Central Drugs Standard Control Organization
The Central Drugs Standard Control Organization (CDSCO) is the national regulatory authority for pharmaceuticals and medical devices in India, operating under the Ministry of Health & Family Welfare. It is responsible for ensuring the safety, efficacy, and quality of drugs, cosmetics, and medical devices in the country.
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Overview
CDSCO plays a crucial role in drug regulation by overseeing clinical trials, new drug approvals, import & export regulations, and quality control. It also works in collaboration with state drug control organizations to enforce Drug & Cosmetic Act, 1940 and its associated rules.
As India’s primary drug regulatory body, CDSCO is aligned with international guidelines to maintain global standards in pharmaceutical manufacturing and distribution. This ensures that the drugs and medical devices available in the Indian market meet high-quality standards and are safe for consumers.
CDSCO has several zonal offices, sub-zonal offices, and port offices across the country, ensuring efficient monitoring and enforcement of drug regulations. It also regulates the licensing of blood banks, vaccines, and investigational new drugs to ensure patient safety and public health.
🌟 Key Highlights of CDSCO
✅ National Drug Regulatory Authority of India
✅ Regulates pharmaceuticals, medical devices, and cosmetics
✅ Oversees clinical trials and new drug approvals
✅ Ensures drug quality, safety, and efficacy
✅ Works under the Ministry of Health & Family Welfare
✅ Aligns with WHO and international guidelines
✅ Issues import, export, and manufacturing licenses
✅ Monitors adverse drug reactions (Pharmacovigilance Program of India - PvPI)
✅ Regulates vaccines, blood banks, and investigational drugs
Services We Offer
✅ Drug License
✅ Retail Drug License
✅ Manufacturing Drug License
✅ Wholesale Drug License
✅ Medical Device Registration
✅ CDSCO Registration
✅ CDSCO Cosmetic Import Registration
✅ CDSCO Medical Device Import License
✅ Cosmetic Manufacturing License
✅ In Vitro Diagnostic Device Manufacturing License
✅ InVitro Diagnostic Device Import License
✅ Drug Export NOC
✅ Dual-Use NOC
✅ CDSCO Test License
✅ ADC NOC
✅ CDSCO Drugs Import License
Required Documents
📌 Application Form (Duly filled)
📌 Cover Letter (Mentioning product details & purpose)
📌 Manufacturing License (For domestic manufacturers)
📌 Import License (For foreign manufacturers)
📌 Product Dossier (Specifications, composition, and quality data)
📌 Clinical Trial Reports (If applicable)
📌 Power of Attorney (For authorized representatives)
📌 Good Manufacturing Practice (GMP) Certificate
📌 Test Reports & Stability Data
📌 Label & Packaging Details
Drug License: A Complete Guide🎯
A Drug License is a legal authorization issued by the Drug Control Department under the Drugs and Cosmetics Act, 1940 to individuals or businesses involved in the manufacturing, distribution, sale, import, and export of pharmaceutical products, medicines, and cosmetics. It ensures that only qualified and authorized entities engage in the pharmaceutical trade, maintaining public health and safety.
Who Needs a Drug License?
✔ Manufacturing pharmaceutical products (allopathic, ayurvedic, homeopathic, or Unani medicines)
✔ Retail and wholesale of drugs, medicines, or cosmetics
✔ Import and export of pharmaceutical products
✔ Online sale of medicines and healthcare products
✔ Distribution and storage of medicines in hospitals, clinics, and pharmacies
Retail Drug License: A Complete Guide
A Retail Drug License is a legal permit issued by the State Drug Control Authority under the Drugs and Cosmetics Act, 1940, allowing businesses to sell medicines and pharmaceutical products directly to consumers. It is mandatory for pharmacies, chemist shops, and medical stores to operate legally in India.
Who Needs a Retail Drug License?
A Retail Drug License is required by:
✔ Pharmacies and medical stores selling prescription and over-the-counter (OTC) medicines.
✔ Standalone chemist shops providing pharmaceutical products to customers.
✔ Hospitals and clinics with an in-house pharmacy.
✔ Online pharmacies delivering medicines to customers.
✔ Healthcare stores selling Ayurvedic, Homeopathic, or Unani medicines.
