#Drugs Technical Advisory Board (DTAB)

[neosciencehub]

Government Panel to Review Future of Home Medicine Delivery Services @neosciencehub #MedicineMisuse #DeliveryServices #GovernmentPanel #neosciencehub

[aakhirtak]

India Bans 156 Combination Drugs: Health Risks Cited

India Bans 156 Combination Drugs Due to Health Risks In a significant move to safeguard public health, the Indian government has banned 156 fixed-dose combination (FDC) drugs that were widely used to treat conditions such as fever, cold, allergies, and pain. The decision follows concerns raised by the Drugs Technical Advisory Board (DTAB) and an expert committee, which found these combinations…

[studymbbsaborad]

How Can I Verify a Medication is Real?

The best option for studying MBBS abroad is in Kyrgyzstan, which is one of the more cheap options. Georgia, a former Soviet republic located at the meeting point of Europe and Asia, is home to both Black Sea beaches and settlements in the Caucasus Mountains. Tbilisi is the capital and largest city of Georgia. Georgia has become one of the popular destinations for MBBS in abroad for Indian students at low cost.

Today, even average consumers struggle to tell bogus medicines apart from legitimate ones, which is a terrible reality. Which is worse? Without chemical analysis, even medical professionals struggle to identify differences and verify the legitimacy of medications.

 To make their products appear to be the most authentic, an overwhelming number of manufacturers have been successful in duplicating practically every physical component of the drug. Packaging, tablet shape, vial shape and size, and coloration are all characteristics that are copyable and have been.

 Verify the legitimacy of the medications.

The seal is the first item you should examine. Do not purchase it if the seal appears to have been tampered with or cracked. Ensure sure the medicine you purchase has an unbroken seal.

You can get a sense of the medicine's genuineness by looking at the box. The font, logo, colour, and name spelling can all be used as telltale signs that a product is false.

Another response to the query "how to check drug validity" is price. There is a good likelihood that any medication that suddenly drops in price is a fake.

If you have unanticipated allergies or adverse effects after ingestion, cease using it right once and see your doctor. It's possible that you've been abusing a fake drug all along.

You can also use SMS to submit the special code hidden on the bottle or package to the Drug Technical Advisory Board's (DTAB) number and confirm its legitimacy. They ought to reply with an authentication message from the company that made the drug.

Verify the legitimacy of the medication. Make sure to check it out with your doctor and pharmacist first before taking it if your red tablet suddenly developed a number stamped in the middle where there had previously been none.

Compare the effectiveness of the medication to the prior times you have taken it.

Try to get medicines only from reputable vendors. Avoid falling for online frauds that provide drugs without a prescription or at exorbitant discounts. Only orders with valid prescriptions are delivered by PharmEasy for medications.

Be wary of relatively inexpensive medications. Because medications are generally made in the same way, changes in one brand's cost could have a significant impact on all other pharmaceutical businesses. Surely, a pharmaceutical company wouldn't do this on a whim.

While the aforementioned recommendations can significantly lower the likelihood that you will purchase a fake drug, keep in mind that chemical analysis is the only surefire technique to determine if your medication is authentic or not.

 A barcode system may soon be used by the Drug Controller General of India (DCGI) in order to verify the legitimacy of both locally produced and imported pharmaceuticals. If put into place, this system can prevent the sale of any form of phoney or counterfeit medication.

[goingglobal1]

How Can I Verify a Medication is Real?

The best option for studying MBBS abroad is in Kyrgyzstan, which is one of the more cheap options. Georgia, a former Soviet republic located at the meeting point of Europe and Asia, is home to both Black Sea beaches and settlements in the Caucasus Mountains. Tbilisi is the capital and largest city of Georgia. Georgia has become one of the popular destinations for MBBS in abroad for Indian students at low cost.

Today, even average consumers struggle to tell bogus medicines apart from legitimate ones, which is a terrible reality. Which is worse? Without chemical analysis, even medical professionals struggle to identify differences and verify the legitimacy of medications.

To make their products appear to be the most authentic, an overwhelming number of manufacturers have been successful in duplicating practically every physical component of the drug. Packaging, tablet shape, vial shape and size, and coloration are all characteristics that are copyable and have been.

Verify the legitimacy of the medications.

The seal is the first item you should examine. Do not purchase it if the seal appears to have been tampered with or cracked. Ensure sure the medicine you purchase has an unbroken seal.

You can get a sense of the medicine's genuineness by looking at the box. The font, logo, colour, and name spelling can all be used as telltale signs that a product is false.

Another response to the query "how to check drug validity" is price. There is a good likelihood that any medication that suddenly drops in price is a fake.

