India

Medical Devices

The Central Drug Standards Control Organization (CDSCO) is India’s main regulatory body for medical devices. The Drug Controller General of India (DCGI) is the key official within the CDSCO. The DCGI is responsible for the approval of the manufacturing of specific medical devices. In India, the manufacturing, import, sale, and distribution of medical devices are regulated under India’s Drugs & Cosmetic Act and Rules (DCA). The Drug and Cosmetic Act  defines medical Devices as;

  1.  substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood and blood component collection bag with or without anticoagulant covered under sub-clause (i);

  2. substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides notified under sub-clause (ii); and

  3. devices notified from time to time under sub-clause (iv), of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940;

Related Links:

Cosmetic and Drug Act of 1940. https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/acts_rules/2016DrugsandCosmeticsAct1940Rules1945.pdf 

 CDSCO website. https://cdsco.gov.in/opencms/opencms/en/Home

Authorized local agent

In India, all imported drugs and certain regulated medical devices need to be registered with the Central Drugs Standard Control Organization (CDSCO). For foreign medical companies exporting their products to India, a local Authorized Agent must be appointed. A local authorized agent must be a resident of India or have an official business address in India and the Agent must have a drug wholesale license and prior industry experience.

GRP Medical Device Services in India:

  • Communication with CDSCO
  • Product Registration
  • Assistance with CDSCO inspection
  • Clinical Trial management
  • Support Importation Process
  • Organize and support Transmutation meetings.
  • Recall or incident report assistance
RESPONSIBILITIES OF AN AUTHORIZED AGENT

In India, the local Agent has legal liability for your medical products and must further take care of liaising with the CDSCO, including post-market surveillance.

Using an independent third party as your Indian Authorized Agent would ensure that you have the registration in your name and thus more control of your marketing strategy. It will be also be easier to switch distributors. For foreign companies that do not want to establish a subsidiary in India, an independent third party acting as your local agent is the best way to get your medical products onto the growing Indian market.

Regulatory intelligence

Regulatory intelligence (RI) is an essential tool for regulatory professionals. RI allows professionals to develop the most appropriate regulatory strategy for a successful, efficient, and cost- effective product development, registration, and commercialization. Due to the continuously evolving nature of the Regulatory environment, it is becoming more challenging for regulatory professionals to stay up-to-date and collect the appropriate RI related to their product in a timely manner.

At Global Regulatory Partners Inc. (GRP), our team of professionals can provide you with tailored Regulatory Intelligence that includes the latest CDSCO regulatory information and our recommendations for the most appropriate and effective strategy to address your particular- needs in India.

Regulatory Strategy

Registering your medical device for sale in India means working with the Central Drugs Standard Control Organization (CDSCO), an agency of the Ministry of Health and Family Welfare. Medical devices were initially brought under regulation in  the Drugs and Cosmetics Act of 1940, but regulators are developing new requirements for medical devices. Currently, only specific devices are subject to the regulation. Global Regulatory Partners, Inc. (GRP) can assist you in evaluating the India medical device regulatory framework as it applies to your device(s).

GRP’s Medical Device Regulatory Strategy Services in India:

  • Regulatory Background on the CDSCO
  • Product Assessment
  • In-Country Representation
  • Medical Device Registration Requirements
  • Costs and Timeframes
  • Labeling and Language Requirements
  • Regulatory Roadmap

Regulatory Affairs

Global regulatory Partner, Inc., (GRP) provides a full regulatory affairs services to Pharmaceutical and Biologic companies globally, from their products’ development and registration till commercialization. GRP regulatory affairs services in India include regulatory intelligence, regulatory strategy, regulatory operations and publishing, product’s registration, products’ life cycle management and maintenance.

Our Regulatory affairs teams help medical device companies understand and efficiently manage the demanding complexity of the diverse Regulatory requirements in India in order to successfully register and commercialize their products in India’s market and maximize the value of their assets.

