AI has rapidly progressed from being merely a computational helper to a functional co-researcher in clinical trials. Nowadays, algorithmic methods are entailed in protocol development, patient selection, adaptive drug dosing, and real-time safety evaluation. However, Indian law still anticipates a research environment run solely by human researchers. The discrepancy between technology’s potential and its legal acknowledgement has resulted in a multifaceted regulatory scenario that needs healthcare regulatory compliance lawyers and healthcare data privacy law firms.

Existing Regulatory Framework
The Drugs and Cosmetics Act, 1940 (DCA) and Drugs and Cosmetics Rules, 1945 (DCR) primarily control clinical trials in India. The older Schedule Y (superseded now) defined standards for trial performance, informed consent, and safety reporting, among other parameters. The New Drugs and Clinical Trials Rules, 2019 – which superseded the older Schedule Y – brought significant changes in India’s clinical trials landscape. It not only defined procedures for approval but also made ethics committee registration a prerequisite. Besides, the legislation established new criteria for safety and compensation. Further, the ICMR National Ethical Guidelines for Biomedical and Health Research Involving Human Participants of 2017 and the GCP Guidelines of CDSCO provide a structure for ethically responsible conduct of clinical trials. Besides, legal advisory for hospitals and wellness centres mandates that the healthcare sector must remain fully compliant with both legislative and regulatory requirements.

AI as Co-Researchers: Evolving Scenario
AI-assisted clinical trials raise several unprecedented legal and ethical questions:
● Defining “Investigator”: According to NDCTR, an investigator is defined as a person who is responsible for carrying out the trial. The situation, however, is different if the AI model performs safety signal detection or recommends protocol amendments—is it just a tool or an entity affecting the trial design?
● Informed Consent: The Apex Court, in the landmark case of Swasthya Adhikar Manch v. Union of India (2013), observed that informed consent and patient protection were not adequately enforced and thus, the new regulations came into being. In the AI-assisted trials, the subjects might need a more sophisticated version of “intelligible consent”, which would provide an extensive discussion of the algorithmic decision-making process’s role, limitations, and risks—a field where the current consent forms do not suffice.
● Liability and Accountability: If AI recommendations go awry, the legislation is unclear on who will be considered guilty – whether the sponsor, investigator, developer, or the institution. The NDCTR 2019 (Schedule VII) mandates providing compensation; the Responsibility of AI-based decisions is still unclear.
● Data protection and Privacy: AI systems depend on sensitive human and health data. The data-protection is rapidly evolving (including the DPDP Rules 2025, EHR Standards 2016, Information and Technology Act, 2000, etc.) and has implications for data usage, algorithmic profiling, and automated decision-making in clinical research.

Legislative Evolution: Potential Direction
In the future, the regulatory framework of India will have to clearly state the participation of AI in clinical trials. The first step would be to grant AI a place under the NDCTR through specific guidelines, thereby creating a formal definition of AI as either a decision-support system or a technology having a considerable impact on clinical results. Ethics Committees might also want detailed AI-risk assessments to be done that would cover issues like model validation, bias, reliability, and the measure of human oversight. It would be necessary to update the informed-consent templates so they will require precise disclosures about the involvement of algorithms—how AI tools are incorporated in the processes of screening, monitoring, or decision-making—and what risks are taken due to the automated processes. The regulations could also impose obligations for keeping audit trails of algorithms, version histories, and validation reports. All these changes together would make it certain that AI-assisted clinical trials in India would be safe, ethical, and in line with the changing biomedical governance landscape. Consequently, the need for the Pharmaceutical regulatory legal services and Medical malpractice defence law firm is also rising among the ecosystem players.

AI is not a peripheral tool anymore; it is an energetic participant in clinical research. The legal framework of India, although strong enough for conventional trials, should change in such a way that the trials with the use of AI would still be ethical, transparent, and focused on the participants. Changing the laws and guidelines at this point will not only help in reducing the risk but also build confidence in India’s fast-growing biomedical research landscape.

Adv. Varun Singh
Founder & Managing Partner
Foresight Law Offices India

The post Evolving Legal Frameworks for AI-Assisted Clinical Trials appeared first on Health Vision.

Hand sanitizers are the most sought-after products for the last two years, for obvious reasons. The Covid-19 outbreak is a wake-up call to investigate our habits to maintain hygiene and to know susceptible we are to a viral or bacterial infection. Washing hands for more than 10 minutes is remains the most effective method against viruses and bacteria. However, in regions with water scarcity, people must choose the second-most effective method, hand sanitizers.

Since the Covid-19 pandemic, hand sanitizers gained a new popularity to the extent that medical stores were experiences shortages and the sanitizer manufacturing facilities were operating at their full potential. The fear of Covid-19 infection and heavy marketing of sanitizers made them the highest selling product during the pandemic. According to Allied Market Research, the global long lasting hand sanitizer market is expected to reach $21.7 billion by 2030. The consumer awareness regarding health & wellness, innovations in hand sanitizers, and social media penetration promotes the demand for long lasting hand sanitizers.

