Setting up Pharmacy Business

Pharmacy business is one of the lucrative businesses which is not affected by the monetary cycles. Increasing developments in the private hospitals has also lead to the increasing demand for pharmacies which has ultimately lead a huge growth in healthcare and pharmacy industry in our country.

E-commerce companies and e-health companies are also increasing their market with easy availability of medicines to customers by providing same day delivery and cost saving. The pharmacies can be setup in hospitals, shopping areas, residential buildings, housing townships. Pharmacies in the residential building are in form of the firms.

No drug license? No pharmacy business!

But one thing which is most important for setting up the pharmacy business without which this business cannot be carried is to obtain a drug license. Drug license is a permission granted by the authority to sale, resale, market, manufacture, trade, etc of drugs. It is regulated by Drugs and Cosmetic Act, 1940.

Drug license is issued by State Drugs Standard Control Organization or Central Drug Standard Control Organization  

There are types of Drug License issued which depends upon the type of activities done.

Categories of activities:

1.      Hospital pharmacy – pharmacy set up in hospitals

2.      Standalone pharmacy– pharmacy set up in residential colonies and areas

3.      Chain pharmacy- pharmacy set up in malls as a part of chain

4.      Township pharmacy- pharmacy set up in towns

Types of Drug License

·         RETAIL DRUG LICENSE

This type of drug license is issued to persons/agencies involved in standalone/ chemist pharmacy shops         

§  WHOLESALE DRUG LICENSE

This type of drug license is issued to persons/agencies involved in wholesale distribution of drugs

§  RESTRICTED DRUG LICENSE

This type of drug license is issued to persons/agencies for operating the general stores.

                                              

Requirement for Issue of Drug License

1.      Area of pharmacy

If you are setting up the pharmacy business, one thing to be kept in mind is about the area of the business which should be min 10 square meters. If you are applying for wholesale drug license the minimum area should be 15 square meters.

2.      Storage facility

Now, the medicines need to be stored in a clean and low temperature premises. They should be stored in cool place so refrigerator and air conditioner is required for its storage. Computer and proper labeling and storage facility for the drugs is also required.

3.      Technical staff requirement

Now the pharmacy business need to be handled by the experiences staff or must be qualified and possess good knowledge of the medicines. So before proceeding for the documentation part, these point to be considered.

Documentation for Obtaining Drug License

After fulfillment of all the requirements, you need to have some important documents. Though the issue of drug license issuance is an individual state matter therefore, documentation for obtaining it may vary from state to state but the generic list of items are as follows:

• Application Form
• Covering letter with the name & designation of the applicant
• Copy of challan obtained by depositing fees for obtaining drug license
• Declaration in prescribed manner
• Site plan for the premises       
• Basis of possession of premises
• In case of rented property, ownership proof of premises or rent agreement
• Document related to constitution of business such as Incorporation certificate/ MOA/ AOA/ Partnership Deed.
• Affidavit related to non-conviction of director/partner/ proprietor.
• Testimony of registered pharmacist or competent person and their appointment letter in case of an employed person.