical company.

Conclusion

Health is the most important part of everyone’s lives and is certainly a business sector that is evergreen. Pharmacy business in India is currently at the growth stage and will continue to flourish in the coming years as well. By following the procedure mentioned in the above write-up, you can easily obtain a drug license and open your own pharmacy store.

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