However, there are many misconceptions when it comes to hand sanitizers. Some believe that once used, the sanitizer can give protection against viruses and bacteria like a glove or an invisible shield. The emergence of long-lasting hand sanitizers helps cement the belief that hand sanitizers are no short of cure against the Covid-19. There are some cases where people drank hand sanitizers to protect themselves from Covid-19 infection. Here we will try to understand long lasting hand sanitizers and how exactly effective they are against viral infection.

Also read: Hand hygiene: The life saviour for corona virus infection

What is a hand sanitizer?

Before we talk about the effectiveness of hand sanitizers, we need to know what hand sanitizers are made of. A common hand sanitizer contains alcohol bases, gelling agent, and water (to activate the gelling agent). The gelling agent gives the sanitizer the thickness but the alcohol does all the work. When applied to the hand, alcohol sanitizes the hand by killing the microorganisms existing on the hand.

Believe it or not, it is possible to make hand sanitizer at home by using aloe vera as a gelling agent and isopropyl alcohol instead of grain alcohol. To make hand sanitizer, the concentration of alcohol must be above 60%. There are believes that you can turn vodka into a hand sanitizer, which is completely untrue. Vodka contains 40% alcohol and 60% water, which is ineffective against microorganisms.

If it is only about alcohol, can hand sanitizer expire?

Most of the purchased hand sanitizers have an expiration data on them but is it commonly far in the future and found to be around three years out. This raises the question whether hand sanitizers have expiration date or the manufacturing companies are legally required to print the expiration date?

The answer is yes, hand sanitizers can expire but it is slightly unusual situation. An five-year old bottle of hand sanitizer that hasn’t been opened, will probably work against microorganisms as alcohol does not go bad in sealed conditions. The most relatable example is wine. You can store it for hundreds of years and it will age amazingly. However, once you open the bottle, the alcohol-eating bacterial come into the picture which define the expiration date of the wine.

In case of hand sanitizers, once the bottle is opened, the alcohol concentration starts to drop as it evaporates quickly into the atmosphere. Once the concentration of the hand sanitizers goes below 60%, it is not useful against microorganisms and therefore hand sanitizers come with a long but specific expiration date.

How effective are long lasting hand sanitizers?

To answer the question of how long a hand sanitizer can last depends on how effective the active ingredients are including isopropyl alcohol or ethyl alcohol. Apart from this, how well you apply the sanitizer also contributes to the effectiveness of the product. Thus, while applying hand sanitizers, you must cover your hands all through the wrist and in between fingers.

However, you must understand that hand sanitizer, even if it is long lasting and effective, cannot be an alternative to washing hand with soaps. Sanitizers can work against bacteria but not food particles. A common hand sanitizer can last up to 2 minutes and it loses its effectiveness when you touch other surfaces. Thus, the demand for long lasting hand sanitizers has increased significantly.

Recently, Fine Hygienic Holding, one of the world’s top manufacturers of hygienic paper products and germ protection solutions launched its new line of germ protection products, which includes a long-lasting hand sanitizer that offers 24-hour protection with only one application. The company states that the hand sanitizer can kill 99.9% of germs including Covid-19 virus. The company also launched disinfectant that offers up to 48 hours of germ protection on all textiles and its laundry disinfectant can provide protection up to 7 days.

Similarly, a biotech startup launched a new long lasting hand sanitizer that offer protection against Covid-19 virus and other microorganisms for more than four hours after application. The sanitizer is called IonLAST and uses a proprietary ionic liquid technology that contains natural materials to improve antiviral protection. The commonly used alcohol-based hand sanitizers fail to give a long-lasting protection but IonLAST is non-alcoholic sanitizer, which therefore that is safe for kids.

The non-alcoholic hand sanitizers are preferred by the people who are worried about alcohol use or who opt to avoid flammable materials in house around kids. These hand sanitizers can alleviate several issues of alcohol-based sanitizers such as drying of skin. The alcohol free sanitizers use other chemicals such as Benzalkonium Chloride that quite safe for topical use and is long lasting.

However, you must remember that the moment you are done using sanitizer, your hands are exposed to all kinds of microorganisms. Thus, after application of hand sanitizer, of you touch any other uncleaned surfaces such as doorknob or mobile phone, you are letting germs come in contact with you. At this moment, hand sanitizer cannot protect you as there is no residue of hand sanitizer left on your hand. However, you can use hand sanitizer in-between steps.

In a simpler term, long lasting hand sanitizers work well to remove germs on your hands but it fails to prevent you from getting contaminated. With that in mind, use both hand sanitizer and handwashing method to maintain your hygiene. As they say, prevention is better than cure and the pandemic has taught us this lesson the hard way.

