Apply Online – Assam – Drugs License to Manufacture, Sale or Distribution

Apply Now for Drugs License to Manufacture, Sale or Distribution in Assam

Specified in Schedule C and C (1) excluding those specified in part XB and Schedule X Form 27

Eligibility Criteria

• The applicant must be a citizen of India
• The applicant must have a registered business in India
• The applicant must have a manufacturing unit in India
• The applicant must have a degree in pharmacy or pharmaceutical sciences

Documents Required for Drugs License to Manufacture, Sale or Distribution in Assam

• Copy of Partnership Deed/Memorandum and Articles of Association.(Notarized)
• Declaration of Proprietor/Partner/Director etc in affidavit. (Notarized)
• Copy of Ration Card/Passport/Electoral Card/Aadhar Card/Bank Passbook details in support of residential address & ID proof of the responsible person.
• Copies of rent/lease deed in case of Rental premises.
• Declaration of owner of the premises owned by the applicant firm or company with the documentary evidence of the ownership like registered sale deed etc and or proof of allotment of the site and or building along with latest property tax receipt.
• Plan and layout of the premises showing the installation of Machinery and Equipment preferably a blue print approved by licensed engineer and sign by the applicant who sign in the statutory form.
• Design and layout of HVAC systems, if applicable.
• Detail list of manufacturing and analytical equipment with copies of purchase bills.
• Approval of technical staff in the prescribed format with enclosed with the consent letters, copies of qualification certificate, experience certificate, proposed technical staff along with earlier approvals if any, appointment letter of the technical staff.
• Permission obtained from the Municipal Authorities/Panchayat Authorities/Certificate in conformity with Factory Act for construction and starting the unit.
• Permission from the Health Authorities/Pollution Control Board/Clearance of the area for setting up the manufacturing facility in case of license for manufacture of API the Assam Pollution Control Board clearance of API is sought.
• Clearance from Drugs Controller General (India), New Delhi in case of a New Drugs (either Bulk drug or formulation)
• Site Master File (refer para 29 of Part 1 of the Schedule M)
• Technical data in respect of the products of the manufacturer.
• Technical document to be submitted for BULK DRUGS
• Manufacturing procedure of each product.
• Flow Chart with structural formula of reaction as per Master Formula record and analytical procedure of the each applied product with mode of procurement of official reference standard or working standard.
• Official Monographs copies.
• Details of effluents generated and their treatment followed.
• Specimen labels of all applied products.
• Technical document to be submitted for Formulations
• Consolidated list of Formulations with packing particulars separately category wise viz. Tablets, Capsules,Injections etc.
• Manufacturing and Analytical procedure of each product.
• Specimen labels.
• Labels of the similar products moving in the market for formulations not included in IP.
• Declaration regarding the Brand Names of the product.
• Copies of monographs of drugs which are not included in IP.

Application Process

Registration (For First-Time Users):

• If the applicant is a first-time user, they need to click the Register tab located in the top-right corner of the page.
• The registration form requires the following details: Full Name, Mobile Number, Email ID (optional), State, and Password.

Login:

• After completing the registration, the applicant needs to log in using the credentials they created by clicking the Login tab.

Application Submission:

• Once logged in, the applicant should click the Apply Online tab.
• The applicant must select the service they wish to apply for and then click the Apply button after reviewing the Requirements tab.

Complete the Application Form:

• The applicant must fill out the application form with the required details and upload all the necessary supporting documents.

Payment of Fees:

• After completing the form, the applicant must pay the required fee to submit the application.

Acknowledgment:

• Once the payment is successfully processed, the application will be forwarded to the appropriate officials for further review.
• An acknowledgment will be generated, containing the application reference number, and this will be sent to the applicant via SMS and Email.

Service Completion Notification:

• After the service is completed, the applicant will receive an SMS and Email notification.
• The applicant must respond to these notifications to acknowledge the completion of the service.

Grant of License:

The applicant will be notified of this via SMS and Email, and they can download the license from the ARTPS portal.

After the successful completion of the service, an Application for the Grant of a License to Manufacture or Distribute Drugs (as specified in Schedule C and C(1), excluding those in Part XB and Schedule X, Form 27) will be generated.

Fees and Timeline

• License Fees of Rs. 6000 plus inspection fees of Rs. 1500 (Rs 7500)
• Mode of Payment:
• Online: The requisite fees to be paid through EGRAS payment gateway only.
• Processing time: 60 days from the date of submission of m, completed in all respect along with documents as per checklist.

Additional Resources

1. Central Drugs Standard Control Organization (CDSCO)
2. State Drugs Controller

Benefits

• Compliance with regulatory requirements
• Increased credibility and reputation
• Better market opportunities
• Protection of public health

---

Frequently Asked Questions (FAQs)