#export ban on pharma ingredients

[researchetcsblog]

Plastic Arupole Forecast For the Coming Years

The global plastic ampoule market is growing very fast indeed and this article will give you information on how it is going to do just that. In the world of cosmetics there are many different products to choose from and the plastic ampoule market is one of them. In the future it is estimated that the plastic ampoule market will expand at a CAGR of about xx% over the next 5 years, will touch xx million US dollars in 2021, and will expand from there. So why are they growing so fast? Let's have a look.

Well it is no secret that Europe is one of the fastest growing regions for plastic ampoule manufacturing. This growth is forecast to continue into the next few years as there are many countries in Europe that are starting to liberalize their laws on cosmetics and skin care. For example in the UK the "SMO" laws were introduced last year which allows for skin care companies to use the word SMO on their packaging without any restrictions. They were also able to increase the size of letters within the brand name to a maximum of two while the size of the bottle remains the same. Other European countries are following suit and some like Spain are even allowing the use of four numbers instead of two.

The plastic ampoule market is expanding into the North America as well. This is due to the large scale restructuring of the Canadian government which allows for much more globalization. The restructuring allows for the production to move closer to the U.S. and allows for the manufacture to be tax free in the U.S. There are many benefits to moving into the North America region including the lower cost of labor, transportation costs are reduced due to the larger number of container ships and the ability to tap into a larger global market.

As this trend continues apace, the need for accurate and up to date market research becomes ever more significant. Market research provides a wealth of information on the trends in the current market growth including trends in packaging and ingredients, demand, marketing, advertising, and distribution. It also gives an insight into the competitive landscape and the strength and weakness of brands. A strong competitive analysis will allow you to develop an effective marketing plan to increase sales and revenue. These reports can be easily purchased from online suppliers and vendors.

Plastic ampoule forecasts for the coming years are based on current and future trends including the current market size, industry growth and predictions for the future. The plastic ampoule manufacturers are seeing an increasing number of orders for these products as the demand increases and the supply remains constant. A plastic ampoule kit can be easily purchased from the market. The forecast shows that the industry is set to experience a steady growth in both sales and revenues.

This forecast is the third chapter in the "Snapshots in the Field" project. This report presents the overview and critical summary of the Snapshot in the Field survey data. The data reveals the current and future competitive situation of the plastic ampoule manufacturing sector.

The research team projects that the Plastic Ampoule market size will grow from XXX in 2020 to XXX by 2027, at an estimated CAGR of XX. The base year considered for the study is 2020, and the market size is projected from 2020 to 2027.

The prime objective of this report is to help the user understand the market in terms of its definition, segmentation, market potential, influential trends, and the challenges that the market is facing with 10 major regions and 50 major countries. Deep researches and analysis were done during the preparation of the report. The readers will find this report very helpful in understanding the market in depth. The data and the information regarding the market are taken from reliable sources such as websites, annual reports of the companies, journals, and others and were checked and validated by the industry experts. The facts and data are represented in the report using diagrams, graphs, pie charts, and other pictorial representations. This enhances the visual representation and also helps in understanding the facts much better.

By Market Players:

 Sanner

 James Alexander

 LF of America

 Bisio Progetti

 Shenzhen Bona Pharma Technology

 Pin Mao Plastic Industry

 Lameplast Group

 Catalent

 Discos

 Punto Pack

By Type

 Up to 2 ml

 3 ml to 5 ml

 5 ml to 7 ml

 8 ml & above

By Application

 Pharmaceuticals

 Chemical

 Veterinary

 Spa Products

 Dental

 Cosmetics & Beauty Aids

By Regions/Countries:

 North America

 United States

 Canada

 Mexico

East Asia

 China

 Japan

 South Korea

Europe

 Germany

 United Kingdom

 France

 Italy

 Russia

 Spain

 Netherlands

 Switzerland

 Poland

South Asia

 India

 Pakistan

 Bangladesh

Southeast Asia

 Indonesia

 Thailand

 Singapore

 Malaysia

 Philippines

 Vietnam

 Myanmar

Middle East

 Turkey

 Saudi Arabia

 Iran

 United Arab Emirates

 Israel

 Iraq

 Qatar

 Kuwait

 Oman

Africa

 Nigeria

 South Africa

 Egypt

 Algeria

 Morocoo

Oceania

 Australia

 New Zealand

South America

 Brazil

 Argentina

 Colombia

 Chile

 Venezuela

 Peru

 Puerto Rico

 Ecuador

Rest of the World

 Kazakhstan

Points Covered in The Report

 The points that are discussed within the report are the major market players that are involved in the market such as market players, raw material suppliers, equipment suppliers, end users, traders, distributors and etc.

 The complete profile of the companies is mentioned. And the capacity, production, price, revenue, cost, gross, gross margin, sales volume, sales revenue, consumption, growth rate, import, export, supply, future strategies, and the technological developments that they are making are also included within the report. This report analyzed 12 years data history and forecast.

 The growth factors of the market is discussed in detail wherein the different end users of the market are explained in detail.

 Data and information by market player, by region, by type, by application and etc, and custom research can be added according to specific requirements.

 The report contains the SWOT analysis of the market. Finally, the report contains the conclusion part where the opinions of the industrial experts are included.

Key Reasons to Purchase

 To gain insightful analyses of the market and have comprehensive understanding of the global market and its commercial landscape.

 Assess the production processes, major issues, and solutions to mitigate the development risk.

 To understand the most affecting driving and restraining forces in the market and its impact in the global market.

 Learn about the market strategies that are being adopted by leading respective organizations.

 To understand the future outlook and prospects for the market.

 Besides the standard structure reports, we also provide custom research according to specific requirements.

The report focuses on Global, Top 10 Regions and Top 50 Countries Market Size of Plastic Ampoule 2016-2021, and development forecast 2022-2027 including industries, major players/suppliers worldwide and market share by regions, with company and product introduction, position in the market including their market status and development trend by types and applications which will provide its price and profit status, and marketing status & market growth drivers and challenges, with base year as 2020.

Key Indicators Analysed

 Market Players & Competitor Analysis: The report covers the key players of the industry including Company Profile, Product Specifications, Production Capacity/Sales, Revenue, Price and Gross Margin 2016-2021 & Sales by Product Types.

