#Cdsco cosmetic import registration in India

[online-legal-advisors]

Innovations in Cosmetic Manufacturing: What’s Changing in 2024?

The cosmetic industry is continuously evolving. As consumer preferences shift and new technologies emerge, cosmetic manufacturing must also adapt to meet the growing demand for innovative, safe, and sustainable beauty products. In 2024, the cosmetic manufacturing sector is witnessing groundbreaking changes driven by advancements in technology, sustainability practices, and changing consumer trends. Visit - https://guest-post.org/innovations-in-cosmetic-manufacturing-whats-changing-in-2024/

[johnwilson88]

Cosmetic Import to India: Online License Acquisition with FDApals.com!

Embarking on the journey of cosmetic importation to India can be daunting, but with FDApals.com, it's a streamlined process. Our online platform revolutionizes license acquisition, offering a user-friendly interface for businesses to initiate and complete the process effortlessly. Say goodbye to paperwork hassles and bureaucratic delays; with FDApals.com, obtaining your cosmetic import license becomes a seamless experience.

Our team of experts provides personalized guidance throughout the process, ensuring that your application meets all regulatory requirements. From document preparation to submission and follow-up, we handle it all, keeping you informed every step of the way. With FDApals.com, businesses gain access to invaluable resources and insights, empowering them to navigate the complexities of the Indian cosmetic market with confidence.

Don't let regulatory hurdles hinder your entry into the lucrative Indian cosmetic industry. Partner with FDApals.com and unlock the potential of this vibrant market, all from the convenience of your computer or mobile device. Streamline your cosmetic importation process today with FDApals.com.

[corpseedgroup]

The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory body for medical devices. An import license is required for importing medical devices CDSCO India is responsible for issuing these licenses. The importer must apply for the license, submit the necessary documents and pay the fees. The documents include information about the device, its manufacturer, testing reports, and registration certificates.

[medwisdom]

What is Drug Regulatory Affairs & Why It is Important?

Regulatory Affairs is the crucial department for Pharmaceutical, Medical Device, Cosmetics, Herbal, and Food Industry that must comply with the global regulatory framework to ensure safety for human use. Regulatory Affairs helps industries and companies at every stage of product life cycle and to get ready with legal and technical documents and dossier in order to get market approval and registration of products in both domestic and International markets. This is a small guide to drug regulatory affairs about the importance, goal, and functions of pharmaceutical regulatory affairs in India and global market.

What Is Drug Regulatory Affairs?

Drug regulatory affairs (DRA) is a discipline in pharmaceutical sciences that ensures quality, safety, and efficacy of drug products. Drug regulatory affairs in India involves the preparation and submission of documents for drug product approval and marketing for commercial purposes. DRA professionals act as the bridge between the pharmaceutical industry and the regulatory authorities like Central Drug Standard Control Organization (CDSCO) for India, United States Food and Drug Administration (US FDA) for US, and European Medicine Agency (EMA) for Europe. 

Primary Goal of Drug Regulatory Affairs

Drug regulatory affairs primary goal is to ensure that drug product meets regulatory standard set by the country specific regulatory authorities for marketing of medicine. Regulatory authorities are responsible for safeguarding the public health by setting the regulatory framework. Therefore, before marketing of drug product, it must follow the regulatory standard, ensuring the safety, quality, and efficacy of drug product in order to 

Importance Of Drug Regulatory Affairs In Pharmaceutical Industry?

Pharmaceutical regulatory affairs plays an important role in ensuring regulatory compliance of drug products with the regulatory framework of specific countries. Pharmaceutical regulatory affairs  is essential for safeguarding public health by making assurance that only safe and effective drugs reaches to consumers. DRA fosters innovation by guiding companies to overcome hurdles of complex regulatory pathway of product approval, ensuring timely market access.

What Are The Benefits Of Drug Regulatory Affairs?

Pharmaceutical regulatory affairs have several benefits, some of the common are listed below:

Drug safety and efficacy assurance 

Regulatory compliance of drug products with the required standard 

Enhances product approval and market acceptance 

Smooth market access on time

Monitor safety of drug through post-marketing surveillance (Pharmacovigilance)

Ensures high quality and safety drug available to consumers, promoting public health 

Establish consumer trust through maintaining  transparency and good regulatory practice 

 What Is The Role of Drug Regulatory Affairs In Drug Development?

