Manufacturing Drug License Registration in Delhi - Fees & Documents

A Manufacturing Drug License certificate is a form of registration or permission granted to drug and cosmetic manufacturers in Delhi 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. Delhi has a unique dual-authority structure for manufacturing drug licenses: Delhi Drug Control Department (State Licensing Authority) issues manufacturing licenses for non-scheduled products and state-licensed drugs; CDSCO (Central Drugs Standard Control Organisation), headquartered at Kotla Road, New Delhi, directly issues manufacturing licenses for Schedule C and C(1) products (injectables, sera, vaccines, biologicals, and specified drugs).

Applicants must fulfill the following eligibility criteria to establish a drug manufacturing unit in Delhi:.

• All drug manufacturing premises in Delhi must comply with Schedule M of the Drugs & Cosmetics Rules, 1945. GMP compliance is the primary criterion verified during factory inspection by Delhi Drug Control Department or CDSCO
• Premises must have separate production, testing, and storage zones; validated equipment; Standard Operating Procedures (SOPs)
• Production Manager having B.Pharm or M.Pharm with minimum 2 years manufacturing experience.
• QC Head with B.Pharm or M.Pharm with laboratory/analytical experience.
• All technical staff must be exclusively employed at this manufacturing unit (cannot hold same position at another firm)
• A Qualified Person (QP) or Head of Production must be a graduate in pharmacy (B.Pharm or higher) with at least 18 months of practical experience at a licensed pharmaceutical manufacturing unit.
• Details of machines used at the manufacturing unit along with purchase invoice for all necessary types of equipment

• 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 must obtain authorization from their drug manufacturing license to operate their manufacturing unit in Delhi without any hassle. It is a necessary procedure for drug and cosmetic manufacturers, requiring approval from the concerned authorities.

Getting the license at the appropriate time will help you avoid complications with the law, delays in production, and financial losses. With expert support from Professional Utilities, you can obtain your manufacturing drug license in Delhi and across PAN India. Contact our experts to commence your drug manufacturing business without any legal interruptions.