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.

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Prohibition on Manufacturing of Drugs

For carrying the legal business, drugs shall be manufactured, sold or distributed by obtaining the drug license issued by State Drugs Standard Control Organization.

Drug license is a permission granted by the authority under the Drugs and Cosmetic act to carry out a business of drugs/medicines or cosmetics

MANUFACTURE OF PROHIBITED DRUGS

Before discussing the impact of manufacturing of prohibited drugs,we should know what are the prohibited drugs?

Drugs and Cosmetics Act, 1940 has provided some list of drugs that are considered as Prohibited.

1.     MISBRANDED DRUGS

·       Drugs which are colored, coated, powdered or polished or if they are likely to appear of better quality than really they are

·       If the drugs has not been labeled as prescribed by the government or they are labeled In such a manner which is misleading the consumer thereby making a false claim

2.     ADULTERATED DRUGS

·       Drugs have been stored in insanitary conditions thereby making them injurious to consumption

·       If the container is composed of poisonous substance thereby making them injurious to health

·       If any substance is mixed with the drugs thereby reducing its quality

3.     SPURIOUS DRUGS

·          Drugs is manufactured under a name which belongs to another drug;

·          if the label of drugs bears the name of an individual or company displaying them as the  manufacturer of the drug , which is fictitious or does not exist

After knowing the ’Prohibited drugs’ no person is allowed to deal in the following manner with respect to the Prohibited drugs.

1.     Manufacture for sale, distribution of the:

·       Mis-branded drugs

·       Drugs of substandard quality

·       Adulterated drugs

·       Spurious drugs

·       Drugs whose sale, manufacturing, distribution are prohibited in original country

2.     Manufacture the drug which has been imported in contravention of the requirement of the Act

PENALTY OF DEALING IN THE PROHIBITED DRUG

If any person himself or on anyone’s behalf manufactures for sale or distribution –

       I.          any drug which is likely to cause his death or cause such harm to the human body within the meaning of section 320 of the Indian Penal Code on account of being adulterated, spurious shall be liable for :

·       Imprisonment of min 5 years to lifetime imprisonment and

·       Fine of min Rs. 10,000

     II.          any drug which is adulterated or without the drug license shall  be liable for:

·       Imprisonment of min 1 year to max 3 years and

·       Fine of min Rs. 5000

Except in the case where court can impose imprisonment of less than 1 year and fine of less than 5000

   III.          any drug which is spurious shall  be liable for :

·       Imprisonment of min 3 years to max 5 years and

·       Fine of min Rs. 5000

Except in the case where court can impose imprisonment of less than 3 year but cannot pass judgment for imprisonment of less than 1 year

  IV.          Any drug in contravention of the provisions of the Act other than above, shall  be liable for:

·       Imprisonment of min 1 years to max 2 years and

·       Fine

Except in the case where court can impose imprisonment of less than 1 year

Source url - http://entersliceindia.webstarts.com/blog/post/prohibition-on-manufacturing-of-drugs

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Want to Set up Pharmacy Business?

Pharmacy business is ideal business. It is the business which is not affected by the monetary cycles.Increasing developments in the hospitals has also lead to the increasing demand for pharmacies. E-commerce companies and e-health companies are increasing their market with easy availability of medicines to customers by providing same day delivery, cost saving. The pharmacies can be setup in hospitals, shopping areas, residential buildings, and housing townships. Pharmacies in the residential building are in form of the firms.

Drug License for All 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 under the Drugs and Cosmetic act to carry out a business of drugs/medicines or cosmetics.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

What is the 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

Though the drug license issuance is a state matter and documentation 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
• 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.

If any kind of suggestions/ consultancy is needed with regard to the above topic discussed, you may reach us anytime.

Source url - http://entersliceindia.webstarts.com/blog/post/want-to-set-up-pharmacy-business

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