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Get your products BIS certified to ensure compliance with Indian standards and build customer trust. We handle end-to-end certification, testing, and documentation for manufacturers,importers, and exporters.
Our expert guidance and support help you stay compliant and gain a competitive edge in the market — your satisfaction is our commitment
Our team simplifies the application process and provides tailored support to meet your EPR compliance requirements effectively.
Our expert guidance and complete support help you achieve LMPC Certification smoothly, giving your business a competitive edge and long-term credibility.
Our comprehensive support ensures smooth WPC compliance and gives your business a competitive edge while prioritizing your long-term success.
Global Approvals help your products meet international regulatory standards, allowing smooth entry into multiple global markets.
Our expert guidance and end-to-end support help you achieve TEC certification smoothly while gaining a competitive edge in the market.
With 25+ years of experience, we help you meet ARAI compliance smoothly and gain a competitive edge in the automotive market.
Struggling to secure BEE Certification in India? Our specialists make the process easy and help you boost customer trust through verified energy ratings.
ISO Certification guarantees your business meets global standards for quality, safety and efficiency.
Flying without proper registration or clearance can lead to fines, drone seizure, and legal action, making regulatory compliance essential for safe and lawful drone operations.
Our expert guidance ensures your steel imports meet Ministry of Steel and BIS standards, helping you stay compliant and streamline the approval process.
How to apply for BIS Certification in 5 Mins!

Apart from product certification, BIS is responsible for framing Indian Standards, conducting laboratory testing, and ensuring consumer protection.

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Some items must be certified before they get released mysteriously made for select goods like cables, switches, cement, gas cylinders, etc.

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CRS Certification- A Complete Guide for Electronic Product Compliance in India

It ensures electronic products conform to Indian Standards (IS).Covers 70+ products including laptops, phones, adapters, TVs, and batteries.

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Hallmarking Certification- Everything You Must Know About Gold and Silver Purity Compliance

Hallmarking Certification is mandatory in India for gold and silver jewellery.The BIS 916 Hallmark confirms 22K gold purity.Silver Hallmarking is compulsory for certain grades like BIS 925.

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FMCS Mark Certification- A Guide for Global Brands Selling in India

FMCS Mark Certification is a BIS-led approval process that enables foreign manufacturers to sell regulated products in the Indian market.

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ECO Mark Certification : Your Complete Guide to Global Eco-Labeling Standards

It helps manufacturers build trust and create a compliance framework. It also markets to eco-conscious consumers.This guide will detail eligibility, provide information on the application procedure, and outline benefits of certification to ISO 14024.

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It is governed by NABL under the Quality Council of India (QCI).Accreditation enhances trust among regulators, industries, and global partners.

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The World Manufacturer Identity (WMI) is a globally recognized code used to identify vehicle manufacturers. WMI registration ensures traceability, compliance, and global brand recognition for automotive makers.

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BIS Scheme X Certification - Process, Documentation and Fees Structure- Updated Guide 2025-2026

Stay ahead of regulatory changes with BIS Scheme X Certification. Now extended to September 1, 2026, under the omnibus technical regulation order 2024. Get complete certification support from Diligence Certification.

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Get your CDSCO registration

Get full assistance for CDSCO registration, medical device import licenses, and cosmetic import licenses with Diligence Certifications. Our expert guidance and comprehensive support ensure your compliance, helping you gain a competitive edge in the market. Your satisfaction is our commitment!

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Drug License

Diligence Certifications is a top-tier name in drug licensing and provides topmost service and knowledge support to all sizes of pharmaceutical companies. Our seasoned team understands the global regulations and has seen several success stories.

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Give Your Products cosmetic license

Having trouble securing Cosmetic License certification in India? Let our ISI certification experts assist you in achieving it and boosting your credibility!

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Get battery waste Compliance Certification for Your Products

Need assistance in Battery Waste Certification? Our experts guide you through every step to ensure smooth and compliant processing.

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Get Plastic waste Compliance Certification for Your Products

Diligence Certifications help businesses go a long way in environmental compliance matters through their management of plastic waste compliance. It rallies your commitment to reducing environmental impacts, increasing your recycling, driving circular economies and, hence, building credibility with consumers as citizens of a wider world contending against plastic pollution with angels and regulators.

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Drug License – Process, Eligibility, and Compliance Requirements

  • A Drug License is a legal permission granted under the Drugs & Cosmetics Act, 1940 to sell ,distribute, manufacture or import medicines
  • As per the Drugs Act, Drug License is issued by CDSCO and designated State Drug Control Departments
  • Retail License, Wholesale License, Manufacturing license, Import License
  • The Drug License is valid for 5 years and can be renewed before expiry
  • You must file documents such as proof of premise, pharmacist certificate, ID & address proof, layout plan of premises, affidavit
  • We can help ensure you comply with regulations while keeping consumers safe and allowing you to do business

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Drug License Info.