For More Information Click :-https://www.alliedmarketresearch.com

The post Hand sanitizer market expected to reach $27.1 million by 2030 appeared first on Health Vision.

Over the last few years, the beauty and skincare industry has evolved at a faster pace right from traditional products and ingredients to modern-day HD beauties. A number of big brands who owe seemingly good products may have deeper secrets that they never reveal to you, which may also include Animal Testing carried on at any stage during the product development process.

The crucial reason behind the animal testing procedure is safety and to meet the legal requirements that identify potential hazards to humans, animals and the environment. Our buying habits have the potential to encourage change, particularly when it comes to what we’re purchasing for ourselves. Apart from the beauty products to meet our requirements, check for the cruelty-free and vegan tag which will in fact create a huge difference. Simply opt for products that are not tested on animals in any way and are Cruelty-Free having zero animal-derived ingredients, i.e. Vegan.

 India prohibited the testing on animals.

As per recent reports, India happens to be the first country to have prohibited the testing of cosmetics and their ingredients on animals. But banning the creation of these products doesn’t mean they don’t exist or can’t make their way to your shelves. Thus, the entire decision relies on the consumers’ hands to make the society a better place to live in for all lives. It also includes not encouraging the ventures that experiment substances with animals or apply any product formulations on them every time a new cosmetics are formulated.

Currently with the rising spotlight, consumers’ conscious steps towards self-education and the brands’ efforts to find effective options to replace the age-old methods, a new resonance has been set for what safe and cruelty-free beauty really is. Choosing the right cosmetics brand that is cruelty free and vegan, can be a little hard, as not all brands are genuine when saying the title, however, one can watch out for the logo on the packaging.

When you opt for cruelty free hair care products you’re ditching toxic and harsh chemicals like sulphates,  parabens and synthetic dyes. Cruelty free hair care products contain natural oils and minerals which will lock the moisture in your strands. It also helps in stimulating hair follicles, making it easier for you to experience new hair growth. In today’s developing society, some brands and new launches have taken the initiative of creating what is not only good for the human skin, but also for Mother nature.  As consumers, the responsibility is to choose beauty and cosmetic products that keep the planet breathing and alive. It is also equally important to encourage organic and natural beauty products in the market and transform our lifestyles to become more sustainable.

​Ms. Devanshi Shah

Production Analyst, Cinderella

The post Check for the cruelty free and vegan tag appeared first on Health Vision.

SHAPEUP INDIA was formed 17 years back by a group of expert doctors and healthcare professionals to promote targeted Nutrition, Regenerative Medicine, Anti-aging and Preventive care at community and corporate levels.

So far in the country there were no affordable products and no company with a proper revenue model to implement across the length and breadth of this country.

Emergence of a few  companies with an intention of preventive care, targeted and tailored Nutritional products to combat micronutrient malnutrition, many cell based products services with good regenerative/anti-aging solutions  and a suitable revenue model to consumers, has enabled Shapeup India to take a real shape and to form NATIONAL CONSUMER FORUM (NCF).

NCF is designed to be an innovative community and consumer driven project aimed to achieve SMART HEALTH and a well- planned economic redistribution at grass root levels leading to SMART NATION.  We are equally inspired by the Nation’s slogan “ATHMA NIRBHAR BHARATH”

Health Vision Spoke to Dr. Srinivas Murthy –  senior consultant clinical sports and nutrition Shape up India on his vision to make the society clean and healthy.

Is it a fact that many people in society are suffering from many diseases due to regular use of commercially sold household products?

Dr. Murthy:  In this regard let us not think of spurious products. Let us talk about only daily use products sold through media support. Just take normal bath soap and toothpaste. Nobody is bothered about the required parameters for bath soap. Now a days some companies are talking about T F M (Total Fatty Material). It should be a minimum of 75% TFM . But majority of available brands have around or less than 70%TFM.

Next toothpaste. As per Central Education and Research Society majority of our toothpastes have high fluoride content. People use high end water filters to filter fluoride in water but consume fluoride while brushing teeth on daily basis. Children in fact eat half of the paste. Fluorosis leads to dental caries, osteoporosis and nerves disorders. If we consider edible and cooking oils it is a major health concern.

According to you which are the false perceptions people have while maintaining their health?

Dr Murthy: From the point of maintaining good health there are many good developments. By looking at walking crowds in the mornings, number of fitness centers everywhere and business of nutritional products speak about the public concern to health.  Like that public have many misconceptions about health. Let me cover just a couple.

As per W H O every 8 minutes one cervical cancer is recorded. In addition PCOD and infertility issues are increasing day by day. As per few surveys it is due to use of Sanitary pads, it is learnt. You chose any best brand in the market and examine they will have plastic and synthetic layers and they have poor absorption and causes itching, irritation and discolouration. In addition the heat generated produces DIOXIN which is the leading cause of all problems.

You mean one has to quit sanitary pads and use clothes like olden days?

