A leading European financial institution has called for increased efforts to tackle environmental pollution by the Indian pharma industry. The city's pharma industry in the past has maintained that there was no clear evidence to link growing antimicrobial resistance to its effluents. The Changing Markets ...
Read more: Indian pharma industry asked to sit up and take notice
Wednesday, January 31, 2018
US FDA News: AirLife Humidification Chamber, Heated Breathing Circuit Kits by Vyaire Medical: Class I Recall - Manufacturing Error
Parts of the chamber may split apart into layers, allowing water to overflow the chamber and back up into the patient breathing circuit, which could lead to serious adverse health consequences, including injury or death.
Read more: AirLife Humidification Chamber, Heated Breathing Circuit Kits by Vyaire Medical: Class I Recall - Manufacturing Error
Read more: AirLife Humidification Chamber, Heated Breathing Circuit Kits by Vyaire Medical: Class I Recall - Manufacturing Error
Pharma Reviews: Despite global momentum to address antimicrobial resistance in environment, critical gaps remain
Independent assessment of six Indian manufacturers among many others reflects that none publicly publish antibiotic discharge levels, audit results, identity of third-party suppliers of active pharmaceutical ingredients or of external waste treatment plants. Few but large Indian industry players such as ...
Read more: Despite global momentum to address antimicrobial resistance in environment, critical gaps remain
Read more: Despite global momentum to address antimicrobial resistance in environment, critical gaps remain
Tuesday, January 30, 2018
Pharma Reviews: Hyderabad: Pharma firms flout norms
The report stated that recent developments indicated that the regulation targeting the pharmaceutical industry was actually becoming lax as the government lifted restrictions on plant expansions. The report warned that by failing to crack down on manufacturing emissions, Indian pharma manufacturers ...
Read more: Hyderabad: Pharma firms flout norms
Read more: Hyderabad: Pharma firms flout norms
Pharma Reviews: Indian pharma industry asked to sit up and take notice
A leading European financial institution has called for increased efforts to tackle environmental pollution by the Indian pharma industry. The call was made in response to a report that alleged uncontrolled pollution from the city's drug producing units. A study conducted by the European non-profit agency, ...
Read more: Indian pharma industry asked to sit up and take notice
Read more: Indian pharma industry asked to sit up and take notice
US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to help prevent new addiction, curb abuse and overdose related to opioid products
Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to help prevent new addiction, curb abuse and overdose related to opioid products
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to help prevent new addiction, curb abuse and overdose related to opioid products
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to help prevent new addiction, curb abuse and overdose related to opioid products
US FDA News: Imodium (loperamide) for Over-the-Counter Use: Drug Safety Communication - FDA Limits Packaging To Encourage Safe Use
Reports of serious heart problems and deaths with much higher than recommended doses of loperamide. FDA working with manufacturers to use blister packs or other single dose packaging and to limit number of doses in a package.
Read more: Imodium (loperamide) for Over-the-Counter Use: Drug Safety Communication - FDA Limits Packaging To Encourage Safe Use
Read more: Imodium (loperamide) for Over-the-Counter Use: Drug Safety Communication - FDA Limits Packaging To Encourage Safe Use
US FDA News: FDA, USDA partner to improve coordination, bolster collaboration
FDA Commissioner Dr. Scott Gottlieb and USDA Secretary Perdue launched an effort today to increase collaboration, efficiency and effectiveness, and provide clarity to food producers.
Read more: FDA, USDA partner to improve coordination, bolster collaboration
Read more: FDA, USDA partner to improve coordination, bolster collaboration
Pharma Reviews: India: Essential Commodities (Control Of Unethical Practices In Marketing Of Drugs) Order, 2017 ...
The need for governing the relationship between pharmaceutical companies and medical practitioners has been felt ever since the exponential growth of the pharmaceutical industry. With this in view, the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, ...
Read more: India: Essential Commodities (Control Of Unethical Practices In Marketing Of Drugs) Order, 2017 ...
Read more: India: Essential Commodities (Control Of Unethical Practices In Marketing Of Drugs) Order, 2017 ...
Pharma Reviews: Pharma company's fish for capital linked subsidy scheme in Union Budget to protect MSMEs
New Delhi, Jan 30 (KNN) Gujarat State Board of Indian Drug Manufacturers' Association (IDMA) has requested the Union Government to grant a special capital linked subsidy scheme in the upcoming Union Budget 2018-19 to support small and medium enterprises (MSMEs) as pharmaceutical industry ...
Read more: Pharma company's fish for capital linked subsidy scheme in Union Budget to protect MSMEs
Read more: Pharma company's fish for capital linked subsidy scheme in Union Budget to protect MSMEs
Monday, January 29, 2018
Pharma Reviews: Pharmaceutical industry seeks subsidy dose in Union budget
AHMEDABAD: As the pharmaceutical industry has to continuously upgrade to comply with changing international standards, Gujarat State Board of Indian Drug Manufacturers' Association (IDMA) has urged the Union government to consider a special capital-linked subsidy scheme in the Union budget ...
Read more: Pharmaceutical industry seeks subsidy dose in Union budget
Read more: Pharmaceutical industry seeks subsidy dose in Union budget
Pharma Reviews: Budget 2018 should be 'healthy' one for all Indians: Industry Leaders
“With the vision of making India as one of the top 3 countries in the pharma industry globally, the Government should allocate more funds for R&D and innovation and should increase it to 2%-3% of GDP from 0.69% GDP at present in their next budget announcement for the pharma industry.” Mudras said ...
Read more: Budget 2018 should be 'healthy' one for all Indians: Industry Leaders
Read more: Budget 2018 should be 'healthy' one for all Indians: Industry Leaders
Sunday, January 28, 2018
Pharma Reviews: Curriculum for Pharm D redesigned
Dr. Suresh said that the Indian pharmaceutical industry has developed wide-ranging capabilities in the complex field of drug process development and production technology. Every year, drugs worth Rs. 1,50,000 crore are manufactured in India, and 50% of India's drugs is exported to the world, ...
Read more: Curriculum for Pharm D redesigned
Read more: Curriculum for Pharm D redesigned
Pharma Reviews: 'Trans-pacific pact could hurt India'
If India were to join the mega-regional Free Trade Agreement (FTA) called the Trans-Pacific Partnership (TPP) and adopt its norms, they would severely hurt the country's agriculture, manufacturing, services and the generic pharma industry, according to a new book. Titled “Trans-Pacific Partnership ...
Read more: 'Trans-pacific pact could hurt India'
Read more: 'Trans-pacific pact could hurt India'
Saturday, January 27, 2018
Pharma Reviews: Davos WEF 2018: Sun Pharma Chairman Says US FDA Scrutiny Will Lead To Better Products
The Indian pharmaceutical industry is upgrading its operations in response to tighter regulations and increased scrutiny from drug regulators. And that will lead to better, more competitive products, according to Sun Pharmaceutical Industries Ltd. Chairman Israel Makov. “Yes, it is a pressure, but it is a ...
Read more: Davos WEF 2018: Sun Pharma Chairman Says US FDA Scrutiny Will Lead To Better Products
Read more: Davos WEF 2018: Sun Pharma Chairman Says US FDA Scrutiny Will Lead To Better Products
Friday, January 26, 2018
US FDA News: FDA approves new treatment for certain digestive tract cancers
FDA approves first radioactive drug for a certain type of digestive tract cancer called GEP-NETs
Read more: FDA approves new treatment for certain digestive tract cancers
Read more: FDA approves new treatment for certain digestive tract cancers
US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA’s strengthened commitments to humane and judicious animal research and the termination of a nicotine study
FDA strengthens commitments to humane and judicious animal research and the termination of a nicotine study
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA’s strengthened commitments to humane and judicious animal research and the termination of a nicotine study
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA’s strengthened commitments to humane and judicious animal research and the termination of a nicotine study
Thursday, January 25, 2018
Pharma Reviews: Pharma firms to tap M&A opportunities to gain scale, tide over challenges
Mumbai: Leading Indian pharmaceutical companies, struggling to cope with a slowdown in growth and reduced profitability over the last couple of years, are expected to try and tap inorganic opportunities globally in order to increase scale of business and rise above challenges. The focus of large Indian ...
Read more: Pharma firms to tap M&A opportunities to gain scale, tide over challenges
Read more: Pharma firms to tap M&A opportunities to gain scale, tide over challenges
Pharma Reviews: Why healthcare should get national priority status
So, how can Budget 2018 nurture Indian healthcare? Two of India's most globally competitive industries hold important lessons for the healthcare sector. Policy changes in India's patent laws in the early 1970s lead to the country's pharmaceutical industry evolving from almost non-existent to accounting ...
