Author: Abhishek Patel

Insight into the Medical Devices Market in India 

Posted on by Abhishek Patel

Over the last decade, the medical device industry in India has experienced remarkable growth, driven by increasing demand for a diverse range of medical devices, including consumables, dental products, diagnostic imaging equipment, orthopedics and prosthetics, patient aids, and more. To encourage and regulate this burgeoning sector, the government has introduced a range of reforms and policies. These initiatives aim to foster innovation, ensure quality and safety, and address the diverse needs of the healthcare system. 

Despite this progress, a significant gap still exists between India’s current demand and the supply of medical devices. To address this, the government has made essential changes to the FDI policy to promote the import of medical devices into India. 

In this blog, we will explore the medical device industry in India and discuss how foreign medical device companies can enter the Indian market. 

Market Size of Medical Devices in India

India is the 4th largest medical devices market in Asia, following Japan, China, and South Korea, and is among the top 20 medical device markets worldwide. Let’s delve into the numbers related to the market size of India’s medical devices sector:

  • In 2022, the medical device market in India was valued at Rs. 90,000 crore (approximately US$ 11 billion). It is projected to expand to US$ 50 billion by 2030, reflecting a compound annual growth rate (CAGR) of 16.4%.
  • The diagnostic equipment market is anticipated to reach US$ 6 billion by 2027, and likely to expand at a CAGR of 16.4% between 2020 and 2030. 
  • India’s dependency on imported medical devices has increased between November 2022 and October 2023, with a 21% rise in imports, totaling Rs. 61,262.84 crore (US$ 7.23 billion). 

Key Market Drivers

There are several factors contributing to the booming medical devices sector in India. The key ones are: 

  • Growing Population: With a population of over 1.4 billion, the demand for medical devices to cater to chronic diseases, diagnostic needs, and advanced treatment options is also increasing.

  • Aging Demographic: According to the National Statistical Office (NSO) report, India's aging population was 138 million in 2021, expected to rise to 194 million by 2030. With a growing number of elderly citizens, there is a rising demand for devices related to diagnostics, mobility aids, and chronic disease management.

  • Increasing Chronic Diseases Due to Lifestyle Changes: According to a report by the International Diabetes Federation, the prevalence of diabetes in India is projected to reach around 74 million by 2025. Not only diabetes but other chronic diseases like cardiovascular conditions, and cancer are also becoming more common due to lifestyle changes, requiring more diagnostic and therapeutic devices.

Key Market Drivers for Medical Device Sector in India

Key Market Drivers for Medical Device Sector in India

  • Increasing Health Insurance Coverage: India’s national health insurance program “Ayushman Bharat” aims to provide healthcare coverage to 500 million individuals. This has led to a substantial increase in the number of patients seeking medical care, thereby boosting the demand for medical devices.  
  • Growing Middle-Class and Health Awareness: It is estimated that 8 percent of Indians will earn more than USD 12,000 per annum by 2026 and around 73 million households will turn into middle-class category in the next ten years. The rising income and awareness of medical devices are leading to higher spending on healthcare including the use of wearable health tech and home diagnostic devices. 
  • Rise of Private Healthcare: The private
    healthcare sector in India has been expanding rapidly. As of 2019, 393 hospitals received accreditation from the National Accreditation Board for Hospitals & Healthcare Providers (NABH). This growth has driven the need for high-quality medical devices to meet accreditation standards. 
  • Medical Tourism: Approximately 2 million patients visit India annually from 78 countries for medical, wellness, and IVF treatments, generating $6 billion for the industry which is expected to reach $13 billion by 2026. This is backed by the Indian government's “Heal in India” initiative making India a hub for medical tourism and driving the demand for medical devices.
  • Favorable Regulatory Environment: Several positive changes to the Indian regulatory framework, pivotal being the Medical Devices Rules, 2017, have made it easier for local manufacturers and importers to enter the Indian market.These factors collectively contribute to the robust growth of the medical devices sector in India.

