Drug License application FAQs

The Drugs and Cosmetics Act, 1940 is an Act which regulates the import, manufacture and distribution of drugs in India. Main objectives of this ac is to make sure that drugs sold or manufactured in India are safe and conform to standards. This act was passed in 1940. Since then, act has gone several amendments. It is also known as Drugs and cosmetics act, 1940.

Drug license or Pharmacy license  is issued foe both wholesale are retail sale purposes. Drug license or Pharmacy license is a mandatory requirement to distribute drugs anywhere in India. In this article, we are going to discuss various documents required for drug license in India.

In this article, we are going to discuss various FAQs related to pharmacy license in India. We would answer all questions related to Pharmacy license, drug license registration, Wholesale drug license, retail drug license, drugs and cosmetics act, drug license login etc

Q – What is drugs and cosmetics act?

A – The Drugs and Cosmetics Act, 1940 is an Act of the Parliament of India which was passed in 1940. Main objective of this act is to regulate the import, manufacture and distribution of drugs in India. Other equally important objective of the act is to ensure that the drugs and cosmetics sold in India are safe, effective and conform to state quality standards.

Q – Is drug license mandatory?

A – Yes, It is mandatory to have drug license for operating a drug business in india.

Q – How to get a drug license?

A – An applicant can get a drug license by applying on online portal at state level drug authority. He or she needs to completely fill application form for respective category along with required documents. Upon submission of application, drug inspector would visit premise to verify details. If details found satisfactory then applicant would be issued a drug license.

Q – How to apply drug license?

A – An applicant can apply for drug license at state level’s drug authority.

• Haryana Drug license – https://fdaharyana.gov.in/
• Delhi drug license – http://drugscontrol.delhigovt.nic.in/
• Maharashtra drug license – http://fda.maharashtra.gov.in/drug.html
• West Bengal drug license – https://www.wbhealth.gov.in/pages/forms_download
• Uttar Pradesh drug license – http://fsdaup.gov.in/
• Bihar drug license – http://xln.bihar.gov.in/ST_Login.aspx?ST=Bqq04P1eg2A=
• Rajasthan drug license – http://www.rajswasthya.nic.in/Licence.htm
• Gujarat drug License – https://xlnindia.gov.in/login.aspx
• Tamil Nadu drug license http://www.drugscontrol.tn.gov.in/guidelines_procedures_grant_renewal_retail_wholesale_licences_allopathic_drugs.html
• Madhya Pradesh drug license – https://fdamp.mponline.gov.in/portal/home.aspx

Q – Where to apply for drug license?

A – An applicant can apply at local level drug authority for obtaining a drug license.

Q – Who can get a drug license?

A – An applicant who is fulfilling following conditions can get a drug license-

1. Pharmacist or a competent individual – Presence of pharmacist is a mandatory requirement for retail drug business. While for wholesale drug business, a competent graduate having more than one year of experience in drugs is required. If he is not graduate then at least 4 years of related experience is required.
2.  Space – For wholesale and retail business, a space of 15 sqm is required. While for other business, arear requirement is 10 sqm.
3. Storage facility – Storage facility is one of the most important criteria for obtaining a license. A decent storage facility along with cold storage and air conditioning is a must.

Q – What is drug license cost?

A – Drug license cost varies from state to state. It also varies for type of drug license applied for.

Q – What is drug license?

A – Drug license is a certificate issued by a drug authority to carry out business related to drugs in India. To carry out manufacturing, distribution, selling of any drug or medicinal item, a drug license is required. Obtaining a drug license is a mandatory requirement under drugs and cosmetics act. Drug license is issued to maintain quality and standards related to drugs in India.

Q – What is drug license number?

A – Drug license number is a unique number issued to each drug license holder.

Q – Is drug license required for sanitizer trading?

A – No, drug license is not required for retail sale of sanitizer trading.

Q – How can one get drug license in West Bengal?

A – To get drug license in the state, you need to apply on drug license in West Bengal portal. Fill in the required application form along with documents.

Q – Can i get a drug license without degree?

A – No, you cannot get a drug license in India without completely qualifying your pharma degree.

Q – What are different types of drug license in India?

A – As per drugs and cosmetics act, there are following drugs license issued to dugs distributor or manufacturer

1. Manufacturing drug license
2. Sale drug license – Retail drug license, wholesale drug license and restricted drug license.
3. Import drug license
4. Loan drug license
5. Multi-drug license

Q – Where can we get a copy of the Drugs & Cosmetic Act 1940 & Rules 1945?

A – You can download or read copy of Drugs & Cosmetic Act 1940 & Rules 1945 on this link.

Q – How many schedules are present in Drug and Cosmetic Act 1940?

A –Drug and Cosmetic Act 1940 contains 168 rules and 25 schedules.

Q – How much does it cost to start a pharmacy in India?