Read more: Why healthcare should get national priority status
Read more: Why healthcare should get national priority status
Pharma Reviews: US generic business to become more challenging for Indian pharmas
Validating the risks for the Indian pharmaceutical companies, credit rating agency ICRA said that the US generic business is expected to remain challenging for the Indian companies in 2018. Adding that the Indian pharma companies are expected to record a pricing pressure of 10-12 per cent.
Read more: US generic business to become more challenging for Indian pharmas
Read more: US generic business to become more challenging for Indian pharmas
Pharma Reviews: Agency Ecology 'Breakdown'?
This was the same time when agencies decided to split the media and creative businesses - clients started paying media and creative agencies separately. ... India's Pharma industry met its darkest hour when the USFDA sounded an 'Import Alert' against a major Indian Pharma company in 2010-11 and ...
Read more: Agency Ecology 'Breakdown'?
Read more: Agency Ecology 'Breakdown'?
Wednesday, January 24, 2018
Pharma Reviews: Intensified competition to weigh on pharma companies' Q3 performance
Pharmaceutical companies are likely to report a moderate or near-flat revenue growth in the third quarter, while the profit for many of them may slip owing ... generic adoption reaching saturation levels and regulatory overhang along with base effect catching up, the Indian pharma sector is likely to curtail ...
Read more: Intensified competition to weigh on pharma companies' Q3 performance
Read more: Intensified competition to weigh on pharma companies' Q3 performance
Pharma Reviews: Indian pharma cos get record 300 USFDA generic drug nods in 2017
Mumbai: Domestic pharma companies received more than 300 approvals in 2017 to launch generic drugs in the US, which is an all-time high. The clearances came despite regulatory pressure from the US Food and Drug Administration (FDA), and unprecedented warning letters issued to the pharma ...
Read more: Indian pharma cos get record 300 USFDA generic drug nods in 2017
Read more: Indian pharma cos get record 300 USFDA generic drug nods in 2017
Pharma Jobs: For CSH and MONS
Company: MonsterIndia.com
Qualification: B.A
Experience: 0 to 4
location: Delhi
Ref: 21672905
Summary: For CSH and Mons
Read more: For CSH and MONS
Qualification: B.A
Experience: 0 to 4
location: Delhi
Ref: 21672905
Summary: For CSH and Mons
Read more: For CSH and MONS
Pharma Reviews: Anti-dumping duty likely on a chemical from China, Germany and Saudi Arabia
NEW DELHI: India may impose anti-dumping duty on a chemical used in pharma industry from China, Germany and Saudi Arabia as the commerce ministry has started a probe into an alleged dumping of the product following complaints by domestic players. Balaji Amines Ltd has filed an application ...
Read more: Anti-dumping duty likely on a chemical from China, Germany and Saudi Arabia
Read more: Anti-dumping duty likely on a chemical from China, Germany and Saudi Arabia
US FDA News: "Zero For Him" Dietary Supplement by Break Ventures/California Basics: Recall - Possible Salmonella Contamination
Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
Read more: "Zero For Him" Dietary Supplement by Break Ventures/California Basics: Recall - Possible Salmonella Contamination
Read more: "Zero For Him" Dietary Supplement by Break Ventures/California Basics: Recall - Possible Salmonella Contamination
US FDA News: Arthri-D 120ct Dietary Supplement by Arthri-D: Recall - Possible Salmonella Contamination
Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
Read more: Arthri-D 120ct Dietary Supplement by Arthri-D: Recall - Possible Salmonella Contamination
Read more: Arthri-D 120ct Dietary Supplement by Arthri-D: Recall - Possible Salmonella Contamination
US FDA News: FDA, FTC warn companies for selling illegal, unapproved opioid cessation products using deceptive claims
FDA and FTC issued joint warning letters to the marketers and distributors of 12 opioid cessation products, for illegally marketing unapproved products with claims about their ability to help in the treatment of opioid addiction and withdrawal
Read more: FDA, FTC warn companies for selling illegal, unapproved opioid cessation products using deceptive claims
Read more: FDA, FTC warn companies for selling illegal, unapproved opioid cessation products using deceptive claims
Pharma Reviews: Wincoat Colours and Coatings appoints Subodh Priolkar as CEO
Subodh was President of Indian Pharmaceutical Association for two consecutive terms from 2004 – 2008 and is still an active part of the senior IPA Leadership for strategic inputs. He has been recipient of IPA Fellowship, Eminent Pharmacist Award from IPA and the Prestigious Pan-Asian Ishidate Award ...
Read more: Wincoat Colours and Coatings appoints Subodh Priolkar as CEO
Read more: Wincoat Colours and Coatings appoints Subodh Priolkar as CEO
Pharma Reviews: Wipro buys Harte Hanks to power 'marketing-as-a-service' offering
The acquisition follows the familiar theme of large Indian services companies making strategic investments in, or tie-ups with niche digital services firms. Besides Wipro, Infosys has been especially keen on such deals. Wipro and Harte Hanks already work together. They jointly market Opera Solutions' ...
Read more: Wipro buys Harte Hanks to power 'marketing-as-a-service' offering
Read more: Wipro buys Harte Hanks to power 'marketing-as-a-service' offering
Pharma Reviews: Davos WEF 2018: Downturn In Generics Won't Last Long, Says Sun Pharma Chairman
Indian pharma companies, which are already playing a role in the consolidation process, will increase their share of the generics market not only in the U.S. but also in other markets, he added. A consolidation among pharmacies and intensifying competition have sent prices for generic drugs in the U.S., ...
Read more: Davos WEF 2018: Downturn In Generics Won't Last Long, Says Sun Pharma Chairman
Read more: Davos WEF 2018: Downturn In Generics Won't Last Long, Says Sun Pharma Chairman
Pharma Reviews: Davos Day 3: Pressure On Generics Industry Is Temporary, Says Sun Pharma Chairman Israel ...
Vedanta Ltd.'s bid for the bankrupt Electrosteels Steel Ltd. was an effort to utilise its own iron ore mine in Jharkhand, company chairman Anil Agarwal told BloombergQuint on the sidelines of the World Economic Forum in Davos. India is producing far less steel than the iron ore reserves it has, he said.
Read more: Davos Day 3: Pressure On Generics Industry Is Temporary, Says Sun Pharma Chairman Israel ...
Read more: Davos Day 3: Pressure On Generics Industry Is Temporary, Says Sun Pharma Chairman Israel ...
Pharma Reviews: Govt needs to widen weighted tax rate from 200 to 250% to drive innovation: Ajay Shah
India pharma has been witnessing a high traction. This is driven by increased focus on health-wellness, government- supported healthcare initiatives and the knowledgeable consumers. The robust sales and simpler forms of medications accessible at competitive prices, pharma companies have ...
Read more: Govt needs to widen weighted tax rate from 200 to 250% to drive innovation: Ajay Shah
Read more: Govt needs to widen weighted tax rate from 200 to 250% to drive innovation: Ajay Shah
Tuesday, January 23, 2018
Pharma Reviews: 'Pharmacy of the world' is in peril
Over the years, India has earned the sobriquet of the 'pharmacy of the world' for being a leading supplier of affordable drugs to many countries. But we could soon lose this tag as the Indian drug industry is increasingly becoming dependent on China for the supply of bulk drugs and intermediaries, a new ...
Read more: 'Pharmacy of the world' is in peril
Read more: 'Pharmacy of the world' is in peril
Monday, January 22, 2018
US FDA News: Basic Drugs Brand of Senna Laxative by Magno-Humphries Laboratories: Recall - Mislabeling
Unintentional consumption of naproxen sodium potentially could result in fatal adverse events in patients with underlying illnesses. Posted 01/22/2018
Read more: Basic Drugs Brand of Senna Laxative by Magno-Humphries Laboratories: Recall - Mislabeling
Read more: Basic Drugs Brand of Senna Laxative by Magno-Humphries Laboratories: Recall - Mislabeling
US FDA News: Multiple Drug Products by Flawless Beauty: Recall - Misbranded or Unapproved
Misbranded or unapproved new drugs present serious public health risks. Posted 01/22/2018
Read more: Multiple Drug Products by Flawless Beauty: Recall - Misbranded or Unapproved
Read more: Multiple Drug Products by Flawless Beauty: Recall - Misbranded or Unapproved
Pharma Reviews: Govt's facilitation a vital cog in pharma industry growth
'Pharma Vision 2020', which aims to make India a major hub for end-to- end drug discovery, is a great initiative by the Government of India. Under this initiative, there are plans to set up a $640-million venture capital fund to enhance drug discovery and support pharmaceutical infrastructure. We look ...
Read more: Govt's facilitation a vital cog in pharma industry growth
Read more: Govt's facilitation a vital cog in pharma industry growth
Pharma Reviews: Tax Sops, Farm and Employment Policies, Ease in GST: Here's Why This Union Budget Needs ...