Product registration

Table 1: Medical Device Classification in India
Device Class Description Examples
Class A Low risk Thermometers, Tongue depressors
Class B Low-Moderate Risk Hypodermic needles, Suction equipment
Class C Moderate-High Risk Lung ventilator, Bone fixation
Class D High risk Heart valves, Implantable device

Non-Regulated Medical Devices with a NOC are exempt from registration. For all other medical devices that do not require registration, the manufacturer should obtain a No Objection Certificate (NOC) from the DCGI. The NOC is a letter from the DCGI stating that the product does not require registration and can be imported freely into India.

Medical Device Registration Requirements in India:

  • Companies must register regulated medical devices with the DCGI before they can be introduced into the Indian market.
  • For new medical devices, prior approval from the DCGI must be obtained before the device can apply for registration.
  • Upon receipt of the application with fees, evaluation begins.
  • The DCGI may require clinical testing in India or abroad.
  • The DCGI may visit the manufacturing premises during the process.
  • Approval in the Country of Origin is required for medical device registration in India.

Registration Timelines

The registration of medical devices in India can take between 9 and 18 months if there are no clinical trials.

Medical Device Registration Process
Step 1 Appoint A Local Agent In India To Be The Applicant And License Holder
Step 2 Prepare Device Master File (DMF)
Step 3 Prepare Plant Master File (PMF)
Step 4 Prepare application Form w/supporting documents
Step 5 Submit above documents to DCGI with fees
Step 6 DCGI reviews and sends back an inquiry letter
Step 7 Applicant responds and addresses inquiries made by the DCGI
Step 8 DCGI may request technical presentation
Step 9 Approval

Medical writing

Medical Writing is an important function of regulatory affairs. It plays a critical role in the development and preparation of regulatory documents and defines the success or failure of new products in India. As Regulatory authorities, the Central Drug Standards Control Organization (CDSCO), expect precise, clear and well-written documents, any bad writing or translation can raise health authorities queries and consequently delay product approval. Global Regulatory Partners, Inc., has a team of professional medical writers who can write regulatory and clinical documents in Electrical Common Technical Documents (eCTD) and CTD modules.

Health authority consultation

It is highly recommended to have a pre-consultation meeting with health authorities such as with the Central Drug Standards Control Organization (CDSCO) during the development of new pharmaceutical or biologic products. Consultation meetings can serve as a valuable tool to discuss needs and challenges specific to the development of the product and design of their proposed nonclinical studies. Sponsors can also discuss their Chemistry, Manufacturing and Controls (CMC) development plan and discuss their overall development plan.

Global Regulatory Partners Inc., (GRP) regulatory affairs team has the expertise in preparing consultation meeting with the CDSCO before starting key milestone of your product development.

GRP regulatory affairs team supports includes: writing, preparation and submission of the meeting package to the CDSCO health authority, prepare the questions based on the status of your product’s development and future, provide support during the meeting, write the meeting minutes and develop the appropriate action plan after the consultation meeting. 

Clinical

In India, medical device approval generally does not require local clinical studies, since foreign data can often be used. Clinical trials in India are typically only required for risky medical devices without predicates.

Requirements for conducting clinical trials

For new medical devices, local clinical trials in India involve completing Application Form 44, receiving approval from the ethics committee, following protocol and Good Clinical Practices (GCP), and reporting all adverse events. All medical device clinical trials need to be registered in the Clinical Trial Registry of India (CTRI) and will be reviewed by the Medical Device Advisory Committee, which is part of the CDSCO.

India’s large population offers many opportunities for medical device and pharmaceutical manufacturers looking to conduct clinical trials overseas. However, managing a smooth clinical trial process in India’s growing markets and evolving regulatory environment can be a challenging task. Global Regulatory Partners has strong expertise in the Indian clinical trial landscape and offers comprehensive clinical trial consulting services. Our on-the-ground personnel are trained regulatory professionals who can assist you in managing your clinical trials in India to completion successfully and efficiently.