Manufacturing Drug License: A Complete Guide
In the dynamic realm of the pharmaceutical industry, obtaining a Drug Manufacturing License is a pivotal step for manufacturers. Whether you’re setting up a new pharmaceutical factory or expanding your existing operations, navigating the licensing process can be intricate. With various regulations set by the State FDA and other governing bodies, it’s crucial to ensure every detail is in place. At Cropsol, we simplify this journey for you, offering comprehensive guidance and services tailored to your needs as per Drugs and Cosmetics Act. Dive into our suite of offerings and discover how we can assist you in seamlessly integrating into the pharmaceutical landscape of India.
At Cropsol, we offer a holistic suite of services tailored to the pharmaceutical industry. Our offerings include expert layout designing for optimal factory setup, meticulous documentation to ensure regulatory compliance, thorough audits to maintain the highest standards, insightful regulatory consultations, and assistance in obtaining WHO-GMP certification. With our comprehensive approach and 27+ years of experience, we aim to be your trusted partner in establishing and maintaining a successful pharmaceutical factory in India.
Documents Required for Drugs Manufacturing License in India
✔ Land Registration Certificate
✔ Partnership Deed / Article of Association
✔ Owner’s ID Proof
✔ Technical Staff Documents
✔ Fire NOC
✔ Pollution NOC
✔ Layouts
✔ Feed Challan
✔ Form 25
✔ Form 28
Types of Manufacturing Drug Licenses in India
🔹 Form 25 – Allopathic Drug Manufacturing License
🔹 Form 28 – License for Manufacturing of Schedule C & C1 drugs (Biological products like vaccines, serums, etc.)
🔹 Form 32 – Homeopathic Drug Manufacturing License
🔹 Form 37 – Loan License for Manufacturing Drugs (Contract Manufacturing)
🔹 Ayush Manufacturing License – For Ayurvedic, Siddha, and Unani Drugs
Wholesale Drug License: A Complete Guide
A Wholesale Drug License is a legal permit issued by the State Drug Control Department under the Drugs and Cosmetics Act, 1940. It allows businesses to buy, store, distribute, and sell medicines in bulk to retailers, hospitals, and other medical institutions.
Any entity engaged in the wholesale trading of pharmaceuticals, allopathic drugs, ayurvedic medicines, vaccines, or medical devices must obtain this license before starting operations.
Who Needs a Wholesale Drug License?
✔ Pharmaceutical distributors supplying medicines to retailers and hospitals.
✔ Stockists and C&F (Carrying & Forwarding) agents dealing in bulk drug distribution.
✔ Wholesalers of allopathic, ayurvedic, and homeopathic medicines.
✔ Medical institutions and healthcare suppliers involved in large-scale drug distribution
Medical Device Registration in India
Medical Device Registration is a regulatory process mandated by the Central Drugs Standard Control Organization (CDSCO) under the Drugs and Cosmetics Act, 1940. It ensures that medical devices meet quality, safety, and performance standards before being marketed in India.
This registration is essential for manufacturers, importers, and distributors dealing with medical devices, including diagnostic equipment, surgical instruments, and implants.
Who Needs Medical Device Registration?
✔ Manufacturers producing medical devices in India.
✔ Importers bringing medical devices from foreign countries.
✔ Distributors & Wholesalers dealing in medical device supplies.
✔ Hospitals & Healthcare Institutions using registered medical devices.
Categories of Medical Devices in India
🔹 Class A (Low Risk) – Thermometers, Surgical Dressings, Tongue Depressors
🔹 Class B (Low-Moderate Risk) – Blood Pressure Monitors, Nebulizers, Needles
🔹 Class C (Moderate-High Risk) – Dialysis Machines, Endoscopes, Bone Fixation Plates
🔹 Class D (High Risk) – Heart Valves, Implantable Pacemakers, Defibrillators
CDSCO Cosmetic Import Registration in India
The Central Drugs Standard Control Organization (CDSCO) regulates the import, manufacturing, and sale of cosmetics in India under the Drugs and Cosmetics Act, 1940 and the Cosmetics Rules, 2020. Any foreign cosmetic brand or importer must obtain a Cosmetic Import Registration Certificate from CDSCO before selling their products in the Indian market.
This registration ensures that imported cosmetics meet safety, quality, and labeling standards as per Indian regulations.
Who Needs a Cosmetic Import Registration?
✔ Foreign manufacturers exporting cosmetics to India.