A report prepared by Deloitte, a consultancy, edited by Forbes India, says: “From banking to aerospace, every sector is bound to have a grouse of its own .... The government's proactive policies have helped domestic private pharma companies build scale, with Indian generic firms recognised the world ...
Read more: Tax Sops, Farm and Employment Policies, Ease in GST: Here's Why This Union Budget Needs ...
Read more: Tax Sops, Farm and Employment Policies, Ease in GST: Here's Why This Union Budget Needs ...
Pharma Reviews: What ails India's pharma sector? Brand launches last year lowest since 2013
The number of brand launches in the domestic pharmaceutical industry during all of 2017 was the lowest since 2013. Of the 3,932 pharma brands launched in the Indian pharmaceutical market (IPM), 386 were in the dermatology segment alone. According to data from market research firm AIOCD ...
Read more: What ails India's pharma sector? Brand launches last year lowest since 2013
Read more: What ails India's pharma sector? Brand launches last year lowest since 2013
Saturday, January 20, 2018
Pharma Reviews: How Wockhardt Chairman Habil Khorakiwala plans to pull the company out of trouble
Also, group company Wockhardt Hospitals sold part of its hospital chain to Fortis for Rs 909 crore to repay loans. Relief was short-lived, though. From 2013, regulatory action by the American Food and Drug Administration (FDA) rocked the Indian pharmaceutical industry that was selling generic drugs in ...
Read more: How Wockhardt Chairman Habil Khorakiwala plans to pull the company out of trouble
Read more: How Wockhardt Chairman Habil Khorakiwala plans to pull the company out of trouble
Friday, January 19, 2018
Pharma Reviews: Digital technologies to transform drug clinical trials : expert
Emerging digital technologies and innovations in artificial intelligence and Internet of Things (IOT) are going to transform the drug clinical trial industry globally and also in India, said James Streeter, Senior Director of Life Sciences Product Strategy, Oracle Health Science. Currently, use of EMR or ...
Read more: Digital technologies to transform drug clinical trials : expert
Read more: Digital technologies to transform drug clinical trials : expert
Pharma Reviews: Pharma logistics forum focuses on innovative strategies, challenges
The role of logistics service providers in the growth of Indian pharmaceutical industry and innovative strategies to overcome the challenges faced by the supply ... Pharmaconnect, a logistics conclave dedicated to the pharmaceutical segment of the industry, was organised by the team that publishes the ...
Read more: Pharma logistics forum focuses on innovative strategies, challenges
Read more: Pharma logistics forum focuses on innovative strategies, challenges
Thursday, January 18, 2018
US FDA News: Levofloxacin in 5 Percent Dextrose 250mg/50mL by AuroMedics: Recall - Presence of Visible Particulate Matter
Use of a non-sterile injectable product could result in fatal infections.
Read more: Levofloxacin in 5 Percent Dextrose 250mg/50mL by AuroMedics: Recall - Presence of Visible Particulate Matter
Read more: Levofloxacin in 5 Percent Dextrose 250mg/50mL by AuroMedics: Recall - Presence of Visible Particulate Matter
US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., on new policy steps for strengthening public warning and notification of recalls
FDA discusses new policy steps for strengthening public warning and notification of recalls
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., on new policy steps for strengthening public warning and notification of recalls
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., on new policy steps for strengthening public warning and notification of recalls
Pharma Reviews: Indian pharma majors rush to 'Make in America'
US President Donald Trump's 'Make in America' pledge may have spooked many, but Indian pharmaceutical companies are optimistic. Several Indian drugmakers that have large operations in the US are now pushing to acquire assets there by either investing in greenfield manufacturing facilities or ...
Read more: Indian pharma majors rush to 'Make in America'
Read more: Indian pharma majors rush to 'Make in America'
Pharma Reviews: Indian pharma firms taking over Pakistan's share
Singapore - Pakistan's pharmaceutical manufacturers are losing their export markets to the Indian industry and this lack of competitive advantage is blamed on the government's indifference to the toll manufacturing arrangement. The domestic industry has urged authorities to allow pharma companies to ...
Read more: Indian pharma firms taking over Pakistan's share
Read more: Indian pharma firms taking over Pakistan's share
Wednesday, January 17, 2018
US FDA News: Zoll LifeVest 4000 Wearable Cardioverter Defibrillator: FDA Safety Communication - Potential Lack of Treatment (Shock) Delivery Due to Device Failure
Failure to immediately replace the device after Message Code 102 appears may result in serious patient harm or death of the patient because the device may fail to deliver therapy when needed.
Read more: Zoll LifeVest 4000 Wearable Cardioverter Defibrillator: FDA Safety Communication - Potential Lack of Treatment (Shock) Delivery Due to Device Failure
Read more: Zoll LifeVest 4000 Wearable Cardioverter Defibrillator: FDA Safety Communication - Potential Lack of Treatment (Shock) Delivery Due to Device Failure
Tuesday, January 16, 2018
Pharma Reviews: NDA, Trilegal, AZB, Khaitan, Samisti on Goldman Sachs $115m MedPlus debt raise to buyout from ...
MedPlus was founded by Madhukar Gangadi in 2006 when he reportedly realised the existing gaps in the Indian pharma industry and decided to launch MedPlus in order to provide a reliable source of medicines to the Indian consumers. The pharmacy retail chain now has over 1,400 stores spread ...
Read more: NDA, Trilegal, AZB, Khaitan, Samisti on Goldman Sachs $115m MedPlus debt raise to buyout from ...
Read more: NDA, Trilegal, AZB, Khaitan, Samisti on Goldman Sachs $115m MedPlus debt raise to buyout from ...
US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., in response to GAO report regarding FDA’s ongoing commitment to employing a least burdensome approach to device review
Statement from FDA Commissioner Scott Gottlieb, M.D., in response to GAO report regarding FDA’s ongoing commitment to employing a least burdensome approach to device review
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., in response to GAO report regarding FDA’s ongoing commitment to employing a least burdensome approach to device review
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., in response to GAO report regarding FDA’s ongoing commitment to employing a least burdensome approach to device review
US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D. responding to report from GAO and updating on FDA’s ongoing efforts to increase access to complex generic drugs
GAO issued the report “Generic Drugs: FDA Should Make Public Its Plans to Issue and Revise Guidance on Nonbiological Complex Drugs,” which contains a single recommendation for the FDA -- that the agency publicly announce its plans to issue or revise guidance for these drug products. The FDA agrees and is actively working to accomplish this goal.
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D. responding to report from GAO and updating on FDA’s ongoing efforts to increase access to complex generic drugs
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D. responding to report from GAO and updating on FDA’s ongoing efforts to increase access to complex generic drugs
US FDA News: FDA Commissioner Scott Gottlieb, M.D., updates on some ongoing shortages related to IV fluids
FDA updates on some ongoing shortages related to IV fluids
Read more: FDA Commissioner Scott Gottlieb, M.D., updates on some ongoing shortages related to IV fluids
Read more: FDA Commissioner Scott Gottlieb, M.D., updates on some ongoing shortages related to IV fluids
US FDA News: Varubi (rolapitant) Injectable Emulsion: Health Care Provider Letter - Anaphylaxis and Other Serious Hypersensitivity Reactions
Symptoms of anaphylaxis can include wheezing or difficulty breathing; swelling of the face or throat; hives or flushing; itching; abdominal cramping, abdominal pain or vomiting; back pain or chest pain; hypotension or shock.
Read more: Varubi (rolapitant) Injectable Emulsion: Health Care Provider Letter - Anaphylaxis and Other Serious Hypersensitivity Reactions
Read more: Varubi (rolapitant) Injectable Emulsion: Health Care Provider Letter - Anaphylaxis and Other Serious Hypersensitivity Reactions
US FDA News: FDA and DoD launch program to expedite availability of medical products for the emergency care of American military personnel
The U.S. Food and Drug Administration and the Department of Defense launch of a joint program to prioritize the efficient development of safe and effective medical products intended to save the lives of American military personnel.
Read more: FDA and DoD launch program to expedite availability of medical products for the emergency care of American military personnel
Read more: FDA and DoD launch program to expedite availability of medical products for the emergency care of American military personnel
US FDA News: FDA Commissioner Scott Gottlieb, M.D., on new steps FDA is taking to enhance transparency of clinical trial information to support innovation and scientific inquiry related to new drugs
FDA takes steps to enhance transparency of clinical trial data used in support of new drug approvals
Read more: FDA Commissioner Scott Gottlieb, M.D., on new steps FDA is taking to enhance transparency of clinical trial information to support innovation and scientific inquiry related to new drugs
Read more: FDA Commissioner Scott Gottlieb, M.D., on new steps FDA is taking to enhance transparency of clinical trial information to support innovation and scientific inquiry related to new drugs
Pharma Reviews: Regulator weighs inspection of drug-making facilities in US
India imports medicines like biologics, cancer medicines, drug intermediates for APIs and patented medicines from places including the US, European Union (EU) and China, said PV Appaji, former director general at Pharmaceutical Export Promotion Council of India (PEPCI). At the same time, there is ...