 (GRP) can act as your contract research organization (CRO) or help you identify a qualified CROs in India. Our local teams and affiliated partners located in India and all-around Asia are highly experienced with the related regulatory affairs and can locally manage the full clinical trial process to ensure that it is conducted effectively and successfully.Clinical trials that are conducted properly in India will facilitate a smooth registration approval process and expedite access to other Asian markets. If you need assistance with clinical trials for your medical product in India, contact us for a consultation with our regulatory experts.

GRP clinical trials services in India:

  • Clinical Trial Consulting Services
    GRP will provide clinical trial consulting services, including consultations with all local government. We can help you develop an effective Clinical Investigation Plan with clinical trial strategy, clinical trial study design, and clinical trial protocol.
  • Regulatory Support
    We can assist with clinical trial applications (CTA) and clinical trial notifications (CTN) as required for clinical trial initiation in India. Our on-the-ground teams consist of experienced professionals who will meet with the appropriate CDSCO regulatory agencies on your behalf throughout the clinical study. We will provide guidance on meeting the Institutional Review Board (IRB) and Independent Ethics Committee (IEC) requirements.
  • Clinical Trials Management
    We can comprehensively manage the clinical trials process by conducting the trials and completing the clinical trial reports. Our experts will evaluate clinical trial and non-clinical trial data; conduct gap analyses; and determine safety and efficacy, along with primary and secondary endpoints, as required for your specific product.
  • Quality Compliance and Audits
    We can conduct on-site audits of your clinical trials and consult on the guidelines for Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Pharmacovigilance Practices (GVP), Good Quality Practice (GQP), Good Manufacturing Practice (GMP), etc.
  • Adverse Events and Post Market Surveillance
    We will report adverse events and implement suggestions on additional tests and required data. We can assist in post-approval and post-clearance clinical trials to maintain the safety, efficacy, and performance of the product through its life cycle.

 

Quality

Costs to manufacture in India are generally significantly less than the costs in China. With more and more Western medical companies sourcing or manufacturing their medical devices or drugs in India, quality management in India has become a key issue.

Global Regulatory Partners Inc. (GRP) has extensive experience and has helped several international medical companies set up their quality management systems in India. Our India quality control/quality assurance experts can help your medical company’s Indian operations and suppliers ensure compliance with all relevant quality standards.

QUALITY CONTROL/QUALITY ASSURANCE FOR MEDICAL DEVICES

Depending on the type of medical device, the Drug Controller General of India (DCGI) and the State FDA will approve or determine the medical device licensing process. The application for a manufacturing license may include manufacturing processes, product details, and information about the staff. In addition, there are many state and local level licenses that are needed to manufacture a medical device. Therefore, understanding the regulations of an Indian State is important when deciding on a manufacturing site location.

Pharmaceuticals

The Central Drug Standards Control Organization (CDSCO) is India’s main regulatory body for pharmaceuticals. The Drug Controller General of India (DCGI) is the key official within the CDSCO. The DCGI is responsible for the approval of the manufacturing of certain drugs (vaccines, large volume parenteral, blood products, r-DNA derived), and new drugs. In India, the manufacturing, import, sale, and distribution of drugs are regulated under India’s Drugs & Cosmetic Act and Rules (DCA).

Related links:

For more information, please check the CDSCO website at: https://cdsco.gov.in/opencms/opencms/en/Drugs/New-Drugs/

Authorized local agent

In India, all imported drugs and certain regulated pharmaceuticals need to be registered with the Central Drugs Standard Control Organization (CDSCO). For foreign drug companies exporting their products to India, a local Authorized Agent must be appointed. A local authorized agent must be a resident of India or have an official business address in India and the Agent must have a drug wholesale license and prior industry experience.