If you have unanticipated allergies or adverse effects after ingestion, cease using it right once and see your doctor. It's possible that you've been abusing a fake drug all along.

You can also use SMS to submit the special code hidden on the bottle or package to the Drug Technical Advisory Board's (DTAB) number and confirm its legitimacy. They ought to reply with an authentication message from the company that made the drug.

Verify the legitimacy of the medication. Make sure to check it out with your doctor and pharmacist first before taking it if your red tablet suddenly developed a number stamped in the middle where there had previously been none.

Compare the effectiveness of the medication to the prior times you have taken it.

Try to get medicines only from reputable vendors. Avoid falling for online frauds that provide drugs without a prescription or at exorbitant discounts. Only orders with valid prescriptions are delivered by PharmEasy for medications.

Be wary of relatively inexpensive medications. Because medications are generally made in the same way, changes in one brand's cost could have a significant impact on all other pharmaceutical businesses. Surely, a pharmaceutical company wouldn't do this on a whim.

While the aforementioned recommendations can significantly lower the likelihood that you will purchase a fake drug, keep in mind that chemical analysis is the only surefire technique to determine if your medication is authentic or not.

A barcode system may soon be used by the Drug Controller General of India (DCGI) in order to verify the legitimacy of both locally produced and imported pharmaceuticals. If put into place, this system can prevent the sale of any form of phoney or counterfeit medication.

[healthcareindustryresearch]

Major Revenue Gains are Predicted in the Global Empty Capsules Market by 2026

Overview of This Study:

This research study on Empty Capsules involved the use of widespread secondary sources; directories; databases such as D&B, Bloomberg Business, and Factiva; white papers; annual reports; and Companies’ House documents. Secondary research was used to identify and collect information for this extensive, technical, market-oriented, and commercial study of the global empty capsules market.

Research Methodologies Followed:

Primary Research:

In the primary research process, various sources from both supply and demand sides were interviewed to obtain qualitative and quantitative information for this report. The primary sources from the supply side include industry experts such as CEOs, vice presidents, marketing and sales directors, product and innovation directors, and related key executives from various key companies and organizations operating in the empty capsules market.

Secondary Research:

The various secondary sources referred for this study include the European Federation of Pharmaceutical Industries and Associations (EFPIA), Central Drugs Standard Control Organization (CDSCO), Drugs Technical Advisory Board (DTAB), Pharmaceutical Research and Manufacturers of America (PhRMA), Indian Pharmaceutical Association (IPA), Indian Drug Manufacturers’ Association, Generics and Biosimilars Initiative (GaBI), PharmaTimes, World Journal of Pharmaceutical Sciences, World Health Organization (WHO), P-MEC News, Expert Interviews, India2Connect, Zauba, CDC, Company Websites, Annual Reports, SEC Filings, Press Releases, Investor Presentations, Journals, Expert Interviews, and MarketsandMarkets Analysis.

Download PDF Brochure @ https://www.marketsandmarkets.com/pdfdownloadNew.asp?id=218018190

Revenue Gains Expectations:

The global empty capsules market is projected to reach USD 3.7 billion by 2026 from USD 2.6 billion in 2021, at a CAGR of 7.2% during the forecast period. Emerging markets, with their low manufacturing costs, are expected to present significant opportunities for players. Other areas of opportunity are the development of halal gelatin and vegetarian capsules.

Opportunity: Expansion of capsule production in emerging countries

The traditionally lucrative pharmaceuticals market is becoming challenging from a growth perspective due to the diminishing drug pipeline, government-induced pressure to reduce costs and regulations on innovative products. This is encouraging pharmaceutical manufacturers to move their manufacturing bases closer to high-growth emerging markets.

Challenges: Rising prices and lower availability of raw materials in the gelatin industry

Globally, the demand for gelatin and its raw materials has witnessed a significant increase over the entire application spectrum—the pharmaceutical industry, in which the demand for capsules for pharmaceutical production has registered a vast increase, and the food processing, nutraceutical, leather, cosmetic, dying & tanning, and paper production industries.

Recent Developments

·        Nutra’V TiO2 launched a new range of TiO2-free capsules. Available both in gelatin and HPMC and with excellent machinability, this range of capsules offers the best encapsulation solution for ingredient masking.

·        ACG acquired Xertecs, Xertecs develops and implements processes, products, and services for pharma companies across the globe. Its acquisition added to ACG’s capabilities.

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By therapeutic application, the antibiotic & antibacterial segment accounted for the largest share of the empty capsules market.

