Types of Drug Manufacturing Licenses in UP
The Drug Licensing Authority in Uttar Pradesh issues several categories of manufacturing licenses depending on the type of product and scale of operation. The most common types include:
Drug Manufacturing License (Allopathic, Homeopathic, and Ayurvedic):
Mandatory for units producing tablets, capsules, injections, syrups, ointments, and other dosage forms.Loan License:
Issued when an applicant manufactures drugs using the facilities of an already licensed manufacturing unit.Repackaging License:
Required for businesses engaged in repacking or labeling medicines without modifying the core formulation.Cosmetic Manufacturing License:
Required for units producing beauty and personal care cosmetic formulations.Medical Device Manufacturing License:
Applicable for Class A, B, C, and D devices based on risk classification under the Medical Device Rules, 2017.
Each category requires compliance with GMP (Good Manufacturing Practices), approved technical staff qualifications, and mandatory infrastructure standards.
Eligibility Infrastructure Requirements
To obtain a drug manufacturing license in UP, the applicant must meet specific eligibility conditions:
Adequate cleanroom and controlled manufacturing environment
Qualified technical staff such as a competent manufacturing chemist and analytical chemist
Valid NOCs from pollution control authorities
Proper storage areas, testing laboratories, and machinery
Quality control systems as per Schedule M of the Drugs and Cosmetics Rules
Authorities may conduct site inspections to verify the readiness and compliance of the manufacturing premises before granting approval.
Documents Required for Drug Manufacturing License in UP
The key documents typically include:
Company registration documents
Layout plan of the manufacturing premises
List of machinery and equipment
Details of technical staff
Proof of GMP compliance
Pollution NOC (UPPCB Consent)
Quality control laboratory layout and instruments list
Affidavits and declarations as per regulatory requirements
Submission accuracy is crucial, as incomplete documentation can lead to delays or rejection.
Application Process for Drug Manufacturing License
The application is submitted online through the UP Drug Licensing portal, followed by uploading documents, fee payment, and scheduling of inspections. The Drug Inspector and Licensing Authority review the application, verify compliance, and issue the manufacturing license upon approval. Processing times vary based on license category and inspection readiness.
Agile Regulatory – Expert Assistance for Drug Manufacturing Licensing in UP
Agile Regulatory provides end-to-end support for businesses seeking Drug Manufacturing Licenses in Uttar Pradesh. Our services include documentation preparation, online application filing, layout planning assistance, technical guidance for GMP compliance, and coordination with authorities for inspections and approvals. With extensive experience in pharma regulatory consulting, we ensure a smooth, accurate, and timely licensing process for manufacturers looking to set up or expand operations in UP.