 Global and Regional Market Analysis: The report includes Global & Regional market status and outlook 2022-2027. Further the report provides break down details about each region & countries covered in the report. Identifying its production, consumption, import & export, sales volume & revenue forecast.

 Market Analysis by Product Type: The report covers majority Product Types in the Plastic Ampoule Industry, including its product specifcations by each key player, volume, sales by Volume and Value (M USD).

 Markat Analysis by Application Type: Based on the Plastic Ampoule Industry and its applications, the market is further sub-segmented into several major Application of its industry. It provides you with the market size, CAGR & forecast by each industry applications.

 Market Trends: Market key trends which include Increased Competition and Continuous Innovations.

 Opportunities and Drivers: Identifying the Growing Demands and New Technology

 Porters Five Force Analysis: The report will provide with the state of competition in industry depending on five basic forces: threat of new entrants, bargaining power of suppliers, bargaining power of buyers, threat of substitute products or services, and existing industry rivalry.

COVID-19 Impact

 Report covers Impact of Coronavirus COVID-19: Since the COVID-19 virus outbreak in December 2019, the disease has spread to almost every country around the globe with the World Health Organization declaring it a public health emergency. The global impacts of the coronavirus disease 2019 (COVID-19) are already starting to be felt, and will significantly affect the Plastic Ampoule market in 2021. The outbreak of COVID-19 has brought effects on many aspects, like flight cancellations; travel bans and quarantines; restaurants closed; all indoor/outdoor events restricted; over forty countries state of emergency declared; massive slowing of the supply chain; stock market volatility; falling business confidence, growing panic among the population, and uncertainty about future.

 Global Plastic Ampoule Market Research Report 2021 Professional Edition Market report offers great insights of the market and consumer data and their interpretation through various figures and graphs. Report has embedded global market and regional market deep analysis through various research methodologies. The report also offers great competitor analysis of the industries and highlights the key aspect of their business like success stories, market development and growth rate.

Global Polyvinylidene Fluoride Powder Market Research Report 2021 Professional Edition Market

Global Polystyrene Foam Tray Market Research Report 2021 Professional Edition Market

Global Atomized Iron Powder Market Research Report 2021 Professional Edition Market

Global Atomized Nickel Powder Market Research Report 2021 Professional Edition Market

Contact us: https://www.reportmines.com/contact-us.php 

[pharmaphorumuk]

The calm after the storm: How COVID-19 is making pharma more resilient

COVID-19 is proving to be the perfect storm in terms of the supply of pharmaceutical products. But learning how to overcome the challenges of 2020 will serve the industry well for years to come. As part of our EU Leader series, Christian Pawlu, head of strategy, portfolio and BD&L at Sandoz, told us about how securing supply in a time of crisis will ensure future access, build resilience, and transform relationships.

Since the start of the year, pharmaceutical companies have been riding a rollercoaster of challenges. Pawlu describes a “perfect storm” as the various strands came together to threaten supply chains.

“First, we saw a doubling or tripling of usual demand for a lot of our products. At the same point, there were big worries about supply chains in China.

“Then, as we went further into the crisis, there were some almost protectionist moves in some countries, as they placed or considered export bans on active pharmaceutical ingredients (API).”

Navigating this rapidly evolving landscape presented a challenge, but not an insurmountable one, Pawlu says.

“The industry, and our company in particular, always has business continuity plans in the drawer. But never in recent history have we had to pull out strategies for so many of our products and subsidiaries at the same time and put them into place.”

Daily calls with supply chain colleagues, activating second sources and alternative supply chains, along with strategic API and finished product stockpiling, all contributed to an absence of any major disruptions.

“For us, the crisis was also a reminder of our purpose as a company: to provide and pioneer access to the patient. We were the first company to commit to keeping prices stable for drugs seen as essential treatments for COVID-related symptoms.

“As an industry, we will have to be more honest with ourselves. We’ll be much better able to see where we have a really deliverable message and when we elicit a response, rather than measuring it by the time people spend with the customer”

“We made a commitment early on that we would not want to benefit from any shortages. In addition, we have made a commitment to provide 15 drugs to low-income countries at cost.”

Remote pharma

COVID-19 has fundamentally changed the way all sectors work on a day to day basis, but pharma did not have the luxury of time in allowing these changes to bed in.

Within a week, all 100,000 employees at Sandoz and parent company Novartis had transitioned from office to remote working, a process Pawlu describes as relatively “frictionless”.

“The biggest challenge was the interaction with our customers, because we weren’t able to see healthcare providers physically anymore. But, in the end, that turned out to be an opportunity.”

Before the pandemic, Sandoz was able to reach around 15% of its customers digitally, but that has now increased to around 70%.

As people adjusted to connecting digitally, through Zoom, Microsoft Teams, and other video-based software, in their private lives, this expanded into their professional lives, says Pawlu.

“Traditionally, the way we interact with our customers has been a big barrier to conveying messages, particularly in off-patent pharma.”

While using digital channels will not necessarily be easier, it will make companies think differently about how best to interact with healthcare professionals, Pawlu believes.

He says: “The key question we need to ask ourselves is, if we have more access to physicians, how do we want to use it? More reach? More efficiency?

“We are working through this as we speak and are thinking how we complement or even replace the traditional channels, and how we can reach customers we haven’t reached so far. It’s exciting.”

As the industry moves from a face-to-face to digital communication model, it needs a change of mindset, he adds.

“A physical person showing up in a physical office is the old normal.

“As an industry, we will have to be a bit more honest with ourselves. We’ll be much better able to see where we get access, where we have a really deliverable message, and when we elicit a response or an active request for follow up, rather than measuring it by the time people spend with the customer.”

Resilient future

Another change Pawlu hopes is here to stay is the increased communication and collaboration between industry and policy makers.

This is, in part, thanks to a greater appreciation of the importance of resilient supply chains, he says.

“Over the last 30 years, the volume of products produced in Europe versus Asia has flipped. The majority of APIs and an increasing share of FDF is currently being manufactured in Asia,” explains Pawlu, adding that this was driven, particularly in generics, by price.

“I think the balance we need to keep in mind is cost, quality, and resilient supply. You can optimise all three, but you can only maximise two at the same time.