Based on therapeutic applications, the empty capsules market is segmented into antibiotic & antibacterial drugs, dietary supplements, antacid & antiflatulent preparations, antianemic preparations (hematinic), anti-inflammatory drugs, cardiovascular therapy drugs, cough & cold drugs, and other therapeutic applications.

North America accounted for the largest share of the empty capsules market

North America accounted for the largest share of 37.4% of the global market. The dominance of the North American region can be attributed to the existing presence of major capsule manufacturers with large production capacities, along with the presence of a number of pharmaceutical giants with large production capacities utilizing these capsules.

[freyrsolutions]

DTAB advises New voluntary indication of Veg/Non-Veg Symbols on cosmetic products

This article talks about the CDSCO's Drug Technical Advisory Board (DTAB) advises a new voluntary specification of Veg/Non-Veg symbols on Cosmetic Products in India.

cosmetic products, Regulatory Affairs, Vegetarian/Non-Vegetarian Products, Drug Technical Advisory Board, DTAB, CDSCO, India

[godollyfan]

Government Approves American Standard Test Method (ASTM) As Product Standards For Medical Devices

The union health ministry has published a draft notification vide no. GSR 98 E dt 5.2.2021 on Medical Devices Amendment rules 2021 to involve American Standard Test Method (ASTM) in standards of product for all medical devices to increase the competency of indigenous medical devices internationally.

According to the draft rule, all these rules might be called the Medical Devices (Amendment) Rules 2021. All these rules will come into force on the date when they are finally published in the official gazette. In the medical device rules 2017, in rule 7, in sub-rule 2, after the words, letters, and bracket" the international electro technical commission ," the words, letter, and bracket or "American standard test method" will  be inserted.

The following draft of specific rules for amending MDR 2017 is done while exercising the powers given by subsection 1 of section 12 and subsection 1 of section 33 of the Drugs and Cosmetics Act,1940. In consultation with the Drugs technical advisory board, it was published to inform every person who is likely to be impacted. Notice is given to all that the said draft rule will be considered on or after 45 days from the date on which the Gazette of India consisting of these draft rules is published.

The central government considers the timeframe specified above. All kinds of objections and suggestions should be addressed to the undersecretary, union health ministry, Government of India. Drugs Technical Advisory Board, after complete deliberation, approved the proposal and suggested these required amendments in the MDR-2017.

It has been suggested since all developed countries possess their own certification needs. So, Indian Medical device manufacturers will be required to meet the needs of countries where they export. According to rule 7 of MDR 2017, the medical device shall conform to the standards laid down by the Bureau of Indian Standards established under section 3 of BIS Act, 1985 or might be notified by the Union health Ministry frequently.

If the standards have not been specified under sub-rule one and sub-rule 2, the device shall be confirmed to the validated manufacturer's standards. This is as per the medical device regulation in India. Because ASTM is accepted at the international level, it was proposed to include ASTM in the sub-rule 2 of rule 70 of MDR 2017.

DTAB was apprised that the Union health ministry notified the MDR 2017 on January 31, 2017, under the provision of the Drugs and Cosmetics Act, 1940.

 Use To Know More Information, Visit - Cosmetic import license | Vaccine Import Registration India

[athiranair23]

Surgical Drapes and Gowns Market Analysis (2020-2027)

Surgical drapes are used in surgical procedures, which prevents the contact of the physicians from unwanted surfaces to prevent contamination and infection risks. It also prevents any kind of contamination and thus maintains sterility. Drapes acts as physical barrier during the surgery against microbes and are resistant to heat. Surgical gowns are worn over in the operating room to perform surgeries. Its characteristics are similar to that of surgical drape. Surgical drapes and gowns are produced according to the type of surgery. These are either disposable or non-disposable. They are generally made from tightly woven fabric, cotton, and polyester, which may or may not be chemically treated.

Market Dynamics

Factors such as active involvement and growth strategies adopted by key players in the market is expected to influence the global surgical drapes and gowns market growth positively. Furthermore, regulatory support and initiatives towards hygiene and prevention of infectious diseases are expected to impact positively on the global surgical drapes and gowns market growth. For instance, in December 2018, Drugs Technical Advisory Board (DTAB) of India, added surgical gowns, surgical drapes, and incision drapes to the list of notified medical devices, as proposed by the Central Drug Standards Control Organization (CDSCO). Moreover, in April 2018, Medline set up a new manufacturing facility for surgical trays that includes drapes and gowns. Hence, these factors are expected to boost the global surgical drapes and gowns market growth.

