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- The Central Drugs Standard Control Organisation (CDSCO) is maintaining the safety and quality of effective drugs being marketed in India.
- It provides drug safety notices for pharmaceutical products that are discovered to be “Not of Standard Quality (NSQ), spurious, or potentially damaging.”
- It runs through the Pharmacovigiliance Programme Of India, which collects and analyzes the reports submitted regarding the adverse reactions related to medications.
- There are reporting systems for adverse effects that healthcare professionals, companies, and the general public can use.
- There may be recalls, warnings, regulatory measures, or use restrictions associated with safety notices related to the use of drugs.
Introduction
The Drug Safety Alert System in India is managed by CDSCO in order to ensure drug safety, quality, and efficacy in India. Drug Safety Alert System is a key part of monitoring risks associated with drugs in order to identify, evaluate, and communicate risks associated with medicines. Drug Safety Alert System in India, in association with PvPI, monitors adverse reactions associated with medication in order to ensure public safety via warnings regarding their safety. For this purpose, it also monitors adverse drug reaction reporting.
What is a CDSCO License?
CDSCO License in particular pertains to the regulatory approval given by the Central Drugs Standard Control Organisation that approves the manufacture, sale, distribution, and import of drugs, cosmetics, and medical devices in the country. This also guarantees the product adheres to the set criteria of safety, quality, and efficacy contrary to the Drugs and Cosmetics Act, hence the need for the approval of the products in respect of the health of the Indian population.
Key Points:
- The license by CDSCO is a drug, cosmetic and medical device regulatory mandatory approval in India by the Central Drugs Standard Control Organization.
- It approves a business to manufacture, import, sell, or distribute certain controlled healthcare products.
- It ensures products meet the prescribed standards of safety, quality, and efficacy under the Drugs and Cosmetics Act.
- Approval by CDSCO is based on evaluation of technical documentation, testing data, and compliance.
- Holding the CDSCO license is mandatory to ensure legally proper market entry in India and consumer protection .
Why is CDSCO Certification Mandatory
CDSCO Certification: CDSCO Certification is a prime need for ensuring that the drugs, devices, or cosmetic products being marketed in India are safe, effective, and of good standard. The CDSCO Certification is a very important step for controlling the manufacturing or import or distribution process for drugs or cosmetics through both the authority of the Drug & Cosmetic Act and for ensuring responsibility.
Key Reasons:
- It ensures the safety, quality, and efficacy of the drugs, medical devices, and cosmetics sold within India.
- This is made possible by the Central Drugs Standard Control Organisation, which ensures that no adverse or below standard products reach the market.
- Certification enforces the Drugs and Cosmetics Act and Rules.
- It ensures that it is a legal mandate for the manufacturing, import, and distribution of the regulated products.
- It protects public health and ensures that consumers gain confidence in products through CDSCO certification.