“If you can go for the highest quality and resilient supply, you will have to pay a higher cost, or you do it the other way around – of course we never want to compromise on quality.”

Supply chain issues during the pandemic have brought this argument into sharp focus, and it is now “on the radar” at an international level.

“Sandoz has been in contact with heads of governments across Europe, and I’m extremely happy that this topic has gained so much attention,” he says, adding that the European Commission has committed to developing a continent-wide pharma strategy.

Back in July, Sandoz announced that it had entered a partnership with the Austrian government to keep production of penicillin at the company’s Kundl facility – the last remaining integrated production chain for antibiotics in the western world.

“Austria is something that’s been very visible, but we’re having similar discussions on other product areas with other governments,” Pawlu says.

Ultimately, 2020 has been a challenging time for pharma, but it has also presented a myriad of opportunities to learn and evolve.

For Pawlu, COVID-19 has highlighted how we transform the way the industry works – from manufacturing and supply chains, to sales and detailing – in a way that ensures everyone can access the high quality, affordable medicines they need to live happier, healthier lives.

About the interviewee

Christian Pawlu is the global head, strategy, portfolio and BD&L for Sandoz and a member of the global Sandoz Executive Committee. Christian studied medicine in Germany, Canada and France and is a licenced physician. Before he joined Sandoz, Christian was a start-up entrepreneur.  He was a partner at McKinsey & Company where he specialised in pharmaceuticals and medical products with a focus on generic drug manufacturers. Prior to joining McKinsey, Christian was a neuroscience researcher at the university of Freiburg, Germany. Christian is married to a professor of medicine and they have three children.

About the author

Dr Paul Tunnah founded pharmaphorum in 2009, which combines industry leading publications (www.pharmaphorum.com) with a specialist strategy and content marketing/communications consultancy (www.pharmaphorumconnect.com). He is a recognised author, speaker and industry advisor on content marketing, communications and digital innovation, having worked with many of the world’s leading pharmaceutical companies and the broader ecosystem of healthcare organisations.

In June 2020, he became chief content officer for Healthware Group, a next-generation integrated consulting group that operates at the intersection of the transformation of commercial operations and digital health, offering a unique range of services combining design, strategy, communication and innovation with technology and corporate venturing.

Connect with Dr Tunnah at https://www.linkedin.com/in/paultunnah/ or https://twitter.com/ptunnah

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[kultejas]

Government curbs exports of paracetamol API - government curbs exports of paracetamol api

Government curbs exports of paracetamol API – government curbs exports of paracetamol api

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New Delhi, May 28 (LANGUAGE) The government on Thursday announced a ban on the export of Paracetamol API (Active Pharma ingredients). In the midst of the Corona virus crisis, the government had curbed exports of paracetamol and its formulations to increase domestic supply. Earlier on April 17, the government lifted the ban on export of paracetamol formulations. Now the Directorate General…

[dailykhaleej]

COVID-19: Trump’s hydroxychloroquine push boon for 160-year-old Indian plantation

Hydroxychloroquine. Picture Credit score: DailyKhaleej

U.S. President Donald Trump’s backing for a malaria drug to deal with COVID-19 has boosted the prospects of an obscure plantation within the mountains of jap India.

About 6,900 acres (28 kilometers) of the decrease Himalayas are below Cinchona cultivation, a tree whose bark is a pure supply of quinine – of which hydroxychloroquine, the drug Trump has touted as a “gamechanger” in treating the coronavirus, is an artificial by-product.

Trump’s backing has fueled stockpiling of the drug amongst hospitals and customers, prompting a tussle for provides that even sparked a short-lived export ban in India. The plantation has accordingly seen a surge of curiosity in its bark.

“Quinine sulphate that we get from cinchona bark is more potent, it has less side-effects,” stated Uden Angmu Yonzone, assistant quinologist on the manufacturing unit in Darjeeling. Harvesting is proscribed to annually, which restricts provide and pushes pharmaceutical corporations towards cheaper artificial elements, she stated.

India has a big stockpile

Uden could not elaborate on the relative advantages of pure quinine. Whereas there is no conclusive proof that hydroxychloroquine works on the virus, demand for the drug created a quick diplomatic spat after Trump warned of potential retaliation if Prime Minister Narendra Modi did not elevate a ban on exports. India has among the world’s largest producers of the completed drugs in addition to its element elements.

Samuel Rai, director on the Directorate of Cinchona and Different Medicinal Vegetation, stated he acquired further queries from Indian pharmaceutical and non-pharma corporations based mostly within the states of Madhya Pradesh, Uttar Pradesh and West Bengal over late March and April relating to buy of the tree bark.

The plantation employs greater than 5,000 everlasting laborers and over 400 authorities staff, with harvests in December and January. The bark bought for 111 rupees ($1.45) a kilogram over the past public sale in November, Rai stated.

The place did all of it begin?

The primary Cinchona seeds have been despatched in 1861 to the Royal Botanical Backyard in Calcutta, then the capital of the British Empire in India, and the Darjeeling plantation was arrange in 1864. The medicinal properties of the bark have been recognized to the Incas of Peru, who known as the tree Kinakina within the native language and Cina in Spanish.

“Just as Lord Hanuman brought the holy medicine from the Himalayas to save the life of Lord Rama’s brother Lakshmana,” India and Brazil will be a part of within the battle towards the virus, Brazilian President Jair Bolsonaro wrote in a letter to Modi, referring to the Hindu epic Ramayana whereas in search of provide of hydroxychloroquine, the Press Belief of India reported this month.

Trump vowed in March to make the inexpensive medicine extensively obtainable to battle the pandemic, which has sickened about 2 million folks globally, killed greater than 126,000, and has no accepted remedy or vaccine. In India, the federal government has advisable hydroxychloroquine as a prophylactic for well being care staff who dose themselves as a safety measure to keep away from contracting the an infection whereas treating Covid-19 sufferers.

Negative effects and fatality

Hydroxychloroquine and its cousin chloroquine have side-effects: the latter can kill an grownup in simply two grams, or twice the each day quantity advisable for remedy, in accordance with a examine by the Wuhan Institute of Virology.