Role of drug regulatory affairs in drug development is crucial as it is integral to every phase of drug development, ensuring smooth changes from laboratory to marketing and commercialization. Some key points of pharmaceutical regulatory affairs roles are as follows:

Clinical study design and safety monitoring of drugs

Regulatory submission of application (IND, NDA, AND ANDA) for product approval and marketing venture 

Labelling and packaging of drug products 

Product lifecycle management from initial registration to renewal of product 

Major Functions of Drug Regulatory Affairs?

Below are the major functions of pharmaceutical regulatory affairs in India:

Dossier preparation and submission to get the registration of products 

Regulatory compliance with regulatory standards 

Communication with regulatory authorities for submission and approval 

Training and audit inspection to confirm the manufacturing process is processing as per Good Manufacturing Practice (GMP)

Review and analysis of CMC (chemistry, manufacturing, control) data

How Medwisdom Lifescience Can Help You In Pharmaceutical Regulatory Affairs?

At Medwisdom Lifescience, we are specialized in dossier preparation for pharmaceutical, which is the most important thing for product registration. We offers end to end regulatory solutions with compliance at cost effective rates. We provides regulatory affairs services compliance with specific country regulatory authority. Some of our expertise for pharmaceuticals regulatory affairs includes:

Dossier compilation with compliance 

CMC documents preparation for product registration 

Regulatory submission and timely approvals 

Product lifecycle management 

Global market consultancy services for regulatory affairs 

More details on website: https://medwisdom.in/

FAQs 

What Is CTD Dossier and Why It Is Important?

Common technical document (CTD) is a standardized format for regulatory submissions to simplify the process of product registration or approval. It is important for presentation of product data across the country where we wants our product to get registration.

What Is The Timeline For Drug Product Approval?

The timeline for drug product approval basically depends upon the regulatory authority and the country where you wants your product to market.

[omcmedicalblog]

India Medical Device Registration - OMC Medical Limited

Regulatory Authority

Central Drugs Standard Control Organization

The Central Drugs Standard Control Organization (CDSCO) is the National Regulatory Authority (NRA) of India, responsible for regulating drugs and cosmetics under the Drugs & Cosmetics Act, 1940 and rules 1945.

It aims to ensure patient safety, rights, and well-being by ensuring the safety, efficacy, and quality of medical products manufactured, imported, and distributed in the country. CDSCO is responsible for drug approval, clinical trials, setting standards, controlling imported drug quality, and coordinating activities of State Drug Control Organizations.

It also grants licenses for specialized categories of critical drugs such as blood and blood products, I.V. fluids, vaccines, and sera, in collaboration with state regulators. The CDSCO strives for transparency, accountability, and uniformity in its services to ensure the safety, efficacy, and quality of medical products in India.

Link for Regulatory Authority

Local Regulation

Medical Device Act, 2017

Classification of Medical Devices

Class A, B, C and D

Listing or Registration Requirements

A voluntary registration pathway is available to medical devices from April 1, 2020, to October 1, 2021. Medical devices submitted under the new voluntary rules are referred to as “Non-Regulatory Medical Devices.” The registration process will generate a file number the same day which the importer must mention on the label of the medical device prior to placing the devices on the market.

After this voluntary period, all classes of products will need to either have an Import License or register through CDSCO’s online portal.

Class A and B non-Notified medical devices will have 12 months (i.e., by October 1, 2022) to obtain an Import License. Class C and D devices will have 24 months (i.e., by October 1, 2023) to meet the same requirement.

Registration for non-notified medical devices has become mandatory since October 2021.

Starting October 2022, class A & B non-notified devices will become notified devices and hence will require full product registration.

Starting October 2023, class C & D non-notified devices will become notified devices and hence will require full product registration

Documents Required for India Medical Device Registration

Form 40

TR6 Challan

Power of Attorney

Schedule D(I)

ISO 13485 Certificate

Full Quality Assurance Certificate

CE Design Certificate

Declaration of Certificate

Free Sale Certificate

Certificate of Marketability from GHTF countries

Regulatory Approvals

PMS Report

Plant Master File

Device Master File

Registration Timeline

6 to 9 Months

Registration Fee

Fee Details CDSCO

Application fees (online)

Class A: INR 500 (one site); INR 50 (each distinct device)

Class B: INR 1,000 (one site); INR 500 (each device)

Class C and D: INR 5,000 (one site); INR 1,000 (each device)

Application fees (hard copy)

Class A: INR 2,000 (one site); INR 500 (each device)

Class B: INR 5,000 (one site); INR 2,000 (each device)

Class C and D: INR 10,000 (one site); INR 5,000 (each device)

License Validity

Registration certificate (valid for 3 years): Generally, it’s recommended to apply for renewal 6 months before expiry. This ensures enough time for processing and avoids potential interruptions in business operations.

