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Expert assistance for all types of drug licenses in India. 15+ years of trusted service across PAN India.
The Drugs and Cosmetics Act, 1940 governs the manufacture, sale, and distribution of drugs in India. Obtaining a proper drug license is mandatory for any business dealing with pharmaceuticals or cosmetics.
A drug license ensures that medicines and drugs are manufactured, stored and sold under proper conditions to maintain their quality and efficacy. It helps regulate and monitor the pharmaceutical industry to prevent misuse of drugs and protect public health.
In India, drug licenses are categorized based on the nature of the pharmaceutical business:
Required for pharmacies and chemist shops selling drugs directly to consumers.
Required for distributors supplying drugs to retailers and institutions.
Required for companies manufacturing drugs and cosmetics.
Required for businesses importing drugs and cosmetics into India.
| License Type | Minimum Area Required | Additional Requirements |
|---|---|---|
| Retail Pharmacy | 10 square meters | Proper storage facilities, display area |
| Wholesale | 15 square meters | Separate storage for different drug categories |
| Manufacturing Unit | As per Schedule M | Separate areas for production, testing, storage |
We simplify the complex drug license application process with our systematic approach
We conduct a detailed consultation to understand your business model and determine the exact type of drug license(s) required. Our experts analyze your premises, staff qualifications, and business operations to ensure all prerequisites are met before application.
Our team prepares the complete documentation package including all required forms, affidavits, and supporting documents. We verify all technical details including premises specifications, pharmacist qualifications, and compliance with storage requirements.
We submit your application to the relevant authority (State Drugs Control Department, CDSCO, or Ayush Department) based on license type. Our team ensures proper filing with all attachments and follows up for acknowledgment.
We coordinate the drug inspector's visit and ensure your premises meets all requirements during inspection. Our experts accompany the inspector and address any queries regarding your application or facility setup.
We follow up with the authorities until your drug license is issued. The original license is collected from the office and delivered to you along with guidance on compliance requirements during the license validity period.
Typically takes 25-30 working days from application submission to license issuance, depending on the state and type of license. Manufacturing licenses may take longer due to additional inspections.
The drug licensing system in India involves multiple regulatory bodies depending on the type of license and products involved:
While retail and wholesale licenses are issued by state authorities, manufacturing licenses for certain categories like vaccines, sera, and blood products require approval from both state and central authorities. Import licenses are exclusively granted by CDSCO.
The Drugs and Cosmetics Rules, 1945 prescribe specific forms for different types of drug license applications:
| Form No. | Purpose | Applicable For |
|---|---|---|
| Form 8 | Application to import drugs (excluding Schedule X) | Importers |
| Form 8A | Application to import Schedule X drugs | Importers of controlled substances |
| Form 19 | Application for retail/wholesale license (excluding Schedule X) | Retailers, Wholesalers |
| Form 19C | Application for retail/wholesale license for Schedule X drugs | Pharmacies dealing in controlled drugs |
| Form 24 | Application for manufacturing license (excluding Schedules C, C(1), X) | Manufacturers of general drugs |
| Form 24F | Application for manufacturing Schedule X drugs | Manufacturers of controlled drugs |
| Form 27 | Application for manufacturing biological products | Vaccine manufacturers, Blood banks |
| Form 40 | Application for registration of imported drugs | Importers of foreign drugs |
The exact form requirements may vary slightly between states. Our experts will guide you on the specific forms needed for your application based on your business location and activities.
Obtaining a drug license comes with ongoing compliance obligations that businesses must fulfill:
The Drugs and Cosmetics Act prescribes strict penalties for violations including imprisonment (1-3 years) and fines (up to Rs. 5000 or more). Serious violations may lead to cancellation of license. Regular compliance audits are recommended to avoid such situations.
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