Key features of the study:

·         This report provides in-depth analysis of global surgical drapes and gowns market and provides market size (US$ Million) and compound annual growth rate (CAGR %) for the forecast period (2018–2026), considering 2017 as the base year

·         It elucidates potential revenue opportunities across different segments and explains attractive investment proposition matrices for this market

·         This study also provides key insights into market drivers, restraints, opportunities, new product launches or approval, regional outlook, and competitive strategy adopted by the leading players

·         It profiles leading players in the global surgical drapes and gowns market based on the following parameters – company overview, financial performance, product portfolio, geographical presence, distribution strategies, key developments, and strategies

·         Key companies covered as a part of this study include 3M, Halyard Health, Medline, Thermo Fisher Scientific Inc., Steril Medical, Alpha Pro Tec, Mölnlycke Health Care AB, Anhui Medpurest Medical Technology Co., Ltd., Lohmann & Rauscher, and Vygon

·         Insights from this report would allow marketers and management authorities of the companies to make informed decisions regarding their future product launches, technology up-gradation, market expansion, and marketing tactics

·         The global surgical drapes and gowns market report caters to various stakeholders in this industry including investors, suppliers, product manufacturers, distributors, new entrants, and financial analyst

·         Stakeholders would have ease in decision-making through the various strategy matrices used in analyzing the global surgical drapes and gowns market

Detailed Segmentation:

·         Global Surgical Drapes and Gowns Market, By Product Type:

o    Surgical Drapes

§  Cardiovascular Drapes

§  General Procedure Drapes

§  Orthopedic Drapes

§  Ophthalmic Drapes

§  Gynecology, Obstetrics, and Urology Drapes

§  Other Surgical Drapes

o    Surgical Gowns

·         Global Surgical Drapes and Gowns Market, By Usage Pattern:

o    Disposable

o    Reusable

·         Global Surgical Drapes and Gowns Market, By End User:

o    Hospitals & Clinics

o    Ambulatory Surgical Centers

·         Global Surgical Drapes and Gowns Market, By Region:

o    North America

§  By Product Type:

§  Surgical Drapes

§  Cardiovascular Drapes

§  General Procedure Drapes

§  Orthopedic Drapes

§  Ophthalmic Drapes

§  Gynecology, Obstetrics, and Urology Drapes

§  Other Surgical Drapes

§  Surgical Gowns

§  By Usage Pattern:

§  Disposable

§  Reusable

§  By End User:

§  Hospitals & Clinics

§  Ambulatory Surgical Centers

§  By Country:

§  U.S.

§  Canada

o    Europe

§  By Product Type:

§  Surgical Drapes

§  Cardiovascular Drapes

§  General Procedure Drapes

§  Orthopedic Drapes

§  Ophthalmic Drapes

§  Gynecology, Obstetrics, and Urology Drapes

§  Other Surgical Drapes

§  Surgical Gowns

§  By Usage Pattern:

§  Disposable

§  Reusable

§  By End User:

§  Hospitals & Clinics

§  Ambulatory Surgical Centers

§  By Country:

§  U.K.

§  Germany

§  Italy

§  France

§  Spain

§  Russia

§  Rest of Europe

o    Asia Pacific

§  By Product Type:

§  Surgical Drapes

§  Cardiovascular Drapes

§  General Procedure Drapes

§  Orthopedic Drapes

§  Ophthalmic Drapes

§  Gynecology, Obstetrics, and Urology Drapes

§  Other Surgical Drapes

§  Surgical Gowns

§  By Usage Pattern:

§  Disposable

§  Reusable

§  By End User:

§  Hospitals & Clinics

§  Ambulatory Surgical Centers

§  By Country:

§  China

§  India

§  Japan

§  ASEAN

§  Australia

§  South Korea

§  Rest of Asia Pacific

o    Latin America

§  By Product Type:

§  Surgical Drapes

§  Cardiovascular Drapes

§  General Procedure Drapes

§  Orthopedic Drapes

§  Ophthalmic Drapes

§  Gynecology, Obstetrics, and Urology Drapes

§  Other Surgical Drapes

§  Surgical Gowns

§  By Usage Pattern:

§  Disposable

§  Reusable

§  By End User:

§  Hospitals & Clinics

§  Ambulatory Surgical Centers

§  By Country:

§  Brazil

§  Mexico

§  Argentina

§  Rest of Latin America

o    Middle East

§  By Product Type:

§  Surgical Drapes

§  Cardiovascular Drapes

§  General Procedure Drapes

§  Orthopedic Drapes

§  Ophthalmic Drapes

§  Gynecology, Obstetrics, and Urology Drapes

§  Other Surgical Drapes

§  Surgical Gowns

§  By Usage Pattern:

§  Disposable

§  Reusable

§  By End User:

