Central Drugs Standards Control Organization

JR Compliance is trusted by industry leaders for our CDSCO-related compliance. The company ensures that critical licensing requirements can be met professionally and efficiently with online CDSCO services 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

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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

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

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

JR Compliance is one of the known name for BIS certification, they are well versed with processes
and guide client properly.

Kartik Shah

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.

K Narayanan

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.

P N Dhawanjewar

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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Central Drugs Standards Control Organization

CDSCO‍ Overview

Market Scenario & Stats

CDSCO Categories

Cosmetics

Medical Devices

Drugs

In Vitro Diagnostics

Challenges of Services

Benefits

Public Health Protection

Regulatory Clarity

Innovation Support

Global Standards

Service Process

Service Breakdown

Products

Products

Who needs it

Who Needs It

Requirements

Requirements

Eligibility

Eligibility

Who Needs

Who Needs

Requirements

Requirements

Why you need CDSCO

Creating Trust-Driven Relationships

Latest Resources

Insightful Perspectives, Unveiled

FAQ

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