Manufacturing Drug Licence in Uttar Pradesh - Fees, Process

A Manufacturing Drug License certificate is a form of registration or permission granted to drug and cosmetic manufacturers in Uttar Pradesh by drug control authorities. This certification is a statutory requirement under the Drugs and Cosmetics Act and Rules. Manufacturers need to submit applications under forms 24, 24A, and 24B for manufacturing drug licenses. For Schedule C and C(1) drug manufacturers in UP, the CDSCO Zonal Office in Ghaziabad is the Central Licensing Authority. Most pharma manufacturers in Noida and Ghaziabad are within easy reach of this office. For other drug categories, the UP-Drug Control Organization (Lucknow) is the State Licensing Authority.

Manufacturing premises in Uttar Pradesh must be located in approved industrial zones under the UP Industrial Area Development Act. Key pharmaceutical manufacturing zones include UPSIDC estates in Noida (Export Processing Zone, Sectors 57-68), Lucknow (SIDCUP Industrial Area, Amausi), Agra (Sanjay Place industrial area), Ghaziabad, and Kanpur (Panki and Dada Nagar industrial areas). Residential premises are not permitted for drug manufacturing. A factory licence from the UP Factories Department is also required.

Following eligibility criteria must be fulfilled to establish a drug manufacturing unit in Uttar Pradesh (UP)

• Blueprint of the manufacturing unit
• Must have a qualified or competent person
• Head of Production B.Pharm or M.Pharm with minimum 2 years of experience in pharmaceutical manufacturing
• Quality Control (QC) Head: B.Pharm or M.Pharm with analytical/QC experience
• All technical staff must be exclusively employed full-time at this manufacturing unit.
• Qualifications and experience certificates must be submitted with the application
• Proof of premises
• Details of machines
• Invoices for all necessary types of equipment

Note: All drug manufacturing premises in Uttar Pradesh must comply with Schedule M of the D&C Rules (Good Manufacturing Practices). Schedule M standards cover: manufacturing premises layout, clean room requirements, equipment qualification, raw material testing, batch manufacturing records, SOPs, and qualified technical personnel.

• Legal Compliance:Ensures compliance with the Drugs and Cosmetics Act, 1940.Demonstrates commitment to operating within the legal framework
• Quality Assurance: Involves rigorous evaluation of products and manufacturing facilities to meet specific quality standards.
• Consumer Trust: Legally approved and regulated products build consumer trust in terms of quality and safety.
• Market Access: Essential for government tenders, hospitals, and medical institutions, expanding market reach.
• Export Opportunities: A prerequisite for exporting pharmaceutical products, ensuring compliance with international standards.
• Regulatory Support: Provides access to regulatory support and updates on industry best practices.
• Business Credibility: Adds credibility in a competitive industry, assuring stakeholders of legitimacy.
• Risk Mitigation: Reduces the risk of product seizures, legal penalties, and damage to the business's reputation.

Manufacturers of drug and cosmetic products in Uttar Pradesh are required to obtain authorization from the Drug Controller General to commence operations in Uttar Pradesh. At Professional Utilities, we offer end-to-end support to ensure that your drug manufacturing license meets all regulatory requirements without any delays. If you are planning to take your drug manufacturing business beyond Uttar Pradesh such as Delhi, Haryana, or Rajasthan, it is important to consider the state’s requirements as well. For instance, you can consider drug manufacturing license in Uttarakhand to get a better understanding of regional compliance.