Read more: Regulator weighs inspection of drug-making facilities in US
Read more: Regulator weighs inspection of drug-making facilities in US
Pharma Reviews: A $300-billion reason India's drug price cap will stay
Even Sun Pharmaceutical Industries Ltd., India's biggest drugmaker, is betting on increased use of branded generics in emerging markets. By 2021, it estimates such products will account for one-fifth of the $1.5 trillion a year spent on medicines worldwide. That's $300 billion -- or almost $100 billion ...
Read more: A $300-billion reason India's drug price cap will stay
Read more: A $300-billion reason India's drug price cap will stay
Monday, January 15, 2018
Pharma Reviews: Over-the-counter route to accelerate sales growth for domestic pharma firms
Domestic pharmaceutical companies are now focusing on the over-the-counter (OTC) segment to accelerate sales growth Piramal Enterprises has been growing its business through acquisitions, while Sanofi has brought its American OTC topical analgesic brand Combiflam Icyhot to India. “Research ...
Read more: Over-the-counter route to accelerate sales growth for domestic pharma firms
Read more: Over-the-counter route to accelerate sales growth for domestic pharma firms
Pharma Reviews: Lupin forays into the OTC segment with Softovac
Nilesh Gupta, Managing Director, Lupin said, ''The OTC segment is one of the fastest growing segments in the Indian pharmaceutical market. This, combined with our capabilities and expertise in this space, makes it a lucrative business opportunity for Lupin. Our long term strategy is to have a portfolio of ...
Read more: Lupin forays into the OTC segment with Softovac
Read more: Lupin forays into the OTC segment with Softovac
Pharma Reviews: Lupin forays into OTC segment with Softovac
Speaking on the development, Nilesh Gupta, managing director of Lupin, said, "The OTC segment is one of the fastest growing segments in the Indian pharmaceutical market. This, combined with our capabilities and expertise in this space, makes it a lucrative business opportunity for Lupin.
Read more: Lupin forays into OTC segment with Softovac
Read more: Lupin forays into OTC segment with Softovac
Pharma Reviews: Lupin forays into OTC segment;eyes Rs 300 crore turnover in 5 years
Lupin, one of the top five pharma companies in the country, plans to launch a variety of products across various categories like vitamins/minerals and ... According to industry sources, the Indian consumer healthcare business is pegged at around USD 2.7 billion (over Rs 18,800 crore) and is expected to ...
Read more: Lupin forays into OTC segment;eyes Rs 300 crore turnover in 5 years
Read more: Lupin forays into OTC segment;eyes Rs 300 crore turnover in 5 years
Pharma Reviews: A $300 billion reason India's drug price cap will stay
Global pharmaceutical companies have bemoaned for years India's capricious policies on prices and patents. Now the government needs billions of dollars for its “Make in India” program, why can't the industry get a fairer deal? When it comes to intellectual property, it's now understood—and grudgingly ...
Read more: A $300 billion reason India's drug price cap will stay
Read more: A $300 billion reason India's drug price cap will stay
Pharma Reviews: 'India - China trade improving in favour of India'
India is one of the biggest manufacturers of generic pharma products. However, we are unable to export to China because of China's stringent protectionist policies. While Indian pharma companies are able to export their generic drugs to USA and EU, it is quite surprising that exports of generic pharma ...
Read more: 'India - China trade improving in favour of India'
Read more: 'India - China trade improving in favour of India'
Sunday, January 14, 2018
Pharma Reviews: These 9 stocks could give huge returns now despite market zooming
Though the growth rate of most Indian pharma companies have fallen due to US FDA-related issues, Granules India has continued with its high growth. Its earnings CAGR for the past six years stands at 39%. This is because active pharmaceutical ingredients (API) and pharmaceutical formulation ...
Read more: These 9 stocks could give huge returns now despite market zooming
Read more: These 9 stocks could give huge returns now despite market zooming
Saturday, January 13, 2018
Pharma Reviews: India-China trade improving in favour of India: study
India is one of the biggest manufacturers of generic pharma products. However, we are unable to export to China because of China's stringent protectionist policies, said Mr Khaitan. While Indian pharma companies are able to export their generic drugs to USA and EU, it is quite surprising that exports of ...
Read more: India-China trade improving in favour of India: study
Read more: India-China trade improving in favour of India: study
Pharma Reviews: Niche Play
Consider this: in the past three years, Sun Pharma, the biggest Indian pharma company, has seen its share price tumble from `827.2 to `578.8, taking its market cap down from `171,316.3 crore to `138,860 crore. Lupin's story is similar - its share price fell from `1,429.7 to `899.2 and market cap slipped ...
Read more: Niche Play
Read more: Niche Play
Pharma Reviews: Domestic pharmaceutical sales growth at eight year low, slips to 5.5%
The industry-wide sales declined 2.4 per cent on a year-on-year (YoY) basis in July. Recovery was slow and in August and September sales growth was under 3 per cent. But drug makers feel recovery is round the corner. “In 2018 we are optimistic that the Indian pharma industry will pick up pace and ...
Read more: Domestic pharmaceutical sales growth at eight year low, slips to 5.5%
Read more: Domestic pharmaceutical sales growth at eight year low, slips to 5.5%
Friday, January 12, 2018
Pharma Reviews: GST, demonetisation disrupt domestic retail pharma market, growth may drop to single-digit in ...
When contacted, Amit Mookim general manager (South Asia), IQVIA, said, "Indian pharmaceutical market has been clocking double-digit growth figures for the past three MAT periods. However, the market has been impacted by multiple developments in 2017 giving it a subdued annual growth.
Read more: GST, demonetisation disrupt domestic retail pharma market, growth may drop to single-digit in ...
Read more: GST, demonetisation disrupt domestic retail pharma market, growth may drop to single-digit in ...
US FDA News: Becton-Dickinson (BD) Syringes Used to Store Compounded or Repackaged Drugs: FDA Alert - Problematic Rubber Stoppers Replaced
eneral use BD syringes are cleared for immediate use in fluid aspiration and injection, but not for use as a closed container storage system for drug products.
Read more: Becton-Dickinson (BD) Syringes Used to Store Compounded or Repackaged Drugs: FDA Alert - Problematic Rubber Stoppers Replaced
Read more: Becton-Dickinson (BD) Syringes Used to Store Compounded or Repackaged Drugs: FDA Alert - Problematic Rubber Stoppers Replaced
Pharma Reviews: Budget 2018: Healthcare needs more specialists, boost to device-makers
Each year during pre-Budget time, the Indian healthcare industry points to the one statistic that refuses to change: government spending on healthcare stays put at around one per cent of the ... First, a point that was raised by the pharma industry too, is on spending on medical research and innovation.
Read more: Budget 2018: Healthcare needs more specialists, boost to device-makers
Read more: Budget 2018: Healthcare needs more specialists, boost to device-makers
Pharma Reviews: Govt stalls plan to cut drug prices after pushback from pharma companies
India's proposal to curb drug prices by stripping generic medicines of their brand names has stalled after the plan faced pushback from the country's pharmaceutical companies, according to people with knowledge of the discussions. The Draft Pharmaceutical Policy circulated last summer by the ...
Read more: Govt stalls plan to cut drug prices after pushback from pharma companies
Read more: Govt stalls plan to cut drug prices after pushback from pharma companies
Pharma Reviews: Budget push may see infra leading capex growth in pvt sector: Chetan Parikh
That is one but one of the issues with the Indian pharma space has been the regulatory issues and somehow these may start getting cleared. In some of the companies, prices have been moving in anticipation of that but the more endurable bet would be companies which are doing hard to manufacture ...
Read more: Budget push may see infra leading capex growth in pvt sector: Chetan Parikh
Read more: Budget push may see infra leading capex growth in pvt sector: Chetan Parikh
US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA decision to seek additional time to reassess rule that would have changed longstanding practices for how the agency determined the ‛intended use’ of medical products
: FDA decision to seek additional time to reassess rule that would have changed longstanding practices for how the agency determined the ‛intended use’ of medical products
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA decision to seek additional time to reassess rule that would have changed longstanding practices for how the agency determined the ‛intended use’ of medical products
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA decision to seek additional time to reassess rule that would have changed longstanding practices for how the agency determined the ‛intended use’ of medical products
US FDA News: FDA approves first treatment for breast cancer with a certain inherited genetic mutation
FDA approves first treatment for breast cancer with a certain inherited genetic mutation
Read more: FDA approves first treatment for breast cancer with a certain inherited genetic mutation
Read more: FDA approves first treatment for breast cancer with a certain inherited genetic mutation
Pharma Reviews: Budget 2018: Pharma companies want government to invest in research, innovation
The government needs to seriously re-think on the ways to promote research and innovation in the country, especially within the Indian pharmaceutical industry. This seems to be coming across as a clear message from the various stakeholders in the Indian pharmaceutical industry. Perhaps, some of it ...
