Pharma Reviews: NetApp aims for better industry-academia collaboration

Interestingly, NetApp is working with many government organisations, public and private sector banks such as the SBI, HDFC, IDBI, and pharma companies in India to manage and store their data, as they are in the process of expanding their digital footprint. At the same time the company is also working ...
Read more: NetApp aims for better industry-academia collaboration

Pharma Reviews: Pharma MNCs outsource PV services to Indian CROs to meet global compliance levels

Pharma MNCs have started outsourcing pharmacovigilance (PV) related services to Indian Clinical Research Organisations (CROs) mostly around case processing which includes receiving, processing and reporting the PV cases to regulators in an effective way. A pharmaceutical company can meet ...
Read more: Pharma MNCs outsource PV services to Indian CROs to meet global compliance levels

Pharma Reviews: New Chinese norms come as booster dose for India's drug, medical-gear companies

Indian pharmaceutical and medical equipment manufacturers are set to gain in the China market, thanks to new regulatory norms notified by the Chinese government. According to a notification received by the Pharmaceutical Exports Promotion Council (Pharmexcil), China's General Office of the State ...
Read more: New Chinese norms come as booster dose for India's drug, medical-gear companies

Pharma Reviews: Is it time to move out of pharma sector funds?

The pharma sector has been facing many regulatory issues since 2016. The industry is facing adverse conditions in both the domestic and global markets. Some of the Indian pharma giants like Lupin, Sun Pharma have seen hurdles in their business due to the stricter norms of US Food and Drugs ...
Read more: Is it time to move out of pharma sector funds?

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s efforts to enhance the patient perspective and experience in drug development and review

FDA issues update to Benefit-Risk Assessment plan as part of efforts to enhance the patient perspective and experience in drug development and review
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s efforts to enhance the patient perspective and experience in drug development and review

US FDA News: FDA expands approval of Blincyto for treatment of a type of leukemia in patients who have a certain risk factor for relapse

FDA expands approval of Blincyto for treatment of a type of leukemia in patients who have a certain risk factor for relapse
Read more: FDA expands approval of Blincyto for treatment of a type of leukemia in patients who have a certain risk factor for relapse

US FDA News: Federal judge approves consent decree with New York dietary supplement manufacturer Riddhi USA

A New York dietary supplement manufacturer has been ordered by a federal court to stop selling its products until the company comes into compliance with the FDA’s dietary supplement manufacturing regulations.
Read more: Federal judge approves consent decree with New York dietary supplement manufacturer Riddhi USA

US FDA News: Federal judge approves consent decree with Florida company that sold unapproved new drugs and misbranded drugs

Federal judge approves consent decree with Florida company that sold unapproved new drugs and misbranded drugs
Read more: Federal judge approves consent decree with Florida company that sold unapproved new drugs and misbranded drugs

Pharma Reviews: From Sun to Cipla - Biggest M&As in the Indian pharma industry that made profits or bombed

Abbott-Piramal acquisition | Year: May 2010 | Deal size: USD 3.7 billion Objective: To increase its presence in the Indian branded generics space. Result: Expensive deal with Abbott paying 8.8 times of Piramal sales. While the acquisition strengthened Abbott's market position and product portfolio in ...
Read more: From Sun to Cipla - Biggest M&As in the Indian pharma industry that made profits or bombed

US FDA News: FDA authorizes first fully interoperable continuous glucose monitoring system, streamlines review pathway for similar devices

The authorization classifies integrated continuous glucose monitoring devices in class II and subjects them to certain criteria called special controls
Read more: FDA authorizes first fully interoperable continuous glucose monitoring system, streamlines review pathway for similar devices

Pharma Reviews: China agrees to improve market access for Indian farm goods

China has reaffirmed its commitment to accelerate the provision of market access for Indian agricultural products, including non-basmati rice, rape-seed meals, soya-meals, pomegranate and pomegranate arils, okra, banana and other fruits and vegetables and bovine meat expeditiously as the two ...
Read more: China agrees to improve market access for Indian farm goods

Pharma Reviews: India, China agree to draw roadmap to address trade deficit: Commerce Ministry

The meeting was chaired by Commerce and Industry Minister Suresh Prabhu and his Chinese counterpart Zhong Shan. ... "The two sides reaffirmed their aim to promote bilateral trade in the field of pharmaceuticals including resolution of issues of Indian pharma products exports to Chinese markets," it ...
Read more: India, China agree to draw roadmap to address trade deficit: Commerce Ministry