GRP Pharmaceutical Services in India:

  • Communication with CDSCO
  • Product Registration
  • Assistance with CDSCO inspection
  • Clinical Trial management
  • Support Importation Process
  • Organize and support Transmutation meetings.
  • Recall or incident report assistance
RESPONSIBILITIES OF AN AUTHORIZED AGENT

In India, the local Agent has legal liability for your medical products and must further take care of liaising with the CDSCO, including post-market surveillance.

Using an independent third party as your Indian Authorized Agent would ensure that you have the registration in your name and thus more control of your marketing strategy. It will be also be easier to switch distributors. For foreign companies that do not want to establish a subsidiary in India, an independent third party acting as your local agent is the best way to get your medical products onto the growing Indian market.

Regulatory intelligence

Regulatory intelligence (RI) is an essential tool for regulatory professionals. RI allows professionals to develop the most appropriate regulatory strategy for a successful, efficient, and cost- effective product development, registration, and commercialization. Due to the continuously evolving nature of the Regulatory environment, it is becoming more challenging for regulatory professionals to stay up-to-date and collect the appropriate RI related to their product in a timely manner.

At Global Regulatory Partners Inc. (GRP), our team of professionals can provide you with tailored Regulatory Intelligence that includes the latest CDSCO regulatory information and our recommendations for the most appropriate and effective strategy to address your particular- needs in India.

Regulatory Strategy

Registering your medical device for sale in India means working with the Central Drugs Standard Control Organization (CDSCO), an agency of the Ministry of Health and Family Welfare. Medical devices were initially brought under regulation in   the Drugs and Cosmetics Act of 1940, but regulators are developing new requirements for drugs.

Let Global Regulatory Partners assist you in evaluating the India medical device regulatory framework as it applies to your device(s). Through our global network of consultants, regulatory sources and industry contacts, Global Regulatory Partners provides incisive analysis of many medical markets.

GRP Pharmaceutical Regulatory Strategy Services:

  • Regulatory Background on the CDSCO
  • Product Assessment
  • In-Country Representation
  • Drug Registration Requirements
  • Costs and Timeframes
  • Labeling and Language Requirements
  • Regulatory Roadmap

Regulatory Affairs

Global regulatory Partner, Inc., (GRP) provides a full regulatory affairs services to Pharmaceutical and Biologic companies globally, from their products’ development and registration till commercialization. GRP regulatory affairs services in India include regulatory intelligence, regulatory strategy, regulatory operations and publishing, product’s registration, products’ life cycle management and maintenance.

Our Regulatory affairs teams help pharmaceutical companies understand and efficiently manage the demanding complexity of the diverse Regulatory requirements in India in order to successfully register and commercialize their products in India’s market and maximize the value of their assets.

Regulatory Operations

Global Regulatory Partners Inc., (GRP) offers full electronic submission services from eCTD preparation, publishing and submission activities in India.  GRP’s dedicated team of experts ensures the quality and validity of the dossier submissions in accordance to the technicalities of regional eCTD requirements.

Global Regulatory Partners Inc. (GRP) Regulatory operation services include consulting services, planning and assembly of submissions, document creation and approval, e-Submission roadmap compliance, publishing, viewing and navigation, archiving, submission process optimization, tracking and lifecycle management.  GRP remains in compliance by implementation of Regulatory Information Management (RIM) with XEVMPD and IDMP requirements.  GRP will facilitate and coordinated management of all paper and electronic submissions, both eCTD and non-eCTD electronic submissions, and ensure timely submissions.

Medical writing

Medical Writing is an important function of regulatory affairs. It plays a critical role in the development and preparation of regulatory documents and defines the success or failure of new products in India. As Regulatory authorities, they expect precise, clear and well-written documents, any bad writing or translation can raise health authorities queries and consequently delay product approval. Global Regulatory Partners, Inc., has a team of professional medical writers who can write regulatory and clinical documents in Electrical Common Technical Documents (eCTD) and CTD modules.