Import license (valid for 5 years): You need to submit the renewal application within 3 months of the expiry date.

Special Labelling Requirements

All the documents must be submitted in English

Additional Comments

Registration for non-notified medical devices has become mandatory since October 2021.

Starting October 2022, class A & B non-notified devices will become notified devices and hence will require full product registration.

Starting October 2023, class C & D non-notified devices will become notified devices and hence will require full product registration

Who should make this Communication?

Manufacturer

Authorized Representative

When to make this Communication?

Before placing a medical device into the market.

Market Access Requirements

Commencing October 1, 2023, the acquisition of an MD-14/15 Import License becomes obligatory for all Class A (Measuring and Sterile), B, C, and D medical devices intended for importation. The MD-14 application procedure mandates the submission of a comprehensive Device Master File (DMF) specific to each product, along with a Plant Master File (PMF) providing details about the manufacturing facility. 

Upon a meticulous approval process, an MD-15 Import License will be issued to a local license holder for the manufacturing site, covering a comprehensive list of all approved medical devices.

As outlined in the Circular (PDF) released on October 12, 2023, it has been specified that non-Notified Class C and D medical devices enlisted in the mandatory registration program, and concurrently undergoing a pending MD-14 application, are granted permission to continue their importation activities for a period of six (6) months.

How OMC Medical can assist you with the Process?

Act as your Authorized representative

Why Choose Us?

Working towards client satisfaction

Cost effective solutions

Project completion before deadline

Quality Regulatory affairs solutions

Contact us for free consultation: info@omcmedical.co.uk

Get more detailed information here: https://omcmedical.com/india-medical-device-registration/

[regulatorysolutionsindia]

Unlocking Compliance: Essential Guide to the Non-Conviction Certificate for Medical Devices in India

In India, medical device registration is essential for manufacturers, importers, and distributors aiming to ensure regulatory compliance and public safety. Governed by the Central Drugs Standard Control Organization (CDSCO) under the Medical Device Rules 2017, the process requires various approvals, including CDSCO medical device registration, product approvals, import licenses, and the Non-Conviction Certificate (NCC). Among these, the NCC is a crucial document that reinforces a company’s compliance record. This guide delves into the Non-Conviction Certificate, highlighting its importance, eligibility, and the steps involved in obtaining it.

What is a Non-Conviction Certificate (NCC)?

A Non-Conviction Certificate (NCC) is issued by the CDSCO to Indian medical device companies. This certificate attests that a company has not been convicted of offenses related to safety, quality standards, or product malfunctions associated with its devices. Often essential in international tenders and product registration in foreign markets, the NCC demonstrates a company's adherence to high regulatory standards. This certification is vital in the medical device regulatory services landscape in India, underscoring the company’s commitment to ethical practices.

Importance of the Non-Conviction Certificate (NCC)

The Non-Conviction Certificate has numerous advantages for medical device companies, including:

- Building Trust: Demonstrates a company’s dedication to safety, quality, and regulatory compliance. - Unlocking Business Opportunities: Required in many tenders and pre-qualification applications, especially in CDSCO medical device registration. - Maintaining Market Reputation: Strengthens a company’s credibility and reputation in the medical devices India sector.

Eligibility Criteria for the Non-Conviction Certificate

To be eligible for the NCC, a company must: - Hold a valid medical device registration India license from the Central Licensing Authority (CLA) or State Licensing Authority (SLA). - Maintain a clean record with no prior convictions or violations under the Drugs and Cosmetics Act 1940 and related Rules.

Required Documentation for the Non-Conviction Certificate

Obtaining an NCC involves compiling the following documents: 1. A cover letter stating the purpose of the application. 2. A copy of the company's valid medical device registration or import license. 3. A list of products for which the NCC is being requested. 4. Prescribed government fees. 5. A Legal Undertaking on a ₹100 registered, notarized stamp paper, confirming no convictions related to product malfunctions or compliance violations.

Who Issues the Non-Conviction Certificate?

The licensing authority that initially issued the manufacturing or import license (either the CLA or SLA) is responsible for granting the NCC.

Validity of the Non-Conviction Certificate

The NCC is valid for one year from issuance or until the company's manufacturing license expires, whichever occurs first.

Steps to Obtain the Non-Conviction Certificate

1. Submit the application with the necessary documents to the relevant licensing authority. 2. For a smooth application process, consider engaging a regulatory consultant in India who specializes in medical device regulatory consultancy.

