DRUG License

What is Drug License?

A drug license is a permission granted by an authority to carry out a business that deals with drugs, medicines, or cosmetics. This act governs the end to end processes from manufacturing to the sale of drugs in India. The Drugs and Cosmetics Act of 1940 manages the import, production, distribution, and sale of drugs and cosmetics in India. The primary intention of the act is to make sure that the drugs and cosmetics sold in India are safe, effective, and conform to state quality standards.
Section 3(b) of the Drugs and Cosmetics Act explained drugs as all medicines for the consumption of humans or animals externally or internally, and all substances purposed to be used for or in the diagnosis, mitigation, treatment, or prevention of any disorder or ailment in animals or human beings, including preparations applied on the human body to repel insects like mosquitoes.

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Types of Drug Licenses in India

  • Manufacturing drug license
  • Sale drug license
    • Wholesale drug license
    • Retail drug license
    • Restricted license for a general store
  • Import drug license
  • Multi-license for drugs
  • Loan drug license

Manufacturing Drug License

The State government grants this license to the manufacturers of Allopathic, Ayurvedic, Homeopathic, Cosmetic products, or other drugs under the Drugs and Cosmetics Act, 1940. For setting such manufacturing units, one needs to obey all the requirements issued by the state authority. Compliance with good manufacturing practices is required to get license approval.

Sale Drug License

The wholesalers and retailers who are engaged in the distribution of drugs in India must acquire this license.

Wholesale Drug License

CDSCO (Central Drugs Standard Control Organization) issues a wholesale drug license to the wholesalers who had obtained a degree/diploma in pharmacy from a recognized university. The applicant should have at least one year of experience in drug dealing

Retail Drug
License

Registered pharmacists under the State Pharmacy Council who deals in the drug business in pharmaceuticals must have this license issued and present at the premises throughout the working hours.

Restricted License for General Stores

This license must be acquired to deal with drugs without the support of a registered pharmacist.

Import Drug License

Whoever engaged in the process of manufacturing, distribution, sale of imported drugs in India should possess an Import drug license. Separate licenses for drugs need to be issued if manufactured in various factories at different locations.

Multi-License for Drugs

Entrepreneurs dealing with drugs in multiple states should acquire a Multi-drug license.

Loan Drug License

Authorities who manufacture drugs on the land of others issued with a manufacturing drug license should hold a Loan drug license.

Essential Requirements to Obtain a Drug License in India?

  • Area for the operation of the business: A minimum area of 10 sq. meters is required to set up a retail pharmacy while a wholesale store should have an area of 15 sq. meters to be eligible for obtaining a drug license.
  • Storage facility: Set up facilities like a refrigerator and air conditioners for medicines that need cool storage spaces.

     Technical staff: A registered pharmacist or a pharmacy graduate with an experience of a minimum of one year in dealing with drugs has to be present within the premises during the working hours

What are the forms under the Drug License application?

Form 8: This is the application form for the import drug license for the drugs not specified in Schedule X.

Form 8A: This is the application form for the import of drug license for the drugs specified in Schedule X.

Form 19: This is the application form for the grant or renewal of a license to sell, stock, exhibit, or offer for sale, or distribute drugs not specified in schedule X.

Form 19A: This is the application form for the grant or renewal of a restricted license to sell, stock, exhibit for sale, or distribute drugs.

Form 19B: This is the application form for the license to sell, stock or an exhibit, or offer for sale, or distribute Homeopathic medicines.

Form 19C: This is the application form for the grant or renewal of a license to sell, stock, exhibit, or offer for sale, or distribute drugs specified in Schedule X.

Form 24: This is the application form for the grant or renewal of the manufacturing license for the drugs not specified in schedule C, C (1), and X.

Form 24A: This is the application form for the grant or renewal of loan license for the drugs not specified in schedule C, C (1), and X.

Form 24B: This is the application form for the grant or renewal for the license to repack for sale or distribution of drugs that are not specified in schedule C, C (1), and X.