Importance and Benefits of CDSCO Certification
| Importance | Benefits |
| It offers safety for the general public through the regulation of drugs, medical devices, and cosmetics. | It gives legal validation for the production, import, and distribution of products in Indian marketplaces. |
| Ensures that there is compliance with Drugs & Cosmetics Act & Rules. | Builds trust with consumers and healthcare professionals. |
| It prevents the flow of unsafe, spurious, or substandard goods. | Improves market acceptance and business credibility. |
| It permits regulatory control by the Central Drugs Standard Control Organisation (CDSCO). | Minimizes risks of penalties for non-compliance and product recalls. |
| It ensures a standardized quality in the healthcare sector in India. | It aids in the sustained growth and conduct of the business by being regulatory compliant. |
Step-by-Step Process of CDSCO Certification
Step1:Documentation
- Define product category (drug, medical device, cosmetic, IVD)
- Technical dossier and product information preparation
- Obtain company registration documents and manufacturing/import licenses
- Compliance with CDSCO documentation requirements
Step2:Product Testing
- Send product samples to NABL-accredited/BIS-recognized
- Perform safety, performance, and quality tests
- Collect valid test reports
- Ensure adherence to CDSCO requirements
Step3:Application Submission
- Register yourself on the CDSCO SUGAM portal
- Submissions of Applications by CDSCO
- As mentioned in various
- All necessary documents and test reports have been uploaded
- Pay the mandated CDSCO government fees
Step4:Scrutiny and Inspection
- CDSCO evaluates submitted documentation
- Technical assessment: Product details
- Manufacturing site inspection can be performed
- Queries/ Clarifications raised, if any
Step5:Grant of License
- Application approved by Central Drugs Standard Control Organization
- CDSCO License / Registration Certificate issued
- Approved product for manufacturing/import and sale in India
- Validity of the license renewable as per regulatory terms
Documents Required for CDSCO Certification
| Category | Documents Required |
| Business Documents | Business license/registration, ISO certificate, organizational details |
| Manufacturer Details | Factory layout, process flow chart, machinery list, production details |
| Product Documents | Product specifications, component list, user manual, model details |
| Testing Documents | Test report from BIS-recognized lab, sample details, test request form |
| Legal & Compliance | Authorization letter, brand ownership proof, trademark certificate (if any) |
| Import/Foreign Manufacturer (If applicable) | AIR (Authorized Indian Representative) details, contract agreement, overseas manufacturer documents |
Timelines, Costs, Validity & Renewal
- Timelines: Processing of CDSCO certification typically consumes 20-30 working days, of which 7-15 days are required for product testing, subject to the nature of the product and resolution of inquiries.
- Expenses: Fees charged by the government differ according to product types, whether it be a drug, medical device, cosmetic, or import product. Other costs can also be incurred depending on inspection, retesting, or changing documentation.
- Validity:In most cases, a CDSCO license/registration certificate is issued with a validity period of 2 years, depending on several regulatory conditions.
- Renewal: The process of renewing a license has to be carried out before its expiry date to prevent a suspension or lapse in the license.
- Renewal Requirements:A set of updated documents, formatted test reports (if needed), and the payment of predetermined fees are the necessities for successful renewal under the Central Drugs Standard Control Organization.
Why Choose Diligence Certifications
Certifications in Diligence are a reliable source of compliance and certification consulting, providing start-to-end support for regulatory approval in India. The professional team, customized counseling, and transparent procedures at Certifications in Diligence Certifications ensure businesses get regulatory approvals on time, with full compliance with the necessary requirements, gaining them time, cost, and effort savings.
Conclusion
Selection of a professional consultancy service for certification would help by ensuring ease, accuracy, and timely completion of the entire compliance procedure. Of course, professional advice would provide complete guidance to prevent any mistakes and therefore reduce the chances of delays by ensuring full compliance with regulatory requirements.
Frequently Asked Questions (FAQs)
What is CDSCO?
Central Drugs Standard Control Organisation (CDSCO) is the national regulatory authority for the country when it comes to drugs, devices, & cosmetics.
What is a Drug Safety Alert System?
It is a way to identify, evaluate, and communicate risks associated with unsafe and/or substandard medications in India.
What are NSQ drugs?
NSQ (Not of Standard Quality) medicines are the medicines that do not comply with the desired standards of quality. They do not conform to the standards
Who issues drug safety alerts in India?
CDSCO announces drug safety alerts based on some pharmacological and biological findings.
What is PvPI?
The PvPI deals with the monitoring of adverse drug reactions in India.
Who can report an adverse drug reaction?
ADRs may also be reported by any healthcare professional, pharmaceutical industry, or the public.
Is the CDSCO certification necessary?
“Yes, it applies for manufacture, import, and sale of regulated products under the laws of India.”
The list of products that need to be approved by the CDSCO:
Approval from CDSCO is required in case of Pharmaceuticals, Medical Devices, Cosmetics, In-Vitro Diagnostic Devices.
WHAT CAN SUCCEED A SAFETY ALERT?
Safety alerts are like recalling, warning notifications, limitations to use, and government actions.
How Long is the duration for CDSCO certification?
This will take approximately 20 to 30 working days.
