Central Drugs Standards Control Organization

JR Compliance, a leading private consultancy firm, is trusted by industry leaders for end-to-end CDSCO compliance services. We ensure that critical licensing requirements are fulfilled professionally, efficiently, and without hassle through our seamless online support across India
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CDSCO‍ Overview

The Central Drugs Standard Control Organization is the national drug and medical device regulatory organization of India. An institution under the Ministry of Health and Family Welfare of the Government of India, it ensures the safety, quality, and efficacy of drugs. CDSCO makes and enforces controls and guidelines and inspects and approves clinical studies. It seeks to serve the public health interest by controlling the drug approval process and its subsequent supervision. On the one hand, this grants a fair amount of ground to the CDSCO in terms of risk management. On the other hand, the inconsistency makes it easier for the CDSCO to encourage innovation by helping maintain high-level standards.

Market Scenario & Stats

1,200+
Registered medical device manufacturers operating under CDSCO's compliance guidelines.
36%
Pharmaceutical units recently marked as non-compliant highlight the significance of regulatory compliance.
2X growth
Expected in India's regulatory filings for pharmaceuticals and medical devices over the next five years.
$27.85B
Worth of pharmaceutical exports in FY 2023-24, driven by CDSCO’s stringent quality standards.

CDSCO Categories

The Central Drugs Standard Control Organization (CDSCO) oversees the regulation of cosmetics, medical devices, drugs, and in vitro diagnostics to ensure they meet the required standards of safety, quality, and efficacy. Each category plays a vital role in safeguarding public health, making proper registration and licensing essential for market approval in India.

Cosmetics

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Medical Devices

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Drugs

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In Vitro Diagnostics

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Challenges of Services

Multiple Administrative Processes
The collections and compilations of the relevant papers are very often time-consuming and tedious. Applicants are required to source a lot of documents to avoid any mistake, which can result in a setback for the application process.
Regulatory Changes Compliance
India’s regulatory framework for medical devices and pharmaceuticals keeps changing, which makes it difficult for Indian and foreign companies to always be informed about.
Lengthy Approval Timelines
The approval process takes upto 6 to 9 months but can be affected if CDSCO raises questions or demands for more paperwork. This can be a negative influence on the market entrance for the companies.
Need for Local Representation
Foreign manufacturers marketing their products in India are bound to appoint an authorized Indian agent in order to deal with the CDSCO. Being crucial for the process, this can lead to confusion or delays.

Benefits

Public Health Protection

Guarantees that only safe and effective drugs and devices go into the public domain, that is, health towards medicines.

Regulatory Clarity

Informs the manufacturers on what is required and aids their compliance and the whole process of operation.

Innovation Support

Facilitates research and development while guaranteeing a suitable level of drugs safety and efficacy of the products in the market.

Global Standards

This brings the Indian system of regulation worldwide and brings more trade opportunities.

Service Process

01
Application Submission
The manufacturers submit applications for licensing or approval through a formalized process on the SUGAM portal.
02
Process
The submitted data is scrutinized by independent review panels of experts regarding safety, quality, and efficacy.
03
Approval and Monitoring
Once approved, the products come under compliance monitoring and inspection evaluation.
04
Public Engagement
CDSCO is highly transparent by maintaining relations with its stakeholders. Healthcare professionals and members of the community are constantly engaged.
05
Renewal & Updates
Regularly renew certifications and stay updated with CDSCO's guidelines to maintain compliance and avoid legal risks.

Service Breakdown

Who needs it

Who Needs It

Anyone in India who wants to deal in drugs, medical devices, cosmetic products and other similar products requires CDSCO licensing approval. This is important to meet CDSCO registration requirements.
Pharmaceutical Companies
Medical Device Manufacturers
Cosmetic Importers
Clinical Research Organizations

Requirements

Requirements

Applicants have to use extensive documentation at this point, including the product description, testing and quality matters, to get approval from the CDSCO.
Application Form
Technical Dossier
Fee Payment
Authorized Agent Appointment

Eligibility

Eligibility

Manufacturers and importers of diagnostic products can register themselves in CDSCO if they meet the quality, safety and efficacy standards of CDSCO. Adhering to the CDSCO certification guidelines is the key to obtaining approval.
Licensed Entities
GMP Compliance
Product Type Approval
Testing Certification

Why you need CDSCO

01
Legal Compliance
Ensure that all your pharmaceutical, medical device, and cosmetic products comply with the safety and efficacy standards of India as maintained by CDSCO, providing assurance and compliance with applicable laws.
02
Commercial Authorization
Obtain such approvals to manufacture, import or market your products in the Indian market, which will subsequently allow smooth business operations and utilization of the growing healthcare business in India.
03
International Acceptance
CDSCO certification will enhance your product's reputation worldwide, which means acceptance in global markets because of stringent regulatory standards.
04
Risk Mitigation
Avoid product recalls, legal penalties, and reputational damage by following CDSCO regulations, ensuring the safety and satisfaction of your end-users.

Creating

Trust-Driven Relationships

We have worked with JR Compliance for 2 years and with their help, we get the BIS license successfully. They always give us very good service and we really appreciate that.
Kate Tran
Published on 4 March 2024
We have outsourced the entire BIS certification responsibility of our panels to JR compliance since 2017 and their service so far has been exemplary.
P N Dhawanjewar
Published on 4 March 2024
We have been using JR Compliance services since last 3 years on various BIS related registration & testing of our various IT & electronic products. We really appreciate your full-fledged & excellent support in all respect in this matter.
Kate Tran
Published on 4 March 2024
Extremely professional company and very prompt service. I am associated with them from last 4 to 5 years. They have never disappointed us in service. Please continue to give this professional service.
Atish Bihani
Published on 4 March 2024

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FAQ

What does CDSCO stand for?
CDSCO stands for the Central Drugs Standard Control Organization. It is primarily India's authority in regulating drugs and medical devices.
How does CDSCO guarantee drug safety?
CDSCO reviews and regulates drugs for safety and efficacy before allowing them to be approved.
What are the functions of CDSCO?
CDSCO is responsible for the approval and monitoring of drugs, cosmetics and medical devices, clinical trials, security, effectiveness and quality control.
How do the manufacturers go about applying for drugs?
They submit an application requesting comprehensive documentation that will be assessed and approved.
Does CDSCO guide clinical trials?
Yes, CDSCO does offer well-defined regulations and ethical guidelines on the safe conduct of clinical trials in a compliant manner.

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