§  Hospitals & Clinics

§  Ambulatory Surgical Centers      

§  By Country:

§  GCC

§  Israel

§  Rest of Middle East

o    Africa

§  By Product Type:

§  Surgical Drapes

§  Cardiovascular Drapes

§  General Procedure Drapes

§  Orthopedic Drapes

§  Ophthalmic Drapes

§  Gynecology, Obstetrics, and Urology Drapes

§  Other Surgical Drapes

§  Surgical Gowns

§  By Usage Pattern:

§  Disposable

§  Reusable

§  By End User:

§  Hospitals & Clinics

§  Ambulatory Surgical Centers

§  By Country/Region:

§  Central Africa

§  South Africa

§  North Africa

·         Company Profiles

o    3M*

§  Company Overview

§  Product Portfolio

§  Financial Performance

§  Key Strategies

§  Recent Developments

o    Halyard Health

o    Medline

o    Thermo Fisher Scientific Inc.

o    Steril Medical

o    Alpha Pro Tec

o    Mölnlycke Health Care AB

o    Anhui Medpurest Medical Technology Co., Ltd.

o    Lohmann & Rauscher

o    Vygon

“*” marked represents similar segmentation in other categories in the respective section.

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[pharmaworldtoday]

A few IMP abbreviations1. Central Drugs Standard Control Organization (CDSCO) 2. Drugs and Cosmetics Act, 1940 3. People for the Ethical Treatment of Animals (PETA) 4. National Pharmaceutical Pricing Authority (NPPA) - NPPA is nodal drug price regulator in India established in 1997 5. Drugs (Price Control) Amendment Order (DPCO), 2016 6. CEPA (Comprehensive Economic Partnership Agreement) 7. Active pharmaceutical ingredients (API) 8. National List of Essential Medicines (NLEM) 9. Trade-Related Aspects of Intellectual Property Rights (TRIPS) 10.The Drugs Technical Advisory Board (DTAB) 11.Drugs Consultative Committee (DCC) 12.DAVA project - Drug Authentication and Verification Application (DAVA) project #pharmaworldtoday https://www.instagram.com/p/CCaJjx8h9wg/?igshid=1i07utwwnwhd2

[mishraji645]

Government Classifies Medical Devices As Drugs To Improve Quality And Price Control

In a notification released on 11th February, 2020, the Central Government in consultation with the Drugs Technical Advisory Board(DTAB) classified medical devices as drugs w.e.f 1st April, 2020.

The definition of devices to be classified as drugs covers all existing medical devices being sold in the market, ranging from disposable syringes to MRI and CT Scan equipment.

Prior to this notification, only 23 medical devices were classified as drugs and were required to undergo the deliberate registration and analysis procedure.

The devices shall also be registered in CDSCO's online registration system from now. However, using the online registration system will be voluntary for a period of 18 months and mandatory thereafter.

What’s Good?

While the drug license registration process is a very detailed and comprehensive application procedure, involving months of careful analysis, trials and approvals. Medical devices(mainly low and medium risk) enjoyed a more lenient process of registration and control.

Devices such as disposable syringes, disinfectants, surgical gloves classified as Class A or B were either not required to obtain a registration or the regulation was not very strict. This often resulted in sub-standard and forfeited products on the market which lacked quality and were probable of causing harm to the safety of the user.

Bringing medical devices under the category of drugs will ensure that better and high quality manufacturing procedures are followed. Resulting in more refined and better quality products being sold in the market.

This would also prevent duplicacy of products and will offer manufacturers a healthy and competitive market.

What’s Bad?

Classifying medical devices as drugs will result in more stringent approval and inspection procedures. That may greatly affect small and medium businesses manufacturing low risk Class A or B devices like masks or gloves. Not every manufacturer can bear the expenses of the drug licensing process. Especially if he/she manufactures multiple devices.

Important Considerations

Even being a groundbreaking event, this reclassification is neither unexpected nor immediate. The authorities have been pondering over this matter for more than an year and have outlooked every possible aspect.

These new rules are not immediate in effect. Since Class A&B medical devices have been exempted from compliance for a period of 30 months from 1st April, 2020. Whereas Class C & D devices have been provided relaxation for a period of 42 months.

India is the fourth largest medical device market in Asia. While the sale of medical devices covers 30% of the total Indian pharma market.

With that said, this reclassification will ensure that the quality of medical devices sold in India is up to the mark and comparable to global standards.

