The Indian herbal medicine market is projected to reach USD 371.45 billion by 2030, driven by increasing demand during the COVID-19 pandemic.

Indian herbal medicine has been found effective in treating diseases like COVID-19, diabetes, and cancer.

Yoga and Ayurveda have been found to relieve anxiety and aid in recovery in COVID-19 patients, with personalized Ayurvedic treatment improving outcomes.

Neem tree extract has anti-parasitic and antiviral properties, and has been shown to decrease COVID-19 virus replication and spread in animal models.

Ayurveda, which often uses turmeric, can help maintain blood sugar levels in Type 2 diabetes patients.

Cardamom has anti-inflammatory properties and is being researched for treating various health issues, including cancer and respiratory problems.

The Indian government established the Ministry of Ayush to regulate and integrate Ayurveda, Siddha, and Unani into modern healthcare.

The Ministry of Ayush is developing healthcare services, aiming for 12,500 Ayush health centers by 2023-24.

The WHO has established a Global Centre for Traditional Medicine in India with a $250 million contribution from India.

The centre will use AI and big data to study traditional medicine, aiming to promote global wellness.

Ashwagandha has anti-inflammatory and anti-stress properties, but may interact with certain medications, requiring caution and medical supervision.

The use of Indian herbal medicine, such as Giloy, can pose risks including liver toxicity, with 43 reported cases of liver injury across 13 Indian hospitals.

Patients should consult their doctor before taking Indian herbal medicines, as they can interact with conventional medications and are not subject to the same FDA controls as drugs.

The Indian government has set new manufacturing standards for pharmaceutical companies to ensure product quality and safety.

The Ministry of Ayush supports Ayurveda development, mandates good manufacturing practices, and requires annual product quality reviews.

The Indian herbal medicine market is projected to reach USD 371.45 billion by 2030, driven by increasing demand during the COVID-19 pandemic.

Title:

Content: Herbal Medicine Market Size to Reach USD 371.45 Billion by 2030 | Exclusive Report by Fortune Business Insights™

Key Companies in Herbal Medicine Market are Cultivator Natural Products Pvt. Ltd. (India), 21ST Century HealthCare, Inc. (U.S.), Herbalife Nutrition (U.S.), ZeinPharma Germany GmbH (Germany), Blackmores Limited (Australia), Himalaya Global Holdings Ltd. (India), Nutraceutical Corporation (U.S.), Emami Limited (India), Nature's Answer, LLC. (U.S.), Patanjali Ayurved Limited (India), and more players profiled.

Pune INDIA

Pune, India, Nov. 28, 2023 (GLOBE NEWSWIRE) -- The global herbal medicine market size was valued at USD 201.06 billion in 2022 and is expected to be worth USD 216.40 billion in 2023. The market is projected to reach USD 371.45 billion by 2030, recording a CAGR of 8.02% during the forecast period.

Herbal medicines are made from natural ingredients to treat a wide range of diseases and improve an individual’s immunity level. Since there has been a drastic change in people’s lifestyle, the incidence of cardiovascular diseases and chronic stress are on the rise. These factors are expected to boost the adoption of herbal medicines as they claim to have no side-effects, unlike the conventional ones.

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Leading Players Featured in the Research Report:

Companies leading Herbal Medicine Market are Cultivator Natural Products Pvt. Ltd. (India), 21ST Century HealthCare, Inc. (U.S.), Herbalife Nutrition (U.S.), ZeinPharma Germany GmbH (Germany), Blackmores Limited (Australia), Himalaya Global Holdings Ltd. (India), Nutraceutical Corporation (U.S.), Emami Limited (India), Nature's Answer, LLC. (U.S.), Patanjali Ayurved Limited (India)

Report Scope & Segmentation:

Report Attributes Details
Forecast Period 2023-2030
Forecast CAGR 8.02%
2030 Value Projection USD 371.45 Billion
Herbal Medicine Market Size in 2022 USD 201.06 Billion
Historical Data 2019-2021
No. of Pages 208
Report Coverage Revenue Forecast, Company Profiles, Competitive Landscape, Growth Factors and Latest Trends
Segments Covered
  • By Application
  • By Form
  • By Region
Regions Covered
  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East and Africa
Herbal Medicine Market Growth Drivers Growing Adoption of Herbal Ingredients in Cosmetic Products to Boost Market Growth

Browse Summary of this Research Report:

https://www.fortunebusinessinsights.com/herbal-medicine-market-106320

COVID-19 Impact:

Growing Health Concerns During Pandemic Boosted Product Demand

The healthcare and pharma industries experienced long and short-term effects of the pandemic as there were several delays in R&D and manufacturing activities to produce effective medicines for the infection. This situation made people more concerned about their health and wellbeing, which boosted the consumption of dietary supplements and immunity boosters that were made from natural ingredients. This accelerated the market’s progress.

Segmentation:

Growing Usage of Herbal Ingredients in Nutraceuticals and Pharma Products to Boost Market Progress

In terms of application, the market is divided into pharmaceutical & nutraceutical, food & beverages, and personal care & beauty products. The pharmaceutical & nutraceutical segment holds the largest herbal medicine market share as herbal ingredients are increasingly used in dietary supplements and medicines to enhance their performance.

Rising Availability of Herbal Medicines in Tablet & Capsule Form to Augment Market Development

Based on form, the market is segmented into powder, liquid & gel, and tablets & capsules. The tablets & capsules segment is expected to capture the leading market share as herbal medicines are produced in the form of tablets and capsules to ease their access to patients.

With respect to region, the market covers North America, Europe, Asia Pacific, South America, and the Middle East & Africa.

Report Coverage:

The research report offers an in-depth analysis of the market and highlights key aspects, such as leading types, companies, and top product forms. It also provides valuable insights into the market segments and trends, while covering key industry developments. Besides the aforementioned factors, the report encompasses many factors that have contributed to the market's growth in recent years.

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Drivers and Restraints:

Growing Adoption of Herbal Ingredients in Cosmetic Products to Boost Market Growth

Exporters of herbal ingredients in the developing countries are viewing the cosmetics industry as a viable medium to help them expand their operations overseas. A growing number of cosmetics manufacturing companies are incorporating natural ingredients to cater to the robust demand for cosmetics that are good for the face, skin, and body. They are replacing synthetic chemicals with herbal ingredients to boost their product’s performance and expand their customer base.

However, stringent guidelines with respect to using herbal ingredients as raw materials may hinder the herbal medicine market growth.

Regional Insights:

Europe Market to Expand Due to Growing Product Usage in Cosmetics Sector

Europe is expected to lead the global herbal medicine market as the region has a vast cosmetics sector. This can present lucrative opportunities for emerging companies that develop and supply herbal ingredient-based products. Many cosmetic companies across the region are witnessing a strong rise in the demand for personal care & beauty products that are made from natural ingredients. This factor will spur the regional market growth.

North America will also grow at a significant pace as customers across the region are becoming more conscious about their health and wellbeing, which has increased the consumption of dietary supplements.

Competitive Landscape:

Key Companies to Use Various Strategies to Boost Their Product Sales

Some of the major companies in the market include ZeinPharma Germany GmbH, Cultivator Natural Products Pvt. Ltd., Blackmores Limited, Herbalife Nutrition, and many others. They are implementing various strategies, such as partnerships and new product launches to increase their product sales and expand their presence in the global market.