Dr murthy: Not like that. The main intention of Shapeup! India is to introduce economical, natural and nutritional products to the society. In this regard we are introducing one international standard smart sanitary pads. These pads have only pure cotton in all layers with max absorption capacity. In Addition it has ACTIVE OXYGEN, NEGATIVE ION, F I R, MAGNETIC and NANOSILVER based chip. Which does many things. Please google and check.

In addition we provide free vaginal test kit with each and every packet. And cost of this kit in market is Rs.175. By using this test kit one can avoid visiting gynecologist frequently by testing themselves. Complete demo of this Pads is available in video format.

Any other false perception People are in?

Dr Murthy: Next Protein Consumption by public is another concern. Since 20 years there are many companies promoting different kinds of proteins at different levels. Big containers with crude concentrates are sold in bazaar in the name of protein. People buy blindly. Many company Reps come to us with preparations less than 30% proteins.

In addition we come across people in parks and public places offering free checkups and saying that if we use their products one can melt like wax in three months and can get away from all other metabolic disorders freely. Many do not know how weight is lost. Weight loss is just based on calorie management. Weight or inches are lost by calories we do not consume and calories we burn by exercise. But not by any secret ingredients as people presume.

Normal general convalescent drinks have around 30% protein. Athletes and sports people need 45-60% protein; Body builders Need 80% protein. In addition almost all general issues by public and for all age related cases one needs PROTEIN RICH IN GLYCINE AMINO ACID. But majority are not aware of this.

What is the solution for this? What kind of preparation SHAPEUPINDIA recommends?

Dr Murthy: People should consult nutritionists before using Protein preparations. One should use protein preparation rich in 65% Glycine. It is present prominently in Muscles, joint cartilages, ligaments, Skin, Heart and nerves. Hence all body builders, sports people, weight Management, neurological, Ortho and Cardiac conditions we need Glycine rich protein.

In addition in all metabolic conditions and age related diseases there is high level of Homocysteine in blood. Only Glycine can break down Homocysteine into methionine and cysteine.

If so where this Glycine rich Protein is available?

Dr Murthy: Shapeup! India has formed National Consumer Forum. Here any one can register from any part of the country and buy products and do social marketing. Courier service is available throughout the country.

Distributors will have all the following benefits-

1. Retail profits
2. Wholesale profits
3. Incentives & bonuses
4. Life time BUY ONE GET ONE FREE
5. International travel opportunities
6. Life time income opportunities for generations
7. BANK LOAN FACILITY for business expansion.
8. Nutritional seminars by experts.
9. Digital marketing support
10. TV and Print media support.

Shape up! India provides

• Info on importance of nutrition and preventive health care in day to day life
• Promotes economical safe natural and nutritional & daily use FMCG products for preventive care purposes.
• Promotes cellular or stem cell therapy to many incurable chronic degenerative conditions including many auto immune disorders and deadly cancerous conditions
• Promotes excellent anti- aging products and stem cell serums soon in Indian market
• Complete ecommerce portal services along with razor pay payment gateway processes are in pipeline.
• World class logistic services throughout the country from well renowned company Ship rocket.
• To unleash dynamic entrepreneurship among the community and corporate members
• Regular online meetings on different health issues by medical and other healthcare experts
• Digital marketing services
• Print and TV media ads

We promote Social marketing through

• women empowerment
• Second career to senior citizens & Unemployed youth

• We have taken steps to provide microfinance through banks to eligible candidates who want to take up marketing.

For video demos and further details whatsapp

94068 49406 /80732 37833

Or visit

Shapeupindia

714, 3rd floor, GIOSTAR-USA hospital building

714, MOdi hospital Road

Rajajinagar, Bangalore-560079

www.shapeupindia.in

The post SHAPEUP INDIA – A project aimed to achieve SMART HEALTH appeared first on Health Vision.

Standardisation of procedures to ensure that it meets international quality standards is the hallmark of any world-class organisation. That is the reason why enterprises strive to set high standards for themselves and adhere to them. International Organization for Standardisation also known as ISO is a non-profit organisation and is a non-governmental body by nature. They establish international safety and quality standards that are accepted globally. Possessing an ISO certificate is considered a cornerstone of achievement.

ISO is needed in the healthcare industry because of several reasons.

• Healthcare is easily accessible. With all aspects such as quality care, health services, cost-effective solutions and safe medical equipment and practices being very affordable nowadays, standardization is necessary to ensure quality.

• Individuals and communities alike can receive the highest quality treatment and care they deserve thanks to the implementation of ISO health standards.

• Organizations and businesses that implement and apply ISO standards demonstrate a proactive commitment to the ideals of quality, openness, accountability, and safety.

• ISO standards make it easier to share information, aggregate data, compare health services, and protect a person’s health privacy.

The implementation of ISO standards creates a standard framework for maintaining quality standards.