Health Authority Consultation

It is highly recommended to have a pre-consultation meeting with health authorities such as with CDSCO during the development of new pharmaceutical or biologic products. Consultation meetings can serve as a valuable tool to discuss needs and challenges specific to the development of the product and design of their proposed nonclinical studies. Sponsors can also discuss their Chemistry, Manufacturing and Controls (CMC) development plan and discuss their overall development plan.

Global Regulatory Partners Inc., (GRP) regulatory affairs team has the expertise in preparing consultation meeting with CDSCO before starting key milestone of your product development. GRP regulatory affairs team supports includes: writing, preparation and submission of the meeting package to the CDSCO, prepare the questions based on the status of your product’s development and future, provide support during the meeting, write the meeting minutes and develop the appropriate action plan after the consultation meeting. 

Product registration

Drug categories:

  • Category A – A drug that has not been marketed in India before.
  • Category B – A drug with a new therapeutic purpose or dosage that has not been marketed in India.
  • Category C – A new fixed-dose combination of two or more drugs, if they have not been approved in such a combination before.
  • Category D – A drug or formulation which received its first new drug approval (of any of the types listed above) less than four years ago. This does not apply if the drug has been included in the Indian Pharmacopoeia since then.
  • Category E – Any vaccine, unless certified otherwise by the DCGI.

Drug Registration Process:

  1. New drug approval the product must go through an approval process to obtain a drug registration (this regulation is dependent upon the type of pharmaceutical and whether a predicate drug or substance is already marketed in India, is not necessarily only for new drugs.
  2. Import registration certificate – This registration is only required for drugs to be imported, not manufactured. It should also not be confused with the import license, which lets a shipment pass through customs. Import registrations are submitted to the DCGI.
    •  The applicant for an import registration certificate must be an entity, which is licensed to either sell wholesale or manufacture drugs.
    • Site evaluation:  site evaluates for Indian Good Manufacturing Practice (GMP), however, the DCGI will usually trust GMP certification from an advanced country such as the US or Europe. *Inspections are more likely for drugs produced in other low-cost countries such as China.
    • Timeline: import registration certificate within 9 months of application. However, the process has been known to go on for longer than this, with further requests for clarification or information.
  1. Import license The final step for a foreign company to bring a drug into India is to receive an import license. Import license application forms can differ depending on the type and purpose of the drug. At the border, the import license is the only regulatory permission needed to bring in shipments besides general customs requirements.
    • Testing at border: Officials may conduct testing to verify that a shipment’s contents and quality adhere to the license terms. Because of testing requirement, drugs may only enter India via cities with appropriate testing facilities. They may enter by sea through Chennai, Kolkata, Mumbai, Kochi, Nhava Sheva, or Kandla, or by air through Chennai, Kolkata, Mumbai, Delhi, Ahmedabad, or Hyderabad.

Clinical

An understanding of the regulatory requirements in India and experience in dealing with the local regulatory authorities CDSCO is essential in administering a smooth, successful clinical trial in India. Global Regulatory Partners, Inc. (GRP) can act as your contract research organization (CRO) or help you identify a qualified CROs in India. Our local teams and affiliated partners located in India and Asia are highly experienced with the related regulatory affairs and can locally manage the full clinical trial process to ensure that it is conducted effectively and successfully.

RULES GOVERNING CLINICAL TRIALS
Rule 122-AApplication for permission to import new drug
Rule 122-B -Application for approval to manufacture new drug
Rule 122-DAMandatory requirement of permission from DCG (I) for conduct of clinical trial of new drug;
Rule 122 DAB -Provision for examination of serious adverse event (SAE) of injury and death and payment of compensation in clinical trial related cases. Provision for debarment of the applicant in case of failure to pay compensation;
Rule 122 DAC -Conditions of permission for conduct of clinical trial which includes mandatory requirement to follow Good Clinical Practice (GCP) guidelines, guidelines and requirements specified in Schedule Y of Drugs and Cosmetics Rules and other applicable regulations. Provision for debarment of applicant and investigator in case of non- compliance
Rule 122 E-Definition of new drug
Schedule Y-Detailed guidelines and requirements for conduct of clinical trial and approval of new drug
Good Clinical Practice Guidelines -issued by CDSCO, Directorate General of Health Services, Govt. of India