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Major Table of Content:

  • Introduction
    • Research Scope
    • Market Segmentation
    • Research Methodology
    • Definitions and Assumptions
  • Executive Summary
  • Market Dynamics
    • Market Drivers
    • Market Restraints
    • Market Opportunities
    • Market Trends
  • Key Insights
    • Overview on the Parent Market
    • Supply Chain Analysis
    • Industry SWOT Analysis
    • Recent Industry Developments - Policies, Mergers & Acquisitions, and New Product Launches
    • Market Analysis and Insights (in Relation with COVID-19)
      • Impact of COVID-19 on the Market
      • Supply Chain Challenges due to the Pandemic
      • Potential Opportunities Due to COVID-19
  • Global Herbal Medicine Market Analysis, Insights and Forecast, 2019-2030
    • Key Findings / Summary
    • Market Size Estimates and Forecast
      • By Form (Value)
        • Powder
        • Liquid & Gel
        • Tablets & Capsules
      • By Application (Value)
        • Pharmaceutical & Nutraceutical
        • Food & Beverages
        • Personal Care & Beauty Products
      • By Region (Value)
        • North America
        • Europe
        • Asia Pacific
        • South America
        • Middle East & Africa
  • North America Herbal Medicine Market Analysis, Insights and Forecast, 2019-2030
    • Key Findings / Summary
    • Market Size Estimates and Forecast
      • By Form (Value)
        • Powder
        • Liquid & Gel
        • Tablets & Capsules
        • Others
      • By Application (Value)
        • Pharmaceutical & Nutraceutical
        • Food & Beverages
        • Personal Care & Beauty Products
      • By Country (Value)
        • U.S.
          • By Application (Value)
            • Pharmaceutical & Nutraceutical
            • Food & Beverages
            • Personal Care & Beauty Products
        • Canada
          • By Application (Value)
            • Pharmaceutical & Nutraceutical
            • Food & Beverages
            • Personal Care & Beauty Products
        • Mexico
          • By Application (Value)
            • Pharmaceutical & Nutraceutical
            • Food & Beverages
            • Personal Care & Beauty Products

To Be Continued…!

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Key Industry Development:

December 2022 – Dabur expanded its Ayurvedic medicines portfolio by introducing Ratnaprash Sugar-Free and Aampachak Kkadha. The former is said to be good for health and provides strength and stamina, whereas the latter strengthens the digestive system and contains herbs, such as shunthi, bhumiamla, harad, pippali, and others.

Read Related Insights:

By 2028, Dietary Supplements Market to Achieve USD 128.64 Billion | Exclusive Research Report by Fortune Business Insights™

Nutraceuticals Market to Hit USD 658.11 Billion by 2028 | With 9.3% of CAGR

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Indian herbal medicine has been found effective in treating diseases like COVID-19, diabetes, and cancer.

Title:

Content: Home » News » education-career » Yoga, Ayurveda Could be Effective in Treating High-Risk Covid-19 Cases, Claims IIT-Delhi Research

Yoga, Ayurveda Could be Effective in Treating High-Risk Covid-19 Cases, Claims IIT-Delhi Research

By: Education and Careers Desk

News18.com

Last Updated: September 13, 2022, 16:36 IST

New Delhi, India

The researchers claimed that that high-risk COVID-19 patients undergo severe anxiety, which may further deteriorate their condition (File Photo)

IIT Delhi researchers suggest that in addition to the treatment for COVID-19, Yoga and Ayurveda maybe instrumental in relieving such patients from anxiety and aid in speedy post-treatment recovery

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Yoga and Ayurveda maybe effective in the treatment of high-risk cases of COVID-19, suggests a research study by IIT Delhi on successful treatment of 30 high-risk COVID-19 patients. This study was conducted by a team of researchers at IIT Delhi and Dev Sanskriti Vishwavidyalaya, Haridwar.

The researchers claimed that that high-risk COVID-19 patients undergo severe anxiety, which may further deteriorate their condition. They further suggest that in addition to the treatment for COVID-19, Yoga and Ayurveda maybe instrumental in relieving such patients from anxiety and aid in speedy post-treatment recovery.

Also read| IIT Delhi Launches App to Prevent Bengaluru Floods Like Situation, to Predict Waterlogging

The findings of the study have appeared in the Indian Journal of Traditional Knowledge. The research team consists of Dr Sumitra A Bentur, Private practitioner, Greater Noida (West), Uttar Pradesh, Dr Alka Mishra, Dev Sanskriti Vishwavidyalaya, Haridwar, Uttarakhand; Dr Yogish Kumar, Advait Clinic, Delhi, Dr Sonika Thakral, IIT Delhi, Sanjiv, IIT Delhi and Shaheed Sukhdev College of Business Studies, University of Delhi, Prof Rahul Garg, IIT Delhi.

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As per the institute, the patients were prescribed Ayurvedic medicines through telemedicine, and administered a personalized therapeutic yoga programme using video conferencing. Almost all the patients were classified as high-risk owing to one or more of co-morbidities such as diabetes mellitus, hypertension, chronic kidney disease, coronary artery disease (which are known to lead to severe outcomes in cases of COVID-19), and/or age above 60, said IIT Delhi.

“The treatment given to the patients was personalized (in accordance with the classical texts) and took account of each patient’s medical history and the symptoms presented, which made it more effective as compared to a fixed standardized treatment plan," said the IIT.

The treatment included ayurvedic medicines, daily yoga-sessions including deep relaxation techniques, pranayama and basic asanas and some lifestyle modifications. Based on the administered treatment, the cases were categorized into YAS (Yoga-Ayurveda based treatment, with possibly allopathic supplements: 4 patients), YASP (Yoga-Ayurveda based treatment, with possibly allopathic supplements and paracetamol: 6 patients), YAM (Yoga-Ayurveda based treatment, and Modern Western Medicine (MWM), that is, allopathy as adjunct: 6 patients), MYA (first tried MWM, later switched to Yoga-Ayurveda: 14 patients). added the institute.

The patients, most of whom presented with many symptoms prior to the yoga and Ayurveda treatment, were followed-up telephonically regularly until recovery. More than half of symptomatic patients started improving within 5 days (90 per cent within 9 days), more than 60 per cent reported at least 90 per cent recovery within 10 days, added IIT Delhi.

Six patients with oxygen saturation (SpO2) below 95 per cent, benefited through Makarasana and Shithilasana; none progressed to composite endpoints (consisting of admission to Intensive Care Unit, invasive ventilation or death). Considering that approximately 19.3 per cent of the patients with these comorbidities progress to composite end points, the p-value was found to be 7.21 x 10−3.

“The study also demonstrates an urgent need to scientifically examine the Traditional Indian Knowledge systems at the top academic institutions. A timely and suitably designed randomized controlled trial evaluating the efficacy of Ayurveda and Yoga based personalized integrative treatment for COVID-19 would have equipped the people with much more credible and dependable information about their use in managing COVID-19" said Prof Rahul Garg, IIT Delhi, who conceptualized the project.

“Most patients reported that the therapy had a profound impact on their recovery process, with many experiencing improvements with respect to their comorbidities too. By the end of the treatment, several patients had decided to adopt Yoga in their lifestyle, and several turned to the Ayurveda doctors in the team for management/treatment of their comorbidities", said Dr Sonika Thakral who coordinated with the patients for routine follow-up.