How Can Foreign Medical Devices Players Access the Indian Market

Foreign medical device players who wish to enter the Indian market must follow the steps that are mentioned below:  

  • Conduct Market Research: Research on factors such as market demand, competition, pricing, and regulatory requirements to identify the potential export opportunities in India.   
  • Regulatory Compliance: Foreign medical device companies must understand India's regulatory framework. The Central Drugs Standard Control Organization (CDSCO) is the regulatory authority for medical devices in India and all medical devices must be registered with CDSCO before entering the market 

For detailed information on the registration of medical devices, read our blog “The   Complete Guide to CDSCO Medical Device Registration”.  

  • Government Initiatives: Leverage the benefits of government initiatives, such as the reduction of customs duties on essential medical devices, which ease the import of high-quality medical devices into the Indian market. Other initiatives include regulatory harmonization by CDSCO, AIFTA, CEPA, and more. 
  • Quality Assurance: Ensure that the medical devices conform to the standards set by the Bureau of Indian Standards (BIS), the International Organization for Standardization (ISO), or the International Electrotechnical Commission (IEC). This will enhance credibility and trust among Indian consumers.  

To learn more about the BIS standards for medical devices, read our blog “Ensuring Quality in Healthcare: The Role of BIS Standards for Medical Devices”.   

  • Regulatory Support: You can partner with regulatory consultants specializing in the Indian medical device sector to understand the regulatory pathway specific to your product portfolio and the associated requirements They can help you in a successful registration of your medical device in India.

Future Perspective

With the Indian government’s ongoing support and advancements in technology, the medical devices market in India is set for significant expansion. The government’s initiatives to streamline regulatory processes, support innovation, and develop a robust manufacturing ecosystem are paving the way for easier market access for exporters. These efforts are crucial in facilitating a smoother entry for international medical device companies and enhancing their ability to tap into India's growing healthcare sector. 

We, at Regulatory Solutions India (RSI), specialize in regulatory consulting services for medical devices, IVD’s and cosmetics. We are eager to partner with you and script your success story in India. Drop us a message here for your specific requirements and we will take it forward from there.

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Registration of Cosmetics in India

Posted on by Abhishek Patel

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:

  1. All cosmetics manufactured in or imported to India must comply with the Cosmetic Rules, 2020.
  2. All manufacturers must obtain a license or loan license from the State Licensing Authority to manufacture cosmetics for sale and distribution in India.
  3. All importers must obtain an import registration certificate from the Central Licensing Authority to import cosmetics to India.
  4. 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

  1. Cosmetics should not contain any of the raw materials listed in Indian Standard IS: 4707.
  2. Cosmetic products should not contain dyes, colours, or pigments other than those specified by the Bureau of Indian Standards (IS: 4707).
  3. 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.
  4. Hexachlorophene should not be an ingredient in any cosmetic.
  5. 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:

  1. Apply to register cosmetics intended for import into India through the central government's online portal, Form COS-1.
  2. 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.
  3. 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.
  4. 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.
  5. 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:

  1. 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.
  2. For a new cosmetic, the manufacturer must obtain prior approval in Form COS-3 from the Central Licensing Authority.
  3. 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.
  4. 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.
  5. 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.

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Materiovigilance Programme of India (MvPI) :DCGI Calls for Strengthening Medical Device Adverse Event Reporting

Posted on by Abhishek Patel

The Drugs Controller General of India (DCGI) has called for the timely reporting of adverse events related to medical devices by issuing a circular dated May 15, 2024. The move aims to strengthen the existing Materiovigilance Programme of India (MvPI) ensuring that medical devices are safe and reliable once in the market.

What does the Circular state?

The Materiovigilance Programme of India (MvPI) is an important programme for reporting adverse events, coordinated analysis related to medical devices, including in-vitro diagnostic devices, therefore it is suggested that all the license holders should also use the MvPI platform to report any adverse events/serious adverse events associated with the devices to enhance the procedure of identifying risk associated with medical devices.

What is MvPI?

The Materiovigilance Programme of India (MvPI) was launched by the Ministry of Health and Family Welfare, Government of India, on July 6, 2015, with the objective to monitor, record and analyse the root cause of adverse events or risks associated with the use of medical devices, including in-vitro diagnostics by healthcare professionals or patients/users and suggesting regulatory bodies to take appropriate action to improve Indian patients’ safety. Indian Pharmacopeia Commission (IPC) is functioning as National Coordination Center (NCC) for MvPI.