GRP  Clinical Trial Services in India:

  • Clinical Trial Consulting Services
    GRP will provide clinical trial consulting services, including consultations with all local government. We can help you develop an effective Clinical Investigation Plan with clinical trial strategy, clinical trial study design, and clinical trial protocol.
  • Regulatory Support
    We can assist with clinical trial applications (CTA) and clinical trial notifications (CTN) as required for clinical trial initiation in India. Our on-the-ground teams consist of experienced professionals who will meet with the appropriate CDSCO regulatory agencies on your behalf throughout the clinical study. We will provide guidance on meeting the Institutional Review Board (IRB) and Independent Ethics Committee (IEC) requirements.
  • Clinical Trials Management
    We can comprehensively manage the clinical trials process by conducting the trials and completing the clinical trial reports. Our experts will evaluate clinical trial and non-clinical trial data; conduct gap analyses; and determine safety and efficacy, along with primary and secondary endpoints, as required for your specific product.
  • Quality Compliance and Audits
    We can conduct on-site audits of your clinical trials and consult on the guidelines for Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Pharmacovigilance Practices (GVP), Good Quality Practice (GQP), Good Manufacturing Practice (GMP), etc.
  • Adverse Events and Post Market Surveillance
    We will report adverse events and implement suggestions on additional tests and required data. We can assist in post-approval and post-clearance clinical trials to maintain the safety, efficacy, and performance of the product through its life cycle.

Clinical trials that are conducted properly in India may facilitate a smooth registration approval process and expedite access to other global markets. If you need assistance with clinical trials for your medical product in India, contact us for a consultation with our regulatory experts.

Quality

India’s GMP Standards

India’s GMP standards for  drugs are covered in Schedule M and Schedule M III of the Drugs and Cosmetics Act (DCA):

  • Schedule M describes the quality assurance, self-inspection and/or quality audit, and quality control system requirements for medical devices and pharmaceuticals; it also lists the requirements for the factory premises, materials, plant, and equipment.
  • These requirements are based on World Health Organization guidelines.
  • For drugs, there are also additional specific requirements for small volume injectables, large volume parenteral, APIs, tablets, capsules, etc.

India’s GMP regulations are now more aligned with ISO 13485. Standardizing quality requirements will help manufacturers in India register their medical devices more effectively.

Nutraceuticals

In India Nutraceuticals are known as “Foods for special dietary uses” and are defined as products that shall provide a physiological benefit and help maintain good health.  The regulation for nutraceuticals can be found under Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016.  In India, nutraceuticals are divided into 8 different categories; Functional foods, Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Specialty food containing plant or botanicals, Foods containing Probiotics, Foods containing Prebiotics and Novel Foods.

To commercialize Nutraceuticals in India, it is mandatory to register them with Food Safety and Standard Authority of India (FSSA) authority, that has very complex confusing procedures.

Global Regulatory Partners, Inc. (GRP), has a team of experts in India who can help Nutraceutical and food supplements companies in India during their products’ development. The team reviews the list of ingredients to make sure that they are safe for consumers and are within the daily dose limits allowed by local regulations. The team also reviews and validate the content of the products labeling and packaging and makes sure that nutrient content claims and health claims made by the manufacturer are validated and supported by scientific data before any products’ commercialization.

Authorized local agent

Global Regulatory Partners, Inc, (GRP) has a team of experts who helps Nutraceutical and dietary supplements companies worldwide to register and commercialize their products in compliance with FSSAI regulatory requirements in terms of labelling , packaging, nutrient content claims and health claims. GRP has local offices and strategic partners worldwide who can help you register and commercialize your complementary medicine in the Indian market.