✔ Indian importers, distributors, or agents bringing foreign cosmetics into India.
✔ E-commerce businesses & retailers selling imported cosmetic products.
Cosmetic Products Covered Under CDSCO Registration
🔹 Skin Care – Lotions, Creams, Sunscreens, Face Wash
🔹 Hair Care – Shampoos, Conditioners, Hair Oils, Hair Colors
🔹 Makeup Products – Lipsticks, Foundations, Eyeliners, Nail Polish
🔹 Fragrances & Deodorants – Perfumes, Body Mists, Roll-ons
🔹 Personal Hygiene – Soaps, Body Wash, Talcum Powder, Bath Salts
Note: If the cosmetic product is medicated or claims therapeutic benefits, it may require a drug license instead of cosmetic registration.
CDSCO Cosmetics Manufacturing in India
India’s cosmetics market has witnessed exponential growth over the past few years. With a diverse population and evolving beauty standards, there’s a rising demand for a variety of cosmetic products. However, to maintain product quality and ensure consumer safety, it’s vital for manufacturers to obtain a Cosmetics Manufacturing License.
The basic requirements for obtaining a cosmetics manufacturing license are pivotal to ensuring product quality and safety. Firstly, a well-maintained manufacturing facility is essential, ensuring a hygienic environment free from contaminants. This facility should be equipped with modern machinery and tools to facilitate efficient production. Secondly, having trained staff is crucial. These individuals should possess the necessary skills and knowledge to handle equipment, understand formulations, and ensure product consistency. Lastly, adherence to Good Manufacturing Practices (GMP) is non-negotiable. GMP guidelines ensure that products are consistently produced and controlled according to quality standards, safeguarding consumer health and maintaining product integrity.
Document Required for the Registration Process:
✔ Aadhaar Card of Owner
✔ Partnership deed/MOA AOA
✔ Rent Agreement or Registry or Conveyance Deed
✔ Chemist Documents
✔ List of Products
✔ Layout
✔ Trademark
✔ Fire NOC
✔ Pollution NOC.
Step-by-Step Process to Obtain the Cosmetics Manufacturing License
🔹 Step 1 – Application Submission on Your Behalf
🔹 Step 2 – Document Verification and Preparation
🔹 Step 3 – Facilitating Facility Inspection
🔹 Step 4 – Ensuring License Issuance
Note: If the cosmetic product is medicated or claims therapeutic benefits, it may require a drug license instead of cosmetic registration.
CDSCO Medical Device Import License🎯
When it comes to importing medical devices into India, the Central Drugs Standard Control Organisation (CDSCO) is the key regulatory authority. Every medical device entering the Indian market must comply with the regulations set by CDSCO, ensuring the safety and efficacy of the product. CDSCO is responsible for setting the standards for drugs and medical devices in India. They control the quality of imported devices and coordinate with State Drug Control Organizations. Their primary goal is to ensure that every medical device available to the Indian population meets stringent safety standards.
As per CDSCO’s new guidance, without an import license, a company cannot import Class A, B, C, and D medical devices after the specified deadline for the mandatory Import license (MD 15). This change underscores the importance of timely compliance with CDSCO regulations. Previously, manufacturers could sell their devices in India without many regulations. However, since 2017, a shift occurred. Now, medical devices entering India must adhere to specific import guidelines set by CDSCO. This procedure applies to all importers and distributors bringing medical devices from other countries into India. Moreover, every device needs classification as per CDSCO’s rules.
In essence, if you’re looking to import medical devices into India, understanding and complying with CDSCO’s regulations and getting an import license is not just recommended; it’s mandatory. Official Circular Link
Steps of CDSCO Medical Device Import License Registration
✔ Step 1 – Applicant Registration
✔ Step 2 – Diving Deeper: Medical Device Import License Application
✔ Step 3 – Application Review by CDSCO
✔ Step 4 – License Approval
Documents Required for CDSCO Medical Device Import License
✔ Manufacturing License
✔ Free Sale Certificate
✔ Free Sale Certificate (From EU, USA, Australia, Canada, Japan)
✔ ISO 13485:2016
✔ CE Certificate
✔ CE Design Certificate
✔ Declaration of Conformity
✔ Audit report of the premises
✔ Device Master File as per Medical Device Rules, 2017
✔ Plant Master File as per Medical Device Rules, 2017
In Vitro Diagnostic Device Manufacturing License🎯
An In Vitro Diagnostic (IVD) Device Manufacturing License is a mandatory authorization issued by the Central Drugs Standard Control Organization (CDSCO) under the Drugs and Cosmetics Act, 1940 and the Medical Devices Rules, 2017. This license is required for manufacturers who develop, produce, and distribute diagnostic devices used for testing biological samples (such as blood, urine, or tissue) outside the human body.