Pharma Reviews: Have started working on India-EU free-trade agreement again: Suresh Prabhu

Similarly, India is a lucrative market for the European auto and pharma companies. At $43 billion, the EU — including the UK — made up for 17.6 per cent of India's goods exports in the first 10 months of the current financial year, while imports from the bloc stood at over $39 billion. Garments were India's ...
Read more: Have started working on India-EU free-trade agreement again: Suresh Prabhu

US FDA News: Eclipse Kratom by Tamarack: 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: Eclipse Kratom by Tamarack: Recall - Possible Salmonella Contamination

Pharma Reviews: Why 2018 will be a challenging year for pharmaceuticals

Post two years of significant underperformance, positioning remains light in the India Pharma sector given multiple headwinds and relatively expensive valuations vs. global peers/Nifty. To gain insight into latest developments and trends, and get a sense of how things are on the ground for our covered ...
Read more: Why 2018 will be a challenging year for pharmaceuticals

Pharma Reviews: India aims to boost exports of fruits and vegetables to China

Issues relating to exports of pharmaceutical products will also be brought in by the Indian side. In China, Indian pharma companies face regulatory hurdles in the form of prolonged and unpredictable timelines for registering Indian drugs, which have adversely impacted expansion plans of these firms.
Read more: India aims to boost exports of fruits and vegetables to China

Pharma Reviews: Top pharmacy body planning exit examination

Ahmedabad: On the lines of the exit examination for the MBBS, the Pharmacy Council of India (PCI) has approached the health ministry for approval to ... He further said that PCI envisages a need to set up National Schools of Pharmacy, jointly by PCI and the pharma Industry as centres of excellence ...
Read more: Top pharmacy body planning exit examination

US FDA News: BD Vacutainer Blood Collection Tubes by Becton, Dickinson and Company (BD): Class I Recall - Chemical Interference with Certain Tests

Falsely lower test results may lead to improper patient management and treatment for lead exposure or poisoning.
Read more: BD Vacutainer Blood Collection Tubes by Becton, Dickinson and Company (BD): Class I Recall - Chemical Interference with Certain Tests

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., on a key step in advancing FDA’s oversight of drug compounding and implementing new laws governing outsourcing facilities

Statement from FDA Commissioner Scott Gottlieb, M.D., on a key step in advancing FDA’s oversight of drug compounding and implementing new laws governing outsourcing facilities
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., on a key step in advancing FDA’s oversight of drug compounding and implementing new laws governing outsourcing facilities

Pharma Reviews: Gujarat FDCA, US FDA to soon meet for discussing training plan for drug regulators towards audit ...

During the meet, Gujarat FDCA also gave a presentation to the US FDA team apprising the latter on the Gujarat pharma industry. ... a workshop at Ahmedabad on how to be prepared timely for US FDA inspections and develop quality culture from bottom to top management in Indian pharma companies.
Read more: Gujarat FDCA, US FDA to soon meet for discussing training plan for drug regulators towards audit ...

Pharma Reviews: On the move for growth

With the pharmaceutical industry growing in double digits every year, there is plethora of career opportunities in the country. Few other sectors today are more lucrative and promising than the pharma sector that has witnessed over 17 per cent annual growth from 2005 to 2016. The size of the industry is ...
Read more: On the move for growth

US FDA News: Statement from FDA’s Donald St. Pierre on findings from ongoing investigation into lead testing issues

FDA on findings from ongoing investigation into lead testing issues; studies find chemical interaction during test processing may contribute to skewing results
Read more: Statement from FDA’s Donald St. Pierre on findings from ongoing investigation into lead testing issues

US FDA News: NeuroBlate Probe by Monteris Medical: Letter to Health Care Providers, Class I Recall - Unintended Heating

Instances of unintended heating and damage to the probe, which may have resulted in unintended damage to surrounding brain tissue.
Read more: NeuroBlate Probe by Monteris Medical: Letter to Health Care Providers, Class I Recall - Unintended Heating

Pharma Reviews: Tata Chemicals launches MedikarbTM - India's first branded pharmaceutical grade sodium ...

Tata Chemicals launches MedikarbTM - India's first branded pharmaceutical grade sodium bicorbonate March 22nd, 2018, Mumbai: Tata Chemicals Ltd today announced the launch of MedikarbTM – India's first branded pharmaceutical grade sodium bicarbonate for pharma API and formulation ...
Read more: Tata Chemicals launches MedikarbTM - India's first branded pharmaceutical grade sodium ...