The drug is understood to have short-term negative effects akin to nausea, diarrhea and tinnitus whereas long-term use can irreversibly impair eyesight.

It is forbidden for pregnant girls as it may well trigger congenital defects in infants.

Synthetic synthesis of quinine within the mid-20th century eroded demand for the cinchona bark and typical purchasers in the present day embody small Indian drug makers who use the ingredient to deal with leg cramps. Yearly, about 200,000 kilograms of Cinchona is harvested, and at the moment there’s an accrued inventory of 500,000 kilograms obtainable, in accordance with Rai.

“We are in a position to harvest more if mandated by the government,” he stated.

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[vsplusonline]

No shortage of key medicines, masks: MoS Mansukh Mandaviya

New Post has been published on https://apzweb.com/no-shortage-of-key-medicines-masks-mos-mansukh-mandaviya/

No shortage of key medicines, masks: MoS Mansukh Mandaviya

NEW DELHI: India has adequate stocks of two key drugs recommended for Covid 19 patients and capacity to manufacture sufficient masks to meet the challenge, Mansukh Mandaviya, union minister of state for chemicals and fertilizers, told ET.

The government has prepared a comprehensive package to make India self-sufficient in the manufacturing of pharmaceuticals, he added. The Department of pharmaceuticals fall under the ministry. The two-time Rajya Sabha MP is also part of the high-level Group of Ministers (GoM) for COVID-19.

“India has 2.8 crore units of immunity-building drugs lopinavir and ritonavir that are otherwise given to AIDS patients,” he told ET on Tuesday, shortly before the 21-day lockdown was announced by Prime Minister Modi. The combination of lopinavir and ritonavir is among the four drugs deemed the most promising against Covid 19 by the World Health Organisation. Last week, India recommended the formulation for Covid 19 patients in the high-risk group—people above the age of 60 with existing medical conditions.

“We are the no. 1 producer of anti-malarial drug Hydrochloroquine that the ICMR (Indian Council of Medical Research) recently said could be given to healthcare workers handling Corona patients or suspects. There is no need for any panic for any medicine,” he added. Director General for Foreign trade (DGFT) — an arm of ministry of commerce – has banned the export of Hydrochloroquine to ensure sufficient availability in the domestic market.

The health ministry has issued a directive saying the anti-malarial drug should not be taken without a prescription.

Countering arguments that there is dearth of masks in the country, the minister said India has 114 mask production units that together have daily capacity to manufacture 1.5 crore masks. “Manufacturing is going on at full scale. The health ministry is procuring them and build sufficient stock,” Mandaviya added.

The government has announced four schemes with a total outlay of Rs 13,760 crore to boost the domestic production of bulk drugs and medical devices in the country. “We have identified 53 critical APIs (active pharma ingredients) that go into the making of anti-diabetic, anti-cancer drugs, and other critical illnesses, for which we are dependent on imports. As of today, India imports 60-65% of APIs. We will now give incentives for local manufacturing that will go a long way in making India self-sufficient,” he added.

“Similarly, India imports 85% of medical devices, including ventilators, pace-makers and scanners. Up to Rs 100 crore will be given for creation of medical device parks in the country.” Without going into further details, the minister, who is a trained veterinary doctor, said India has a sufficient number of ventilators to handle Covid patients.

The minister, who also holds the independent charge of the ministry of shipping, added that necessary steps were taken well in time to check the spread of Coronavirus via the sea route. “Since 95% cargo lands by sea route, thermal scanning has been made mandatory at all ports for all crew (since January), no foreign cruise is being allowed to touch Indian ports, PPE (Personal Protective Equipment) has been made mandatory for captains who go for pilotage, no foreign crew is being allowed to deboard on Indian shores and a Standard Operating Procedure has been set for disposal of bio-medical wastes such as masks.”

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[inkariasacademyworld]

Impact Of Chinese Goods On Indian Industry

Hard Numbers: India-China Trade Quantum

China is India’s largest goods trading partner and the bilateral trade reached $89.6bn in 2017-18, from $38bn in 2007-08.

China’s share in India’s imports stands at 16.6% in FY1718.

Trade deficit with China at $63bn constitutes more than 40% of India's total trade deficit.

Between FY0708 and FY1718, Indian exports to China increased by $2.5bn but the imports, however, increased by $50bn.

China has increased prices of bulk pharma drugs by 1200% over the last two years, impacting prices of finished products by Indian pharma industry.

No bilateral trade agreement between the two, to accord preferential treatment to the Chinese products.

The Parliamentary Standing Committee on Commerce tabled a report titled “Impact of Chinese goods on Indian industry” in Rajya Sabha.

Highlights of the Report Numerous anti-dumping investigations have been initiated against China; also majority (i.e. 102/144) of the enforced anti-dumping duties are against Chinese products.

All the industries affected by the dumping are not able to reach Directorate General of Anti-Dumping and Allied Duties (DGAD) on account of high cost involved in moving the applications.

Delayed action in the part of DGAD causes permanent damage to the industry in question, leaving little or no

How Chinese goods find their way to Indian markets?

Dumping of cheap Chinese products.

Under-invoicing of Chinese goods: causes revenue loss to the Government as well as puts the domestic manufacturers at a disadvantage in terms of price of like items.

Re-routing of products via countries that have FTAs with India.

Flouting of Rules of Origin norms e.g. setting shops in Least Developed Countries(LDC) arrangements under Duty Free Tariff Preference (DFTP) scheme.

Mis-declaration and mis-classification of prohibited goods.

Smuggling of proscribed items: In April to December 2017-18, as many as 1,127 cases of smuggling have been registered by India, recovering more than Rs 5.4 billion worth of Chinese goods.

Circumvention of duties due to lax implementation of Indian regulations.

scope for remedial measures.

No impact assessment of anti-dumping/counter-veiling duties by the government leading to non-review of such duties, renders the anti-malpractices framework ineffective.

One estimate suggests that due to the dumping of Chinese solar panels, nearly two lakh jobs are lost as nearly half of our domestic industry capacity remains idle.

Chinese products are certified/ registered quite easily and faster by India's Bureau of Indian Standards. To the contrary, Indian products suffer delays and high fee for getting certified/ registered with Chinese authorities before exporting into China.