“On the whole, the belief of the patients in the efficacy of these traditional systems of medicine was extremely enhanced," said Dr Alka Mishra who administered Ayurveda treatment to some patients. “We are observing an increasing trend towards ancient systems of medicine", said Dr Yogesh Kumar who also administered Ayurveda treatment to some patients.

“The said interventions are believed to have collectively accelerated the recovery process by checking anxiety, instilling peace of mind and enhancing the overall well-being of the patients," said Dr Sumitra A Bentur, private practitioner, who designed the Yoga intervention and conducted Yoga sessions for some of the patients.

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first published: September 13, 2022, 16:30 IST
last updated: September 13, 2022, 16:36 IST

Yoga and Ayurveda have been found to relieve anxiety and aid in recovery in COVID-19 patients, with personalized Ayurvedic treatment improving outcomes.

In what areas have the medical uses of traditional Indian medicine been studied?

What does traditional Indian medicine generally treat?

It addresses the psychological aspects of health conditions.

What is the traditional Indian medical system called?

What mental health problems does traditional Indian medicine treat?

Support the management of symptoms related to mental health.

Neem tree extract has anti-parasitic and antiviral properties, and has been shown to decrease COVID-19 virus replication and spread in animal models.

Title:

Content: Neem tree extract may help treat, cut spread of COVID-19: Study

PTI | New Delhi | Updated: 01-03-2022 15:22 IST | Created: 01-03-2022 15:08 IST
  • Country:
  • India

Extract from the bark of the Neem tree may help treat and reduce the spread of SARS-CoV-2, the virus that causes COVID-19, according to a study led by researchers at the Indian Institute of Science Education and Research (IISER) Kolkata.

The Neem tree, indigenous to India, has been used for thousands of years for its anti-parasitic, anti-bacterial and antiviral properties, the researchers said.

The bark extract has helped treat malaria, stomach and intestinal ulcers, skin diseases and many other diseases, they said. The latest study, published recently in the journal Virology, shows that components of Neem bark may target a wide range of viral proteins, suggesting its potential as an antiviral agent against emerging variants of coronaviruses, including SARS-CoV-2.

''The goal of this research is to develop a Neem-based medication that can reduce the risk of serious illness when someone is infected with coronaviruses,'' said study co-author Maria Nagel, a professor at the University of Colorado School of Medicine, US.

''We hope that scientists won't have to continuously develop new therapies every time a new SARS-CoV-2 variant emerges,'' she said.

Just like how people take penicillin for strep throat, the researchers envision taking the Neem-based drug for COVID-19, allowing them to resume their normal lives without fear of hospitalisation and death.

The scientists investigated the impact of the bark extract against coronaviruses in their laboratories.

Researchers at IISER Kolkata tested the extract in animal models and showed that it had antiviral properties against coronavirus.

Using computer modelling, the researchers predicted that Neem bark extract will bind to the SARS-CoV-2 spike protein at various locations, preventing virus entry to host cells.

The spike protein is used by the SARS-CoV-2 virus to enter and infect cells.

Nagel's lab at the University of Colorado tested the Neem bark extract in SARS-CoV-2 human lung cells.

The extract proved as effective as a preventive drug for infection and also decreased virus replication and spread after infection.

''The next step in our research is to identify the specific components in Neem bark extract that are antiviral. Because these components bind to various regions of SARS-CoV-2, we believe that it will be effective on emerging variants with spike mutations,'' said Nagel.

''We will then determine the formulation of dosage for an antiviral drug to treat coronavirus infections,'' she said.

The findings could guide new antiviral therapeutic efforts to combat the ongoing pandemic, while holding out the promise for treating new coronavirus strains, the researchers added.

(This story has not been edited by Devdiscourse staff and is auto-generated from a syndicated feed.)

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Ayurveda, which often uses turmeric, can help maintain blood sugar levels in Type 2 diabetes patients.

Title:

Content: News

Take up pilot project on Ayurveda treatment: MLA Ramdas

August 29, 2022

Mysore/Mysuru: Studies conducted across the world have found that several traditional medicines commonly used in India as part of Ayurveda are effective in maintaining blood sugar levels in patients with Type 2 diabetes.

Ayurveda is a traditional medical system that has been used for thousands of years in India and some of the herbs included are also used in other parts of the world. In this direction, a systematic project must be developed to treat diabetes, suggested MLA S.A. Ramdas. The suggestion was accepted by Ayurveda practitioners and experts in the field.

The MLA was speaking after inaugurating a free Ayurvedic treatment camp organised at the Sri Ganapathy Ashram on Nanjangud Road yesterday. The camp was organised inside the auditorium of Lakshminarasimha Kuteera of the Ashram by the Government Ayurvedic Research Centre and Ayurveda Academy of Chamarajpet in Bengaluru.

Ramdas suggested the doctors and officers launch a pilot project in a particular locality or a Ward and assured of making all facilities on behalf of the Government. He said that the project can be taken up on Sept. 17, the birthday of Prime Minister Narendra Modi for one year to achieve tangible results for the target population, he suggested.

Modern diabetes drugs are known for side effects and toxicity while Ayurveda works by controlling blood sugar and limiting the harmful effects of other drugs. Turmeric, for example, has been used for the treatment of diabetes in Ayurveda and traditional Chinese medicine, he added.

He said new Ayurvedic remedies were still in great demand for treating diabetes because of the limited efficacy and undesirable side effects of current drugs. A multi-pronged and individualised approach must be used to manage health conditions such as lifestyle modification, Ayurvedic detoxifying and purifying therapies and Ayurvedic medicines containing plant, animal, or mineral-origin ingredients, he added.

University of Mysore Vice-Chancellor Prof. G. Hemantha Kumar, Assistant Director of Government Ayurvedic Research Centre Dr. Lakshminarayana Shenoy, Joint Secretary of Ayurveda Academy Dr. Prashanth Ghokale, Junior pontiff of Ganapathy Ashram Datta Vijayananda Theertha Swamiji and others were present.

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In what areas have the medical uses of traditional Indian medicine been studied?

What does traditional Indian medicine generally treat?

It addresses the physical aspects of health conditions.

Cardamom has anti-inflammatory properties and is being researched for treating various health issues, including cancer and respiratory problems.

Title:

Content: Express Pharma

Zum Heilen announces patent for cardamom-based nutraceutical Recovereez

Launches Recovereez at the World Spice Congress

0 22

The World Spice Congress hosted at Mumbai by the Spices Board of India saw the launch of a cardamom-based nutraceutical called Recovereez. Zum Heilen Diagnostic & Therapeutics, a startup company based in Thrissur in Kerala has developed the product and formulation and has been awarded the Indian patent. The product was launched by Amar Singh Bhatia IAS -Chairman Spices Board, D Sathyan, IFS – Secretary Spices Board, and Dr Remahsree, Director, Spices Board.

Reportedly, a comprehensive clinical study conducted by Dr Varkey and his team has revealed that cardamom has profound anti-inflammatory activities, solidifying its potential as a valuable addition in treatment of various conditions ranging from respiratory health to cancer.

The ongoing studies being done by Dr Varkey along with Dr Remashree and her team at the Indian Cardamom Research Institute (ICRI) under the Spices Board of India also substantiated cardamom’s anti-inflammatory properties applicable in the treatment of triple receptor negative breast cancer, a variant of breast cancer that often has poor response to current treatments.

