Drug License
A Drug License is mandatory for businesses involved in the manufacture, sale, import, or distribution of pharmaceutical products in India. Regulated under the Drugs and Cosmetics Act, it ensures that pharmaceutical operations meet essential safety and quality standards. Whether you're opening a medical store, running a wholesale drug operation, or dealing in Ayurvedic or imported medicines, this license is a legal prerequisite.
Types of Drug Licenses
- Retail Drug License: Required for pharmacies and medical stores selling medicines directly to consumers.
- Wholesale Drug License: Issued to distributors who supply medicines in bulk to retailers or institutions.
- Manufacturing License: Mandatory for companies involved in producing drugs or cosmetics.
- Loan License: For businesses using another licensed facility to manufacture medicines.
- Import License: Needed for importing pharmaceutical products into India.
- Multi-Drug License: Required for businesses operating in multiple states or having multiple outlets.
Who Needs a Drug License?
- Pharmacists and retail pharmacies
- Wholesale drug distributors
- Pharmaceutical manufacturers
- Importers of drugs and cosmetics
- Dealers in Ayurvedic, Siddha, or Unani medicines
Eligibility Criteria
- Qualified Personnel: Pharmacists (for retail) or experienced individuals (for wholesale)
- Premises: Adequate space, cleanliness, and required equipment (refrigerators, storage)
- No criminal background: Applicant must not have any drug-related convictions
- Registration: With State Pharmacy Council (for pharmacists)
Documents Required
- Application Form (Form 19)
- Identity and address proof of proprietor/partners
- Educational qualification and registration certificate of pharmacist or competent person
- Affidavits and photographs of the applicant and pharmacist
- Blueprint/layout of premises
- Electricity bill and refrigerator purchase bill
- Ownership proof or rent agreement of premises
Validity and Renewal
Drug Licenses are valid for 5 years and must be renewed before expiry. Timely renewal is essential to avoid penalties or cancellation.
How to Apply for a Drug License
- Register and create a user ID on the state drug control department portal
- Prepare and upload all required documents
- Submit the application form with fees
- Undergo inspection by the drug inspector
- Respond to any queries or document requests
- Receive license approval upon successful verification
Download & Track Drug License
Once approved, the license can be downloaded from the official state drug department portal using your login credentials. Regularly check the license status for compliance updates and renewal timelines.
Why Choose Hiva Professionals?
- Expert Consultation: We guide you through every step of the process
- Complete Documentation: Our team prepares and verifies all paperwork
- Online Submission: Hassle-free submission and liaison with authorities
- Timely Follow-ups: Renewal reminders and compliance support
- Affordable Plans: Tailored services ideal for startups and businesses of all sizes
With Hiva, focus on your pharmaceutical business while we take care of your legal and licensing needs.
