Drug License

What is Drug License?

Individuals, corporations, and partnership firms are required to acquire a legitimate Drug License from the relevant State Authorities, specifically the Drugs Control Department. This requirement is mandated by the Drugs and Cosmetic Act of 1940 and its corresponding Rules of 1945, which are applicable across India.

Why you need it:

It's the law: In India, you can't sell or distribute drugs without a Drug License. It's like a driving license for your pharma business.
Big market, big opportunities: India's pharma market is huge - 3rd biggest in the world! With a license, you can tap into this giant pool of customers.

Who can get one?

Pharmacy pros: If you're a qualified pharmacist, you're good to go. Just show your degree and pharmacist registration.
Distribution experts: Don't have a pharmacy degree? No worries! If you have experience in drug distribution, you can still get a license.

Find your license type: Wholesale, retail, manufacturing - different licenses for different businesses. Choose the one that fits yours.

Documents required for Drug License:

Company Foundation:

If you're a company, provide your Memorandum of Association (MOA) and Articles of Association (AOA).

Partnerships and LLPs:

For partnerships and Limited Liability Partnerships (LLPs), furnish your Partnership Deed.

Proof of Ownership or Occupancy:

Owned Property: If you own the premises, present the Registry Deed, Lease Deed, or Power of Attorney (POA).
Rented Property: If you're renting, provide a copy of the Rent Agreement.

Official Documents:

Board Resolution and Director Details: For companies, include a Board Resolution outlining the decision to apply for the license, along with a list of Directors and the Certificate of Incorporation.
ID Proof: Submit ID proofs for all Directors, Partners, or Proprietors.

Premises Blueprint:

Layout Clarity: Provide a detailed key plan and site plan (blueprint) of your premises, showcasing its layout and spatial organization.

Equipment Invoices:

Refrigeration and Climate Control: Include an invoice copy for any refrigerator or air conditioner purchased for use in the premises.

License-Specific Requirements:

Retail and Wholesale: Furnish an affidavit from the Registered Pharmacist or Competent Person, as applicable.
Manufacturing:

Affidavit from the employer and/or Technical Staff, affirming their full-time commitment to the firm.
List of Technical Staff, including their educational qualifications, experience certificates, biodata, appointment letters, and three photographs each.
Affidavit of Non-Conviction, demonstrating a clean legal record.
Comprehensive lists detailing the equipment and machinery used for manufacturing, as well as testing equipment.

Procedure to get Drug License:

State-Specific Portals:

Each state in India boasts its own dedicated Drug Licensing Portal, acting as your gateway to registration. Access the portal relevant to your location.

Central Authority for Specific Cases:

A central Drug Licensing Authority oversees a separate portal for select cases and matters spanning multiple states.

Credentials for Returning Applicants:

If you already possess login credentials, seamlessly log in to initiate your application process.

New Applicants: Secure Your Access:

First-time applicants will need to establish their digital identity by visiting the relevant authority in person and submitting a request letter detailing their firm's information. This grants them a unique login ID and password—keys to the online application realm.

Carefully Crafting Your Application:

Enter Essential Details: Once logged in, meticulously input the required information, including pharmacist and competent person details, pharmacist council registration, and pertinent names.
Select the Right Form: Choose the appropriate form (Form 19, 19A, 19B, or 19C) based on your specific application type.
Precision is Paramount: Ensure accuracy and completeness in all fields, as editing after submission is typically not possible.
Digital Submission: Confidently submit your application through the online portal.

Facilitating Inspection and Assessment:

Scheduling a Visit: Upon successful application submission, the Drug Licensing Authority (DLA) will schedule an inspection of your premises.
Scrutinizing Your Space: A designated Drug Inspector will conduct an on-site visit to meticulously examine your premises for compliance with Drug License requirements.
Document Verification: The inspector will also verify the authenticity of your original documents.
Report Submission: Following the inspection, a comprehensive report is submitted to the DLA for further evaluation.

Awaiting the Verdict:

Review and Decision: The Drug Licensing Authority carefully analyzes the inspector's report, assessing your adherence to Drug Rules.
Granting the License: If the report favors your application and confirms compliance, the appropriate authority bestows upon you the coveted Drug License, digitally authenticated with an official e-signature and seal.

Why choose Ecfile for obtaining your Drug License:

Guidance and Expertise:

Expert Assistance: Ecfile provides expert guidance and support throughout the application process, ensuring clarity and understanding of requirements.
Responsive Customer Service: Access to prompt and helpful customer service to address queries and concerns, aiding applicants at every stage.

Transparency and Tracking:

Real-Time Tracking: Applicants can track the progress of their application, staying informed about the status and any updates or requirements.
Transparent Procedures: Ecfile offers clarity in the application process, ensuring applicants understand each stage and necessary documentation.