Dr Varkey said,  “Our research sheds light on cardamom’s untapped potential as a natural anti-inflammatory agent and its application across many diseases with a simultaneous monitoring of the inflammatory genes that give confidence to the treating doctors. We have developed novel molecular diagnostic tests done from saliva that measure gene markers that are capable of giving the doctor and the patient information on the response to   the cardamom-based nutraceuticals. The implications for such an integrated approach are unique and immense, offering a promising avenue for both preventive measures and therapeutic interventions.

Indian Cardamom Research Institute is collaborating with Zum Heilen on completion of clinical trials in breast cancer to then offer this product to the global market as an adjunct treatment along with standard care

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The Indian government established the Ministry of Ayush to regulate and integrate Ayurveda, Siddha, and Unani into modern healthcare.

Title:

Content: J&K Has Been A Major Center Of Indian System Of Medicine Since Ancient Times: LG Sinha

– Lt Governor addresses Consultative meeting of Commission for Indian System of Medicine.
– Reiterates J&K Government's commitment to make the UT a hub of medical and wellness and to contribute to PM Narendra Modi's vision of ‘Heal in India' and ‘Heal by India'.
– With a rich legacy of medicine system, we are committed for investment and innovation in AYUSH and to strengthen traditional system of medicines. It has tremendous growth potential and J&K bestowed with nature's bounty and rich medicinal plants will promote startups and business units in AYUSH: LG.
– LG highlights several milestones achieved in AYUSH sector of J&K UT.
– Ayurvedic Medical College & Hospital at Akhnoor, Unani Medical College & Hospital at Ganderbal and upgradation of 442 AYUSH Dispensaries have been done for well-being of the people: LG.
– Five 50-Bedded Integrated AYUSH Hospitals in Districts of Kulgam, Kathua, Kupwara, Kishtwar and Samba have been approved by Ministry of AYUSH under National AYUSH Mission to strengthen AYUSH secondary healthcare in the UT of J&K: LG.
– In order to promote Medical Tourism in UT, 6 Specialized AYUSH Wellness Centres at famous tourist places-Pahalgam, Gulmarg, Sonamarg, Patnitop, Katra and Golf Course & Srinagar have been approved, out of which three centres have been made operational: LG Sinha.

Srinagar, Jun 2: Lieutenant Governor Manoj Sinha addressed a Consultative meeting on “Ayushman Bharat Digital Mission – Heal in India, Heal by India,” organized by National Commission for Indian System of Medicine (ISM), Ministry of AYUSH, today at University of Kashmir. Addressing the gathering of health professionals and practitioners of ISM from across the country, the Lt Governor reiterated the commitment of the J&K Government to making the UT a hub of medical and wellness tourism and to contribute to Prime Minister Narendra Modi's vision of ‘Heal in India' and ‘Heal by India'.
He said the deliberations during this important meeting will build a solid framework for exchange of ideas to promote ISM and implementation of two important components of Ayushman Bharat Digital Mission – Healthcare Professional Registry and Healthcare Facility Registry in the UT.
“J&K has been a major center of the Indian system of medicine since ancient times and according to Kalhana's Rajtarangini, a well developed Ayurveda hospital was functional those days. Kalhana wrote that J&K had flourishing Ayurvedic drug manufacturing units and Ayurvedic pharmacies,” said the Lt Governor. With such a rich legacy, we are committed for investment and innovation in AYUSH and to strengthen the traditional system of medicines. It has tremendous growth potential and J&K bestowed with nature's bounty and rich medicinal plants will promote startups and business units in AYUSH, he added. He said the world has recognized the Indian System of Medicine as the oldest, effective and scientific health system for prevention and cure. Now the time has come to connect the new generation with this heritage and rich legacy to fulfil the vision of One Earth, One Health, he added. At the consultative meet, the Lt Governor shared the efforts to strengthen the basic health infrastructure, promote medical tourism in the J&K UT and provide the people with access to world class, affordable and quality healthcare services.
Under the guidance of Prime Minister Narendra Modi ji, the Ministry of AYUSH and J&K administration are working together with the vision of ‘One Earth, One Health' to serve the global community through integrated and ancient Indian System of medicine, he said.
Jammu Kashmir is fully prepared to become an important centre of AYUSH and ‘Heal in India' campaign, which will not only promote medical tourism in the Union Territory, but also create immense business and employment opportunities in the healthcare sector, added the Lt Governor. The Lt Governor also highlighted several milestones achieved in the AYUSH sector of J&K UT. Ayurvedic Medical College and Hospital at Akhnoor, Unani Medical College and Hospital at Ganderbal and upgradation of 442 AYUSH Dispensaries have been done for the well-being of the people. Five 50-Bedded Integrated AYUSH Hospitals in Districts of Kulgam, Kathua, Kupwara, Kishtwar and Samba have been approved by Ministry of AYUSH under National AYUSH Mission to strengthen AYUSH secondary healthcare in the UT of J&K, he said.
In order to promote Medical Tourism in UT, 6 Specialized AYUSH Wellness Centres at famous tourist places-Pahalgam, Gulmarg, Sonamarg, Patnitop, Katra and Golf Course Jammu and Srinagar have been approved, out of which three centres have been made operational, he further added. India is home to the world's oldest medical systems. It is not limited to treatment only. It is a science of understanding life and wellbeing in a holistic manner. Through Yoga and Ayush Centres, it is our endeavour to spread the vision and benefits of Ayurveda to all sections of the society, observed the Lt Governor. The Lt Governor also shared valuable suggestions for integrating local health traditions with the mainstream of Ayurveda by promoting People's Science preserved for centuries and transcribing the rich and diverse Indian medicine knowledge in simple language for the new generation. It is also necessary to understand the roots of the traditional system to establish harmony between the Registry of Professionals and the Registry of Facility and all other disciplines of medicine, he added.
Vaidya Jayant Deopujari, Chairman National Commission for Indian System of Medicine and Prof. (Vaidya) Rakesh Sharma, President, Board of Ethics and Registration, also spoke on the occasion and threw light on the key features of the Ayushman Bharat Digital Mission and the aims and objectives of consultative meeting. Prof. Nilofer Khan, Vice Chancellor, Kashmir University; Bhupinder Kumar, Secretary, Health & Medical Department; Ayushi Sudan, State Mission Director, Ayushman Bharat Digital Mission; senior officials from National Health Authority, ISM and UT Administration; HoDs and scores of health professionals and Ayurvedacharya were present.

The Ministry of Ayush is developing healthcare services, aiming for 12,500 Ayush health centers by 2023-24.

Title:

Content: you are here: HomeNewsIndia

Govt working towards scientifically integrating traditional and modern medicine: Sonowal

The ministry is working on operationalisation of 12,500 Ayush health and wellness centres through the support of state and Union territory governments under the National Ayush Mission (NAM) by 2023-24, Sonowal said.

September 07, 2023 / 12:48 AM IST

Ayurveda representational image

India's rich heritage of traditional form of medicine has withstood the test of time and the government has been working towards scientifically integrating it with modern medicine, Union Ayush Minister Sarbananda Sonowal said on Wednesday.

The Regional Review meeting of National Ayush Mission was ceremonially inaugurated by him along with his deputy Munjpara Mahendrabhai.

During the meeting, representatives of all participating states and Union territories presented detailed presentations on the state of Ayush and progress of leading Ayush programmes under implementation.