Benefits of Hiring a Regulatory Consultant for NCC Application

Engaging a medical device regulatory consultant in India can ease the application process, given their expertise in regulatory consultancy services. Consultants bring several advantages: - Requirement Clarity: Ensures the applicant meets eligibility criteria and provides complete documentation. - Efficient Navigation of Procedures: Streamlines applications and reduces potential delays. - Expert Advice: Consultants bring in-depth knowledge, particularly beneficial for medical device registration India requirements. - Peace of Mind: Consultants manage the regulatory process, allowing companies to focus on core operations.

Consult Regulatory Solutions India for Your NCC Needs

Regulatory Solutions India (RSI) offers expert regulatory consultancy services for medical devices and IVDs in India, providing end-to-end support for compliance, including CDSCO consultancy services. With RSI's guidance, you can ensure compliance with regulatory standards, obtain the Non-Conviction Certificate, and gain a competitive edge in India’s regulated markets. ContactRSI today to discuss your specific requirements. Our team of regulatory consultants is here to assist with your CDSCO medical device registration and NCC needs, making the compliance journey smoother and more efficient.

[corpbizlegal]

"CDSCO Approval for Pharma Products"

CDSCO registration is crucial for companies looking to import pharmaceuticals, medical devices, and cosmetics into India. This registration ensures that imported products meet Indian quality and safety standards, protecting consumers and supporting market access for international businesses. Navigating the CDSCO registration process is essential for successful importation and compliance with Indian health regulations

CDSCORegistration, Pharmaceuticals ,MedicalDevices,

[haccpcertificationinseychelles]

Free Sale Certification in Bangalore: Ensuring Export Compliance

Free Sale Certification (FSC) plays a vital role in facilitating international trade, enabling businesses to prove that their products are freely sold and legally marketed in their country of origin. In Bangalore, a leading hub for manufacturing, pharmaceuticals, and technology, Free Sale Certification is crucial for businesses looking to expand into international markets. This blog will cover the implementation of Free Sale Certification in Bangalore, the services available to businesses, and the audit process involved in obtaining the certification.

Free Sale Implementation in Bangalore

Free Sale Certification in Bangalore is typically sought by companies in sectors such as pharmaceuticals, medical devices, cosmetics, food products, and consumer goods. The certification confirms that a product is legally sold within India and meets all local regulatory standards, making it easier for companies to export these products to foreign markets.

To implement Free Sale Certification, businesses in Bangalore need to ensure that their products comply with all Indian regulatory and quality standards. This often involves:

Regulatory Compliance: The company must demonstrate that the products they intend to export are legally sold within India and meet relevant regulatory standards. This could involve compliance with the Food Safety and Standards Authority of India (FSSAI) for food products or the Central Drugs Standard Control Organization (CDSCO) for pharmaceuticals and medical devices.

Document Preparation: For a company to receive Free Sale Certification, they must provide a range of documents, including proof of product registration, a manufacturing license, and any necessary approvals from regulatory bodies. This paperwork serves as evidence that the product is legally sold within India.

Product Quality Assurance: Companies must also ensure that the product quality meets both domestic and international standards. For businesses in Bangalore, this often means adhering to ISO certifications such as ISO 9001 for quality management systems or ISO 13485 for medical devices.

By effectively implementing Free Sale Implementation in Bangalore, businesses in Bangalore can streamline their export processes and expand into global markets with greater ease. This is particularly important for businesses looking to export to countries that require proof that the product is freely sold in its country of origin before granting import approval.

Free Sale Services in Bangalore

In Bangalore, various services are available to help businesses obtain Free Sale Certification. These services include consultation, regulatory assistance, documentation support, and liaison with relevant authorities to ensure smooth certification processes.

Consulting Services: Regulatory consultants in Bangalore specialize in guiding companies through the complex process of obtaining Free Sale Certification. These experts help businesses understand the requirements for their specific industry, whether it's pharmaceuticals, cosmetics, or consumer goods. Consultants can also identify potential regulatory roadblocks and provide strategic advice on how to address them.

Documentation and Regulatory Assistance: Preparing the necessary documentation for Free Sale Certification is a key part of the process. Certification service providers in Bangalore assist companies in compiling and organizing the required documents, including product licenses, approvals, and regulatory compliance records. They ensure that all documentation aligns with the legal requirements of both India and the target export market.

Liaison with Regulatory Authorities: Navigating the various regulatory bodies in India, such as the CDSCO or FSSAI, can be challenging for businesses. Free Sale Certification services in Bangalore often include liaison with these authorities to ensure the timely approval of documents and certificates. This helps businesses avoid delays in the certification process and ensures compliance with all regulatory requirements.