A – It depends from state to state and also on the size of operations. But, usually it takes somewhere between 8-10 lakhs Rs to start a pharmacy business in India. This would also includes 40-50 thousand spent on regsitration for pharmacy license.

Q – What the different steps for a drug license application?

A – Following steps need to be taken for drug license application-

1. Obtain Login credentials
2. Prepare Documents
3. Filling of application
4. Visit by the drug inspector
5. Issuance of License

Q – What is a wholesale drug license?

A – A wholesale drug license is issued to firm or individual who wants to supply drugs or medicinal items on wholesale level.

Q – What is a retail drug license?

A – Retail drug license is issued to a individual or firm who wants to open a chemist shop.

Q – What is a drug license number?

A – Drug license number is a unique number issued to each drug license holder. It acts as a primary key in databases of drug authority and helps in retrieving records related to drug license holder.

Q – Can i get D. Pharma license on rent?

A – No it is illegal. Getting d pharmacy license on rent is illegal under Indian law and hence punishable.

Q – What is the minimum eligibility for getting a d pharmacy license?

A – Minimum eligibility for getting a d pharmacy license in India are –

• The applicant should be a Citizen of India and should have completed 18 years of age.
• Registerable Qualifications – D. Pharm, B. Pharm, Pharm D approved by Pharmacy Council of India
• Institution / College should have been approved by Pharmacy Council of India at the time of admission to 1st year.

Q – What is pharmacy license on rent price?

A – Getting a Pharmacy license on rent is illegal and is punishable under Indian law.

Q – What are the different steps for pharmacy certificate renewal?

A – Different steps for pharmacy registration renewal are –

• Login to drug portal
• Enter drug license number
• File renewal application
• Upload documents
• Pay require fee
• Submit application
• Appraisal of application
• issuance of renewal certificate

Q – How can i verify dug license online?

A – Drug license verification can be done online on respective state’s drug authority website. You need to enter unique drug license number to verify details of drug license.

Q – How can i downlead drug license?

A – You can download drug license from respective state’s drug authority websites. Some of the links are mentioned below –

• Haryana Drug license – https://fdaharyana.gov.in/
• Delhi drug license – http://drugscontrol.delhigovt.nic.in/
• Maharashtra drug license – http://fda.maharashtra.gov.in/drug.html
• West Bengal drug license – https://www.wbhealth.gov.in/pages/forms_download
• Uttar Pradesh drug license – http://fsdaup.gov.in/
• Bihar drug license – http://xln.bihar.gov.in/ST_Login.aspx?ST=Bqq04P1eg2A=
• Rajasthan drug license – http://www.rajswasthya.nic.in/Licence.htm
• Gujarat drug License – https://xlnindia.gov.in/login.aspx
• Tamil Nadu drug license http://www.drugscontrol.tn.gov.in/guidelines_procedures_grant_renewal_retail_wholesale_licences_allopathic_drugs.html
• Madhya Pradesh drug license – https://fdamp.mponline.gov.in/portal/home.aspx

Q – What are the documents required for fresh retail and wholesale drug license?

A – You can access complete list of documents for fresh retail and wholesale drug license here.

Q – What are the documents required for additional wholesale or retail Pharmacy license?

A –

• Application for the relevant drug license (Form 19/19A/19B/19c). These forms can be downloaded from respective state drug authority. For Delhi drug license you can visit this link.
• Affidavit regarding non-conviction of Property/Partner/Director as well as the firm under Drugs & Cosmetics Act, 1940
• Documents related to wholesale drug license competent person – 1) Proof of qualification for pharmacy such as final degree certificate or provisional degree certificate along with marksheets 2) Experience certificate 3) Appointment letter along with Bio data.
• Documents related to registered pharmacist for retail drug license – 1) Proof of qualification for pharmacy degree such as final or provisional degree certificate along with mark sheets of all years. 2) Registration of state level pharmacy council 3) Appointment letter and bio data
• Fee deposits receipts

 

 

Q – What is Manufacturing Drug License?

A – Manufacturing drug license is issued to a business that manufactures drugs or medicinal items that includes allopathy and homeopathy medicines too.

Q –What is Restricted drug license?

A – Restricted drug license is issued to those business or stores which sell drugs and medicines that doesn’t require any medical supervision. Restricted drug license holder can only issue list of restricted drugs items from his premise.

Q – What is Import drug license?

A – Import drug license is issue to business or person who are engaged in selling, manufacturing and distributing imported drugs in India.

Q – What is Loan drug license?

A – Loan drug license is issued to a person who doesn’t have any manufacturing facility of his own. He or she uses manufacturing facility of another business premise for his drug manufacturing.

Q – What is Multi Drug License

A – Multi drug license is issued to those person or business who are operating two or more different states with same business name.

Q – What are different types of drug application forms?

A – To access complete list of drug application forms, you can visit Drug application form.