Drug CDSCO Registration

The drug registration process in India involves rigorous evaluation by the Central Drugs Standard Control Organization (CDSCO) to ensure safety, efficacy, and quality before granting approval for marketing and distribution and with a rapidly growing pharmaceutical industry, CDSCO is strongly implementing regulatory requirements on each company. So if you are starting or an established pharmaceutical company in India, get your CDSCO drug registration today.

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Service Overview

CDSCO drug registration in India is handled through the SUGAM portal. This online portal allows applicants to submit applications for various drug-related activities like import, manufacture, and clinical trials. The process involves online registration, submission of required documents, and subsequent approval by CDSCO.

‍Challenges of Filing for a Private Limited Company

Complex Procedures

The formation of the private limited company is quite complex as it requires many legal formalities.

Time-Consuming

Sometimes, its exhausting to gather all the necessary papers and fill out all necessary documents.

Share Limit

In a Private Limited Company there is a limit of 200 shareholders, with a restricted limit on share transfers.

Business Commencement

Within 180 days of registering a Private Limited Company, the certificate of commencement of business must be obtained.

‍Challenges of Filing for Drug CDSCO Registration

Regulatory complexity

The regulatory landscape in India can be challenging, with multiple agencies involved in the drug approval and registration process.

Affordability

Balancing the need for affordable drugs with maintaining profitability is a constant challenge.

Diverse socio-economic segments

Particularly in a market with diverse socio-economic segments, this impacts accessibility to essential medications.

Quality control

While India has made significant strides in improving the quality standards of its pharmaceutical products, concerns about product quality and counterfeit drugs persist.

Advantages Of Drug CDSCO Registration

Access to global market

CDSCO registration can facilitate access to the global market for certain products and services.

Efficient import

It can also streamline the import and distribution of medical devices, making the process more efficient.

Efficient patient care

For healthcare providers, CDSCO-registered medical devices provide assurance of safety and effectiveness, leading to better patient care.

Legal Protection and Risk Management

CDSCO registration ensures compliance with healthcare regulations, protecting businesses from legal liabilities.

Service Process

01

Online Registration

Applicants, typically authorized signatories or responsible persons, must register on the SUGAM portal.

02

Document Submission

Required documents, including ID proof, undertaking, address proof, and relevant licenses, must be submitted online.

03

Application Filing

Once registered, applicants can file applications for various purposes like import, manufacture, or clinical trials.

04

Query Resolution Handling

If CDSCO raises any queries, we offer prompt support in preparing responses and modifying submissions to avoid further delays.

05

Approval

CDSCO will evaluate the submitted documents and either approve or reject the application.

06

Post-Approval

For post-approval changes or additions, separate applications may be required.

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Service Process

Consultation

We will have a consultation regarding your business vision and requirements to decide on whether the private limited company fits you well.

Documentation

We will help you to do the paperwork involving preparation of the Memorandum of Association and Articles of Association.

Registration

We will then forward all the necessary documents to the Registrar of Companies as required for registration.

Support

We will always be here with you to offer assistance and advice so that you can efficiently run your private limited company.

Compliance:

We will assist you in maintaining a continuing compliance with all legal and regulatory standards.

Service Process

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Service Breakdown

Eligibility

Manufacturing Location: Only drugs manufactured in facilities compliant with international Good Manufacturing Practices (GMP) are eligible for CDSCO registration.

Market Approval in Other Countries: Drugs already approved by recognized international regulatory bodies (USFDA, EMA, etc.) are eligible for expedited CDSCO registration in India.

Indian Market Entry: Any drug intending to enter the Indian market must comply with Indian standards, requiring proper registration with CDSCO.

Safety and Efficacy Proof: Drugs must demonstrate safety and efficacy through clinical trials or bioequivalence studies to be eligible for CDSCO registration in India.

Documents

Duly apostilled/notarized copy of Free Sale.

Device Master file from the Manufacturer.

Self-attested copy of valid whole sale licence or manufacturing licence.

Constitution details of domestic manufacturer or authorized agent require for Class B, C and D.

Notarized copy of overseas manufacturing site or establishment or plant registration, by whatever name called, in the country of origin issued by the competent authority.

Notarized copy of Duly notarized valid copies of Quality Certificate in respect of the legal and actual manufacturing site (s) (wherever applicable).

Notarized copy of Certificate supporting quality management system (ISO: 13485).

Notarized Full quality Assurance Certificate/CE type examination Certificate/CE product quality asurance.

Notarized CE design Certificate File Upload.

Notarized Declaration of conformity.

Who Needs

Domestic Drug Manufacturers: Indian drug manufacturers must register their products with CDSCO to market them legally within India and comply with regulatory standards.

Foreign Drug Manufacturers: Foreign pharmaceutical companies wishing to sell or distribute their products in India need to appoint an authorized agent for CDSCO registration.

Drug Importers and Distributors: Importers and distributors must ensure that drugs are CDSCO-registered before distribution in India, ensuring compliance with Indian regulatory laws.

New Drug Developers” Developers of new drug formulations or novel products need CDSCO approval before marketing and selling them within the Indian market.

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FAQ

What is CDSCO drug registration?

CDSCO drug registration is a mandatory process for registering pharmaceutical drugs with India's central regulatory authority to ensure they meet safety and efficacy standards.

Who can apply for CDSCO registration?

Any drug manufacturer, importer, or distributor, whether domestic or foreign, can apply for CDSCO drug registration through an authorized Indian agent.

How long does the registration process take?

The registration process typically takes 6 months to a year, depending on the type of drug, documentation completeness, and compliance with regulatory standards.

Can foreign companies apply for CDSCO registration?

Yes, foreign companies can apply for CDSCO drug registration, provided they appoint an authorized Indian agent to handle the process.

What happens if CDSCO registration is not obtained?

Selling or importing unregistered drugs in India is illegal and can lead to penalties, product seizures, and reputational damage for non-compliance.

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Drug CDSCO Registration

Service Overview

‍Challenges of Filing for a Private Limited Company

‍Challenges of Filing for Drug CDSCO Registration

Advantages Of Drug CDSCO Registration

Service Process

Service Process

Service Process

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