Pharmaceutical industry has played an important role in developing the healthcare economy of India. It is governed by strict laws so as to ensure safety, efficiency as well as the quality of drugs and cosmetics that are produced and circulated across the nation. The major regulatory statute for the same is Drugs and Cosmetics Act, 1940 that mandates the requirement of drug licenses for any business like that of manufacturing, distributing and sale of pharmaceutical products.

Understanding Drug License Regulations

Under the purview of the Drugs and Cosmetics Act, of 1940, businesses dealing with drugs or cosmetics in India, including Allopathic, Homeopathic, Ayurvedic, or Unani drugs, are required to obtain a drug license from the competent authority. This license is essential for ensuring compliance with quality standards and regulatory guidelines set forth by the Act.

Licenses can be majorly classified into two types –

  • Manufacturing License

To produces allopathic or homeopathic drugs and cosmetics can be granted only in recognized industrial areas

  • Selling License

It refers to license to sell drugs in open market. Further, it is categorized into:

a. Retail Drug License

b. Wholesale Drug license

The Selling License can be further classified as –

  • Retail Drug License (RDL)

It is issued to run a chemist shop. It is issued to only those persons who possess a degree or diploma in pharmacy from a recognized university.

  • Wholesale Drug License (WDL)

It is a license which is issued to a person who is engaged in the business of wholesale drugs and medicines.

Karnataka Drugs Control Department

The Karnataka Drugs Control Department which was incorporated in Mysore has been vested with the power of licensing the manufacturing as well as sales of the drugs and cosmetics in the state. The primary function is to ensure that the drugs are supplied at a price that is determined through the statute.

The entity comprises of three wings, namely:

  • Enforcement wing
  • Educational wing
  • Drugs testing laboratory

Infrastructural Specifications

If the authorized person wishes to establish a medical shop or pharmacy a carpet area of 10 square meters is required whereas a store business that includes retail as well as wholesale requires a carpet area of 15 square meters. The premises must have refrigerator as well as air conditioners as certain drugs like vaccines, insulin injections, etc. are required to be stored in the fridge. The medicines are required to be stored in a cool and clean atmosphere.

Staffing Requirements

The drugs should be handled by a registered pharmacist. The trading affairs of the retail store shall be controlled by a qualified pharmacist whereas the whole sale store shall be handled by a graduate with experience 1 year or an SLCC pass out with 4 years of experience.

DOCUMENTS TO ESTABLISH DRUG MANUFACTURING UNIT IN KARNATAKA

General Documents

  1. Cover Letter by the manufacturer that states the purpose of the said unit
  2. The list of directors has also to be submitted
  3. The copy of Memorandum of Association (MoA) and
  4. Articles of Association (AoA) of the Company is also required
  5. The address proof and Identity Proof of Directors is a mandatory compliance
  6. The copy of resolution passed by the Board of Directors in the Board Meeting is also required to be submitted for obtaining license.

Process

Step 1: Submission of Application

  • The applicant has to submit a statutory application as specified in the portal.
  • The specified fees are required to be submitted.
  • The documents above specified need to be duly submitted.
  • The concerned authority may as well ask submission of further documents to validate the information as provided by the applicants.
  • The said forms need to be filled with official authority.
  • In the case of Karnataka, it is Karnataka Drugs Control Organization. The said application needs to filled with required forms that have been signed by the competent authority.

Step 2: Scrutiny and Inspection  

  • The said documents after proper validation is processed in the portal and are submitted to the concerned Assistant Drugs Controller.
  • The concerned person may either scrutinize the same by inspecting the premises or forward the applicant if found to be adequate to the Drug Inspector for the same.

Step 3: Issue of License

  • If the application is not as per the rules, and requires certain qualifications, a compliance letter is issued to the applicant.
  • If the submitted documents submitted are found to be correct and as per the rules, the concerned Assistant Drugs Controller as well as delegated License Authority shall grant license to the applicant.

Documents required for Manufacturing License

  1. The major plan of the manufacturing plant as well as the site plant should be required in blueprint.
  2. A declaration form is required to be duly filled (if any) is also required
  3. Any proof regarding possession of the property or rent agreement
  4. The proof of ownership like Copy of registered GPA or sale deed or receipts of Property tax should be submitted as well.
  5. There should be an affidavit attached for Non-Conviction
  6. The list of equipment and machinery that are engaged in manufacturing should be provided as well.
  7. The list of all the equipment engaged in testing of drugs should also be prepared.
  8. The list stating technical staff for manufacturing and also their attached Self-Certified Photocopies of Educational qualifications as well as experience should also be submitted.
  9. The list of the technical staff engaged in testing along with their self-certified photocopies of their educational qualification as well as experience is also required.
  10. There should be an affidavit attached declaring full-time working with the firm of the employer and the technical staff.