Speaking on the occasion, Sonowal said, "Our rich heritage and potential of traditional form of medicine has withstood the test of time in generations of humanity to live a better, healthier and happier life. We must take full advantage of this generous forms of medicine - be it Ayurveda, Siddha, Unani, Yoga, Naturopathy, Sowa Rigpa, or Homoeopathy."

He also said that under the visionary leadership of Prime Minister Narendra Modi, the government has been working towards scientifically integrating traditional forms of medicine with the modern medicine.

Highlighting the utility of Ayush system of medicine, he further said that it has some robust programmes like Ayurvidya for promotion of healthy lifestyle through Ayush for school children, Supraja for maternal and neonatal intervention, Vayomitra for geriatric issues; prevention and management of Osteoarthritis and other musculo-skeletal disorders, and Ayush mobile medical units.

The ministry is working on operationalisation of 12,500 Ayush health and wellness centres through the support of state and Union territory governments under the National Ayush Mission (NAM) by 2023-24, Sonowal said.

The ministry of Ayush has so far released Rs 719.70 crore to southern states and Union territories - Andhra Pradesh, Karnataka, Kerala, Lakshadweep, Puducherry, Tamil Nadu and Telangana - under NAM since 2014-15, he said, adding it has also supported 17 Integrated Ayush hospitals in the southern states and out of that six are operational as reported by them.

Mahendrabhai stressed on the need to emphasise on outcomes as a more meaningful measure of programme value than output.

"We may have to realign our strategies and techniques to plan, execute and report our performance that facilitates measure of outcomes," the minister of state for Ayush said.

NAM is being implemented with the vision and objectives to provide Ayush health care services throughout the country by strengthening and improving facilities, to provide informed choice to the needy public.

PTI
first published: Sep 7, 2023 12:47 am

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The WHO has established a Global Centre for Traditional Medicine in India with a $250 million contribution from India.

Title:

Content: Archive / Lifestyle
The World Health Organization is interested in alternative medicine.
Mohamed Ismail - Cairo - DPA -
Many people use traditional medicine – but what do these methods really do?
A new WHO centre intends to explore this.
The center is based in India, a country where alternative medicine is so important that it even has its own ministry – which specializes in Ayurveda, Yoga, Physiotherapy, Greek Medicine, Master and Homeopathy.
Indian Prime Minister Narendra Modi attended the opening of the centre in Jamnagar in mid-April, saying: “India ’ s traditional medicine system is not just a cure.
It ’ s a comprehensive science of life. ”
According to the World Health Organization (WHO), the Indian government is supporting the centre with US $250 million (230 million euros).
WHO President Tedros Adhanom Ghebreyesus said: “The center aims to be an engine of innovation, moving towards an agenda of evidence, data and sustainability in traditional medicine, ” adding that the center would connect traditional medicine practitioners around the world and help set standards for research.
Traditional medicine is a broad field.
According to the World Health Organization ’ s statement for the center, 80% of the world ’ s population uses traditional medicine, which includes among other things acupuncture, Ayurvedic medicine and herbal blends.
Traditional medicine is also represented in modern science.
According to the World Health Organization, about 40% of all drugs approved today are derived from natural substances.
The discovery of aspirin, for example, is based on ancient recipes made from the bark of the willow tree.
The research for artemisinin for use in the fight against malaria, for which the Nobel Prize was awarded in 2015, began with the study of ancient texts of Chinese medicine.
George Rochmeyer of Cochrane, an international network that provides the scientific basis for decisions in the health field, said it makes sense at least to take a closer look at treatment methods that have been developed over centuries, to verify the reasonableness of these methods, and to conduct clinical studies on them in case of doubt.
Cochrane reviews are systematic reviews that collect all scientific evidence on a specific issue from medicine or other health sciences.
However, Rochmeyer also stressed that besides the examples of traditional methods cited by the WHO, which form the basis of currently developed treatments, there are likely many other examples where traditional methods of careful review have proven ineffective or even dangerous, such as phlebotomy, noting that spending too much money on studies to review a therapeutic practice is always a matter of discretion.
Rochmeyer stated that there are many Cochrane reviews about the use of traditional methods such as acupuncture in certain cases, but: “From my personal experience at Cochrane, I would say that I have not come across many reviews that have shown really compelling evidence for traditional therapeutic practice. ”
This is often due to the fact that when searching for these treatments we find only a few often-poorly conducted studies that cannot prove or disprove any benefit from them – which brings us back to the question of whether the already limited research funds should be invested in a scientifically unreasonable procedure – for example, homeopathy.
Professor Emeritus Edzard Ernst, a longtime professor of alternative medicine at the University of Exeter, noted that while it was necessary to wait and see who would lead the center and what it would do, the WHO press release was full of exaggerations.
The World Health Organization says it also wants to use new technologies at the new center for the study of traditional medicine — via artificial intelligence and big data, for example.
The center is expected to focus on providing a reliable evidence base for policy and standards of traditional medicine practices and products.
In addition, the center is supposed to help countries integrate these practices into their health systems.
You may also read.

The centre will use AI and big data to study traditional medicine, aiming to promote global wellness.

Ashwagandha has anti-inflammatory and anti-stress properties, but may interact with certain medications, requiring caution and medical supervision.

Title:

Content: General Supervision
Elham Aboul Fath
Editor-in-Chief
Thank you for your patience.
General Supervision
Elham Aboul Fath
Editor-in-Chief
Thank you for your patience.
The controversial Ashwagandha herb on social media..
Everything you need to know about her
Ashwagandha is a medicinal herb used in traditional Indian medicine (Ayurveda) for centuries and has become controversial on social media due to some interesting claims about its potential benefits.
However, we should treat this information with caution and regard it as public information.
Dr. Abdulrahman Shams, a nutritionist, revealed in special statements to Sada Al-Balad, the following are some of the main points of your knowledge of this herb and the possible allegations about it:
1.
Traditional use: Ashwagandha is believed to have soothing, anti-inflammatory and anti-stress properties.
It has been used in the Indian tradition to treat a variety of conditions such as stress, anxiety, sleep disorders and fatigue.
1.
Scientific research: There are some scientific studies that support some of the potential benefits of ashwagandha.
Some research has shown its potential effect in reducing anxiety levels, improving sleep, and supporting mental functioning.
However, more research is still needed to confirm the efficacy and safety of this herb.
1.
Side Possibilities: Typically, ashwagandha is considered safe when taken in moderate doses.
However, some minor side effects such as drowsiness or digestive disorders may occur.
Consult your doctor before taking ashwagandha, especially if you have an existing medical condition or are taking other medications.
1.
Drug interactions: Interactions may occur between ashwagandha and some other drugs.
It is advised not to take ashwagandha if you are taking medications such as antibiotics, depression inhibitors or thyroid medications, unless you consult your doctor.
You should remember that ashwagandha is not an officially recognized remedy for any health condition.
If you are considering using them, you should consult your physician or use a specialist healthcare practitioner for personal advice and guidance appropriate to your individual health condition.

What mental health problems does traditional Indian medicine treat?

Support the management of symptoms related to mental health.

The use of Indian herbal medicine, such as Giloy, can pose risks including liver toxicity, with 43 reported cases of liver injury across 13 Indian hospitals.

Title:

Content: Dr Abby Philips who warned against the use of a herb widely used in alternative medicine, has been sent a letter from the Kerala State Medical Council for Indian Systems of Medicine.