Reasons for deluge of Chinese imports to India

Chinese imports flood the Indian markets due to high demand owing to large size of the Indian market and also competitive prices of these products. Elaborative reasons behind this phenomenon include:

Industry-friendly lending rates, lower logistics and energy costs as compared to India: On account of costlier energy, finance and logistics, Indian goods are costlier by about 9% in the global market. Chinese industry gets loans at 6%, compared to 11-14% in India. Logistics costs are 1% of the business in China, compared to 3% in India.

Chinese exports largely constitute manufactured products related to expanding sectors such as telecom and power (while Indian exports to China are primary products largely).

Support by the Chinese government e.g. export rebate, state-owned enterprises, tax discounts within the provinces.

Currency manipulation for export competitiveness.

Non-transparent trade policy, unfair trade practices such as exports subsidies that are against the WTO regulations.

Robust and integrated global value chain along with leveraging of economies of scale.

Infrastructure required to address the demands of quality checks is inadequate.

Delays in firming up the Quality Control Orders (QCOs) helps the Chinese industry monopolise its low quality goods in the market e.g. toys, low-quality LEDs etc.

Implications for the Indian Economy Labour-intensive industries such as textiles, solar, firecrackers etc., in India are worse affected by Chinese imports.

Many MSMEs in the stainless steel industry have shut down.

Direct and indirect tax collections take a hit due to smuggling, under-invoicing etc. This will fall further as domestic manufacturers shrink or dissolve in future.

Aims and targets of the Make In India programme are undermined.

Banking sector, already reeling under the NPAs, faces further stress.

Low-quality products from China adversely impact the environment.

Manufacturers are turning into traders, having negative impact on the employment.

Overt dependence on imports of key products such as the bulk drugs can have cascading effects on supply of many products, employment etc., in addition to self-reliance, national interests and security in critical situation

Recommendations of the Report Governmental should provide financial assistance to recognized industry forums to improve the access of MSMEs/SSIs to trade remedial measures.

Creation of a DGAD platform for continuous dialogue with the Indian industry on WTO non-compliant subsidies.

Shortening of time period for investigations and notifications.

Stringent implementation of anti-dumping framework, to check smuggling, misclassification and other trade malpractices.

Augmentation and strengthening of the Directorate of Revenue Intelligence (DRI) workforce.

Working out a formal arrangement with China, to avail price and other relevant information on imports suspected of under invoicing – for Indian Customs administration.

Better enforcement of FTAs and Rules of Origin norms by a joint verification/ certification mechanism with the partner countries.

Study of the likely impact of the tariff concessions under ongoing RCEP negotiations on our domestic industry, to ensure zero cost to Indian industrial health.

Easing of the restrictive and discriminatory clauses being faced by the Indian Industry in public tenders and implementation of Public Procurement (Preference to Make in India), Order 2017 in spirit. State governments should also be sensitized in this regard.

Steeping up the surveillance of Land Ports especially in the Indo-Nepal Border and North East border.

Support to the Bureau of Indian Standards (BIS) in terms of availability of technical manpower and infrastructure Identification and inclusion of more products under technical regulations specifying compliance.

Representation of BIS on SWIFT to further add to the effectiveness of the latter.

Countervailing duty (CVD)

Additional import duty that is imposed to neutralize the negative effects of subsidies

Safeguard duty

Tariff imposed to restrict imports of a product temporarily (take “safeguard” actions) if its domestic industry is injured or threatened with injury caused by a surge in imports

Anti-dumping duty (ADD)

Protectionist tariff that a domestic government imposes on foreign imports that are priced lower than their value in their home market

Inverted Duty Structure

It implies a situation where import duty on finished goods is low compared to the import duty on raw materials that are used in the production of such finished goods.

This makes domestically produced goods more expensive that their imports from other countries.

Sensitization of enforcement agencies like Customs authorities, State Governments etc. to work in co-ordination with the Regulators.

Necessary and immediate review of the existing inverted duty structure.

Production subsidy or incentives should entail government tariff protection, to match the Chinese assistance so that our domestic production gets a real boost.

Constitution of steering committee to oversee the revival of the API industry, including reviving PSUs like IDPL and Hindustan Antibiotics, especially at the time when many APIs units in China are closing due to strict environment norms there.

To protect the solar industry, ADD may be

SWIFT – Single Window Interface for Facilitating Trade

Single Window provides a single platform for relevant agencies like Wildlife, Drug Control, Animal Quarantine, Plant Quarantine, FSSAI and Textile Committee for necessary clearance or certification before the goods are released inland from the ports

Optimal use of SWIFT can ensure effective quality control of all the imports of products under QCO/technical regulations.

levied in a differential manner to facilitate level pegging for domestic industry.

Solar power industry must explore the avenues of protection under CVD since Chinese solar industry enjoys WTO non-complaint subsidies of the Chinese Government.

Import of finished toy products from China must be banned as it has affected 50% of the domestic toy industry and traditional skills are getting lost with artisans migrating to other vocations.

Stringent penal actions to create effective deterrence against unscrupulous elements.

Creation of public opinion in the country to discourage buying of sub-standard imported product, with

API – Active Pharmaceutical Ingredients These are those constituents of drugs that are responsible for effects produced by these drugs. The other constituents of the drugs called excipients are chemically inactive substances, which help carry APIs to the body system or target organ etc.

engagement of the industry, thus popularising ‘Swadeshi apnao’ (buy made-in-India products).

Steps being taken

Since India and China are the members of the WTO, no restrictions can be imposed on the WTO-compliant trade. While the action to be taken on the basis of the Report is yet to be determined, certain measures have already been taken to protect the domestic industry and to curb the flood of Chinese imports that include:

Market Economy Status of the WTO MES is accorded by the WTO to the countries where economic decisions and the pricing of goods and services are guided solely by open competition, with little or no government intervention or central planning

China’s bid for this status is opposed by the US, the EU, India and other parties

If granted this status, imposition of anti-dumping duties and other trade defences gets difficult to impose against such a nation.

Safeguard duty has been imposed on the solar cell imports from China and Malaysia for two years, till July 2020.

DGAD has recently opened an assistance counter for the help of the MSME Sector.