Importance

Types Of Drug License

Procedure for drug License

Required Documents for Drug License

Challenges and Consederations

Timeline for Getting A Drug License in India

why choose us?

FAQ

Introduction

Pharmaceutical industry, one of the most significant pillars of healthcare, functions strictly under drug laws that exist in the country to determine if the medicines are safe or efficacious for use. It is drug licensing, which authorizes a person or entity to engage in activities such as manufacture, distribute or sell pharmaceutical products.

A drug license is a kind of permission issued by a government regulatory authority, like the CDSCO (Central Drugs Standard Control Organization) in India, or the FDA (Food and Drug Administration) in the United States, to allow an individual or organization to manufacture, sell, distribute, or dispense medicines. Without it, those doing any of those could not do so legally and it is a danger to public health

Drug License (CDSCO Certification)

What is Drug License?

A Drug License is a government-issued legal authorization under the Drugs and Cosmetics Act, 1940 which permits a business or individual to sell, stock, distribute, manufacture or import medicines and other healthcare products in India.

It guarantees that qualified and authorized persons handle drugs with complete protection of quality standards concerning public health and safety. The Drug License is granted by the Central Drugs Standard Control Organization (CDSCO) and respective State Drug Control Departments as applicable based on the business type.

Importance of Drug License

Imagine a world where there exists no rule about drugs. The scenario will be full of potentially dangerous and ineffective drugs drifting in the markets. This scenario is where CDSCO and drug licensing would want to come. These licenses and certifications should be acquired for making sure of:

  • Consumer Safety: The drugs would go through tests before reaching them on how safe and how effective they are.
  • Quality Assurance: Quality has been set at a huge level so that they are manufactured and consumed at par.
  • Following the Law: Operating legally and morally, within the framework set by the Indian government.
  • Market Access: A valid drug license is an essential prerequisite for the manufacture, distribution, and sale of drugs in India.
  • Trustworthiness: Generates trust between the consumer and the health promotion persons through commitment to quality and safety.

How CDSCO Regulates Drugs and Clinical Trials in India?

It is the Central Drug Standard Control Organization that is a national regulation drug control body of India that operates under the Directorate General of Health Services Ministry of Health & Family Welfare. The CDSCO will be involved in:

  • Approving new Drugs: Safety and efficacy data of novel drugs to be evaluated, before launching them into the Indian market.
  • Regulating Clinical Trials: Clinical trials will have to be conducted under ethical and scientific rigor.
  • Standards for drug manufacturing: Establishment and enforcement of Good Manufacturing Guidelines (GMP).
  • Import Licenses: Control the import of drugs into India.
  • Drug Quality: Inspect drug samples, conducting surveillance to prevent spurious drugs entering the market.

Types of Drug License

The specific type of drug license is determined according to your business activities. Some of the common types are:

  • Manufacturing License: Required for the manufacture of drugs and includes possible categories such as allopathic, ayurvedic, homeopathic, and cosmetic products. Specific requirements concerning the manufacturing of a specific product are based on the category, structure, equipment, and manpower.
  • Sale License Generally: Under this category, one must apply either as a retail pharmacy or wholesaler supplying to retailers to get a license for selling drugs. Storage, qualified personnel (pharmacist), and records keep are all issues included.
  • Import License (CDSCO Import License): This is specific CDSCO License for import of drugs into the country with raw materials and medical devices. Very tight regulations apply to this regarding registration of the product and documents required for the inspection. This is an area where Diligence Certifications can do a great deal for you.
  • Blood Bank License: It is mandatory for a blood bank to operate and has well-established quality control and safety measures.
  • Restricted License: This classification is attributed to the fact that pharmacist qualification is not needed for selling drugs, usually in underdeveloped rural areas.

Key Features

There are a number of critical issues that require to be paid attention when applying for a drug license and its maintenance.

  • Licensing Definitions: Licence types cater specifically to activities. The Right License should thus be ascertained based on the business operation, e.g, retail, wholesale, or manufacturing of drugs. Each license has different eligibility for applicants and process of application.
  • Eligibility Criteria: Review the detailed guidelines for eligibility by the concerned authority. These generally regard:
  • Premises: Space standards, storage conditions (temperature, humidity) and hygiene.
  • Technical Staff: Qualification and experience of pharmacists or other qualified professionals.
  • Financial Soundness: Proof of adequate financial resources to operate the business responsibly.

Required Documents for Drug License

  • Create an accurate and complete set of documents. Items usually required include:
  • Application forms
  • Proof of ownership or lease of premises
  • Site plan of premises
  • Qualification certificates and experience letters of technical staff
  • Purchase invoices for equipment and machinery (for manufacturing licenses)
  • No Objection Certificate (NOC) from relevant authorities

Conformity with Good Manufacturing Practices (GMP)

It is significant for manufacturing licensing. GMPs make sure that the drugs are manufactured and controlled continuously according to quality standards.

