Overview
A drug license essentially serves as permission granted by an authority under the government that allows enterprises to engage in businesses related to drugs and cosmetics. Without such a drug license certificate, no person can operate a company that deals in drugs or medicines.
All cosmetics or drugs, including ayurvedic, allopathic, homoeopathic, and Unani formulations, come under the purview of the Drugs and Cosmetics Act, 1940. Such drug license rules help the government monitor and maintain the quality of drugs sold in India. In this article, we will take a look at the drug license procedure, and why such a license is vital in India.
Benefits of Obtaining a Drug License Certificate
- Businesses must file such a drug license application because it is illegal to engage in the manufacturing or sale of drugs in India without it.
- Having such a drug license helps the government monitor and regulate the sale of medicines in India, making your business credible and trustworthy.
- A drug license certificate proves to your consumers that you follow stringent quality measures while manufacturing drugs.
- Having such a valid license proves to customers that your medicines and drugs are safe and pose no health hazards.
- Applicants can use the import drug license to grow their business and expand their products to foreign countries
Types of Drug License
In India, the government allows the following types of drug licenses;
- Manufacturing License – Allows manufacturers to produce drugs and medicines of all kinds
- Sale License – Licenses which help establishments sell drugs are of the following types;
- Wholesale Drug License
- Retail Drug License
- Restricted Drug License
- Loan License – Used by businesses which use the manufacturing complex of another facility to produce drugs
- Import License – Enables enterprises to import drugs
- Multi-drug License – For companies that operate pharmacies in multiple states in the same name
Checklist for Drug License Application and Issue
- Before applying for a drug license online, the entrepreneurs should ensure they have a competent pharmacist on their payroll. A qualified person must handle all the medicines sold by such establishments.
- In case you are applying for a Retail Drug License, you will need a qualified pharmacist. Meanwhile, a wholesale permit will require a graduate who has over a years’ worth of experience or an undergraduate with a minimum of four years experience.
- To open a pharmacy, the carpet area of the establishment must exceed at least 10 square metres. In case you are applying for a wholesale drug license, the minimum area required is 15 square metres, and the property must be well-ventilated.
- All the drugs must be stored in a cool, clean and well-ventilated area. In case certain vaccines or drugs require special storage conditions, such as low-temperature zones, the facility must have the necessary arrangements and facilities. As a result, all such properties must have adequate refrigeration and air conditioning capabilities.
- To complete the drug license verification, a drug inspector will visit your place of business to ensure you comply with all the required particulars. They might also interview the competent person or pharmacist to ensure they have the required knowledge and skills.
How to file a drug license application?
- The most crucial step involved in a drug license application is preparing the documents required. The directors will have to obtain all the necessary documents and get them attested by the required authorities before they start the application process.
- The drug license application occurs online nowadays, and applicants may visit the official website of their state authority to fill out the form.
- Once they fill out the form and upload the required supporting documents, applicants will have to pay the required processing fee for the same.
- In certain states, after submitting the documents online, applicants will have to take a print out of the application and the supporting documents and send it to the District Licensing Office.
- To verify the documents submitted and ensure the premises are suitable, a drug inspector will visit the place of business.
- After completing such a visit, the inspector might call the applicant and the competent person for an interview.
- Once verification is complete, if the enterprise clears the guidelines, the Controller of Drugs will issue a drug license for the establishment
Upon successful registration, the applicant will receive a unique Registration Number which they use for further processing and reference. Also, in states where applicants have to submit the documents physically, the printouts must reach the concerned authority within 15 days of submitting the online application.
Documents required for drug license verification
- Certificate of Incorporation
- Memorandum and Articles Of Association/ Partnership Deed/ LLP Agreement
- Pan Card
- Cancelled Cheque
- Photo ID of the applicant
- Address Proof of Directors/Partners/Applicant
- Affidavit from Directors
- Bio-data of the competent person(CP) in a prescribed format
- Appointment Letter of CP
- Experience Certificate and Qualifications of CP
- Photo, ID proof and Address proof of CP
- In case the applicant owns the place of business, its registered Sale Deed / GPA / Conveyance Deed
- Unregistered Sale Deed / GPA along with Electricity/Water Bill or property tax receipt
- If located in a village, Khasra Khatauni documents
- For rented premises- Registered Rent Agreement along with the Rent Receipt
- Unregistered rent agreement along with Electricity/Water Bill or property tax receipt
- No Objection Certificate from the owner
- Site Plan of the premises attested by an architect/mapmaker
For drug License application or renewal for manufacturers
Along with the other required documents, manufacturers will also have to submit the following documents;
- Covering letter and payment receipt
- Form 24 - Application for manufacturers specified in Schedule C, C (1) and X
- Form 27 - Application for manufacturer specified in Schedule C and C (1), excluding X
- Product List
- List of Excipients
- Similar Product
- Draft Label
- Method of Analysis
- Additional Information Form
FAQs on How to Obtain a Drug License in India
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