Read more: Budget 2018: Pharma companies want government to invest in research, innovation
Read more: Budget 2018: Pharma companies want government to invest in research, innovation
Pharma Reviews: India's plan to reduce medicine prices faces industry pushback
The government's draft policy also called for sweeping changes to improve India's manufacturing standards and enforcement, increased oversight of the drug price regulator and new rules covering how drugs are marketed. The Indian Pharmaceutical Alliance and other industry bodies argued these ...
Read more: India's plan to reduce medicine prices faces industry pushback
Read more: India's plan to reduce medicine prices faces industry pushback
Pharma Reviews: Govt is said to stall plan to cut drug prices as industry balks
Mumbai/New Delhi: India's proposal to curb drug prices by stripping generic medicines of their brand names has stalled after the plan faced pushback from the country's pharmaceutical companies, according to people with knowledge of the discussions. The Draft Pharmaceutical Policy circulated last ...
Read more: Govt is said to stall plan to cut drug prices as industry balks
Read more: Govt is said to stall plan to cut drug prices as industry balks
Thursday, January 11, 2018
Pharma Reviews: Budget 2018-19: Infra spending to benefit the Logistics sector eventually
While the logistics industry would not get many direct benefits from the Union Budget 2018-19, the sector is likely to benefit from upcoming major transportation projects. The transportation projects would aid transportation and logistics companies by reducing costs, increasing transit speeds and lowering ...
Read more: Budget 2018-19: Infra spending to benefit the Logistics sector eventually
Read more: Budget 2018-19: Infra spending to benefit the Logistics sector eventually
US FDA News: FDA warns Becton Dickinson & Company of significant violations of the law as part of ongoing investigation into lead testing issues
FDA warns Becton Dickinson & Company of significant violations of the law as part of ongoing investigation into lead testing issues
Read more: FDA warns Becton Dickinson & Company of significant violations of the law as part of ongoing investigation into lead testing issues
Read more: FDA warns Becton Dickinson & Company of significant violations of the law as part of ongoing investigation into lead testing issues
Pharma Jobs: PRODUCTION ENGINEERS/MANAGER
Company: Randwin Exim Private Limited
Qualification: B.Pharm
Experience: 5 to 10
location: Mumbai
Ref: 21746327
Summary: As a Production Engineer, you'll be involved with the planning, coordination and control of manufacturing processes. You'll make sure goods and services are produced efficiently and that....
Read more: PRODUCTION ENGINEERS/MANAGER
Qualification: B.Pharm
Experience: 5 to 10
location: Mumbai
Ref: 21746327
Summary: As a Production Engineer, you'll be involved with the planning, coordination and control of manufacturing processes. You'll make sure goods and services are produced efficiently and that....
Read more: PRODUCTION ENGINEERS/MANAGER
US FDA News: Certitude Delivery System by Edwards Lifesciences: Class I Recall - Mold Overflow Defect Which May Obstruct Blood Flow
An embolism could obstruct blood flow to critical organs, leading to serious injury and/or a need to surgically extract the overflow material from the patient. Severe neurologic, cardiac, limb, renal, or gastrointestinal injury may result.
Read more: Certitude Delivery System by Edwards Lifesciences: Class I Recall - Mold Overflow Defect Which May Obstruct Blood Flow
Read more: Certitude Delivery System by Edwards Lifesciences: Class I Recall - Mold Overflow Defect Which May Obstruct Blood Flow
US FDA News: Prescription Opioid Cough and Cold Medicines: Drug Safety Communication - FDA Requires Labeling Changes
Risks of slowed or difficult breathing, misuse, abuse, addiction, overdose, and death with these medicines outweigh their benefits in patients younger than 18.
Read more: Prescription Opioid Cough and Cold Medicines: Drug Safety Communication - FDA Requires Labeling Changes
Read more: Prescription Opioid Cough and Cold Medicines: Drug Safety Communication - FDA Requires Labeling Changes
US FDA News: FDA acts to protect kids from serious risks of opioid ingredients contained in some prescription cough and cold products by revising labeling to limit pediatric use
The U.S. Food and Drug Administration announced today that it is requiring safety labeling changes to limit the use of prescription opioid cough and cold medicines containing codeine or hydrocodone in children younger than 18 years old because the serious risks of these medicines outweigh their potential benefits in this population. After safety labeling changes are made, these products will no longer be indicated for use to treat cough in any pediatric population and will be labeled for use only in adults aged 18 years and older. Labeling for the medications also is being updated with additional safety information for adult use – including an expanded Boxed Warning, the FDA’s most prominent warning ‒ notifying about the risks of misuse, abuse, addiction, overdose and death, and slowed or difficult breathing that can result from exposure to codeine or hydrocodone.
Read more: FDA acts to protect kids from serious risks of opioid ingredients contained in some prescription cough and cold products by revising labeling to limit pediatric use
Read more: FDA acts to protect kids from serious risks of opioid ingredients contained in some prescription cough and cold products by revising labeling to limit pediatric use
US FDA News: Feeding Tube Placement Systems: Letter to Health Care Providers - Reports of Pneumothorax Events
Reported pulmonary events required urgent intervention, including needle decompression or chest tube placement. Several of these events were associated with cardiopulmonary arrest and patient death.
Read more: Feeding Tube Placement Systems: Letter to Health Care Providers - Reports of Pneumothorax Events
Read more: Feeding Tube Placement Systems: Letter to Health Care Providers - Reports of Pneumothorax Events
Pharma Reviews: Live: Nifty Futures Indicate Stock Losses As Global Rally Loses Steam
Jindal Drilling: Indico Prefab and Allied Industries LLP sold 2 lakh shares or 0.7 percent equity at Rs 225.45 each. ... Indian pharma majors weigh bids for Sanofi's $2 billion European generics business; Aurobindo, Apax-Cadila, Intas and Torrent Pharma evaluate bids that must be put out by mid Jan.
Read more: Live: Nifty Futures Indicate Stock Losses As Global Rally Loses Steam
Read more: Live: Nifty Futures Indicate Stock Losses As Global Rally Loses Steam
Pharma Reviews: Policy anomalies mar Indian API firms, help China rule the roost
If proper and regular inspections are conducted, many Chinese bulk drug exporters will be out of the game, industry sources say. The argument holds water as recently India's drug regulator Drug Controller General of India (DCGI) has banned the import of ingredients of drugs from six major Chinese ...
Read more: Policy anomalies mar Indian API firms, help China rule the roost
Read more: Policy anomalies mar Indian API firms, help China rule the roost
Pharma Reviews: Telangana IT minister KT Rama Rao seeks Central funds for Pharma City in Hyderabad
HYDERABAD: IT and Industries Minister KT Rama Rao called on Union Minister of Commerce and Industry Suresh Prabhu in Delhi on Wednesday with a request to release Rs 1,500 crore for the development of Hyderabad Pharma City. KTR met Prabhu at the Udyog Bhavan in New Delhi. The minister ...
Read more: Telangana IT minister KT Rama Rao seeks Central funds for Pharma City in Hyderabad
Read more: Telangana IT minister KT Rama Rao seeks Central funds for Pharma City in Hyderabad
Wednesday, January 10, 2018
Pharma Reviews: KTR seeks Central funds for Pharma City in Hyd
HYDERABAD: IT and Industries Minister KT Rama Rao called on Union Minister of Commerce and Industry Suresh Prabhu in Delhi on Wednesday with a request to release `1,500 crore ... He also participated in Persons of India Origin Parliamentarian meeting held under leadership of Sushma Swaraj.
Read more: KTR seeks Central funds for Pharma City in Hyd
Read more: KTR seeks Central funds for Pharma City in Hyd
Pharma Reviews: Drug regulator teaming up to re-inspect manufacturing plants of pharma cos in next three weeks
"Several small companies would have to close down if the standards are made too strict," an industry executive told ET on condition of anonymity. The Central Drugs Standard Control Organisation (CDSCO), India's apex drug regulatory body, initiated risk-based inspections in 2016 to weed out supplies ...
Read more: Drug regulator teaming up to re-inspect manufacturing plants of pharma cos in next three weeks
Read more: Drug regulator teaming up to re-inspect manufacturing plants of pharma cos in next three weeks
Pharma Reviews: Indian pharma majors weigh bids for Sanofi's $2 billion European generics business
Interestingly, Intas is currently the sole contender left in fray for Mallinckrodt's generics drug business in the US, a potential $1.5-billion transaction that would give the drugmaker access to the attractive therapeutic segment of controlled substances, or opioids, that have steep entry barriers and high ...