[myabhijitr]

Surgical Drapes and Gowns Market - Industry, Size, Share, Trends, and Forecast 2018-2026

Surgical drapes are used in surgical procedures, which prevents the contact of the physicians from unwanted surfaces to prevent contamination and infection risks. It also prevents any kind of contamination and thus maintains sterility. Drapes acts as physical barrier during the surgery against microbes and are resistant to heat. Surgical gowns are worn over in the operating room to perform surgeries. Its characteristics are similar to that of surgical drape. Surgical drapes and gowns are produced according to the type of surgery. These are either disposable or non-disposable. They are generally made from tightly woven fabric, cotton, and polyester, which may or may not be chemically treated.

Request Sample Copy of this Report: https://www.coherentmarketinsights.com/insight/request-sample/2818

Factors such as active involvement and growth strategies adopted by key players in the market is expected to influence the global surgical drapes and gowns market growth positively. Furthermore, regulatory support and initiatives towards hygiene and prevention of infectious diseases are expected to impact positively on the global surgical drapes and gowns market growth.

For instance, in December 2018, Drugs Technical Advisory Board (DTAB) of India, added surgical gowns, surgical drapes, and incision drapes to the list of notified medical devices, as proposed by the Central Drug Standards Control Organization (CDSCO). Moreover, in April 2018, Medline set up a new manufacturing facility for surgical trays that includes drapes and gowns. Hence, these factors are expected to boost the global surgical drapes and gowns market growth.

Key players are indulged in obtaining approvals for their products from regulatory bodies which is expected to impel the global surgical drapes and gowns market growth. For instance, in 2017, Anhui Medpurest Medical Technology Co., Ltd. received an U.S. Food & Drug Administration (FDA) approval for Poly-Reinforced Specialty Surgical Gown, Fabric-Reinforced Surgical Gowns, and Non-Reinforced Surgical Gowns. These are disposable, sterile gowns that prevents the risk of infections.

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Furthermore, the global surgical drape and gown market growth is expected to boost over the forecast period, owing to increasing product launches. For instance, in 2015, Lohmann & Rauscher introduced Sentinex Mini Thermo Poncho that is worn by the operating room staff and as well as by the patients. Its characteristics include low lint, low microbe and air permeability, which prevents any kind of contamination and maintains sterility in the environment.

Moreover, key players are also focused on participating in conferences and events, which is expected to drive the global surgical drapes and gowns market growth. For instance, in May 2019, Mölnlycke Healthcare AB participated in the event European Operating Nurses Association (EORNA) congress, which was held in the Netherlands. The focus of the event was on quality management and hygiene of patients and staff in operating room. The company showcased its product in the event to increase awareness among people.

Major players operating in the global surgical drapes and gowns market include 3M, Halyard Health, Medline, Thermo Fisher Scientific Inc., Steril Medical, Alpha Pro Tec, Mölnlycke Health Care AB, Anhui Medpurest Medical Technology Co., Ltd., Lohmann & Rauscher, and Vygon

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[divyatyagi22]

Barcoding to become mandatory for drugs in India

The Union Health Ministry in India is going to make barcoding necessary for drugs after an alarming report by US Trade Representative (USTR) which revealed that India was one of the largest producers of fake medicines in the world.

The Drug and Technical Advisory Board (DTAB) had earlier recommended that an Indian law should be made that makes barcoding mandatory for all medicines. This would allow pharmacists, customers and the government to trace medicines across the supply chain and identify where a drug was manufactured

The barcoding would help pharmacist, consumers and government bodies to track and trace solution medicines across a supply chain. The Indian government is taking the measure after a USTR report which mentioned that up to 20% drugs sold in India are fake and could pose a serious risk to the health and safety of the patient.

To know more please read our blog at - https://bit.ly/2SfOIIw

[thatisymagazine-blog]

#Saridon. #panderm #healthcare Supreme Court Removes Ban On Saridon And Skin Cream Panderm Supreme Court ordered Government to ban 328 FDC drugs to stop their "irrational use". Now the top court has allowed the sale of pain killer Saridon and Skin Cream Panderm.

[pmsmedia-blog]

बंद हुआ नकली दवा का व्यापर | Watsapp पे Check करने का नया तरीका | Dru...

[moorthimany]

Medical Devices to boost ‘Make in India’ for the world | Apollo Telehealth

In a move considered long overdue, the government has initiated a major regulatory reform of the medical devices sector, notifying that all devices, equipment, and even software intended for medical use will now be treated as “drugs” for purposes of regulation and quality control. All devices for sale in India, whether manufactured locally or imported, will now require online registration with the Central Licensing Authority under the Central Drugs Standard Control Organization (CDSCO), the apex drug regulator in the country. Such registration is voluntary for a period of 18 months, after which it will be mandatory. With the inclusion of new published rules in 2020 under Drug and Cosmetics Act 1940, “Medical Device Amendment rules” comes into picture. With this, the manufacturer/ importer has to undergo a stringent set of steps like uploading all the details related to product, certificate of compliance with respect to ISO 13485, clinical validation/accuracy certificate, showcasing free sale certificate from the country of origin, etc. The landmark reform promises to redefine the medical devices sector in India by ushering in an era of better-quality control and boosting safety and regulation standards within the local manufacturing sector.  It will also ensure that foreign companies do not market sub-standard products in India.