Form 24C: This is the application form for the grant or renewal of the license to manufacture Homeopathic medicines.

Form 24F: This is the application form for the grant or renewal of the license to manufacture the drugs which are specified in schedule X, but not specified in schedule C, and C (1).

Form 27: This is the application form for the grant or renewal of a license to manufacture drugs that are specified in Schedule C, and C (1) but not specified in part XB, and schedule X.

Form 41: This is the Registration Certificate for the registration of the premises and drugs manufactured meant for import.

What are the documents required for applying for Drug License?

  • Documents required for manufacturing drug license:

    • Passport size photograph.
    • Identity proof.
    • Address proof.
    • Evidence for depositing the application fees.
    • Application form duly filled and signed.
    • Self-attested copy of the registered plant layout.
    • Utility bill as the certified office proof, in case of land, owned.
    • Rent agreement, if applicable.
    • No-objection certificate from the landlord. (In case of rented property)
    • Educational background and experience letter of the registered pharmacist.
    • Invoice of the refrigerator for business purposes.
    • Invoice of the purchase of air-conditioner.
    • Partnership deed for a partnership firm.
    • List of all partners in case of a partnership firm.
    • Certificate of incorporation in case of private limited and public limited companies.
    • Memorandum of Association in case of private limited and public limited companies.
    • Article of Association in case of private limited and public limited companies.
    • Appointment of the concerned and authorized person who will be responsible for daily operations in case of private limited and public limited companies.
    • Copy of the board resolution regarding the authorized person who will be responsible for the day to day operations in case of private limited and public limited companies.
     

    Documents required for sale drug license:

    • Memorandum of Association, Articles of Association for a company.
    • Partnership deed, LLP agreement in case of a partnership, and LLP.
    • ID proof of partner or director or proprietor.
    • Copy if ownership documents of property or rental agreement.
    • Site plan and key plan of the site.
    • Copy of board resolution permitting obtaining a license.
    • Proof of accessibility of storage space as cold storage, refrigerator, etc.
    • Copy of challan as a proof of depositing fee.
    • Affidavit regarding non-conviction of proprietor or partner or director, and the firm.
    • The affidavit from the registered pharmacist, or competent person.
    • Proof of qualification, registration of local pharmacy council, and appointment letter of the pharmacist
     

    Documents required for drug import license:

    • Cover letter.
    • Form 8 or form 8A duly filled and signed by the applicant.
    • The undertaking given by the manufacturer or on behalf of the manufacturer.
    • Notarized copy of the wholesale or manufacturing license.
    • Copy of valid Registration Certificate (RC) duly attested by the Indian agent or importer.
    • Copy of permission under rule 122A in case of a new drug in the name of the importer.
     

    Documents required for drug loan license:

    • Manufacturing license copy of the manufacturer.
    • Documents related to the marketing firm or company.
    • Competent person’s detail and qualification certificates.
    • Any other documents asked by the authority.

What is the procedure for the Drug License Application?

  • Make sure a valid and active e-mail id and mobile number are ready by hand.
  • Register online to complete the Drug store registration & licensing system.
  • Make sure the applicant’s name is spelled correctly before submission as it appears on the license.
  • Once submitted, the system generates a Unique Registration Number for each application for future processing and references.
  • Submit the printout of the forms along with the fee challan and supported documents attached to the District Licensing Authority Office within 15 days from the date of submission of the application online.

What if you violate the law?

A person who sales any medicine without a drug license and fails to comply with the rules and regulations of the drug license process will be liable to a punishment of imprisonment for a period not less than 1 year which may extend to 3 years and with a fine not less than Rs.5000.

Conclusion

Being the owner of drug business in India, one must possess a drug license under the Drugs and Cosmetics Act, 1940. It is required for them to strictly follow the rules and regulations of the act. Failing to comply with these may lead to punishable offenses under the act.

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