Industry:

 ISO standards are strategic instruments that assist firms obtain a competitive edge by providing safe, dependable, and trustworthy products and services.

Consistency is ensured by the implementation of ISO health standards. National governments, Healthcare providers, and manufacturers profit from not having to meet numerous market demands and criteria.

 Regulators

ISO standards give instruments for assessing and evaluating conformance, giving health policy a firm technological foundation.

Regulators can rely on internationally standardised solutions that are examined and updated on a regular basis to offer the technical foundation for market-friendly policies that fulfil citizens’ expectations.

 Consumers

ISO standards aim to standardise the healthcare sector in order to minimise costs while also improving access to care and efficiency.

ISO standards protect the interests of consumers by providing high-quality care and safe and dependable products and services.

Data privacy being priority at all levels, ISO standardization helps setting up of benchmarks and protect the consumer interest.

Some of the Health sector areas that implement ISO Standards include –

• Dentistry
• Sterilization of healthcare products
• Equipment used for transfusions
• Traditional Chinese medicines
• Medical devices
• Healthcare organization management
• Surgery
• Surgical implants
• Infusions and injections
• Health informatics
• Optics
• Assistive products

The advantages of ISO 9001:2015 certification for the hospitals are as follows:

• Internal audits and management reviews are conducted on a regular basis.

• Control and measurements of the suppliers.

• Conduct periodic customer satisfaction surveys and verify that preventative measures are implemented.

• Corrective action methods that are standardised and formalised.

• Risk management and assessment ensure that no unprecedented event takes place.

• Continual improvement through process improvements and increased productivity.

ISO standards ensure quality and safety in products and services offered by the healthcare industry. Businesses can optimise costs by improving systems and procedures.  The ISO standard demonstrates your commitment to standardisation, consistency, continuous improvement and patient delight. These are tangible, measurable benefits that help to create a sustained culture of high performance. The ISO 9001 standard provides the benchmarks for a quality management system that enables healthcare providers to provide superlative healthcare that meets the needs of patients while managing the statutory and regulatory requirements. It serves as a hallmark of the superior service standards that your organisation strives to live by.

Dr.Chinmaya P Chigateri

Director and CEO

Healthminds,Bengaluru

The post Relevance of  ISO Standardisation in Healthcare appeared first on Health Vision.

Experts believe that even if the waivers as demanded by India are granted, they would not suffice, and India needs to expand its demands to meet the objectives of ensuring easy availability and local production of critical supplies.

The proposal that has being tabled essentially seeks a waiver for a period of 3 years from the date of the decision, the provisions related to Copyright, Industrial Designs, Patents and Undisclosed Information in relation to health products and technologies including diagnostics, therapeutics, vaccines, medical devices, personal protective equipment, their materials or components, and their methods and means of manufacture for the prevention, treatment or containment of COVID-19.

The proposal of 60 member countries led by India is due for a detailed discussion at the WTO on June 8/9, 2021. It is imperative that the final outcome of these WTO deliberations ought to be inclusive of nations, governmental and non-governmental agencies and sectorial industries in preparing the members of WTO to responsibly mitigate and manage the present and future pandemic shocks.

Explaining this, leading IPR Expert, Professor (Dr.) Prabuddha Ganguli, CEO, Vision-IPR, explains, “India as a major global vaccine manufacturer and lead producer of generic drugs has rightfully taken a leadership role in initiating the discussion at the WTO with far reaching consequences, especially preparing the league of nations to responsibly mitigate and manage any future pandemic shocks. However, mere waiver of the Sections 1, 4, 5, and 7 of Part II of the TRIPS Agreement which is too myopic and of little or no significance, will be inadequate to meet the key objectives of the India-Africa Proposal. It is not surprising that the USA and several countries in the EU have consented to initiate discussion on the text-based negotiations”.

“The text-based negotiations at the WTO should holistic and strategically be directed to a declaration committed to the optimal boosting of the production and distribution of Covid-19 pandemic related products and services, coupled with enhancement of the much-needed accessibility & affordability in developing and least developed countries”, he added.

Prof. Ganguli has outlined a 3-point agenda which the Indian negotiators at the WTO must include as part of their demands for the new guidelines to be inclusive of nations, governmental and non-governmental agencies and sectorial industries:

1. A “Trade-related IPR Package” going beyond a “mere IPR waiver”, to include transfer of technology knowhow, facile access to raw materials for production, diagnostic methods, equipment for testing / diagnostics, and all items related to medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or other treatment associated with the present pandemic.
2. Pragmatic pathways to execute measures that prevent the abuse of IPR by right holders or the resort to practices which unreasonably restrain trade or adversely affect the international transfer of technologyby invoking IPR and technology enabling options under the Articles 7 & 8 of the TRIPS Agreement.