Recent creation of an integrated single umbrella National Authority, namely, Directorate General of Trade Remedies (DGTR) will be effective in providing comprehensive and swift trade defence mechanism in India.

Measures have been taken to increase the efficacy of Risk Management System (RMS) – to tighten the inspection infrastructure at the entry points.

Introduction of the GST will help in business efficiency, better record-keeping infrastructure, easier audits and controls and creation of uniform market across the country.

India needs to stay firm on its non-MES status stand to China at the WTO to ensure protection to its domestic industry.

[lindamcsherry]

Valsartan Manufacturing Problems Lead to Lawsuits, Ban on Imports from Chinese Pharma Company

The Chinese drug manufacturer linked to recent problems with contaminated valsartan indicates that it will discuss its future with investors today, following a recent FDA ban on all products manufactured by the pharmaceutical company and an increasing number of valsartan recall lawsuits alleging that individuals developed cancer after using the blood pressure drug.

Late last month, the FDA stopped all imports of drug ingredients and medicines made by Zhejiang Huahai Pharmaceuticals in China. The decision came following an inspection report (PDF) that outlined manufacturing problems at the company’s facility in late August.

The report indicates the company failed to properly validate production processes, and cleaning procedures, and failed to properly evaluate changes in the manufacturing of active pharmaceutical ingredients. European regulators came to a similar conclusion, saying that the company failed to meet good manufacturing practices and de-authorized the company’s factory in Linhai, China, the same one the FDA inspected, from making generic valsartan.

On Sunday, the company said the decisions will impact its export sales, and indicated that a growing number of product liability lawsuits are being filed in U.S. courts over the valsartan manufacturing problems that resulted in pills containing an impurity that is known to increase the risk of cancer. The pharmaceutical company indicates that it could also face further actions by European regulators.

The first valsartan recalls were announced in Europe on July 5, after batches of the active ingredient supplied by Zhejiang Huahai Pharmaceuticals in China, tested positive for NDMA, which may increase the risk of several different types of cancer among humans. That initial recall affected about 2,300 batches of valsartan and valsartan HCTZ shipped throughout Europe and Canada. The same manufacturer made the recalled Torrent Pharmaceutical pills.

The FDA followed with its own recall announcement on July 13, indicating that the agency had launched an investigation to determine the scope of the contamination and the potential risk to consumers.

The FDA has assigned a group of pharmacists and nurses to answer consumer’s questions about the recalls. Since the first recalls, the agency indicates it has received more than 6,000 inquiries from patients, doctors, nurses, pharmacists and academics. Inquiries can be made by calling 855-543-3784 or by sending an email to druginfo@fda.hhs.gov.

There are a growing number of individual and class action lawsuits being investigated by valsartan lawyers, including claims for kidney cancer, liver cancer and other digestive tract cancers.

The post Valsartan Manufacturing Problems Lead to Lawsuits, Ban on Imports from Chinese Pharma Company appeared first on AboutLawsuits.com.

[gossipnetwork-blog]

How Booming Israeli Weed Industry Is Changing American Pot

New Post has been published on http://gossip.network/how-booming-israeli-weed-industry-is-changing-american-pot/

How Booming Israeli Weed Industry Is Changing American Pot

Standing on the rear balcony of a gray factory building off the side of a highway, Tamir Gedo shields his eyes from the blazing sun. He points to the 23 acres of agricultural fields spread out before him. “We’ll be able to produce more cannabis here than the entire state of Colorado,” he says. Minutes later, walking past the 8,000 square-foot storage room, he adds, “We can store enough in this warehouse to supply medical marijuana for the whole United States.”

With one million square feet of cultivation fields, a 35,000-square-foot production plant, and 30,000 square feet of grow rooms and labs, Gedo’s company, Breath of Life Pharma (BOL), is about to open the world’s largest medical marijuana production, research and development facility. According to Gedo’s estimates, BOL will produce 80 tons – more than 175,000 pounds – of cannabis per year.

A tour of BOL’s new facility feels like a walk through the medical-marijuana version of Willy Wonka’s Chocolate Factory. With its patented extraction and purification equipment, grow rooms and germination labs, BOL will be pumping out pharmaceutical-grade cannabis tablets, capsules, inhalers and oils that are customized to treat certain ailments, with specific and controlled consistencies.

And no, this isn’t happening in Colorado, California, or anywhere near America for that matter. This medical weed wonderland sits in what might be the last place you would imagine finding the world’s largest facility for medical marijuana: Israel.

Over the past 50 years, Israel has become the epicenter of medical pot. Home to Raphael Mechoulam, the pioneer of marijuana research, Israel is where THC and the endocannabinoid system were first discovered. And with the world’s largest number of clinical trials testing the benefits of medicinal cannabis, Israel has become the global destination for medical cannabis research and development. Now it is becoming the offshore greenhouse for American cannabis companies seeking to overcome the federal roadblocks standing in their way.

Israel was among the first countries to legalize medicinal use, and is one of just three countries with a government-supported medical cannabis program. Though recreational use remains illegal, support for legalization is a bipartisan issue, with some of the most outspoken proponents coming from the right. Until now, Israel’s role in this multi-billion dollar field has been limited to R&D. Yet now that the Israeli government has approved the export of medicinal cannabis products, companies there are hoping to gain a larger piece of the market. While importing cannabis into the United States is illegal under federal law, companies can get around that ban by receiving drug approval from the FDA – and that is exactly what Israeli companies hope to do. According to the FDA, nothing is stopping them, as long as they meet the agency’s arduous requirements for drug approval.

Breath Of Life Pharma says it will produce 80 tons – more than 175,000 pounds – of cannabis per year. Jack Guez/AFP/Getty

While the FDA has approved three drugs containing synthetic cannabinoids (Marinol, Syndros and Cesamet, which treat symptoms of AIDS and chemotherapy), it has never approved a product derived from botanical marijuana. According to the agency’s guidelines, “Study of marijuana in clinical trial settings is needed to assess the safety and effectiveness of marijuana for medical use.” Yet initiating clinical trials on U.S. soil is difficult to the point of being nearly impossible. So, American companies are increasingly taking a shortcut: beginning phases 1 and 2 of their clinical trials in Israel, after which they will complete phase 3 in the U.S., speeding up the process through which they can apply for FDA approval of the botanical cannabis drugs they are developing.