GRP Nutraceutical Services  in India:

  • Regulatory intelligence
  • Regulatory strategy
  • Regulatory affairs
  • Product Registration
  • Verification of Nutrient Content Claims
  • Verification of Health Claims

Regulatory intelligence

Regulatory intelligence (RI) is an essential tool for regulatory professionals. RI allows professionals to develop the most appropriate regulatory strategy for a successful, efficient, and cost- effective product development, registration, and commercialization in India. GRP experts can collect the regulatory and other important requirements applicable from FSSAI to your product such as: registration dossier, claims, prohibited list of ingredients, importation regulations, specification of ingredients and labeling requirements that are needed to establish the correct strategy for your product commercialization in India’s market.

Regulatory Strategy

Developing the right regulatory strategy for your Nutraceuticals in different markets is crucial for successful product development, registration, and commercialization. Global Regulatory Partners, Inc., (GRP) team has expertise in developing the appropriate and effective regulatory strategy for different types of Nutraceuticals for the Indian market. GRP strategy will help you meet your business objectives and goals and reduce your risk of failure. In developing the regulatory strategy, our team takes into consideration different factors such as information on your products and similar products on the market, your product development status and milestones, your business goals, your timelines, the regulatory requirements related to your product, cost, and risks.

With a global presence and a local team of experts, GRP regulatory strategy will help forecast your Nutraceutical launch and commercialization with confidence.

Regulatory Affairs

Global regulatory Partner, Inc. (GRP) provides a full regulatory affairs service from product concept throughout product development till product registration. Our regulatory affairs services in India include regulatory intelligence, regulatory strategy, labelling , packaging, nutrient content claims and health claims.

Our Regulatory affairs teams can help nutraceutical and dietary supplements companies understand and efficiently manage the demanding complexity of the Indian Regulatory requirements in order to successfully register and commercialize their products in the Indian market and maximize the value of their assets.

Verification of Nutrient Content Claims

Nutritional claims are those that state, suggest or imply that a food has some particular- beneficial nutritional properties. A nutritional claim suggests a food has beneficial nutritional properties, such as “low fat”. A Claim is a statement that suggests a relationship between food and health. For instance, a Food can “help lower cholesterol.” This information helps consumers to take an informed decision about whether to purchase and consume the product or not. In addition, the FSSAI regulations have certain rules governing the provision of voluntary nutrition information, particularly for the front of pack labeling, the nutritional labeling of non-pre-packaged foods and the labeling of energy drinks. Some nutrients are now prohibited to be declared. A nutrient content claim expressly or by implication characterizes the level of a nutrient in a dietary supplement.

Verification of Health Claims

Health claims are directed to the general population or designated subgroups (e.g., the elderly) and are intended to assist the consumer in maintaining healthful dietary practices. Global Regulatory Partners Inc. (GRP), team has the expertise in reviewing and validating the health claims that you are making for you nutraceutical products or dietary supplements in India to make sure that they are supported by scientific data, are accurate and can be accepted by health authorities FSSAI. 

Product Registration

Regulatory Requirements in India:

  1. Product Evaluation: Examination of each active ingredients & additive. Various steps in the product evaluation include: Developing extracts of documents, sample collection, Sample dispatch to the concerned authority and Food analysis.
  2. Licenses: To get Product registered in India, it might be required to include: Import licensing, Manufacturing licensing, Marketing licensing and Other state and national level clearances/licenses required from the regulatory side. These must be approved before product launch in India.
  3. Health and label claims verification:Health claims” means any representation that states, suggests or implies that a relationship exists between a food or a constituent of that food and health. This includes: India specific labeling and packaging requirements, Packaging of the consignment composition of the consignment and approach to market the same, need for sample material and declaration for registration, Label content and claim structure – function claim.

Global Regulatory Partners, Inc. (GRP), has a team of experts in India who can help Nutraceutical and food supplements companies in India during their products’ development. GRP can help you navigate the Indian nutraceutical regulatory environment and successful register your product in the Indian Market.

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