• A mechanism for the creation of a Structured Publicly Accessible International Database of all the Essential IPRs of Covid-19 (ECOVIPRs) related to products and processes (including pending applications in copyright, industrial design registrations, patents) and the products that have been cleared by Regulatory Bodies in various countries. It should be the responsibility of each Member State to ensure quarterly updating of the ECOVIPRs database with the filings / grants in their respective countries.

Such a publicly accessible transparent Worldwide IPR database would facilitate and promote seamless, fair, reasonable and non-discriminatory utilisation of the global knowledge bank and equip Member States in real time, to design and gear up their respective national production and sourcing plans.

The concept of “Standard Essential Patent” (SEP) and “Fair, Reasonable and Non-Discriminatory” (FRAND) terms is by now well established in the field of electronics and communications technology. Standards organizations, therefore, often require members disclose and grant licenses to their patents and pending patent applications that cover a standard that the organization is developing.  Some of the global lessons learnt in the operation of SEPs and FRAND may be appropriately adopted in the creation and operation of ECOVIPR.

The post India needs to expand its waiver demands at the WTO appeared first on Health Vision.

The global COVID-19 sample collection kits market size is expected to reach USD 16.56 billion by 2028 according to a new study by Polaris Market Research. The report “COVID-19 Sample Collection Kits Market Share, Size, Trends, Industry Analysis Report, By Product (Swabs, Viral Transport Media, Blood Collection Kits, Others); By Application (Diagnostics, Research); By Collection Site (Hospitals & Clinics, Home Test), By Regions; Segment Forecast, 2021 – 2028” gives a detailed insight into current market dynamics and provides analysis on future market growth.

Asia Pacific COVID-19 sample collection kits industry is expected to witness a lucrative growth rate over the assessment period. This is since, this pandemic tends to hit countries more severely, owing to its fragile and underfunded healthcare systems, as there is a disparity between need and purchasing power capacity for preventive measures.

Countries in the region actively engaged in containing COVID-19 infection spread. For instance, in November 2020, ICMR introduced an ambulatory covid-19 RT-PCR lab at its facility. The government has also announced to establish more labs to boost COVID-19 testing.

In 2020, the swabs COVID-19 sample kits industry segment accounted for the largest share. This high share is attributed to the reliance on several approved diagnostic products on the use of nasopharyngeal swabs. As per CDC, samples could also be collected from the respiratory tract, when the use of nasopharyngeal swabs is not sufficient.

Key players in the market for COVID-19 sample collection kits are employing several market strategies to accelerate the supply of products for coronavirus sampling. In line with this, in November 2020, Puritan has received funding of more than USD 11.6 million for the expansion of swab production to cater to the demand of around 3 million swabs in a month. The company has also received additional funding from Paycheck Protection Program.

However, the blood collection kits segment is projected to witness a lucrative market growth rate over the assessment period. Such growth is due to approvals in the blood-related detection tests. For instance, in November 2020, U.S.-based company AnPac Bio-Medical announced the approval of its EUA-antibody test by the FDA for Roche’s Elecsys Anti Sars-COV-2 test.

COVID-19 sample collection kits industry participants such as Lucence Diagnostics Pte Ltd., Laboratory Corporation of America Holdings, Trinity Biotech, Puritan Medical Products, Danaher Corporation, Becton, Dickinson and Company, Thermo Fisher Scientific, Inc., COPAN Diagnostics, Hardy Diagnostics, Quidel Corporation, Quest Diagnostics, Vitagene Inc., HiMedia Laboratories, and VIRCELL S.L. are some of the key players operating in the COVID-19 sample collection kits industry.

Players and organizations across the globe are developing innovative products for sample collection. In line with this, in January 2021, the India-based, Defence Research, and Development Organization (DRDO) introduced COVSACK, a sample collection kiosk for the health practitioners to collect samples, without any need of PPE kits. Polaris Market research has segmented the COVID-19 sample collection kits market report on the basis of product, application, collection site, and region.

The post Polaris Market Research : COVID-19 sample collection kits market size worth $16.56 billion by 2028 | CAGR: 2.3% | appeared first on Health Vision.

The revised notice issued by The Department of Pharmaceuticals (DoP) on the Public Procurement Order on March 25, 2021, where they have incorporated 19 medical devices in the revised guidelines of the PPO will boost the domestic medical device manufacturing by strengthening “Make in India” and is estimated to reduce imports bill by approx Rs. 4000 crore.

This comes as a great relief to the 85% import dependence forced upon India and an ever increasing import bill of over Rs. 42000 Crore. According to  Mr. Rajiv Nath, Forum Coordinator, AiMeD , “This is a real boost to Make in India. This single strategic action will help boost domestic manufacturing imports bill reduction by nearly 10 percent so approximately Rs. 4000 Crore impact is foreseen. Many thanks to the Department of Pharmaceuticals for using the Public Procurement Order as a Make in India enabler while addressing the issue of pseudo manufacturers. Now actual manufacturers who do the real value addition and not just sticking labels or repackaging will get the gain of their investments in India.”