The regulatory reform comes at a time when the medical devices sector is poised for major growth. The Indian medical devices market is the fourth largest in Asia and is expected to grow to USD 50 billion in size by 2025. The sector includes a wide array of devices, medical equipment, patient aids, remote care technology, diagnostic equipment, and implants. However, in the absence of a supervising regulatory authority, the sector stood largely unregulated. A study conducted by Anna University in Tamil Nadu threw up shocking facts last year. It found that just one in five ventilators in hospitals across the state had been certified safe by biomedical engineers, resulting in a large number of life-saving equipment short of credibility.

Indian importers, medical fraternity as well as consumers relied largely on foreign regulations like FDA, CE approvals for quality assurance. In the face of rapid growth and proliferation of devices, regulation standards must be strengthened and harmonized with international standards.

The need for better safety and quality assurance

This move has been a long time in the making. Last year, the Drugs Technical Advisory Board (DTAB) had recommended that all medical devices should be notified as “drugs” under the drug regulation law to ensure they maintain safety and quality standards. The government then made it mandatory for all medical devices — manufactured locally or imported – to get notified and get a CDSCO certification. 

The series of developments have come after intense debate and discussion over the need for better quality assurance for Indian consumers for a long time. India’s medical devices sector is heavily dependent on imports, with almost 70% of the demand for devices met by imports. Many of these imported equipment and devices do carry regulatory certificates in other countries, but many countries do not regulate their exports. This lack of regulation might allow certain manufacturers to take advantage of the loopholes and float low-grade devices and equipment in the market, which is a major worry for Indian healthcare. This is why regulating imports becomes extremely important to ensure quality and safety. The new amendment assures– that every medical device, either manufactured in India or imported, will have to have quality assurance before they can be sold anywhere in India.

Boost for local manufacturing

While the potential of the medical devices sector was duly acknowledged with its inclusion in the ‘Make in India’ initiative, several problems continue to hamper indigenous manufacturing and export potential. The absence of a concrete regulatory framework specific to medical devices was a leading factor that constrained investments in the market. Investors are discouraged by the lack of a concrete regulatory and legal framework to govern the sector. As mentioned above, almost 70% of the demand for medical devices in India is still met by imports. Hopefully, the introduction of the regulatory reform will change this. Apart from bringing radical improvements in standards of quality, safety and effectiveness in medical devices, the move will also act as a boost for the local manufacturing sector. The need for instituting strong quality controls will push manufacturers towards better compliance while gradually ensuring harmonizing of quality control protocols with international standards. Better regulatory mechanisms will, therefore, help Indian manufacturers produce globally competitive devices and equipment that are fitter for exports. In a nutshell, the harmonization of India’s regulatory structure with global norms will enable Indian manufacturers to ‘Make in India’ for the world. On a parallel note, a concrete regulatory framework will also boost investments, including from foreign players in the sector, and thereby help in reducing the gap between technology and research in India.

Need for building appropriate expertise

While the reform is much needed, it brings with it a major requirement of bolstering competency and auditory expertise. As regulatory standards become more stringent, regulatory bodies would require more specialized auditors and technical inspectors. On the other hand, all manufacturers – big or small – will also need to institute strong quality control checks internally. This will create major demand for competent bio-medical engineers, lab technicians, doctors and pharma experts to work closely with device manufacturers. This capacity building is an area that needs to be worked upon diligently to make the regulatory reform a success.

With the CDSCO also required to take up the regulatory role for devices along with drugs, it is also essential for the body to ensure it has the necessary capacity and expertise to conduct the process seamlessly. Greater investment in capacity building, skill enhancement, and recruitment of specialized auditors will be needed on a major scale. This comprehensive reform will benefit not only the medical devices sector but also the healthcare service consumer at large. 

