Trusted Drug License Consultant in Baddi Himachal Pradesh
Your Trusted Partner for Regulatory Compliance and Plant Setup
The pharmaceutical industry is subject to stringent regulations to ensure the safety and efficacy of drugs. Compliance with the Drugs & Cosmetics Act and Rules of India is paramount for any pharmaceutical manufacturing enterprise. MedDev Experts offers comprehensive consultancy services to guide businesses through the intricate process of setting up pharmaceutical manufacturing plants and obtaining necessary approvals.
Turnkey Services for Pharmaceutical Industries
PROJECT PLANNING
Feasibility Study, Site Selection, Scope Definition, & Regulatory Compliance.
FACILITY DESIGN
Conceptual Design, Detailed Engineering, Facility Layout & Utility Systems Design
CONSTRUCTION
Equipment Selection, Procurement, Construction & Installation
VALIDATION
Validation Master Plan, Qualification e.g. DQ, IQ, OQ, & PQ
COMMISSIONING
System Integration, Testing and Commissioning, Personnel Training & Startup
DOCUMENTATION
GMP Compliance, Preparing project documentation for regulatory compliance
REGULATORY
Obtaining necessary licenses and permits for facility operation
HAND OVER
Transferring the facility to the client, including training and support
MedDev Expert, India's Leading Drug License Consultant
Secure Your Drug License with Our Expert Guidance
Drug Manufacturing License
A Drug Manufacturing License is a mandatory permit issued by the State Drug Controller in India to manufacture, pack, or repack drugs. It ensures adherence to Good Manufacturing Practices (GMP) and quality standards. Obtaining this license involves meeting stringent requirements related to infrastructure, personnel, and manufacturing processes.
- FORM 25 License to manufacture for sale or for distribution of drugs other than those specified in Schedules C and C(1) and X.
- FORM 25F License to manufacture for sale or for distribution of drugs specified in Schedule X and not specified in Schedules C and C(I).
- FORM 28 License to manufacture for sale or for distribution of drugs specified in Schedules C and C (1) excluding those specified in Schedule X.
- FORM 25A Loan License to manufacture for sale or for distribution of drugs other than those specified In Schedules C and C (1) and X.
- FORM 28A Loan Licence to manufacture for sale or for distribution of drugs specified in Schedules C and C (1) excluding those specified in Schedule X.
- FORM 25B License to repack for sale or distribution of drugs being drugs other than those specified in Schedules C and C (1) excluding those specified in Schedule X.
- FORM 28D License to manufacture for sale or for distribution of Large Volume Parenterals/Sera and Vaccines/recombinant DNA (r-DNA) derived drugs specified in Schedules C and C(I) excluding those specified in Schedule X.
- FORM 28DA Loan License to manufacture for sale or for distribution of Large Volume Parenterals/Sera and Vaccines/recombinant DNA (r-DNA) derived drugs excluding those specified in Schedule X
Drug Test License
A Drug Test License authorizes a laboratory to conduct tests on drugs and cosmetics. It’s essential for quality control and ensuring product safety. Laboratories must meet specific criteria for infrastructure, equipment, and personnel to obtain this license. The license is granted by the State Drug Controller.
- FORM 29 Test License to manufacture drugs for purposes of examination, test or analysis
Drug Import License
A Drug Import License is necessary for importing drugs into India. It’s issued by the Central Drugs Standard Control Organization (CDSCO). Importers must comply with various regulations, including product registration, customs clearance, and quality control standards. The license ensures that imported drugs meet Indian safety and efficacy requirements.
- Form 10 License to import drugs (excluding those specified in Schedule X) to the Drugs and Cosmetic Rules, 1945
- Form 10A License to import drugs specified in Schedule X to the Drugs and Cosmetics Rules, 1945
- FORM 45 Permission to import Finished Formulation of a New Drug.
WHO GMP Certification
While not strictly a license, WHO GMP certification is a globally recognized standard for drug manufacturing. It signifies adherence to stringent quality management systems. Obtaining this certification enhances a company’s credibility and facilitates market access in various countries. It’s a voluntary certification but is increasingly becoming a prerequisite for export markets.
Drug Retail & Wholesale License
A Drug Retail or Wholesale License permits the sale and distribution of drugs. Retail licenses are issued to pharmacies, while wholesale licenses are granted to drug distributors. Both licenses are governed by state drug control authorities. License holders must comply with regulations related to drug storage, display, and record-keeping.
- Form 20 Licence to sell, stock or exhibit or offer for sale, or distribute drugs by retail other than those specified in Schedules C, C(1) and X.
- FORM 20F Licence to sell, stock or exhibit for sale or distribute by retail drugs specified in Schedule X.
- FORM 21 Licence to sell, stock or exhibit or offer for sale, or distribute by retail drugs specified in Schedules C and C (1) excluding those specified in Schedule X.
- Form 20B Licence to sell, stock or exhibit or offer for sale, or distribute by wholesale, drugs other than those specified in Schedules C, C(I) and X.
- FORM 20G Licence to sell, stock or exhibit or offer for sale, or distribute by wholesale drugs specified in Schedule X
- FORM 21B Licence to sell, stock or exhibit or offer for sale, or distribute by wholesale drugs specified in Schedules C and C (1) excluding those specified in Schedule X.
- Form 20BB Licence to sell, stock or exhibit or offer for sale by wholesale, or distribute drugs other than those specified in Schedule C and Schedule C (1) from a motor vehicle.
- FORM 21BB Licence to sell by wholesale or to distribute drugs specified in Schedule C and Schedule C (1) from a motor vehicle.
Drug Manufacturing License
A Drug Manufacturing License is a mandatory permit issued by the State Drug Controller in India to manufacture, pack, or repack drugs. It ensures adherence to Good Manufacturing Practices (GMP) and quality standards. Obtaining this license involves meeting stringent requirements related to infrastructure, personnel, and manufacturing processes.
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Let MedDev Experts guide you through the process.