Objectives of MvPI:

The core objectives of MvPI are as follows:

  • To promote the reporting of adverse events related to medical devices by clinicians, biomedical engineers/clinical engineers, hospital technology managers, pharmacists, nurses, technicians, medical-device manufacturers.
  • To collect adverse event reports, assess them, and submit medical device reports to the medical device regulator.
  • Voluntary registration of medical device manufacturers to:
  • Report adverse events, associated.
  • Root cause analysis and corrective/prevention action to IPC-NCC.
  • To develop and implement an electronic reporting system (e-reporting).
  • To support the health system where in procurement of medical device is only undertaken after studying adverse events associated with the medical device intended for procurement.
  • To make it mandatory, in the long term, – for all healthcare providers under the Clinical Establishment Act to report adverse events associated with medical devices.

Important Responsibilities under MvPI:

Medical device organisations, including in-vitro diagnostics, are important stakeholders to make the MvPI programme a success. The key responsibilities of such organisations as a result of the MvPI are as follows:

  • Robust Post-Market Surveillance: Post-market surveillance refers to the vigilance on the use of medical devices, including the information on the quality, safety. or performance of medical devices after the medical device is placed on the market. With a robust post-market surveillance system, organizations can reduce, -the chances of adverse events that may lead to any harm/ injury to the patient. Moreover, the regular vigilance process reduces the likelihood of the same type of adverse incident being repeated in different places at different times.
  • Reporting of Medical Device Adverse Event: In case an adverse event or incident related to a medical device has been noticed by the manufacturer or healthcare service provider, or Medical Device Adverse Event Monitoring Centers (of public/private hospitals), it should be reported immediately, and its root cause of failure should be investigated and intimated to IPC-NCC.
  • Reporting of Field Safety Corrective Action: A field safety corrective action (FSCA) notification form has been developed to notify the regulatory authority and the consignees regarding any corrective action or recall that has been initiated by the manufacturer/importer to reduce any serious adverse reaction associated with the use of medical devices. Concerned organizations must take cognizance of this form and use it for reporting their FSCAs.


Materiovigilance Programme of India (MvPI)

Benefits of MvPI:

  • It is crucial for providing secured, sensible and responsible healthcare to citizens in India.
  • It contributes to establishing a system in India for systematic, scientific and practical means of screening large medical device adverse events datasets at the national level.
  • It contributes to public health by identifying potential safety issues more accurately and quickly.
  • It promotes patient safety by identifying adverse events that could result in patient harm.
  • It encourages Medical Device Manufacturers/ Importers to put products in market with a sense of ethical business, analyze and improve design and performance of products.
  • It can provide supportive data to improvise product standards developed by ISO/BIS.

Conclusion:

MvPI is a critical components of India's healthcare delivery system, guaranteeing the safety and efficacy of medical devices while increasing healthcare quality. Prioritizing transparency and employing cutting edge technology can create an efficient Materiovigilance system which can protect public health while improving healthcare quality.
For more information on India's Materiovigilance Programme and its effect on medical device safety, visit, https://www.ipc.gov.in/mandates/materiovigilance-programme-of-india-mvpi/about-us.html.

How can Regulatory Solutions India Help You?

Regulatory Solutions India (RSI) is your reliable partner when it comes to medical device regulation. Since 2011, they have successfully registered over 450 products ranging from medical devices, IVDs and cosmetics across 25+ categories such as stents, catheters, intraocular lenses, orthopedic implants, ablation devices surgical dressings, hypodermic syringes/needles and more from clients from 15+ countries.

RSI provides its clients with a unique combination of technical, strategic and project management support backed by rich industry experience. We help companies register their products with India's central licensing authority (CDSCO) while offering expert knowledge into CDSCO medical device registration and import license processes in order to navigate successfully the regulatory landscape.

Why Choose RSI?

  • Regulatory Strategy for Medical devices: Analyse the portfolio, interpret regulatory requirements, identify potential problems, and design the right strategy for medical devices accordingly.
  • Regulatory Application Submission to CDSCO: Review regulatory documents, validate dossiers and submit applications for Import License.
  • Registration Approval: Technical support for scientific meetings with regulators and for responding to regulatory queries.
  • Post Registration Support: It also offers post registration support in labeling recommendations & regulatory compliance, post registration compliance reporting obligations and advise on impact, if any, due to regulatory changes.