International Market Support: Free Sale Certification service providers in Bangalore also assist companies in understanding the specific requirements of the export market. Many countries require Free Sale Services in Bangalore for imported products, and these service providers can offer insights into the different standards and regulations required for exporting to countries like the U.S., European Union, or Middle Eastern nations.

By utilizing these services, companies in Bangalore can ensure that their certification process is smooth and efficient, reducing time to market and enabling faster global expansion.

Free Sale Audit in Bangalore

The audit process is a critical component of obtaining Free Sale Certification in Bangalore. Although the certification primarily focuses on ensuring that the product is freely sold in India, companies must also undergo an audit to confirm compliance with local and international regulatory standards.

Pre-Audit Evaluation: Before the formal audit begins, many businesses opt for a pre-audit evaluation. This step involves a thorough review of the company’s regulatory compliance and documentation to ensure that all necessary approvals and certifications are in place. Pre-audit assessments help identify any potential issues that may arise during the official audit, allowing companies to rectify them beforehand.

On-Site Audit: The audit process typically includes an on-site visit by auditors who evaluate the company’s production processes, quality management systems, and regulatory compliance. Auditors verify that the company is adhering to the necessary legal and regulatory standards for selling their products in India. They also review whether the company has the appropriate approvals and licenses required for the Free Sale Certification.

Document Verification: Auditors will closely review the company’s documentation to ensure that it complies with both Indian regulatory standards and international export requirements. This includes verifying product registrations, quality control records, and any other approvals needed for certification.

Corrective Actions: If any issues or gaps are identified during the audit, businesses in Bangalore must take corrective actions to address these deficiencies. This could involve updating certain documentation, improving quality control measures, or securing additional regulatory approvals. Once these actions are completed, the company can proceed with the certification process.

Final Certification Approval: After the successful completion of the audit and any necessary corrective actions, the certification body will issue the Free Sale Certificate. This document serves as proof that the product is legally sold in India and meets all the necessary standards, enabling the business to export it to global markets.

Conclusion

Free Sale Registration in Bangalore is essential for businesses in Bangalore that aim to expand their operations internationally. By ensuring that their products comply with local and international regulations, companies can tap into new markets and enhance their global presence. With the support of specialized services and a rigorous audit process, businesses can navigate the certification journey efficiently, ensuring they meet all the necessary legal and regulatory standards.

For businesses in Bangalore, obtaining Free Sale Certification is not just a regulatory requirement—it is a strategic move toward global expansion and increased market competitiveness.

[psrcompliances]

CDSCO Registration Online in India

CDSCO Registration is a compulsory requirement for any entity seeking to manufacture, distribute, or import pharmaceuticals and cosmetics. This regulatory approval ensures compliance with safety and quality standards, granting a license to operate in the Indian market the process involves submitting detailed applications, complying with firm guidelines, and undergoing regulatory inspection. 

[agileregulatory1]

Apply for Drug License Registration for Retails and Wholesale License in Delhi

Drug licenses in India are granted through the CDSCO to control abuse and misuse by individuals. It is mandatory for all individuals involved in the pharmaceutical and cosmetic industries, including sellers, dealers, wholesalers, retailers, manufacturers, pharmacists, and importers of drugs, cosmetics, and ayurvedic products, to obtain this license. For more details, please visit us or call +91 8178731176.

[corpseed22]

Understanding the Latest Requirements: Form 42 and Form 43 for the Import Cosmetics in India

In the dynamic landscape of global trade, the Indian cosmetics market stands out as a lucrative opportunity for businesses seeking expansion. However, entering this market requires careful navigation of regulatory requirements, particularly in terms of form submission. Two critical documents, Form 42 and Form 43, play a pivotal role in facilitating the importation of cosmetics into India. In this article, we'll delve into the latest requirements surrounding these forms and their significance for importers.

The Importance of Form 42 and Form 43

Form 42 and Form 43 for the import of cosmetics in India are mandated by the Drug Controller General of India (DCGI) under the provisions of the Drugs and Cosmetics Act, 1940, and the rules framed thereunder. These forms serve as crucial instruments for ensuring the safety, quality, and compliance of imported cosmetics entering the Indian market.

Form 42: Import of Cosmetics

Form 42 is a document prescribed for the import of cosmetics into India. It is essentially an application form that importers need to submit to the DCGI for obtaining authorization prior to importing cosmetics. The form includes essential details such as the name and address of the importer, details of the manufacturer, product information, and compliance declarations.