Documents Required for Retail Drug License

  1. A cover letter from the side of the person who wishes to engage in retail drug license stating the purpose of the same should be framed and submitted.
  2. It is mandatory to fill Form 19/19C that has an application to grant license to sell, stock, exhibit or distribute as well as sale of drugs, other than the ones stated in Schedule X.
  3. An Additional Information Sheet (AIS) shall be filled including any additional information regarding the store.
  4. In case of challan its copy and if the payment has been made, the acknowledgement of such payment shall be attached.
  5. A sketch of the copy of premises is required to be submitted.
  6. In case the property is on rent or on lease, the agreement for the same shall be submitted.
  7. The information including proof and qualification of the authorised person shall be attached.
  8. The original as well as a copy of the REGISTRATION certificate from Karnataka State Pharmacy Council (KSPC) shall also be required.
  9. The proof of approval shall be attached in duplicate.
  10. The affidavit shall be stamped in Rs. 20 stamp paper.
  11. The invoice for the refrigerator purchased for the storage of drugs is also required.
  12. A declaration of sole proprietorship or the partnership deed or the MoA or AoA of the company, as the case may be, shall also be submitted.
  13. The proof of address of the sole proprietorship or partnership or company shall be submitted.
  14. A Passport size photograph of the applicant is also necessary.

Documents Required for Wholesale Drug License

  1. A cover letter from the side of the person who wishes to engage in retail drug license stating the purpose of the same should be framed and submitted.
  2. Form 19/19C is also required.
  3. An Additional Information Sheet (AIS) shall be filled including any additional information regarding the store.
  4. In case of challan its copy and if the payment has been made, the acknowledgement of such payment shall be attached.
  5. A sketch of the copy of premises is required to be submitted.
  6. In case the property is on rent or on lease, the agreement for the same shall be submitted.
  7. The information including proof and qualification of the authorised person shall be attached.
  8. The Qualification Certificate of the competent person is a mandate.
  9. Experience Certificate of the competent person.
  10. An Affidavit of Rs. 20 in stamp paper.
  11. The invoice for the refrigerator purchased for the storage of drugs is also required.
  12. A declaration of sole proprietorship or the partnership deed or the MoA or AoA of the company, as the case may be, shall also be submitted.
  13. The proof of address of the sole proprietorship or partnership or company shall be submitted.
  14. A Passport size photograph of the applicant is also necessary.

Documents Required for Drugs Sold under Schedule X

  1. A cover letter from the side of the person who wishes to engage in retail drug license stating the purpose of the same should be framed and submitted.
  2. The Form 19/19C, that has an application to grant license to sell, stock, exhibit or distribute as well as the sale of drugs, other than the ones stated in Schedule X.
  3. An Additional Information Sheet shall also be required to be submitted for any extra information for the drugs being sold.
  4. In case pf challan its copy or the acknowledgment of payment, if made shall also be made.
  5. Copy of licenses issued in Form 20 as well as Form 21 as well as 20B & 21B shall also be submitted.
    • Form 20 – It refers to the License to sell stock or exhibit or offer for sale, or distribute] drugs by retail other than those specified in 2 [schedules c and c (1) and x,
    • Form 21 – It is the license to sell, stock or ehibit as well as sale or distribution by retail drugs specified in Schedule C and C (1) 3, Excluding the ones stated in Scheule X, and/or
    • 20B - the wholesaler gets a wholesale drug license for drugs that are not specified in Schedule C, C (1), and X of the Drugs & Cosmetics Act and Rules and
    • 21B - grants permission to wholesalers to sell, and distribute drugs defined in Schedule C & C (1) of the Drugs & Cosmetics Act and Rules. 
  6. An undertaking stating that Schedule X drugs will be maintained discreetly.

Documents Required for Grant of Restricted Licenses in Form 20A and Form 21A

Form 20A – It refers to restricted [licence to sell, stock or exhibit or offer for sale, or distribute] drugs by retail other than those specified in [schedule c, c (1) and x] for dealers who do not engage the services of a qualified person

Form 21A – It refers to restricted [licence to sell, stock or exhibit or offer for sale, or distribute] by retail drugs specified in [schedule c (1)] 3 [excluding those specified in schedule x] for 6 [***] dealers who do not engage the services of a qualified person

  1. A Cover letter that includes the purpose of the same.
  2. Form 19A is required to be filled.
  3. An Additional Information Sheet (AIS) is required so as to include relevant information required to be attached.
  4. A copy of challan or the acknowledgment of payment, if made, is required to be attached.
  5. A duplicate copy of the sketch of the premises is required to be submitted.
  6. In case the premises is on rent or on lease, a Rental agreement or lease deed is to be submitted.
  7. A declaration regarding the proprietorship agreement, or partnership deed in case of partnership or MoA and AoA in case of the company shall also be submitted.
  8. A proof of address of the company is also required to be furnished.
  9. A passport size photograph of the applicant is required to be submitted as well.
    Article by 

Aarushi Ghai, an intern at Corpzo