Though this level of American R&D in Israel is new, Israel’s impact on the American cannabis industry is not. The very fact that medical marijuana is now legal in 29 U.S. states and counting, is a direct result of Israeli research, which essentially legitimized the study of cannabis in the international scientific community that had long stigmatized it. Without this research, “We wouldn’t have the scientific interest we have now around the world,” says Paul Armentano, deputy director of the D.C.-based National Organization for the Reform of Marijuana Laws (NORML). “That really opened the door to making the study of cannabis and cannabinoids a legitimate avenue for more conventional scientists and researchers.”

“The seriousness with which the Israeli scientific community approaches this is incomparable,” says Charles Pollack, director of the Lambert Center for the Study of Medicinal Cannabis at Thomas Jefferson University in Philadelphia. “Israel is a hotbed of quality cannabis research, because they have a much more favorable regulatory climate for doing serious scientific research on medical cannabis.”

Israel is becoming the offshore greenhouse for American cannabis companies seeking to overcome the federal roadblocks.

The Lambert Center is one of several American institutions that have partnered with BOL, collaborating on at least one of the more than 50 clinical trials the Israeli company will begin once its new facility is fully operational in late September. Of the 15 international companies that have already signed up to conduct their R&D at BOL’s facility, at least six are American, and Gedo is in talks with more.

BOL isn’t the only Israeli cannabis company benefitting from international interest. A growing number of American investors are getting on the Israeli cannabis wagon, which they see as the best vehicle for transforming the medical cannabis field, still in its infancy, into a pharmaceutical-level industry.

According to Saul Kaye, the founder of iCAN, an Israeli cannabis R&D firm, 2016 saw the investment of more than $250 million in Israeli cannabis companies and startups – half of that investment came from North America. Kaye predicts that investment will grow ten-fold over the next two years, reaching $1 billion. At least 50 American cannabis companies – and counting – have established R&D operations in Israel.

Israel’s journey to the forefront of the medical cannabis field began with 86-year-old Israeli chemist Raphael Mechoulam, known in the field as the Grandfather of Medical Marijuana. In 1963, as a young researcher, Mechoulam secured 11 pounds of Lebanese hashish, which had been confiscated by his friend at a police station in Tel Aviv. He used that hash to identify, isolate and synthesize THC, the psychoactive compound in cannabis, for the first time in history, and study its medical uses. He was also the first to decode the structure of CBD, the plant’s primary non-psychoactive ingredient. But Mechoulam’s most groundbreaking discovery came in 1992, when he and his team at Hebrew University in Jerusalem discovered the physical reason humans can get high.

Raphael Mechoulam discovered THC and the endocannabinoid system, opening up the field of medical marijuana. Hebrew University/Raphael Mechoulam

“It turned out that the cannabinoids in the plant actually mimic the compounds that we form in our brain,” says Mechoulam, a professor and researcher at Hebrew University who works with several American cannabis companies. He and his team discovered that THC triggers the human body’s largest receptor system, now known as the endocannabinoid system, and that the human brain produces its own cannabinoids – compounds that stimulate the body almost exactly the way THC does.

While Mechoulam’s research is what first placed Israel on the medical marijuana map, the country’s progressive attitudes toward cannabis, coupled with the Israeli government’s liberal regulatory policies and the nation’s technological leadership, are what have maintained Israel’s status as the capital of medical marijuana research and development. It might also help that Israel has the world’s highest ratio of marijuana users, according to Israel’s Anti-Drug Authority, with 27 percent of the population aged 18-65 having used marijuana in the last year. That rate is followed by Iceland and the U.S., at 18 and 16 percent respectively.

While the Israeli government invests millions of dollars in medical cannabis research, the U.S. government makes the same research nearly impossible.

“There are onerous restrictions on conducting this research in the U.S. that don’t exist in Israel,” says one expert.

Despite the fact that 95 percent of the U.S. population lives in states where cannabis is legal in some form, marijuana remains federally illegal. This policy makes conducting research into the medical benefits of marijuana notoriously difficult on U.S. soil. Researchers who wish to do so must go through the DEA, the FDA and the National Institute on Drug Abuse (NIDA). Even when American researchers are given approval, they have only one source for their material: a cannabis farm at the University of Mississippi, operated by NIDA. The process, if successful, can take years.

“There’s a lengthy and arduous regulatory process for getting approval for doing studies, and limited resources at these agencies for processing those requests,” says Pollack, of Thomas Jefferson University. “It’s deliberately made very difficult for us.” In Israel, on the other hand, a cannabis clinical trial can get off the ground in a matter of months.

“I think they have approached the issue in a more even-handed and genuine way than the U.S. government has,” says Armentano of NORML. “There are onerous restrictions on conducting this research in the U.S. that don’t exist in Israel.”

This is precisely why many American researchers from universities and private companies are using Israel as an offshore research hub. For example, Pollack, from Thomas Jefferson University, will be conducting clinical trials at BOL’s new facility. Since the trials haven’t begun, he won’t divulge details, but says they will focus on orphan drug indications, meaning they will be testing the benefits of cannabinoids on people with diseases that don’t afflict many people in the U.S. (It also means that the clinical studies are smaller – and go faster – given that fewer patients are needed for these trials.) For that reason, he said, “Big pharma companies tend not to pursue them because there’s not a big enough market for these drugs.”

The treatments coming out of BOL will be derived from marijuana plants – but they won’t be the plants themselves. Jack Guez/AFP/Getty

Kalytera – a California-based company with a lab in northern Israel and Mechoulam on its scientific advisory board – is also focusing on orphan drug indications, conducting clinical trials at Israeli clinics and hospitals in order to bring to market a cannabinoid drug for the treatment of graft-versus-host-disease, which can happen after certain kinds of transplants.

What institutions like Kalytera and Thomas Jefferson University do is they conduct the initial phases of their clinical trials in Israel, since it’s much easier to get the process started here, and then they do the final stages in the U.S., since FDA approval requires that part of the study be done there. Once they reach the final stage (phase 3) it’s much easier to conduct the rest of their study in the U.S., because they’ve already amassed enough data to show that it’s safe. This is the ultimate goal for Kalytera, Pollack and other researchers in Israel: to speed track the process of conducting a clinical trial that meets FDA standards, thus shortening the journey toward FDA approval of their drugs.