While MNCs / overseas global investors are very welcome to Make in India, reality is that very few have made efforts to put up green field projects in last 10 years and the ones that have done so and other Indian entrepreneurs who have bravely invested and competed with imports in an eco system that’s favoured imports and made India over 85% imports dependent need to be applauded.

“It’s expected of any responsible government to have strong policies to promote Growth and expansion of their own Industries that create Jobs in every sector in the long term interests of their own Citizens. GOI is doing just that what Government of every great country we admire does.

We should be happy and celebrate that Government has acknowledged that the domestic players have grown large, achieved scale and are able to succeed in supplying Global Markets and this has been amply demonstrated during Covid when Indian Manufacturers not only met local demand with good quality affordable products and kept their offices and factories working all days practically round the clock as cost of imports rocketed and supply went for a toss due to disrupted logistics; but Domestic Manufacturers  were able to supply to the world  in addition to meeting greater domestic demand, thereby demonstrating that Indian Medical Device Industry has come of age. The day has arrived to remove the digressive policies of encouraging and relying heavily on imports to meet India’s needs for Medical Devices.” says Mrs. Mala Vazirani, Executive Director of Transasia, India’s largest IVD manufacturer and Jt Coordinator AiMeD, Legal Affairs .

“Covid has shown the spirit of Indian entrepreneurs to Make in India rather than import into India. When imports got disrupted, specific devices detailed with quantified production shortages and a focused Inter-Ministry Group coordinating with domestic manufacturers via AiMeD had addressed production bottlenecks and challenges so that not only capacity got utilized but also ramped up rapidly. This spirit needs to be fanned not doused by seeking roll back of these initiatives” stated Mr. Rajiv Chibber, Vice President of SMT the leading stents & cardiac care medical devices manufacturer and Jt Coordinator Govt Affairs, AiMeD.

Govt. needs to support the ones who have invested and allow other fence sitters to make up their minds in due course as many members of importers associations though claiming to be voice of Industry have neither put up green field factories nor will encourage those of us who continue to do so and discourage any steps taken to protect these initiatives and investments by crying wolf that these would discourage FDI and deny patient access.

India to emerge as a manufacturing superpower.

Large scale FDI did not happen in medical devices since duties fell to zero or 5% or when there was no PPO or there were zero regulations or second hand imports were not restricted so holding this as a threat is meaningless.  “Govt. needs to focus on Indian entrepreneurs and help them grow to be globally competitive. The fence sitting competing MNCs will invest when they will start losing market dominance and wish to also avail the competitive advantage created for those who make in India eg – under the PLI scheme, PPO or PMP ( Phased manufacturing plan) – initiatives that AiMeD’s Make in India passionate members are thankful for” said Mr. Nath.

“The Govt. is not here to deny access to public healthcare for medical devices so if there are no class 1 suppliers, exceptions will be made for permitting class 2 suppliers to bid – until then, class 2 may standby and consider to increase domestic content to 50% by making in India under PLI or PMP rather than importing into India” Explained Mr. Nath.

Other countries like USA, China, Russia, South Africa, Saudi Arabia, Iran, Indonesia, Uganda etc have clearly stated preferential procurement policies to support indigenous manufacturing. Even World Bank encourages this by supporting a 15 % price preference for any indigenous products made in any country for any tender being financed by World Bank / ADB etc

Did MTAI which mainly represents the interest of importers lobby ever take up the cause of Patients access to affordable quality home grown healthcare with the Govt. when exclusionary clauses are cleverly inserted in tenders of seeking USA FDA approval & thereby denying affordable access to patients & market access by Indian manufacturers who may not be initially seeking to sell in USA & US FDA certification?

“We are thankful to The Department of Pharmaceuticals for announcing various schemes to ensure the growth of a vibrant ecosystem of medical devices manufacturing in India. The PLI scheme, The PPO scheme, the PMP scheme on X-Ray machines and its components and the setting up of medical device manufacturing parks in various states would provide a huge boost to domestic manufacturing.

Such supporting policies are needed and need to be expanded to other medical devices so that Indian Medical Devices Industry can make quality healthcare accessible and affordable for common masses. PM Shri. Narendra Modi’s call for self-reliance and an Aatmanirbhar Bharat will not only see India emerging as a manufacturing superpower but will also strengthen India to vie for being the 2^nd factory in world for Medical Devices & a dependable Manufacturer of quality products in Global supply chain. We have shown the ability and capability of Indian Entrepreneurs to Make in India when we have the support of Govt.” Concluded Mr. Rajiv Nath.

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India is witnessing the 2nd wave of Corona in almost all major states of India. The infection is spreading faster which is a major concern for the Indian government authorities as well as for the Indian healthcare system. The 3Ts of Testing, Tracking & Treatment are of the utmost importance to fight during this pandemic, which at times is struggled because of improper space needed for the healthcare people to perform their duties in this pandemic.