Dr Abby Philips / YouTube screenshot
news Controversy Saturday, February 05, 2022 - 13:46

An interview given by a Kerala hepatologist on the ill effects of ingesting a widely used herb Giloy (Tinospora cordifolia) has landed him in trouble, with the Kerala State Medical Council for Indian Systems of Medicine sending him a notice. For the past seven months, Dr Abby Philips has been receiving several letters, with the most recent one from the Council, for an interview he gave to a Malayalam YouTube channel on Herb-Induced Liver Injuries, in June of last year.

In the video, the Aluva based doctor speaks about liver injuries that are specifically caused by consuming unsafe or toxic herbs as treatment. Speaking to TNM, he said that he referred to published evidence regarding all pseudoscientific practices and specifically some herbal drugs which are toxic to the liver. “I specifically spoke about Giloy, which is very liver toxic, based on a paper from Jaslok Hospital and Research Centre, Bombay,” Philips said. He is a faculty of the Asian Pacific Association for the Study of the Liver (APASL), and has authored guidelines and recommendations to specifically treat ‘herbal liver injuries’, specifically on how to treat and diagnose drug induced liver injuries.

Soon after the interview was released, a complaint was filed and the issue was kicked from one department to another. “A complaint was sent to the Prime Minister’s grievance redressal cell, stating that I was denigrating Ayurveda and causing a split in public opinion. This letter was sent to the AYUSH ministry, which forwarded it to the National Medical Commission (NMC),” he said.

The letter, pointing out Philips's statement in the interview, stated that ‘the said derogatory and misleading clause be immediately removed…otherwise the Ministry shall be compelled to initiate defamatory proceedings against the contravening doctor.’ The NMC’s department of Ethics and Medical conduct forwarded it to Kerala's Ayush department saying that some action should be taken. The state Ayush department forwarded it to the Travancore Cochin Medical Council (TCMC) asking to take specific action as needed. “Finally, I got a letter from the Kerala State Medical Council for Indian Systems of Medicine,” he said and added that the ‘funny’ part is that he is not even a part of the said council, but is a member of TCMC in the Modern Medicine division.

Philips said, “They have not identified or informed me about the kind of professional misconduct I am accused of. One cannot defame a ‘system’ or a ‘supposed science’. I have been asked to respond in my personal capacity but there is no mention of a deadline or what the misleading clause is.” He clarified that there is no separate clause under the Medical Code of Ethics for saying alternative medicine is pseudoscience. While the notice mentions a punishment clause, there is no mention of the crime committed. Dr Philips is now planning to reply through a lawyer asking the Council for proof of what his professional misconduct is, according to the Code of Ethics.

“Just this month, our group alone reported 43 Giloy liver injury cases all over India from 13 hospitals, which was also published in the official journal of the American Association of Study of Liver Diseases (AASLD). I am talking with evidence, so how can they say it is demeaning or degrading?” he asked.

Dr Philips said that he did not have a problem with AYUSH being an independent body, but complained there was no regulation. “Ayush is a regulatory body which is supposed to regulate all alternative medicines and their practice in India. But when a study states that a particular herb is potentially toxic, AYUSH should make the public aware of the issue and caution them. Instead, they are defending the concern and further promoting its sale,'' he alleged.

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Patients should consult their doctor before taking Indian herbal medicines, as they can interact with conventional medications and are not subject to the same FDA controls as drugs.

Title:

Content: 6 Herbs That May Increase Heart Disease Risk
Millions of people around the world are taking herbal remedies for multiple reasons, including high cholesterol levels and depression, and despite popular belief that they are safe, some of these products may lead to dangerous interactions in people taking prescription drugs to treat cardiovascular problems.
Add Announcement
The Food and Drug Administration (FDA) has indicated that dietary supplements are not subject to the same levels of control as drugs, meaning that the efficacy of standard ingredients and doses has not yet been proven, increasing the risk of drug interactions.
According to the National Center for Integrative and Complementary Health, there are several herbal supplements that should be avoided for those taking specific medications, highlighting the need for caution when using herbal remedies in conjunction with medical medications.
Among the herbs that you should stay away from or reduce as much as possible in case you suffer from heart disease we find:
Risk of heart disease..
Green Tea
Green tea, extracted from the leaves of Camellia sinensis, is widely consumed around the world in various forms such as beverages, capsules and extracts, for its various health benefits; for its ability to help lose weight, enhance mental alertness, reduce cholesterol levels in the blood, as well as its potential role in preventing cancer.
However, consuming green tea may carry some risks, especially for people taking certain medications.
Studies, including those published in the Journal of the American College of Cardiology, show that green tea may negatively affect the effectiveness of certain drugs because of its vitamin K content, which is known to reduce the effectiveness of anticoagulant drugs such as warfarin.
In addition, the caffeine found in green tea can interfere with beta inhibitors, drugs commonly used to treat high blood pressure and heart rhythm disorders.
Care should also be taken when taking green tea in conjunction with adosine, which is used to treat irregular heart rhythm disorders, because of the potential for interaction between the two.
It is essential for people taking any of these medications or suffering from certain health conditions to consult their health care providers before including green tea in their diet or treatment, to ensure that any adverse drug interactions are avoided and their health and safety are maintained.
Consumption of garlic
According to the American site "health", garlic is part of the onion family, sold in the markets in the form of oil, extract or grain, in addition to its natural form.
According to the National Center for Integrative and Complementary Health (NCCIH), garlic is known as a treatment that contributes to lowering levels of total cholesterol and LDL cholesterol, as well as blood pressure.
Healthy individuals, as well as those with high levels of LDL cholesterol and triglycerides, may benefit from eating garlic to improve heart health.
However, patients using anticoagulant or antiplatelet drugs should stay away from taking "tetragonal G", which includes garlic, ginkgo biloba, grape seeds, and green tea.
People with low blood pressure are also advised not to use garlic because of its ability to lower blood pressure.
Garlic ’ s anticoagulant properties may increase the likelihood of bleeding, especially in people taking aspirin and warfarin, a drug used to reduce blood clotting and often prescribed to patients with heart rhythm problems, heart attacks or heart valve swaps.
These recommendations emphasize the utmost importance of caution when using garlic as a dietary supplement, especially for people taking certain medications, to prevent the risks of drug interactions.
Ginger and Heart Disease
Throughout the ages, ginger has been used in traditional medicine to treat many health problems, especially those related to the digestive system, such as nausea, diarrhea, and stomach pain.
Not only has it been used to relieve joint and muscle pain, making it an important ingredient in a wide range of medical treatments and supplements.
However, scientific research shows increasing interest in the effect of ginger on the clotting process, especially for people taking drugs such as warfarin, an anticoagulant, or aspirin, which is used to prevent the formation of blood clots.
Studies show that ginger may increase the risk of bleeding through its effect on blood clotting, which requires additional studies to understand this effect more deeply.
Given these considerations, people who take ginger as a supplement, especially if they are also using warfarin or aspirin, are strongly advised to consult with their health care providers before continuing to use it.
This precautionary approach aims to avoid the potential risks of drug interactions that may lead to an increased risk of bleeding, and to ensure that ginger is used in a safe and effective manner, in line with an individual ’ s overall health condition.
Licorice Juice
Licorice root, which is extracted from the licorice plant and usually taken as a dried extract in the form of capsules, has multiple medical uses including the treatment of peptic ulcers, various stomach problems, bronchitis, throat infections, and viral infections.
Licorice is known for its various health benefits, but some groups should exercise caution when using it.
According to the National Center for Integrative and Complementary Health (NCCIH), the potential effects of licorice on the body ’ s potassium levels and blood pressure are a concern, especially for people with high blood pressure or who have heart or kidney problems.
These effects can exacerbate or complicate their health problems.
In addition, licorice root is likely to affect the effectiveness and safety of certain medications, such as ACE inhibitors, drugs used to lower blood pressure, and diuretics used to regulate blood pressure.
Consult with your doctor or health care provider before starting licorice root supplements, especially for people taking these types of medications, to avoid adverse drug interactions and ensure safe and effective use.
Herbs...
Aloe Vera and its supplements
Aloe vera is known to be used as an ointment or lotion. Aloe vera (aloe vera) is also used orally to treat serious health conditions such as arthritis, epilepsy, diabetes, and asthma.
However, aloe vera can cause low potassium levels in the blood, which can lead to heart rhythm problems.
Low potassium levels may also lead to complications for heart patients taking digoxin to treat heart rhythm disorders or congestive heart failure.
Furthermore, alovera "has the potential to increase bleeding if anti-platelet analgesics such as aspirin and non-steroidal anti-inflammatory drugs (NSAIDs) are used at the same time," according to a study published in the journal EPMA in January 2019.
This information suggests that caution should be exercised when using aloe vera, especially if you are taking medications that may interact with it and cause additional health risks.
- Arabic Post
Also read:
Herbs that help in the treatment of heart disease and angina pectoris
Risks of Medicinal Herbs for People with Heart Disease

