For Free Consultation, Please contact us at +91 8000028250

DRUG LICENSE

Drug License in India


Starting Rs. 15,000/- (all inclusive)

DRUG LICENSE

Drug license is a permission granted by the authority under the Drugs and Cosmetic Act in order to carry out a business of drugs/medicines or cosmetics. The Drug license is issued by the State Drugs Standard Control Organization or the Central Drug Standard Control
Organization. Without a Drug License no person can do pharmacy business or even start to associate with any dealings. Doing so is a cognizable offence. Hence one must obtain an appropriate Drug License for conducting such activities under the drug and cosmetics act of 1940 under which all types of drugs and cosmetics businesses are covered which includes allopathic drugs, homeopathic drugs and even the Ayurveda or Unani drugs.

The quantity of the drugs used and produced and packed in a dose is the responsibility of all the persons involved in the whole line of work. In case any consumer of these products suffers from any unmentioned harm, these persons will be held responsible and answerable to the event and is an offence of grievance which can go under trial under IPC. Hence vigilance is important.

Basic Requirement for Obtaining Drug License

According to the provision of Drug and cosmetics act, to get a drug license the below- described requirements to be met by the trader.

  • Area Recruitment

    The minimum area required for setting up a medical shop or pharmacy is 10 square meter. In case of the store business combination with the wholesale and retail of drugs then the minimum area of 15 square meters is required. License for the sale of drugs can be issued in the commercial premises or other premises independent of residence.

  • Storage Facility

    It is vital to have an air conditioner and refrigerator on the premises because some medicines such as insulin injections, vaccines are needed to be stored in the refrigerator.

  • Technical Staff

    Sale of drugs should be carried in the presence of a registered Pharmacist approved by the State Government who is required throughout the working hours in the retail shop.

The wholesale of drugs can be made either by a registered pharmacist or any competent authority who graduate and having experience in drugs or in the presence of an of person who has passed SSLC having experience of four years in drugs/medicines business, specially approved by Health and Family Welfare Department.

Classification of State Drug License

Based on the requirement of the pharmaceutical business, State Drug License can be classified in the following categories:
-> Sale License
-> Manufacturing License

SALE LICENSE

 

Sale license is issued to persons or agencies engaged in the sale of drugs or medicines in State. The sale drug license is further classified into the following two types.

  • Retail License: It is granted to run and sell drugs or drug products in State.
  • Wholesales License: It is provided to a person or agency engaged in wholesale of medicine or drugs

MANUFACTURING LICENSE

 

Manufacturing license is granted to a person or agencies involved in the manufacturing of drugs, medicines and cosmetics. The government of State also issued Manufacturing loan license.

Documents required for registration of an LLP

  1. Signed copy of Application Form 19 / Form 19 C/ Form 19 B
  2. Signed copy of Additional Information Form
  3. True Copy of Partnership deed or Memorandum of Article of Association & List of Directors, if any
  4. Appointment Letter of a Registered Pharmacist
  5. Educational certificate copies of proprietor (Self attested)
  6. Consent Letter of a Registered Pharmacist with Details of Previous Service, if any
  7. True Copy of Registration Certification issued by Gujarat State Pharmacy Council
  8. True Copy of Renewal Receipt of Gujarat State Pharmacy Council as a Proof of Registration of the Pharmacist has been Renewed
  9. Passport Size Photographs of the Pharmacists
  10. An Affidavit of the Pharmacist on INR 20 Stamp paper
  11. True Copy of Rent Receipt for the Premises & Necessary Proof for the Legal Possession of the Premises like Copy of the Registered Sales deed etc.
  12. Rough Sketch of the Premises
  13. Copy of Ration Card or PAN
  14. Refrigerator invoice and details

Additional documents may be required depending upon your State.

Inspection by Drug Inspector

Before the grant of a drug license, the drug inspector having jurisdiction of the area visits the premises where drug license is required and verify the particulars furnished with the application and if required take measurement of the premises and also interview the competent person.

Drug License in India Registration Process

The most important step in obtaining the drug License is the preparation of documents which includes, preparation of key plan and site plan and various affidavits and declaration as prescribed under law.

The drug License applications are filed online, these days including the payment of government fee. All documents are scanned and uploaded at the time of filing the application. However, filed documents are verified by the inspector.

After the application for grant of drug license is filed, the same is marked for inspection and thereafter the drug inspector personally visits the shop to verify the documents and correctness of information.

After the Inspection is complete and in case personal interview is called for is cleared by the competent person and upon verification all information and documents furnished is correct the controller of drugs issues the Drug License.

What Is Included In Our Package?

WHY CHOOSE LEGALSAHAYATA?

Low Price

No Office Visit

No Hidden Cost

Charges After Work Completion

Frequently Asked Question

  1. What are essential requisites for obtaining Sales Drugs Licences(Retail)?

The applicant’s shop/premises should have an adequate area of not less than 10 sqr.mtrs. and person in charge (Competent Person) must be a Registered Pharmacist/who has passed Matriculation or its equivalent with four year’s experience in dealing with Drugs or who holds a degree of a recognized university with one year’s experience in dealing with Drugs.

The applicant’s shop / premises should have an adequate area of not less than 15 sqr. mtrs.

Written complaint about doubtful quality of Drugs can be made to the Drugs Control Department, Govt. of N.C.T. of Delhi, at F-17, Karkardooma, Shahdara, Delhi-32 indicating name and address of the complainant,name and other particulars of the Drug under complaint and nature of complaint.

Written complaint about doubtful quality of Drugs can be made to the Drugs Control Department, Govt. of N.C.T. of Delhi, at F-17, Karkardooma, Shahdara, Delhi-32 indicating name and address of the complainant,name and other particulars of the Drug under complaint and nature of complaint.

Shopping Basket
Need Help?