Who Needs an IVD Device Manufacturing License?
✔ Companies manufacturing diagnostic devices for disease detection and health monitoring.
✔ Manufacturers producing reagents, kits, and laboratory testing equipment.
✔ Medical device companies engaged in contract manufacturing of IVD products.
✔ Organizations developing new diagnostic technologies for commercialization.
In-Vitro Diagnostic (IVD) Device Import License
An In-Vitro Diagnostic (IVD) Device Import License is a regulatory authorization required to import IVD devices into a country. IVDs are medical devices used to perform tests on biological samples (e.g., blood, urine, tissues) to diagnose diseases, monitor treatments, or assess health conditions.
Who Needs an IVD Import License?
✔ IVD Manufacturers & Exporters – Foreign companies exporting IVDs to a regulated market.
✔ Local Distributors & Importers – Businesses importing IVDs for resale or distribution.
✔ Hospitals & Laboratories – If directly importing IVDs for in-house use (some countries allow this under specific conditions).
✔ Research Institutions – If importing IVDs for clinical trials or studies (may require special permits).
✔ Government Health Agencies – When procuring IVDs for public health programs.
Why is an IVD Import License Important?
✔ Ensures safety, efficacy, and quality of diagnostic products.
✔ Prevents counterfeit or substandard IVDs from entering the market.
✔ Compliance avoids customs seizures, fines, or legal penalties.
Drug Export NOC?
A No Objection Certificate (NOC) for drug exports is an official document issued by a national drug regulatory authority (e.g., FDA, CDSCO, EMA) certifying that the pharmaceutical product meets quality, safety, and regulatory standards for export.
Key Requirements for Drug Export NOC
✔ Product Registration – The drug must be approved in the exporting country (e.g., USFDA, EMA, CDSCO).
✔ GMP Compliance – Proof of Good Manufacturing Practices (e.g., WHO-GMP, EU-GMP, USFDA certification).
✔ Purchase Order/Agreement – From the foreign buyer/importer.
✔ Free Sale Certificate (FSC) – Proving the drug is legally sold in the home country (required by some nations).
✔ Stability & Quality Testing Data – For temperature-sensitive or high-risk drugs.
✔ Import Authorization – If the destination country requires prior approval.
Dual-Use Goods No Objection Certificate (NOC)
A Dual-Use NOC is a mandatory export control clearance required for goods, software, or technology that can be used for both civilian and military applications. Many countries regulate these exports to prevent proliferation risks (e.g., nuclear, chemical, or missile technology).
Required Documents
✔ Technical specifications of the product
✔ End-User Certificate (EUC) from the importer
✔ Purchase Order/Contract
✔ Non-Proliferation Undertaking (for sensitive items)
Why is a Dual-Use NOC Important?
✅ Legal Compliance – Avoids heavy fines or export bans (e.g., penalties under ITAR in the US).
✅ Prevents Misuse – Ensures items don’t contribute to WMDs (Weapons of Mass Destruction).
✅ Smooth Customs Clearance – Required for shipping controlled goods.
CDSCO Test License – Complete Guide
A CDSCO Test License (also called Import License for Test or Analysis) is issued by India's Central Drugs Standard Control Organization (CDSCO) to allow the import of unapproved drugs, medical devices, or cosmetics for testing, research, or clinical trials in India.
Who Needs a CDSCO Test License?
Pharmaceutical Companies – Importing new drugs for clinical trials or bioequivalence studies.
Research Institutions – Conducting studies on unregistered drugs.
Hospitals/Labs – Testing investigational drugs for patient treatment (under special cases).
Medical Device Manufacturers – Importing devices for performance evaluation.
When is a Test License NOT Required?
✔ If the drug is already approved in India.✔ For personal use (limited quantity with prescription).
✔ Samples for exhibitions (non-testing purposes).