Read more: Indian pharma majors weigh bids for Sanofi's $2 billion European generics business
Read more: Indian pharma majors weigh bids for Sanofi's $2 billion European generics business
Pharma Reviews: Intas low-balls Mallinckrodt unit bid to $1 billion on legal fears
If the deal happens, this will still be the largest overseas acquisition by Indian pharma industry, marginally topping Lupin's buyout of US-based Gavis Pharma for $880 million two years ago. Intas acquired Teva's Actavis units in the UK and Ireland for $732 million last August. India's $36-billion pharma ...
Read more: Intas low-balls Mallinckrodt unit bid to $1 billion on legal fears
Read more: Intas low-balls Mallinckrodt unit bid to $1 billion on legal fears
US FDA News: Clopidogrel Tablets USP, 75 mg by International Laboratories: Recall - Product Mislabeling
Missed doses of Clopidogrel increases the risk of heart attack and stroke which can be life threatening.
Read more: Clopidogrel Tablets USP, 75 mg by International Laboratories: Recall - Product Mislabeling
Read more: Clopidogrel Tablets USP, 75 mg by International Laboratories: Recall - Product Mislabeling
Pharma Reviews: Here's Why Pharma Exports Dipped in FY17
He said some of the reasons cited for a decline in exports include absence of blockbuster drugs going off-patent; consolidation of buyers in the US into three large groups with significant bargaining power; and some of the Indian companies shifting their manufacturing bases to the EU, US and other ...
Read more: Here's Why Pharma Exports Dipped in FY17
Read more: Here's Why Pharma Exports Dipped in FY17
Pharma Reviews: Implications of cyber-attacks on healthcare sector critical
The populated geographies like India can become a rich source of medical research data by virtue of the sheer size of the sample. This data can be exploited for unregulated drug mafia and pharma companies. Advanced attacks like ransomware can cause major operation disruption by holding critical ...
Read more: Implications of cyber-attacks on healthcare sector critical
Read more: Implications of cyber-attacks on healthcare sector critical
Tuesday, January 9, 2018
Pharma Reviews: Pharma companies focus on limited competition drugs for the US market
His peers from Aurobindo Pharma, Cipla, Glenmark and Wockhardt will also be sharing their strategy for limited-competition drugs at the conference that is known as the biggest annual event for the health care industry globally. As Indian generic makers face pricing pressure in the US, they are looking ...
Read more: Pharma companies focus on limited competition drugs for the US market
Read more: Pharma companies focus on limited competition drugs for the US market
Pharma Reviews: Relief for Indian tech workers
Recently, Trump also decided to cut corporate tax from 35% to 21% which will improve their competitiveness in their domestic market. It is expected to impact Indian IT and ITeS, pharma and contract manufacturing industries as the US companies will find their home more attractive destination for ...
Read more: Relief for Indian tech workers
Read more: Relief for Indian tech workers
Pharma Reviews: How Allergan Continues to Make Drug Prices Insane
Minastrin 24 Fe: A birth control pill that comes in a chewable tablet, Minastrin 24 Fe raises a different question about pharmaceutical pricing. In 2017, Minastrin 24 Fe cost about $547 for a five-month supply. But in early spring, an Indian generic company, Lupin Pharmaceuticals Inc., along with Israel's ...
Read more: How Allergan Continues to Make Drug Prices Insane
Read more: How Allergan Continues to Make Drug Prices Insane
Pharma Reviews: Indian Pharma market grew at 7.8 per cent in December 2017 to Rs. 10000 crore
The Indian Pharma market registered a growth of 7.8 per cent during December 2017 to Rs. 10,000 crore. The growth of the market is slightly lower than last month. According to AIOCD Pharmasofttech AWACS report, the volumes have posted a positive growth, however price component is dragging the ...
Read more: Indian Pharma market grew at 7.8 per cent in December 2017 to Rs. 10000 crore
Read more: Indian Pharma market grew at 7.8 per cent in December 2017 to Rs. 10000 crore
Pharma Reviews: Indian pharma market grows 7.8 percent in December on uptake in respiratory and anti-infectives
The Indian pharmaceutical market (IPM) grew 7.8 percent in December, helped by improved uptake in anti-infectives, respiratory and chronic segment like diabetes, according to market research firm AIOCD-AWACS. For the third quarter ended December, IPM grew 7.2 percent, recovering from the wash ...
Read more: Indian pharma market grows 7.8 percent in December on uptake in respiratory and anti-infectives
Read more: Indian pharma market grows 7.8 percent in December on uptake in respiratory and anti-infectives
Monday, January 8, 2018
Pharma Reviews: NITI Aayog may revamp process of drug selection for price control
The next round of meeting with pharma lobby groups such as Indian Pharmaceutical Alliance (IPA), Indian Drugs Manufacturers' Association (IDMA), and officials from pharma companies is slated scheduled for 9 January. NITI Aayog had earlier sent a three-page questionnaire to the lobby groups, which ...
Read more: NITI Aayog may revamp process of drug selection for price control
Read more: NITI Aayog may revamp process of drug selection for price control
Pharma Reviews: NPPA lens on five pharma companies for Hepatitis C drug overcharge
MUMBAI | NEW DELHI: Five pharmaceutical companies including Cipla, Hetero and Dr Reddy's Laboratories are under the Indian regulator's scanner ... While NPPA had set this drug's retail price in November, four companies started selling their versions as early as May 2017 for about Rs 1,000 more, ...
Read more: NPPA lens on five pharma companies for Hepatitis C drug overcharge
Read more: NPPA lens on five pharma companies for Hepatitis C drug overcharge
Sunday, January 7, 2018
Pharma Reviews: 8 Chinese companies get notices for poor quality of APIs
Most Indian pharma firms are of late depending on active pharmaceutical ingredients (API) or raw material for medicine from Chinese companies, raising concern in the Indian government. According to a pharma industry body, Indian pharma companies secure 70-75 per cent of APIs from China.
Read more: 8 Chinese companies get notices for poor quality of APIs
Read more: 8 Chinese companies get notices for poor quality of APIs
Pharma Reviews: DCGI bans import of drug ingredients from six Chinese firms
New Delhi: Citing quality issues, India's drug regulator Drug Controller General of India (DCGI) has banned the import of ingredients of drugs from six major Chinese pharmaceutical firms. The move, according to pharma lobby groups could have serious ramifications for the Indian pharma industry, even ...
Read more: DCGI bans import of drug ingredients from six Chinese firms
Read more: DCGI bans import of drug ingredients from six Chinese firms
Pharma Reviews: Eight Chinese pharma firms may be blacklisted over quality issues
NEW DELHI: The Indian government has issued showcause notices to, and may soon blacklist, eight Chinese pharmaceutical companies found to be ... in the DCGI, the companies on the verge of getting blacklisted are currently supplying a huge chunk of raw material to the Indian drug manufacturers.
Read more: Eight Chinese pharma firms may be blacklisted over quality issues
Read more: Eight Chinese pharma firms may be blacklisted over quality issues
Friday, January 5, 2018
Pharma Reviews: As India set to sign FTA with Peru, govt seeks industry views on export import duty rates
In view of this, the Pharmaceuticals Export Promotion Council of India (Pharmexcil) has sought the opinion of Industry leaders in order to assess the pros and cons of free trade agreement with the South American Country on Indian exports. “We understand that the government of India is planning to sign ...
Read more: As India set to sign FTA with Peru, govt seeks industry views on export import duty rates
Read more: As India set to sign FTA with Peru, govt seeks industry views on export import duty rates
Pharma Reviews: Pharma landscape '18: Watch out for the 'black swan'
“The single-minded pursuit of 'access at affordable prices' by the Government and the complete disregard for the promotion, development and growth of the industry will have a major adverse impact on the growth and sustainability of Indian pharmaceutical industry in 2018,” says DG Shah of the Indian ...
Read more: Pharma landscape '18: Watch out for the 'black swan'
Read more: Pharma landscape '18: Watch out for the 'black swan'
Pharma Reviews: Why should investors lower their expectation from market in 2018?
Government's emphasis on 'Housing for All by 2022', RERA and infrastructure status to reality sector provided the required revival to the reality ... and Visa norms in the US put weight on IT companies, while, slow approvals by USFDA and pricing pressure kept the Indian pharma companies underneath.
Read more: Why should investors lower their expectation from market in 2018?
Read more: Why should investors lower their expectation from market in 2018?
Pharma Reviews: Sensex ends up 184 points; Nifty, Midcap at record close; Yes Bank gains 5%
The said company is jointly promoted by Dilip Buildcon Limited and M/s VPR Mining Infrastructure Private Limited, with equity participation of 74 percent and 26 percent, respectively, in the equity share capital of the said company. 1:20 pm Pharma Earnings Preview: The Indian pharma sector's ...
