Manufacturing Drug License Registration in Haryana - Process & Fees

To obtain a drug manufacturing license in Haryana applicants must submit following documents:

A Manufacturing Drug License certificate is a form of registration or permission granted to drug and cosmetic manufacturers in Haryana by drug control authorities. The State Licensing Authority (SLA) of Haryana, headed by the Drug Controller, Haryana, is responsible for issuing manufacturing drug licenses for most drug categories. The Drug Controller's office operates from Panchkula, Haryana. 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 licenses for non-biological, non-Schedule X drugs. Form 27 and Form 27-B are applicable for manufacturing in states where the State Licensing Authority (not CDSCO) issues the license.

To obtain a manufacturing drug license in Haryana applicants must fulfill the following eligibility criteria:

• Manufacturing premises must comply with Schedule M of the Drugs & Cosmetics Rules, 1945
• Non-compliance with GMP is the most common reason for manufacturing license rejection or suspension.
• Manufacturing premises must be located in an approved industrial area, commercial zone, or any location specifically permitted by Haryana's state planning authority
• Production Manager/Head of Manufacturing must hold a B.Pharm or M.Pharm from a recognized university with 2+ years relevant experience
• Quality Control (QC) Head having B.Pharm or M.Pharm with analytical experience
• For Ayurvedic/Herbal manufacturing, BAMS/BUMS/relevant degree holders may qualify
• All technical staff must be employed full-time and cannot hold simultaneous positions at other manufacturing units
• Minimum manufacturing premises area requirements under Schedule M: adequate built-up area to accommodate all manufacturing, quality control, storage, and administrative functions as separate defined zones
• For oral solid dosage forms (tablets/capsules), a minimum clean room area and segregated production, packaging, and QC zones are typically required

Note: Specific area requirements vary by product type

Classification of Products under Drugs & Cosmetics Act, 1940

Manufacturing licenses in Haryana are issued for:

• Allopathic drugs (Forms 24/24-B)
• Ayurvedic, Siddha & Unani drugs
• Homoeopathic drugs, and
• Cosmetics manufacturing

• 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 Haryana must obtain a manufacturing drug license to commence operations within the state, including its major cities such as Gurugram, Faridabad, Ambala, & Hisar. Drug manufacturing license ensures that the business follows the regulatory standards of safety and quality.

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 including Haryana. Contact our experts to commence your drug manufacturing business without any legal interruptions.