Form 43: Test License for Import of Cosmetics

Form 43, on the other hand, pertains to the issuance of a test license for the import of cosmetics. Importers are required to submit this form along with the requisite fees to the DCGI for obtaining a test license. The test license allows importers to import a small quantity of cosmetics for testing and analysis purposes before commercial distribution.

Latest Requirements and Updates

In recent years, the Indian regulatory landscape governing cosmetics importation has witnessed notable updates and amendments. Importers must stay abreast of these changes to ensure compliance with the latest requirements. Key considerations include:

Product Registration: Certain categories of cosmetics may require product registration with the Central Drugs Standard Control Organization (CDSCO) before importation. Importers must verify whether their products fall under the purview of mandatory registration.

Labeling and Packaging Requirements: Compliance with labeling and packaging regulations is paramount. Cosmetics intended for importation into India must adhere to specific labeling requirements, including the declaration of ingredients, usage instructions, and safety warnings in the prescribed format.

Good Manufacturing Practices (GMP): Importers are expected to source cosmetics from manufacturers adhering to Good Manufacturing Practices (GMP) to ensure product quality and safety.

Conclusion

In conclusion, navigating the regulatory framework for importing cosmetics into India requires a thorough understanding of the latest requirements, including Form 42 and Form 43. Importers must diligently comply with these requirements to facilitate smooth and legally compliant importation processes. By staying informed and proactive, businesses can seize the vast opportunities offered by the thriving Indian cosmetics market while upholding the highest standards of quality and safety.

[johnwilson88]

Simplify Cosmetic Registration in India with FDApal

Simplify the intricate process of cosmetic registration in India with FDApal. Our intuitive platform provides step-by-step guidance, ensuring compliance with regulations. Trust FDApal to streamline your registration journey, saving time and resources while navigating the complexities of the Indian market seamlessly.

[e-startupindia1]

US FDA suspend eye product Indian Company

The United States Food and Drug Administration (FDA), founded in 1906, is the federal agency presently in charge of enforcing the requirements of the Federal Food and Drugs Act. The Food and Drug Administration (FDA) is one of the world’s oldest organisations committed to consumer protection. As a result, gaining certification from the US Food and Drug Administration is not only a valuable asset, but also a must for starting the process of extending your business in the United States of America. Following an examination of the items by an FDA representative, the FDA will deliver Form 483 for FDA Certification of the products. . A US FDA Certification is a document that certifies that your product is safe and effective for use. The U.S. FDA to ensure that products, particularly those related to food, drugs, medical devices, biologic, and cosmetics, meet certain standards of safety, efficacy, and quality. . It also indicates that the items being exported to the United States of America are made in conformity with the FDA Guidelines for Current Goods Manufacturing Practices (CGMP). . All enterprises in India that make food, pharmaceuticals, medical devices, or cosmetics must be certified by the US Food and Drug Administration to export their products in the USA along with having Import Export Code Registration. . You won’t be allowed to sell your product in the United States market until it has been approved by the Food and Drug Administration via US FDA Certification.

Why did the US FDA recalled eye drops?

. Lack of acceptable microbiological testing, . Formulation concerns (the business manufactures and distributes ophthalmic medications in multi-use bottles, without a suitable preservative), . and a lack of basic controls for tamper-evident packaging

These are all reasons the FDA implied recalling the eye drops. Furthermore, The reason was infections with drug-resistant bacteria, which caused irreversible visual loss in many persons.

You can understand the detailed process at: How to Get US FDA Certificate in India?

CDSCO starts probe on eye drops manufacturing company “CDSCO and TN State Drug Controller teams (three people each) are on their way to the manufacturing factory in Chennai. It’s a contract manufacturing facility that supplies the US market through others. This particular medicine is not offered in India “It was said. If the CDSCO has initiated a probe into an eye drops manufacturing company, it is likely that the investigation will focus on aspects such as: 1.Good Manufacturing Practices 2.Product Quality 3.Product Quality 4.Compliance with Regulations . 5.Adverse Events Reporting

If you want any other guidance relating to the US FDA Certification, please feel free to talk to our business advisors at 8881-069-069.

Visit Here for more information https://www.e-startupindia.com/

[professionalutilities1]

What is a "CDSCO Drugs Import License"?

The responsibility for issuing licenses for Specialized Categories of Critical Drugs, including blood and blood products, I.V. fluids, vaccines, and sera, lies with the Central Drugs Standard Control Organisation and state regulators. Importing drugs into India necessitates a Drugs Import License, which must adhere to government regulations.

CDSCO holds the designation of being the National Regulatory Authority (NRA) in India. The regulation of Import, Manufacturing, Sale, and Distribution of Drugs in India is governed by the Drugs & Cosmetics Act of 1940 and Rules of 1945.