Read more: Sensex ends up 184 points; Nifty, Midcap at record close; Yes Bank gains 5%
Read more: Sensex ends up 184 points; Nifty, Midcap at record close; Yes Bank gains 5%
Pharma Reviews: Infosys partners ValGenesis to offer paperless validation system to pharma, biotech industry
Indian IT major informs that its Life Sciences Practice works with over 50 leading pharmaceutical and medical devices companies, providing premium regulatory, quality and compliance services. Leveraging its extensive capabilities and experience in the life sciences space, Infosys will deploy the ...
Read more: Infosys partners ValGenesis to offer paperless validation system to pharma, biotech industry
Read more: Infosys partners ValGenesis to offer paperless validation system to pharma, biotech industry
Pharma Reviews: Pharma sector earnings to remain muted on weak US business, strong rupee
New Delhi: The Indian pharma sector's December-quarter revenue is estimated to remain flat, while profits are likely to slip owing to decline in US businesses and a sharp appreciation in rupee, says a report. According to an Edelweiss Securities report, though the October-December quarter was “action ...
Read more: Pharma sector earnings to remain muted on weak US business, strong rupee
Read more: Pharma sector earnings to remain muted on weak US business, strong rupee
Pharma Reviews: Closing bell: Sensex ends up 184 pts; Nifty, Midcap at record close; Yes Bank gains 5%
The domestic brokerage firm said weak US business and INR appreciation against US dollar/Brazilian Real/Japanese Yen/ South African Rand are expected to drag earnings of Indian pharma companies. "US revenue expected to decline 11 per cent year-on-year for the sector in constant currency (CC), ...
Read more: Closing bell: Sensex ends up 184 pts; Nifty, Midcap at record close; Yes Bank gains 5%
Read more: Closing bell: Sensex ends up 184 pts; Nifty, Midcap at record close; Yes Bank gains 5%
Pharma Reviews: CCI slaps fine on two Gujarat chemists associations
The Competition Commission of India (CCI), which has been making efforts to sensitise the public on unfair ways in the pharma industry, has also asked the two associations and their respective office bearers to cease and desist from indulging in anti-competitive practices. In an order passed on January ...
Read more: CCI slaps fine on two Gujarat chemists associations
Read more: CCI slaps fine on two Gujarat chemists associations
Pharma Reviews: NPPA evokes special powers to fix prices of 14 formulations
New Delhi: India's drug pricing regulator has invoked its special powers to fix the prices of 14 formulations including glucose injections, morphine ... D.G. Shah, secretary general of the Indian Pharmaceutical Alliance (IPA), which represents 20 of the country's biggest drug makers, said that due to a ...
Read more: NPPA evokes special powers to fix prices of 14 formulations
Read more: NPPA evokes special powers to fix prices of 14 formulations
Thursday, January 4, 2018
US FDA News: Statement by FDA Commissioner Scott Gottlieb, M.D., update on recovery efforts in Puerto Rico, and continued efforts to mitigate IV saline and amino acid drug shortages
Statement by FDA Commissioner Scott Gottlieb, M.D., update on recovery efforts in Puerto Rico, and continued efforts to mitigate IV saline and amino acid drug shortages
Read more: Statement by FDA Commissioner Scott Gottlieb, M.D., update on recovery efforts in Puerto Rico, and continued efforts to mitigate IV saline and amino acid drug shortages
Read more: Statement by FDA Commissioner Scott Gottlieb, M.D., update on recovery efforts in Puerto Rico, and continued efforts to mitigate IV saline and amino acid drug shortages
US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA Food Safety Modernization Act enforcement discretion guidance
FDA announced today guidance outlining four key areas that it does not intend to enforce in the FDA Food Safety Modernization Act rules. The provisions relate to the “farm” definition, requirements related to written assurances from a manufacturer’s customers, requirements for importers of food contact substances, and requirements related to certain human food by-products for use as animal food.
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA Food Safety Modernization Act enforcement discretion guidance
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA Food Safety Modernization Act enforcement discretion guidance
Pharma Reviews: Seamless project approval experienced in TS: DelExcel Pharma CEO
He also held the position of Head of Research and Development (R&D) at Aizant and alumni of National Institute of Pharmaceutical Education and Research (NIPER), Mohali (Punjab). He spent about 12 years with major Indian pharmaceutical companies including Aizant, Genovo, Zydus Cadila and Dr ...
Read more: Seamless project approval experienced in TS: DelExcel Pharma CEO
Read more: Seamless project approval experienced in TS: DelExcel Pharma CEO
US FDA News: FDA warns American CryoStem Corporation of significant deviations related to its unapproved stem cell product, Atcell
FDA warns American CryoStem Corporation of significant deviations related to its unapproved stem cell product
Read more: FDA warns American CryoStem Corporation of significant deviations related to its unapproved stem cell product, Atcell
Read more: FDA warns American CryoStem Corporation of significant deviations related to its unapproved stem cell product, Atcell
US FDA News: Ampicillin and Sulbactam for Injection USP 1.5 g/vial by Auromedics: Recall - Presence of Glass Particles in Vial
Administration of glass particulate may result in local irritation or swelling in response to the foreign material. More serious potential outcomes would include blockage and clotting in blood vessels, which may be life-threatening.
Read more: Ampicillin and Sulbactam for Injection USP 1.5 g/vial by Auromedics: Recall - Presence of Glass Particles in Vial
Read more: Ampicillin and Sulbactam for Injection USP 1.5 g/vial by Auromedics: Recall - Presence of Glass Particles in Vial
Pharma Reviews: Will promote competition to reduce prices, reiterates USFDA in a new statement
The US Food and Drug Administration (USFDA) Commissioner Dr Scott Gottlieb talked about new steps to facilitate efficient generic drug review to enhance competition, promote access and lower drug prices in a statement. For many of those within the Indian pharma industry, the note is on expected ...
Read more: Will promote competition to reduce prices, reiterates USFDA in a new statement
Read more: Will promote competition to reduce prices, reiterates USFDA in a new statement
Pharma Reviews: Drop in pharma exports due to shifting of Manufacturing base
New Delhi: The ongoing winter session of Parliament is briefed with various issues and according to a PTI report submitted in Parliament, the dip in India's pharmaceutical exports is stated as shifting of manufacturing base units of domestic companies to overseas markets and also absence of ...
Read more: Drop in pharma exports due to shifting of Manufacturing base
Read more: Drop in pharma exports due to shifting of Manufacturing base
Pharma Reviews: NIIT acquires US-based corporate training firm
NIIT Limited, which made a name for itself training millions of Indians with IT skills, said it acquired a US-based corporate training company. NIIT will ... Institute provides training programs for companies adopting sophisticated cloud-based applications in the Pharmaceutical and Life Sciences industry.
Read more: NIIT acquires US-based corporate training firm
Read more: NIIT acquires US-based corporate training firm
Pharma Reviews: Indian pharma growth likely to be moderate: ICRA
New Delhi , Jan 3 : The growth trajectory for Indian pharmaceutical industry is likely to be moderate, according to credit rating agency ICRA. ... generic adoption reaching saturation levels, and regulatory overhang along with base effect catching up; the Indian pharma sector is likely to curtail aggregate ...
Read more: Indian pharma growth likely to be moderate: ICRA
Read more: Indian pharma growth likely to be moderate: ICRA
Product Recall Alerts: Arthritis capsule recalled by Scottsdale company over liver and lung safety concerns
A Scottsdale company removed its osteoarthritis capsule Limbrel from the market following a Food and Drug Administration recall based on reports the ... The company said in a letter to the FDA that it was surprised by the federal agency's initial safety alert, issued last November, which was followed by a ...
Read more: Arthritis capsule recalled by Scottsdale company over liver and lung safety concerns
Read more: Arthritis capsule recalled by Scottsdale company over liver and lung safety concerns
Pharma Reviews: Several odds likely to curtail Indian pharma growth to single digit: ICRA
The growth trajectory for Indian pharmaceutical industry is likely to be moderate on back of slowing growth from US given the relatively moderate proportion of large size drugs going off patent, increased competition leading to price erosion in low–to--mid-teens, generic adoption reaching saturation ...
Read more: Several odds likely to curtail Indian pharma growth to single digit: ICRA
Read more: Several odds likely to curtail Indian pharma growth to single digit: ICRA
Wednesday, January 3, 2018
Product Recall Alerts: Recall RoundUp: Apples, Smoked Salmon, and Pharmaceuticals
At this time, not adverse affects incidents have been reported related to this recall. The product can be identified as being packed in blister packs with UPC code 847046009785. The affected lots include all lot numbers with expiration date of 7/1/2018. The product was distributed nationwide between July ...