The Indian government has set new manufacturing standards for pharmaceutical companies to ensure product quality and safety.

Title:

Content: Drug Regulation Trade Secret

IP Reveries: Class 5.2 – Interrogating India’s Drug Regulation System

CDSCO Vision – To Protect and Promote Public Health in India.

Prof Antilegend is back to greet you all on this yuletide! After brooding over the basics in the last class, this session (i.e. class 5.2) sieves through the Indian drug regulation system, which has attracted much attention in the last few months. For the previous class, please go here. And if this is your first time coming across the IP Reveries series, you can see what it is about as well as get links to our previous classes in the introductory post here. IP Reveries is co-authored by Swaraj Barooah and myself. For these classes that touch upon Indian drug regulation, we’d like to give a shout out of appreciation for the works of Prashant Reddy T & Dinesh S Thakur which we have learned and are tremendously learning from.

Interrogating India’s Drug Regulation System

Prof. Antilegend: Hello Stars, good morning. Now that you have got an inkling of the drug innovation process from the last class, let’s dig a little bit into the realm of (dodgy?) drug regulation. (smiling)

Slato: Yes. Those readings, that you suggested, gave us a bit more of an introduction to this whole pharmaceutical IP and non-IP world. But Prof. … so much information, trials, waivers and whatnot, we’ll have to break it down.

Prof. Antilegend: Yes, yes, we will need to. Why don’t we start with you telling me what stood out to you from your reading so far? Any particular part that you’d like to start with?

Pocrati: Hmm… I seem to have gathered several small bits of information but not sure how to piece it all together.

Prof Antilegend: Sure, let’s tread with your troves of information.

Pocrati: Okay, So… It appears that in India, regulatory approval for the import, manufacture, distribution and sale of drugs is still governed by the pre-independence Drugs and Cosmetics Act, 1940 (along with some associated Rules). Is this actually the law that governs current medicine too? In any case, as per this regulatory setup, manufacturers of ‘new drugs’ need to submit data from the different phases of clinical trials, including trials conducted within India, to the regulators for them to check if it’s safe and provides the benefits it claims to. Here you may ask – what are ‘new drugs’? Well, while you can find exact details in the legislative provisions, for purposes of our current discussion, what I’ve understood is that the “new drugs” label is given to those that haven’t received regulatory approval in the form or combination that is sought to be sold; it is also given to novel drug delivery systems, or biologics/vaccines. This ‘new drug’ status lasts for 4 years, except for biologics/vaccines which are considered ‘new drugs’ indefinitely.

Feus: Wait – what does that mean … if it’s 3 years old, it’s still new? What’s the point of this legal fiction?

Prof Antilegend: Good question. What this means is that if you want regulatory approval for a drug that hasn’t been sold in India before, then you will need to submit clinical trial data to the regulators for approval. If your drug is approved, then for the first 4 years of approval, it will continue to be considered a ‘new drug’. This means that if anyone else also seeks to sell their version of that drug, they too will need to submit clinical trial data, even though your version of the drug has been approved. And as we’ve seen in the previous class, this is very expensive and time-consuming, and it automatically reduces the number of potential competitors. And this requirement remains for 4 years after the first approval, unless it is a vaccine or biologic drug. So far, so good, right? You can get a better idea about this from this reasoned report, see paragraphs 142-143.

Akira: Wait … isn’t this a bit duplicative? And perhaps ethically questionable? Repeating expensive trials on human subjects, for drugs that have already received approval?

Prof. Antilegend: It might be and there’s a whole additional ‘data exclusivity’ debate waiting for you if you go there. But – as it turns out, the question to be asking is whether this actually plays out this way in practice! (And let’s not even go into the practice of regulation of manufacturing standards and other details!!)  In reality, it is often the case that new drugs are introduced into the Indian market after they have received foreign regulatory approval. Resultantly, the Indian drug regulator normally exempts manufacturers or importers of a new drug to submit trial reports and grants approval on the basis of bioequivalence and bioavailability tests.

Feus: bio-equivalence … available tests … What’s that now?

Prof. Antilegend: Essentially, these tests show that the concerned drug produces the same effect at the same rate, as the already approved drug.

Nya: Okay … and (confused face) Prof., you also said that once approved in other markets, they are generally accepted in India. But then those drugs must have been tested primarily on foreigners with different genetic compositions. How ethical and logical is it to assume that tests conducted in the X part of the world on a certain population with different genetic dispositions be suitable to the population of our country (again with a much more diverse population)? This is a matter of health, the mere availability of *a* vaccine/medicine isn’t always the answer. It should be effective as well as safe in the long run. No? What about their testing requirements on the Indian population

Prof. Antilegend: Hm. Technically, Yes, there is a requirement for local trials to ensure that drugs work well on the Indians. In fact, the 59th Parliamentary report on CDSCO highlighted this point noting that:

There is evidence that the effect of some drugs can vary among various ethnic groups. For example, the blood levels reached after intake of lipid lowering agent rosuvastatin are far higher in Asians, compared to Europeans and North American Caucasians, Hispanics and Blacks needing lowering of dosage. Failure to lower dose in Indians can result in severe toxicity, including life-threatening muscle injury leading to fatalities. Hence, testing drugs in the Indian ethnic groups is of paramount importance before approving any drug of foreign origin.” (¶ 7.10)

However, like other things, they can also be waived in the “public interest”. From what I have understood so far from reports and articles is that these waivers have become the norm, meaning that no/very few generic companies conduct these trials before getting approvals in India. Please go searching for data on this though, if you can find any! But note, generic companies are still required to submit bioequivalence and bioavailability studies without any exceptions when a drug is new i.e. in the initial 4 years. (with a pause) Although it’s a different discussion that some Indian Clinical Research Organisations have fudged even them. Anyway, You can read about them after class here, here, and here.