Benefits of CDSCO Drugs Import License:

Legal Compliance

Quality Assurance

Consumer Safety

Business Credibility

Supply Chain Integrity

Customs Clearance

Marketing Authorization

Documents of CDSCO Drugs Import License:

Covering Letter

Form 8 or 8-A

TR6 Challan

Testing Protocol

Product Label and Brochures

FSC Certificate in the Country of Origin

Notarized Agreement

Ethics Committee Approval

Original Power of Attorney

Plant Master File

Drug Master File

Copy of BA/BE site registration (as approved by CDSCO in case of BA/BE approved sites)

Manufacturing License or Wholesale License (in the case of Import)

[lifecarenutritions]

How to Import Pharmaceutical Medicines From India

The pharmaceutical market in India is growing repeatedly due to an increase in various health problems for many reasons. However, India does not have the latest and modern medical infrastructure that helps us to treat various medical illnesses. This improves the trade of pharma medicine from one country to another countries. However, Importing Pharmaceutical Medicine from India can be a critical process due to some rules and legal processes. In this article, we help you to know “how to Import Pharmaceutical Medicine from India.

Process to Import Pharma Products From India to Fulfill Market Demand  

The Drugs and Cosmetics Rules, 1945 and  Drugs and Cosmetics Acts, 1940 are the two laws governing the Import, manufacture, export, sale, and distribution of Drugs in India. Any product falling under the category of Drugs or Medical related devices needs to be registered before getting imported to India.

Registration Certificate and Import License

CDSCO is also known as the Central Drug Standard Control Organisation and works under the Ministry of Health and Family Welfare, Governed by the Government of India. It is the National Drug Regulatory Authority of India that maintains and controls all the processes related to the Import, Medicines, Medical Devices, Export, Registration, manufacturing, and Licensing of Drugs, IVDs, and medical-related products in India. Before importing pharma products from India, it is necessary process the obtain the registration certificate and import License from CDSCO. 

Eligibility to Import pharmaceutical medicines from India

Foreign Pharma Products manufacturers who have obtained a license for the sale or distribution of drugs in India. Local authorized Agent of the foreign Pharmaceutical medicine manufacturing companies who have obtained manufacturing or sales licenses. 

Document required to import medicine 

Documents Required for Import Pharma Drugs 

Application Form

Power of Attorney 

Copy of wholesale license 

Covering Letter

Manufacturing License & Market Authorization Certificate

Establishment License 

The process to obtain a license for Import 

Any pharma manufacturer first needs the registration license from CSCO which helps you to import any products that are related to the medical field. To obtain this license follow the procedure is:  

Firstly fill out the application Form-40 and submit it to the licensing authority. 

 After approval, this certificate will be valid for 3 years. 

After receiving the registration certificate, you can fill out the form for an import license to the license authority in Form 8 with application fees of 1000 rs for each product and an extra 100 for each additional medicine.

The Import License is then obtained as Form-10 from the CDSCO office and is also valid for 3 years. 

In conclusion 

Lifecare Nutritions is an ISO-certified Pharmaceutical company that gives the facility to import pharma medicine from India to fulfill the huge demand for registered pharma drugs. The company gives all related benefits to the new investor who wants to create a pharma business to overcome the needs of customers and people. In India is a strict need to regulate the actions and working of the Industry in order to avoid low quality and unsafe goods from reaching the common crowd.

[regulatorysolutionsindia]

Registration of Cosmetics in India

Cosmetics are utilized to improve a person’s appearance. These are used for various beauty treatments such as skin tightening, hair removal, spot reduction, achieving radiant skin, and many more. They play a critical role in boosting an individual’s self-confidence and positive outlook. Consequently, there has been a significant increase in demand for cosmetics in the Indian market, resulting in substantial growth in the cosmetic industry in recent years. However, ensuring the highest quality and safety of cosmetics remains a major concern for the industry. 

For this reason, it is mandatory to register every cosmetic in India. The registration process must be compliant with the Drugs and Cosmetics Act of 1940 and the Cosmetic Rules of 2020. The Central Drug Standard Control Organisation (CDSCO), under the Ministry of Health and Family Welfare, is the regulatory authority responsible for overseeing these regulations. All cosmetics manufactured in or imported into India must be registered with the CDSCO.

Definition of Cosmetics as per the Drugs and Cosmetics Act, 1940

Under section 3(aaa) of the Drugs and Cosmetics Act, 1940, cosmetics is defined as, “any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness or altering the appearance, and includes any article intended for use as a component of cosmetic”.