Take Action Today

Partner with Regulatory Solutions India to ensure the safety and security of the medical devices. Visit us here.

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Intraocular Lenses and Regulatory Processes

Posted on by Abhishek Patel

Intraocular Lenses (IOLs) are special lenses put inside the eye during surgery to replace the natural lens. This often happens when someone has cataract surgery, but they can also be used for other vision correction surgeries.

What Are Intraocular Lenses (IOLs) Regulatory Processes?

IOLs are artificial lenses made from clear plastic, silicone, or acrylic. They help people see better by focusing light onto the retina, just like the natural lens in our eyes. Unlike contact lenses that sit on the eye’s surface, IOLs are implanted inside the eye.

Types of Intraocular Lenses

There are different types of IOLs for different vision needs:

1. Monofocal IOLs: These lenses have one focusing distance, usually for clear distance vision. You might still need glasses for reading or close-up work.

2. Multifocal IOLs:  These lenses provide multiple focal points, so you can see clearly at different distances (near, intermediate, and far). This reduces the need for glasses.

3. Toric IOLs: These lenses help people with astigmatism, which is when the cornea is curved unevenly.

4. Accommodative IOLs: These lenses move or change shape inside the eye, offering a more natural range of vision.

5. Extended Depth of Focus (EDOF) IOLs: These lenses provide a continuous range of vision with one elongated focal point, offering better intermediate vision without causing glare or halos.


A technical chart illustrating the intraocular lens placement procedure in front of an eyeball, detailing four key steps: 1) An incision is made, 2) Emulsification breaks up the cloudy lens, 3) The intraocular lens is implanted, and 4) The incision heals on its own.

Intraocular Lenses (IOLs) and Regulatory Processes in India

Uses of Intraocular Lenses

IOLs are used in several situations:

● Cataract Surgery: The most common use of IOLs is to replace the natural lens when it becomes cloudy due to cataracts.

● Refractive Lens Exchange (RLE): This surgery is similar to cataract surgery but is done to correct vision problems like near-sightedness, far-sightedness, and presbyopia.

● Phakic Intraocular Lens (PIOL): These lenses are implanted without removing the natural lens to correct high levels of near-sightedness or far-sightedness.

In India, the Central Drugs Standard Control Organization (CDSCO) regulates IOLs. Here’s what you need to know about the approval process:

Regulatory Approval for Intraocular Lenses in India

In India, the Central Drugs Standard Control Organization (CDSCO) regulates IOLs. Here’s what you need to know about the approval process:

Classification of Intraocular Lenses

As per the risk-based classification of medical devices under the Medical Device Rules (MDR), IOLs are classified under Category C, which means they are considered moderate-to-high risk devices.

Regulatory Pathway

● CDSCO Registration: All IOLs must be registered with the CDSCO. This includes submitting clinical data, technical details, and manufacturing information.

● Licensing: Manufacturers and importers need licences to manufacture or import IOLs.

● Clinical Evaluation: Clinical trials might be needed to prove that IOLs are safe and effective.

● Quality Management Systems: Compliance with standards like ISO 13485 is necessary to ensure safety and quality.

How RSI Helps in the Regulatory Process?

Regulatory Solutions India (RSI) is a leading regulatory consultancy in India that assists companies with medical device regulations. Our team comprises experts experienced in the regulatory requirements for medical devices, including IOLs. Here's how we can help:

  • Preparing and submitting regulatory documents
  • CDSCO Registration/Licensing
  • Submission of IL renewal/retention applications
  • Post-market surveillance and compliance

Conclusion:

Understanding the rules and steps for getting approval for intraocular lenses in India can be challenging, but with the right help, it becomes easier. Knowing about the  regulatory requirements is key for successful market entry. RSI has helped several companies over the years register their products over a wide range of applications, some of which are Ophthalmic, Neurological, General Hospital, Respiratory, Dental, Ear, Nose and Throat (ENT), Obstetrical and Gynecological (OG), Software, Operation Theatre (OT), Gastroenterological, Oncology and more.

By working with Regulatory Solutions India (RSI), you can ensure compliance and focus on bringing your IOL’s and other medical devices to market.

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