Need for separate regulatory bodies

Medical devices and equipment today are used for a wide variety of medical purposes. From diagnostic uses such as CT scan, MRI to Telehealth software platforms used for providing remote consultations, the use of medical equipment is widespread and versatile. The emergence of telemedicine as a major element in furthering the goals of Universal Healthcare has driven the production of devices, software, and equipment dedicated to improving telemedicine experience. Manufacturers are continually working to develop reliable devices and equipment to be able to deliver quality medical images and precision patient data, even from remote terrains. This calls for a broader rethinking of the regulatory approach. While the introduction of the regulatory process is highly welcome, it is imperative that as a country, we gradually move towards separate regulatory regimes for drugs and devices. Devices being engineering products cannot and must not be treated as drugs, and the government must take these efforts to the next level by establishing a separate body for regulating devices, equipment, and technology used for medical purposes.

The industry has so far reacted positively with the new move, though doubts remain about the ability of the Central Drugs and Standards Control Organisation (CDSCO) to effectively regulate both drugs and medical devices. The Govt needs to play a crucial role in making this new move implement successfully by helping provide certifying labs, manpower, technical & clinical assistance as way ahead for Quality Healthcare

To know more visit our website: Best Telehealth services in India

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Mixture drug market declines 56% in March as govt clamps down

With the federal government clamping down on mixture medicine, the newest market information exhibits that in March, the fixed-dose mixture (FDC) market declined 56.four per cent when the non-FDC market confirmed a progress of 9.2 per cent and single molecule medicine grew 9.four per cent.

An FDC drug is one which accommodates two or extra energetic substances in a fixed-dosage ratio. Final 12 months, the federal government banned over 340 ‘irrational’ FDCs that have been discovered to pose well being dangers to sufferers. Extra FDC medicine are below the scanner in the intervening time which can additionally come below the ban.

Consequently, pharmaceutical corporations have pared their publicity to FDCs and are additionally proscribing the launch of recent mixture medicine. “Earlier than the ban got here mid final 12 months, we had braced for a similar and weeded out FDCs from our home portfolio. Henceforth we’ve got been cautious about launching new mixture medicine. As such the federal government is finding out the efficacy of one other 940 FDCs and subsequently, there’s a sense of uncertainty on this market,” mentioned the chief of a number one pharmaceutical participant.

Knowledge from market analysis agency AIOCD AWACS displays the temper available in the market. In March the market associated to FDCs noticed a decline of 56.four per cent. The worth element for the FDCs noticed a 1.three per cent progress whereas volumes shrunk by 57.9 per cent, AIOCD AWACS mentioned. Compared, the non-FDC market grew 9.2 per cent whereas single molecules noticed a 9.four per cent progress in March.

When it comes to transferring annual turnover (MAT), which displays the final twelve months information, the FDC market noticed a 20.6 per cent decline in worth phrases at Rs 641.6 crore whereas the unit gross sales fell by 16 per cent. The non-FDC section noticed a 10 per cent progress in worth phrases to Rs 62,517 crore whereas the one molecule market grew 9.6 per cent to Rs 67,347 crore. The general Indian pharmaceutical market (IPM) grew 9.6 per cent to Rs 1.three trillion.

Sudarshan Jain, secretary basic of the Indian Pharmaceutical Alliance (IPA) that represents the research-based pharma corporations in India identified that the FDC market captured within the AIOCD AWACS information refers to people who have come below the scanner. “There are numerous authorised FDC medicine too. Cardiovascular and another therapies would see extra mixture medicine. Nevertheless, for any new drug to be launched, one has to take regulator approval, which is stringent now. The ban on the ‘irrational’ FDCs is within the curiosity of the affected person,” he mentioned.

Jain additional famous that corporations have consciously moved away from FDCs which are already below the scanner and a ban is possible within the close to future.

One other senior official in a home pharma firm mentioned that solely small and medium-size gamers proceed to make these FDCs which are below scrutiny, and most huge corporations have already weeded these out of their portfolio.

In March 2016, the ministry of well being and household welfare had applied a ban on 349 FDCs primarily based on suggestions of the Chandrakant Kokate committee that discovered these drug mixtures to be irrational and posing well being dangers. In December 2017, the Supreme Courtroom referred the matter to the Drug Technical Advisory Board (DTAB) for a contemporary assessment after drugmakers challenged the ban.

The DTAB, in a gathering held in New Delhi in July final 12 months, strengthened the ban on 343 of the 349 medicine. At the moment, the marketplace for these FDCs was estimated to be round Rs 2,000 crore or so. Subsequently, the well being ministry banned the manufacture, sale, and distribution of 328 fixed-dose mixtures (FDCs) of medicine in September 2018. Manufacture, distribution and sale of some FDCs (instance Saridon by Piramal Enterprises) have been allowed ultimately following beneficial court docket orders.

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source https://webart-studio.com/mixture-drug-market-declines-56-in-march-as-govt-clamps-down/