Container Designer Veepul Kaushik, the Promoter of Prisha Container lines brought a novel concept of temporary health care units in containers with the complete facility of medical care in case of emergency. These containers can be used for testing, treatment, and in vaccination drive, wherever there is a shortage of health centers.

These health centers are made in portable centers with the complete facility of medical care in case of emergency. Each center has 8 -10 beds with safe spacing along with the Doctor cabin, separate toilets, and facility for a medical emergency as in the case of ICU units. These containers are designed to maintain the standard norms, which are required in every building architecture and interiors.

According to Veepul Kaushik, “these containers are perfect to be used where there is a requirement of the healthcare centers. Even these can be used in industries, factories, or any place, which is in emergency need. Team of professionals who are experts in civil engineering, architecture, and interior designing designs the containers. All Electrical works, ceiling, flooring, plumbing, drainage & all other aspects are taken into consideration while curating these shipping medical centers.

“We are also making accommodation containers for the companies along with the health centers, which help the companies to use them for stay purpose for their employees”, adds Veepul. With many advantages, these containers can be developed in a short period and can be customized with the best technology and architecture practices. Moreover, these containers are low in cost construction and are very strong in strength to experience any weather condition and are a perfect example of recycling, as these are made of the old container, which is not in use.

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The onset of the COVID-19 pandemic has brought in so many changes in the lives of the people almost setting a new normal of living. Of many changes brought in due to the pandemic, the rise in the demand for Ayurveda products is one of them, which is prevalent everywhere. The rising demand for Ayurveda products seems to help the Indian Ayurveda market achieve its growth target before the expected forecast period (2019-2024).

During pre-COVID, the ayurvedic market typically witnessed 15-20% growth annually. In the last quarter, many companies, large and small, have witnessed anywhere between 50-90% growth. The adoption of Ayurveda as holistic, natural healthcare will have a positive impact on the market. Since last March, the demand for honey has gone up by 45%, Chyawanprash by 85% and turmeric by 40% in ayurvedic stores. The interest in these products has mostly been fuelled by the recommendations from the Ministry of AYUSH to fight the coronavirus.

Rising demand of different Ayurveda products 

“Of course, we see the rising demand of different Ayurveda products ranging from Ayurvedic Rasayanas to various immunity-boosting products of Ayurveda. Our honourable PM also stated that despite our nation being very populous, the COVID-19 situation is under control because every household is consuming immunity boosters like turmeric milk, the ashwagandha herb, kaadha etc. And in the last few quarters, we have also seen a remarkable rise in the sales of various Ayurvedic products like Maharishi Amrit Kalash and Ayur Defence. The sale of Maharishi Amrit Kalash has increased by over 26% from the year 2020,” says Mr Anand Shrivastava, Chairman – Maharishi Ayurveda.

Market Research Company, Nielsen’s report in the month of July reveals that Chyawanprash sales have increased by 283% in June, while the sales of branded honey increased by 39%. Chyawanprash and herbal teas which are supposed to improve immunity had increased 17-18% month on-month. In North India, the sales of these products have been very high during the month of January and February. The sales of ‘Guduchi’ have also gone up three times. The northern states such as Delhi, Madhya Pradesh, Punjab, Haryana, Uttar Pradesh and Gujarat are driving the demand.

The spread of the COVID-19 pandemic has led to a sharper growth in consumer interest, awareness and demand for Ayurvedic therapies and medicines. People are now more inclined to prophylactic health remedies, especially immunity-boosting products. Elaborating on the increased demand of the Ayurveda products during and post COVID, Dr Saurabh Sharma, Hospital Superintendent – Maharishi Ayurveda Hospital said, “Indeed, the unprecedented COVID-19 pandemic has opened the eyes of the world about the importance of good health and strong and resilient immune systems. While effective and curative medicines are indispensable in fighting such aggressive viruses, our best defence lies within our bodies, which is now proven with strong evidence. Perhaps, this is the reason why from big fast-moving consumer goods firms to young start-ups, everyone is lining up for Ayurveda-based nutrition and wellness products, riding on a spike in demand for traditional brews and blends in a world suffering its worst health crisis. We also see that after the outbreak of COVID-19, the demand for various Ayurvedic products has increased dramatically.”

The Ayurveda market in India expected to reach INR 710.87 billion

The Ayurveda market in India was valued at INR 300 billion in 2018, and is expected to reach INR 710.87 billion by 2024, expanding at a compound annual growth rate (CAGR) of 16.06%. The rising sales registered by Indian Medicines Pharmaceuticals Corporation Limited (IMPCL), a government enterprise and manufacturer of Ayurveda and Unani medicines reveals that the consumption of ayurvedic medicines and products has increased during the COVID-19 pandemic significantly. The IMPCL registered sales of ₹69.60 crore up to August 2020 as compared to last year’s ₹26.73 crore.

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