Pocrati: Wait, with so many tests, I am a bit confused now. Please confirm this – there is one test of bio-equivalence/availability in the initial 4 years period when a drug is ‘new’. This is to enter the market and escape clinical trials. Correct? And there is another test on the Indian population to confirm the therapeutic efficacy which is waivable. Okay? But (curiously) what happens after 4 years when a drug loses the label of “new drug”?

Prof. Antilegend: Yes, you are correct. Regarding your question – the answer is a bit bizarre.  So … before 2017, even the bioequivalence/bioavailability studies were not required after 4 years. But then came a notification which mandated these bioequivalence/availability tests for certain classes of drugs (not treading into the technicalities here!). But this notification only has a prospective application. This means that before 2017, those generic companies which applied for approval (which they generally did) after 4 years may not have submitted these tests. What this means is that we are very likely to have some ‘untested’ drugs in the market today and the 2017 notification can’t help it.

Slato: Oh, sounds damn dangerous!!!

Prof. Antilegend: Exactly, it is! This issue was raised by the Ranjit Roy Choudhary Committee which recommended making these studies mandatory for all generics. (Unfortunately, the report itself doesn’t seem to be available online anywhere – so if any of you can share it, we could share it with the rest of the class!) Sadly, the CDSCO’s drugs consultative committee consisting of state drug controllers and the Drug Controller General of India rejected this recommendation on commercial grounds. There were even FIRs filed that asked, among other things, for the mandating of these tests for all the generics, but were dismissed as raising issues of only “academic interest”.

Pocrati: That’s sad though I am glad that something happened finally in 2017. But for ‘untested drugs’ that actually go wrong and harm people – there would be some harsh punishment, no? What are those punishments? Even in the Gambia tragedy, I believe that the accused drug manufacturer would be banned now from manufacturing drugs. Please tell us a bit about that.

Prof. Antilegend: Speaking ideally, yes, a minacious manufacturer should face harsh punishments. But now speaking legally, it is not the case in India, sadly! On paper, the highest punishment is 10 years which can be extended to life imprisonment with a fine of 3 lakhs when the drug causes or is likely to cause death. And, for a sub-standard drug, the punishment is between 1-3 years with a fine. However, health researchers and activists say that it does not happen in practice, (sometimes it even turns out that most punishments are just for sitting one day in court!). And what further flaws this fettle is the recent Drugs, Medical Devices and Cosmetics Bill 2022 lowering these punishments.   The Bill, under its Section 56(e), establishes a new category of offences relating to the production or distribution of misbranded medications Technically, this is about “NSQ” drugs i.e. drugs “not of standard quality”! The bill, in its fourth schedule, mentions 43 manufacturing-related defects for which the lowest punishments can be given i.e. imprisonment of up to one year and a fine of at least two lakh rupees. And the defects which are not in the “43 defects list”, the manufacturer is liable for a higher punishment of up to 2 years imprisonment and a fine of Rs 5 lakh.

Coming to the Gambia incident, things are in utter uncertainty – while the Drugs Controller General of India gave a clean chit to Maiden Pharmaceuticals saying that the drugs complied with standards and has no diethylene glycol (DEG), a Geneva lab revealed otherwise claiming the presence of the toxin DEG in impugned syrups. So, no punishment as such except Haryana Government’s order to stop the manufacturing. It is important to note here it is not the first time Maiden Pharmaceuticals to create a cause of consternation! See this image prepared by an Indian newspaper:

Source – Times of India

Slato: But there must be some “Good Manufacturing Practices” that manufacturers should adhere to. Can you give any examples from this “43 defects” club?

Prof. Antilegend: Good question. Yes, there are some good practices but no-following them is not punishable by our laws. And for the examples … (thinking) … it includes “heavy metals” and “particulate contamination/foreign matter”. Meaning that if a medicine is found to have metals, fungus, or glass particles (which are supposedly dangerous for our consumption), the manufacturer will receive a reduced sentence or maybe no imprisonment at all! Note, the story does not end here – the Bill even has a compounding provision in Section 71 which means that the trial and prison time for the offence can be waived as long as the manufacturer agrees to pay the fine. Moreover, Section 58 even empowers the government to expand the list of exceptions i.e 43 defects lists with the lowest list can be expanded. …

Feus: Prof., I think we should definitely do something about it. But let’s start with taking a break and coming back with more mental mettle! (with a smug)

Prof. Antilegend: Sure. Although I have a few more things to discuss, I want someone to summarise this class, relating it to the previous class.

Sugastine: Yes, I can do it. So …  first, we had a ‘theoretical’ session about drug innovation, its stages, tests etc. Then, in this class, we discussed the practicality of the previous class as to how drug innovation actually works in India. Here, we saw the dire state of our drug regulation, the increasing discretions (and discrepancies) and decreasing punishment and checks. Anything left?

Prof. Antilegend: Fair enough. In the next class, let’s mix theory and practical understanding and deliberate on the future of drug regulation and come back to where we started – “test data”, its importance and implications. But before you leave, here’s a reading recommendation –  Allison Durkin, at el.’s Addressing the Risks That Trade Secret Protections Pose for Health and Rights.

Mindy: Sure, see you in the next class. Thanks

(steps of the students leaving the class)

Image from here

Lokesh Vyas

Lokesh graduated from the Institute of Law Nirma University (2021 batch) and won the first edition of the Shamnad Basheer Essay Competition, 2020. He is currently pursuing an LLM from the American University Washington College of Law and working as a researcher at the Program on Information Justice and Intellectual Property (PIJIP). He is a recipient of the Arcadia Fellowship and Arodhum Scholarship.

The Ministry of Ayush supports Ayurveda development, mandates good manufacturing practices, and requires annual product quality reviews.

Title:

Content:     The Economic Times daily newspaper is available online now.

    Pharma MSMEs can get govt help to upgrade facilities

    Synopsis

    The health and family welfare ministry has made good manufacturing practices mandatory for pharma companies. A recent notification by the ministry covered the revised Schedule M rules for good manufacturing practices and requirements of premises, plant and equipment for pharmaceutical products, with provisions for an annual product quality review, risk management and a quality system.

    New Delhi: The Department of Pharmaceuticals has proposed to offer financial assistance to micro, small and medium enterprises (MSMEs) to help them upgrade their facilities to ensure better quality of medicines.

    "Under a central scheme, which is called Pharmaceutical Technology Upgradation Assistance Scheme, MSMEs can seek financial assistance from the government," said Arunish Chawla, secretary, Department of Pharmaceuticals. "This will open a new window for MSMEs who have an opportunity to get some assistance and be able to get the quality certifications that are now mandatory."

    The health and family welfare ministry has made good manufacturing practices mandatory for pharma companies. A recent notification by the ministry covered the revised Schedule M rules for good manufacturing practices and requirements of premises, plant and equipment for pharmaceutical products, with provisions for an annual product quality review, risk management and a quality system.

    In July last year, health minister Mansukh Mandaviya said that Schedule M should be made compulsory for the MSMEs in the pharma industry in a phased manner. The health ministry said drug manufacturers with an annual turnover of over ₹250 crore must comply with the standards within six months starting from August 1, 2023. Smaller companies will get one year, he had said.
    (Catch all the Business News, Breaking News Events and Latest News Updates on The Economic Times.)

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