In addition to Kalytera, Mechoulam works with ​two other American​ companies, helping them develop new cannabinoid drugs and delivery methods out of his lab in Jerusalem, where he tests the specific properties, compositions and combinations of the cannabis compounds that are best suited to alleviate a specific ailment. American companies then use that research and data to manufacture cannabinoid drugs in the U.S.

According to Saul Kaye of iCan, about 50 U.S. cannabis companies are conducting research in Israel through partnerships, joint ventures or by employing Israel-based researchers like Mechoulam. At least 15 American cannabis companies have set up their entire R&D operations on Israeli soil, conducting clinical trials, and developing the appropriate dosing forms and delivery systems for pharmaceutical-grade cannabis-based drugs. According to Michael Dor, senior medical advisor at the Health Ministry’s cannabis unit, at least 120 clinical trials are currently under way in Israel to test the medicinal benefits of cannabis — more than any other country.

At least 15 American cannabis companies have set up their entire R&D operations on Israeli soil.

Cannabics, a Maryland-based, publicly-traded company, is conducting a clinical trial at an Israeli hospital in order to develop a capsule for cancer treatment. In 2015, One World Cannabis Pharmaceuticals, a public company based in Delaware, established an Israeli subsidiary overseen by Yehuda Baruch, the first head of the Israeli government’s medical cannabis program, established in 2007. They are now beginning phase 1 of a clinical trial to test the benefits of a topical cannabis cream to treat psoriasis. Their next trial will study the efficacy of a soluble pill for the treatment of chronic pain. They eventually plan to conduct clinical trials on patients with multiple myeloma.

Some Israeli companies have partnered with American companies to establish a presence in the U.S., where they sell products that were developed in Israel. For example, Tikun Olam, Israel’s first medical cannabis distributor, opened an American subsidiary in 2016. It now sells its proprietary medical-grade plant strains at 10 dispensaries in Delaware and Nevada and will soon be available at dispensaries in Oregon and California. Their most popular strain is Avidekel, a non-psychoactive CBD blend used to help children with seizures.

Some American researchers have even moved to Israel all together. Alan Shackelford, a Harvard-trained physician, was among the first American doctors to prescribe cannabis to a child. His eight-year-old epileptic patient Charlotte Figi sparked national interest in CBD after her miraculous story aired on CNN’s Weed documentary in 2013.

Yet after years of failed attempts to conduct clinical trials in the U.S., Shackelford recently established his own research entity in Israel because of his frustration with the American government’s stonewalling.

“The U.S. government has funded $1.4 billion in marijuana research since 2008,” says Schackelford. “Yet $1.1 billion of that went to studying addiction, withdrawal and drug abuse,” problems that barely exist with cannabis when compared to the effects of other legal medications, like prescription painkillers, which killed more than 17,000 Americans in 2016.

His research subjects in Israel will include the development of new delivery methods, he says, “because to date, most medical cannabis products no matter where you look in the world, are pot-culture derived. They’re things like brownies, cookies, candy and smoking. Even with advances to these things being much more consistent, they’re still not medically appropriate.”

While the U.S. government restricts American cannabis companies on U.S. soil, it does not prevent them from or penalize them for conducting their work in Israel. According to Robert Farrell, president of Kalytera, “The FDA has no problem with this work being done in Israel. When you file with the FDA, in the application you say, ‘Look we’ve done the previous studies in Israel, gave the drug to this many patients, the drug is safe, it works, now we want to conduct a larger study with patients in the U.S.’ If the FDA is satisfied with the data, they’ll say, ‘Go ahead, try it in the U.S.'”

The FDA will never get behind cannabis the plant as medicine, since it can’t be controlled as a consistent drug.

Even the National Institutes of Health (NIH) has funded cannabis research in Israel. Indeed, much of Professor Mechoulam’s groundbreaking research was funded by the American government. The NIH provided him with grants to the tune of $100,000 a year for over four decades, says Mechoulam.

There is also nothing preventing Israeli companies from receiving FDA approval for their cannabis-based drugs, as long as they meet FDA requirements. In order to do so, they will need to develop the kind of products that are more in line with pharmaceutical standards, such as the kinds of capsules and inhalers BOL is developing.

While that goal is feasible, Gedo and others admit that it will take time, perhaps several years, to achieve. The process of getting FDA approval is an arduous one, especially for a drug that has long been viewed with skepticism by the medical establishment. Yet it is these clinical trials that are taking place at a record pace in Israel, along with the advancement of pharmaceutical grade cannabinoid drugs, that will enable Israeli companies to eventually receive FDA approval for their drugs, or for the drugs that they are helping American companies to develop.

As Gedo notes, the FDA will never get behind cannabis the plant as medicine, since it can’t be controlled as a consistent drug that has the same effect day in and day out. After all, there are 140 active compounds in cannabis, and the composition of the flowers plucked from one branch can fluctuate wildly, by up to 300 percent. “The experience of a user will vary a lot with the same strain,” says Gedo. “So even if you have the best-grown product, it will never become a scientific pharmaceutical product.”

This is precisely why the FDA has never approved a botanical marijuana drug, a larger problem than scheduling when it comes to drug approval. According to Senate testimony by the FDA’s Douglas Throckmorton in 2016, in order to obtain FDA approval, drug manufacturers “must demonstrate that they are able to consistently manufacture a high-quality drug product. This is an essential part of drug development and presents special challenges when the drug is derived from a botanical source, such as marijuana…. If there is any future for marijuana as a medicine, it lies in its isolated components, the cannabinoids and their synthetic derivatives.”

BOL and other Israeli companies are working to meet that challenge by developing cannabis-based drugs – the capsules, inhalers, creams and oils composed of isolated, controlled and consistent cannabinoids. Going this route, they could eventually receive FDA approval.

While Gedo is optimistic, he’s also realistic, knowing the complexity of the FDA’s drug approval process, and the skepticism that remains among many in the medical establishment.

Still, asked when Israeli companies might be exporting their cannabis medicine to the U.S., Michael Dor, of the Israeli Health Ministry says, “I believe it’s not far.” 

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