Read more: Recall RoundUp: Apples, Smoked Salmon, and Pharmaceuticals
Read more: Recall RoundUp: Apples, Smoked Salmon, and Pharmaceuticals
Pharma Reviews: Indian pharma growth likely to be moderate: ICRA
New Delhi [India], Jan 3 (ANI): The growth trajectory for Indian pharmaceutical industry is likely to be moderate, according to credit rating agency ICRA. Owing to slow growth from US given the relatively moderate proportion of large size drugs going off patent, increased competition leading to price ...
Read more: Indian pharma growth likely to be moderate: ICRA
Read more: Indian pharma growth likely to be moderate: ICRA
US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D. on new steps to facilitate efficient generic drug review to enhance competition, promote access and lower drug prices
FDA today announced additional steps to encourage generic competition as part of our continued implementation of the Drug Competition Action Plan. FDA is releasing two documents that together will improve aspects of the submission and review of generic drug applications (known as Abbreviated New Drug Applications, or ANDAs).
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D. on new steps to facilitate efficient generic drug review to enhance competition, promote access and lower drug prices
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D. on new steps to facilitate efficient generic drug review to enhance competition, promote access and lower drug prices
Pharma Reviews: Startup Watchlist: 11 Indian Healthtech Startups To Watch Out For In 2018
Thus, opening up doors of opportunities for healthtech startups trying to disrupt untapped niche sectors in this space. As per Inc42 DataLabs, in 2017, Indian healthtech startups raised about $346 Mn across 111 deals. A significant contribution here is although made by online pharmacy startups such as ...
Read more: Startup Watchlist: 11 Indian Healthtech Startups To Watch Out For In 2018
Read more: Startup Watchlist: 11 Indian Healthtech Startups To Watch Out For In 2018
Pharma Reviews: Dip in pharma exports due to shifting of manufacturing bases, market consolidation: Government
He said some of the reasons cited for the decline in exports include absence of blockbuster drugs going off-patent; consolidation of buyers in the US into three large groups with significant bargaining power; and some of the Indian companies shifting their manufacturing bases to the EU, US and other ...
Read more: Dip in pharma exports due to shifting of manufacturing bases, market consolidation: Government
Read more: Dip in pharma exports due to shifting of manufacturing bases, market consolidation: Government
Pharma Reviews: Dip in pharma exports due to shifting of mfg bases, market
consolidation: Govt New Delhi, Jan 3 (PTI) Shifting of manufacturing bases to overseas markets by certain domestic companies and absence of blockbuster drugs going off-patent are some of reasons for dip in India's pharmaceutical exports, Parliament was informed today. In 2016-17, the exports ...
Read more: Dip in pharma exports due to shifting of mfg bases, market
Read more: Dip in pharma exports due to shifting of mfg bases, market
Pharma Reviews: Indian pharma growth likely to be moderate: ICRA
The growth trajectory for Indian pharmaceutical industry is likely to be moderate, according to credit rating agency ICRA. Owing to slow growth from US given the relatively moderate proportion of large size drugs going off patent, increased competition leading to price erosion in low-to-mid-teens, generic ...
Read more: Indian pharma growth likely to be moderate: ICRA
Read more: Indian pharma growth likely to be moderate: ICRA
Pharma Reviews: Indian pharma will continue to stare at single digit growth: ICRA
MUMBAI: The growth trajectory for Indian pharmaceutical industry is likely to be moderate on back of slowing growth from US given the relatively moderate proportion of large size drugs going off patent, increased competition leading to price erosion in low-to--mid-teens, generic adoption reaching ...
Read more: Indian pharma will continue to stare at single digit growth: ICRA
Read more: Indian pharma will continue to stare at single digit growth: ICRA
Tuesday, January 2, 2018
Pharma Reviews: Tarnea Technology gears up to digitize pharmacies in India as GST drives need for tax compliance ...
Indian pharma retail has challenges. The new pharmaceutical policy will bring about far reaching changes to which the retailers will have to quickly adapt. With all businesses becoming digital, pharmacies are slow to adopt this. The advent of online pharmacies and chain stores pose new forms of ...
Read more: Tarnea Technology gears up to digitize pharmacies in India as GST drives need for tax compliance ...
Read more: Tarnea Technology gears up to digitize pharmacies in India as GST drives need for tax compliance ...
Pharma Reviews: Pharma & healthcare sectors to see accelerating growth in 2018 with adoption of artificial ...
According to Taher Abbasi, COO & Co-Founder of Cellworks Research India, 2018 would witness an accelerating change for pharma & healthcare industry. The sector is set to take it to the next level and expected to see a huge adoption of artificial intelligence and big data in treatment process.
Read more: Pharma & healthcare sectors to see accelerating growth in 2018 with adoption of artificial ...
Read more: Pharma & healthcare sectors to see accelerating growth in 2018 with adoption of artificial ...
Pharma Reviews: MedPlus raises $115 M debt fund from PE investors
Madhukar launched MedPlus in 2006 when he realised the existing gaps in the Indian pharma industry. He found that around 30 per cent of the fake medicines sold across the world came from India and thus decided to launch MedPlus in order to provide a reliable source of medicines to the Indian ...
Read more: MedPlus raises $115 M debt fund from PE investors
Read more: MedPlus raises $115 M debt fund from PE investors
US FDA News: Compounded Sterile Products by PharMEDium Services: Recall - Lack of Sterility Assurance
Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.
Read more: Compounded Sterile Products by PharMEDium Services: Recall - Lack of Sterility Assurance
Read more: Compounded Sterile Products by PharMEDium Services: Recall - Lack of Sterility Assurance
US FDA News: Reprocessed Agilis Steerable Introducer Sheath by Sterilmed: Class I Recall - Improper Seal of Sheath Hub
Improper seals can allow blood to leak through the hub, cause the cap to fall off during the procedure, or can create a difference in pressure that allows air into the circulatory system (air embolism).
Read more: Reprocessed Agilis Steerable Introducer Sheath by Sterilmed: Class I Recall - Improper Seal of Sheath Hub
Read more: Reprocessed Agilis Steerable Introducer Sheath by Sterilmed: Class I Recall - Improper Seal of Sheath Hub
Pharma Reviews: 2017 Rogues' Gallery: Indian Americans Who Made News for Wrong Reasons
According to prosecutors, Insys is an example of American pharmaceutical companies prioritizing profits over public health. Kapoor, 74, who stepped down as the company's CEO in January 2017, pleaded not guilty to these charges and of conspiracy to commit mail and wire fraud, and conspiracy to ...
Read more: 2017 Rogues' Gallery: Indian Americans Who Made News for Wrong Reasons
Read more: 2017 Rogues' Gallery: Indian Americans Who Made News for Wrong Reasons
Pharma Reviews: FROM MAGAZINE: India the new destination for air cargo
Pharmaceuticals, auto ancillaries and fashion products will continue to play major role in the growth of the air cargo industry. The registered double-digit growth in air cargo justifies the growing potential." A significant achievement for India last year was the opening of the air cargo route between ...
Read more: FROM MAGAZINE: India the new destination for air cargo
Read more: FROM MAGAZINE: India the new destination for air cargo
Pharma Reviews: MedPlus Raises $117.67 Mn Debt Fund To Buyback 69% Stake From PE Investors
Madhukar launched MedPlus in 2006 when he realised the existing gaps in the Indian pharma industry. He found that around 30% of the fake medicines sold across the world came from India and thus decided to launch MedPlus in order to provide a reliable source of medicines to the Indian consumers.
Read more: MedPlus Raises $117.67 Mn Debt Fund To Buyback 69% Stake From PE Investors
Read more: MedPlus Raises $117.67 Mn Debt Fund To Buyback 69% Stake From PE Investors
Monday, January 1, 2018
Pharma Reviews: Indian cos now in race to create generic versions of biologics with larger global opportunity: Kiran ...
It demonstrates that Indian scientists, researchers and engineers are second to none and that Indian biopharma companies can develop advanced therapies that conform to best-in-class global quality standards. Over time, other pharma and biotech companies could emulate our success if like Biocon, ...
Read more: Indian cos now in race to create generic versions of biologics with larger global opportunity: Kiran ...
Read more: Indian cos now in race to create generic versions of biologics with larger global opportunity: Kiran ...
Pharma Reviews: Union Bank invites bids for sale of 17 NPAs worth Rs1,287 cr
Union Bank of India has invited initial bids from asset reconstruction companies, banks, financial institutions, and non-banking finance companies for the proposed sale of non-performing loans of 17 accounts worth Rs1,287cr. The bidding entities have to complete the due diligence on these loans by ...
Read more: Union Bank invites bids for sale of 17 NPAs worth Rs1,287 cr
Read more: Union Bank invites bids for sale of 17 NPAs worth Rs1,287 cr
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