Drug License – Application, Documents, Registration, & Forms
Ensuring everyone has equal and fair access to drugs and medicine is the primary concern of any government. But the right to manufacture and sell treatments and drugs has to be given cautiously. Hence the government has stringent rules for granting licenses for the manufacturing and selling of drugs and medicine. The Act that governs the end to end process from manufacture to the sale of drugs in India is the Drugs and Cosmetics Act, 1940.
Meaning of Drugs
Section 3(b) of the Drugs and Cosmetics Act,1940 defines "drug" to include all medicines and devices for the use of human beings or animals internally or externally. All substances planned to be used for or in the diagnosis, mitigation, treatment, or prevention of any disorder or disease in animals or human beings, including preparations applied on the human body to repel insects like mosquitoes; it also includes all substances that can use for the destruction of insects and all components of a drug – like empty gelatin capsules—amended the definition in 1964 to include Ayurvedic and Unani Drugs.
Types of Drug License
Looking at the definition of "drug", the pharmaceutical business in India requires the following types of licenses:
- Manufacturing License– License issued to a business that manufactures drugs inclusive of allopathic/homoeopathy medicines.
- Sale License – License issued for the sale of drugs. It has the following bifurcations: – Wholesale Drug License – Retail Drug License – Restricted Drugs.
- Loan License – License issued to a business that does not own the manufacturing unit but uses the manufacturing facilities of another licensee.
- Import License – License issued for the import of drugs.
- Multi-Drug License – License issued to businesses that own pharmacies in multiple states with the same name.
Prerequisites For Obtaining a License
- Pharmacist/ Competent Individual: The pharmacist must be qualified in the case of a retail business. In the case of a wholesale company, the individual must be a graduate with 1-year experience or an undergraduate with four years of experience.
- Space Requirement: The other requirement is space, which is the area of the pharmacy/unit. – For both wholesale and retail license – 15 square meters. -In all other cases – 10 square meters. The sale premises' clear height shall be as per the guidelines laid down under the National Building Code of India, 2005.
- Storage Facility: The other requirement is a storage facility. Since some drugs are required to be stored in low temperatures, refrigerators and air conditioners are a must.
Application for a Drug License
The following are the steps to be taken for obtaining the drug license:
- The applicant must apply online for the permit as per the line of business, for which they must have a valid email id and contact number.
- The next step is to keep all the documents updated.
- Next is to upload the documents and the form along with the applicable fees.
- Upon completion of the online process, an inspector will visit the site and verify the validity of the documents.
- If all the above steps have been duly complied with, the authority will issue the drug license.
List of Essential Documents For Obtaining a License
The documents essential for obtaining a sale license are:
- Constitution of the entity – Memorandum of Association (MOA), Articles of Association (AOA) for a company, partnership deed, LLP agreement in case of partnership and LLP.
- ID proof of partner/director/proprietor.
- Documents related to premises – Copy of property or rental agreement ownership documents as the case may be.
- Site plan and critical plan of the premises.
- Copy of Board resolution permitting obtaining of a license.
- Proof of availability of storage space as cold storage, refrigerator, etc.
- Copy of challan as proof of depositing fee.
- Affidavit regarding non-conviction of proprietor/partner/director and the firm.
- The affidavit from the registered pharmacist/competent person.
- For a pharmacist at a retail sale: – Proof of qualification – Registration of local pharmacy council – Appointment letter
- For a pharmacist at a wholesale sale:: – Proof of qualification – Experience certificate – Appointment letter
| Sr. No | Form No | Purpose |
| 1 | Form 19 | Application for grant or renewal of a license to sell, stock, exhibit, or offer for sale or distribute drugs apart from those specified in Schedule X. |
| 2 | Form 19A | Application for granting or renewing a restricted license to sell, stock, exhibit or offer for sale or distribute drugs by retail via dealers who don't engage the service of a qualified individual. |
| 3 | Form 19B | Application for license to sell, stock or exhibit or offer for sale, or distribute Homoeopathic Medicines. |
| 4 | Form 19C | Application for grant or renewal of a [license to sell, stock, exhibit or offer for sale, or distribute] drugs specified in Schedule X. |
| 5 | Form 24 | Application for either the grant of a license or the renewal of a permit or to manufacture for sale or distribution of drugs other than those specified in [Schedule C, C (1) and X]. |
| 6 | Form 24A | Application for either the grant of a loan license or renewal of a loan license to manufacture for sale or distribution of drugs other than those specified in Schedule C, C (1) and X. |
| 7 | Form 24B | Application for grant or renewal of a licensee to repack for sale or distribution of drugs, being drugs other than those specified in Schedule C and C (1) excluding those set in Schedule X. |
| 8 | Form 24C | Application for the grant or renewal of a license to manufacture for sale [or for distribution] of Homoeopathic medicines or a permit to manufacture potentized preparations from back potencies by licensees holding a license in Form 20-C |
| 9 | Form 24F | Application for grant or renewal of a license to manufacture or distribute drugs specified in Schedule X and not defined in Schedule C and C(1). |
| 10 | Form 27 | Application for grant or renewal of a license to manufacture for sale or distribution of drugs specified in Schedule C and C (1) excluding those set in part XB and Schedule X |
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