Under the provisions of the aforesaid Act, the manufacture of cosmetics is regulated by the State Licensing Authorities appointed by the respective State Governments, while the import of cosmetics is regulated by the Central Licensing Authority appointed by the Central Government. The Drugs Controller General (India) is the Central Licensing Authority who grants registration certificate for import.

Key Requirements for Cosmetics in India

To ensure the safety, quality, and efficacy of cosmetics in India, key requirements under the Cosmetic Rules, 2020 are as follows:

All cosmetics manufactured in or imported to India must comply with the Cosmetic Rules, 2020.

All manufacturers must obtain a license or loan license from the State Licensing Authority to manufacture cosmetics for sale and distribution in India.

All importers must obtain an import registration certificate from the Central Licensing Authority to import cosmetics to India.

All the manufacturers of cosmetics in India must label and pack the cosmetics in accordance with the Cosmetic Rules, 2020 and Legal Metrology (Packaged Commodities) Rules, 2011, before selling or distributing the product.

Additional Regulatory Requirements for Cosmetics in India

Cosmetics should not contain any of the raw materials listed in Indian Standard IS: 4707.

Cosmetic products should not contain dyes, colours, or pigments other than those specified by the Bureau of Indian Standards (IS: 4707).

Cosmetic products that contain permitted synthetic organic and natural organic colours should not contain arsenic trioxide, lead, mercury, or heavy metals in excess of the quantities specified in the Cosmetic Rules, 2020.

Hexachlorophene should not be an ingredient in any cosmetic.

Manufacturers should not use animals for testing cosmetics.

Process to get Import Registration Certificate

Under Sections 12 and 13 of the Cosmetic Rules, 2020, a foreign manufacturer's authorised agent or authorised subsidiary may obtain import registration certification through the following process:

Apply to register cosmetics intended for import into India through the central government's online portal, Form COS-1.

The Form COS-1 can be submitted either by the manufacturer himself or his authorized agent or the importer or an Indian subsidiary authorized by the manufacturer.

If the Central Licensing Authority deems the documents provided with the application satisfactory, it may grant the applicant the Import Registration Certificate. The Central Licensing Authority may also reject an application, documenting its reasons in writing within six months of the application date.

If the Central Licensing Authority rejects the application, the applicant has forty-five days to appeal to the Central Government. If the government considers it necessary, it can pass orders in relation thereto within a period of ninety days from the date of appeal.

Before registering the import of a new cosmetic into India, the applicant must obtain prior permission from the Central Licensing Authority in Form COS-3 before registration of the cosmetic.

Process to get Licence or Loan Licence to Manufacture Cosmetics for Sale or Distribution

Under Section 23 of the Cosmetic Rules, 2020, anyone intending to manufacture cosmetics for sales and distribution should obtain a license from the State Licensing Authority through the following process:

Apply for a license through an identified online portal, (can apply offline if online portal is not operational) in Form COS-5 for a license or in Form COS-6 for a loan license.

For a new cosmetic, the manufacturer must obtain prior approval in Form COS-3 from the Central Licensing Authority.

In addition to the required documents, the applicant must also submit a self-declaration in Form COS-7 conforming to Good Manufacturing Practices and additional manufacturing related requirements.

Upon receipt of the application, within a period of forty-five days, the State Licensing Authority will grant a license or loan license after confirming that all requirements have been met or will inform the applicant if it determines that the applicant has not fulfilled the requirement.

Within thirty days from the date of grant of the license or loan license, the manufacturing site will be inspected by the subordinate officer delegated by the State Licensing Authority to verify the information given in the self-certificate in Form COS-7.

Requirements for Registration of Cosmetics for Import

Following is the list of main documents/details that need to be submitted at the time of applying for a cosmetic registration for import.

Authorization from Manufacturer as per First Schedule

Product details and undertaking as per Second Schedule Part I

Regulatory Certificates (manufacturing license/Free Sale Certificate)

Non-Animal Testing Declaration

Declaration for Heavy Metal and Hexachlorophene content

Applicable Government Fees to be paid

Conclusion

The regulations for registration and import of cosmetics in India are crucial for ensuring the quality of cosmetics and safeguarding the well-being of the consumers. Therefore, any manufacturer or importer/authorized agent involved in the cosmetics industry must follow these regulations to ensure the quality and safety of all.

At Regulatory Solution India (RSI), we specialize in providing regulatory consulting services for cosmetics. If you need assistance navigating the submission process or ensuring compliance with the latest regulations, Contact us.