  • Regular inspections and compliance: Regular inspections by regulatory officers are conducted for licensed companies. Compliance to all the rules, including the storage conditions for record keeping and handling, guarantees the renewal of licenses and protection against fines.
  • Record Maintaining: Maintenance of detailed and accurate records is mandatory for all drugs received, sold, or stored in the facility. Such records facilitate traceability during product recalls and in cases of investigations.
  • Changes: Pharmaceutical regulation undergoes changes continuously, and changes in Laws, Guidelines, and Notifications must all be updated from time to time.

Challenges and Considerations:

  • Regulatory Complexities: Different segments of the same country will have different regulatory environments within three to four states or jurisdictions, thus making the maze difficult that companies have to navigate.
  • Lengthy Application Procedure: It is a very long and cumbersome process and very well needs to be planned ahead and prepared in order to achieve a drug license.
  • Cost for Compliance: The heavy economic burden of the requirements pertaining to premises, equipment, and manpower would be quite burdensome.
  • Maintaining Compliance: It impacts resources quite heavily for maintaining compliance given the changing scenario of the regulatory affair.

Timeline for Getting a Drug License in India

Phase 1: Preparation & Application (1 to 2 Weeks)

  • Documents Collection: Obtain all the documents required for drugs applications, including company registration, premises documents, educational qualification certificates for pharmacists/chemists, and compliance certificates.
  • License Type Selection: Determine the license that best suits your business activity, whether manufacturing, sales or import, etc.
  • Online Application: Submit the application for drug license online along with all relevant documents/fees as per the State Licensing Authority online portal.

Phase 2: Inspection & Verification (4-8 Weeks)

  • Premises Inspection: The Drug Control Officer shall inspect the premises with regard to infrastructure and storage facilities, and GMP or GSP compliance, respectively.
  • Verification of Documents: The licensing authority will authenticate and validate all documents.

Phase 3: Issuance of License (2-4 Weeks)

  • Review & Approval: Licensing authority will review the inspection report before verifying the documents.
  • Issue License: The applicant shall be issued the drug license upon satisfactory review.

Time Estimate Total: 7 to 14 weeks (This is a rough estimate; actual time may vary depending on state, type of license applied for, and efficiency of the respective licensing authority.)

Why Choose Diligence Certifications?

Navigating this terrain could prove to be quite challenging if not difficult: the terrain of drug licensing and CDSCO certification. This is the moment that one would fall back on Diligence Certifications as their strategic partner, offering professional assistance and guidance through the entire process.

What Role Diligence Certifications Play in the Certification:

  • Expert Consultation: Diligence provides detailed consultancy for the realization of your specific needs and its orientation toward what is most suited for the particular license requirements.
  • Documentation Support: Diligence Certifications will provide specific support in documentation preparation and compilation for your application.
  • Application Filing & Follow-up: Application would be filed through Diligence Certifications, and follow-up with the licensing authorities would be done to further speed up the procedures.
  • GMP Compliance Support: Diligence Certifications would provide guidance and assistance to implement Good Manufacturing Practices (GMP) for compliance with regulatory requirements.
  • Import License: Also, Diligence Certifications will facilitate CDSCO Import License applications through product registration, documentation and liaison with CDSCO.
  • Training & Education: Training programs will be organized that will enlighten your team on the regulatory requirements and best practices.
  • Liaison Services: Communication between your company and CDSCO will be facilitated to ask questions and to clear up problems.

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Frequently Asked Questions

A Drug License is an official authorization that provides businesses or individuals permission to sell, manufacture, distribute, or import medicines and other healthcare products in compliance with regulations set by the government.

Drug Licenses are issued by the Central Drugs Standard Control Organization (CDSCO) and State Drug Control Authorities

The major types of Drug Licenses include Retail Drug License (RDL), Wholesale Drug License (WDL), Drug Manufacturing License, and Drug Import License.

Any business or individual engaged in the sale, distribution, or manufacture of medicines can apply for a drug license. To be eligible to apply, a be able to apply, an applicant needs to have a qualified pharmacist or competent person in charge of the drug license.

The important documents needed are (a) proof of (business) premises, (b) pharmacist registration, (c) id/address proof, and an affidavit of non-conviction.

A drug license is valid for 5 years and a licensee must renew a drug license before it expires.

A Drug License allows medicines to be sold and manufactured in a safe manner to protect public health and allows a business to manage its legal obligations.

Possession and/or selling of unauthorized medicines can create serious penalties, including significant fines, jail time, suspension of business activity and civil penalties.

No, each location must have separate Drug License.

A renewal application must submitted online/offline to the appropriate authority with updated documents, prior to the expiry of the license.