Pharma Reviews: Tata Chemicals launches India's first branded pharmaceutical grade sodium bicarbonate

Sanjiv Lal, COO, India Chemicals Operations, Tata Chemicals Ltd. said, “Medikarb is India's first branded premium grade of sodium bicarbonate suitable for use ... This will give Indian pharma manufacturers a high-quality product manufactured in a state of the art FDA certified facility from a trusted brand.
Read more: Tata Chemicals launches India's first branded pharmaceutical grade sodium bicarbonate

Pharma Reviews: Tata Chemicals launches Medikarb – India's first branded pharmaceutical grade sodium bicarbonate

Mumbai: Tata Chemicals (BSE: TATACHEM), the country's leading producer of Soda Ash and Sodium Bicarbonate, today announced the launch of MedikarbTM – India's first branded pharmaceutical grade sodium bicarbonate for pharma API and formulation manufacturing. MedikarbTM will be ...
Read more: Tata Chemicals launches Medikarb – India's first branded pharmaceutical grade sodium bicarbonate

Pharma Reviews: Tata Chemicals launches a pharma grade sodium bicarbonate

Tata Chemicals Ltd., the country's leading producer of Soda Ash and Sodium Bicarbonate, announced the launch of Medikarb^TM – India's first branded pharmaceutical grade sodium bicarbonate for pharma API and formulation manufacturing. Medikarb^TM will be manufactured in state of the art FDA ...
Read more: Tata Chemicals launches a pharma grade sodium bicarbonate

Pharma Reviews: Pharmaceutical can exports pharma products without obtaining NOC from regulatory authorities ...

New Delhi, Mar 22 (KNN) With an aim to further improve ease of doing business, government of India announced that all pharmaceutical companies can exports drugs and medical devices without obtaining any sort of clearance from drug regulatory authority. In a notice issued by the Central Drugs ...
Read more: Pharmaceutical can exports pharma products without obtaining NOC from regulatory authorities ...

Pharma Reviews: Impact of US trade tariffs on imports not to affect medicine supplies from India

The recent tariff announcements from the US government is not going to impact the Indian pharma products. This is because India has a cost advantage ... While there has been no specific mention on the pharmaceutical imports, there are apprehensions on such move. “The current retaliatory trade tariffs ...
Read more: Impact of US trade tariffs on imports not to affect medicine supplies from India

US FDA News: FDA expands approval of Adcetris for first-line treatment of Stage III or IV classical Hodgkin lymphoma in combination with chemotherapy

FDA approves Adcetris (brentuximab vedotin) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL) in combination with chemotherapy
Read more: FDA expands approval of Adcetris for first-line treatment of Stage III or IV classical Hodgkin lymphoma in combination with chemotherapy

Pharma Jobs: Chemical Engineering walk in Interview

Company: Confidential
Experience: 0 to 5
location: UK, US
Ref: 22010370
Summary: Operating process by DCS controlling. Distillation like simple,vaccum and continuous distillation process handling. Active participation in project activities, plant operation and start up. Process optimization and ....
Read more: Chemical Engineering walk in Interview

Pharma Jobs: Chemistry / Pharma walk in Interview

Company: Confidential
Experience: 0 to 5
location: UK, US
Ref: 22010376
Summary: Prepares medications by reviewing and interpreting physician orders; detecting therapeutic incompatibilities. Dispenses medications by compounding, packaging, and labeling pharmaceuticals. Controls....
Read more: Chemistry / Pharma walk in Interview

Pharma Jobs: Chemistry / Pharma walk in Interview

Company: Confidential
Experience: 0 to 5
location: UK, US
Ref: 22010387
Summary: Prepares medications by reviewing and interpreting physician orders; detecting therapeutic incompatibilities. Dispenses medications by compounding, packaging, and labeling pharmaceuticals. Controls....
Read more: Chemistry / Pharma walk in Interview

Pharma Jobs: Chemistry / Pharma walk in Interview

Company: Confidential
Experience: 0 to 5
location: Canada, South Africa
Ref: 22010462
Summary: Prepares medications by reviewing and interpreting physician orders; detecting therapeutic incompatibilities. Dispenses medications by compounding, packaging, and labeling pharmaceuticals. ....
Read more: Chemistry / Pharma walk in Interview

Pharma Jobs: Chemical Engineering walk in Interview

Company: Confidential
Experience: 0 to 5
location: Canada, South Africa
Ref: 22010467
Summary: Operating process by DCS controlling. Distillation like simple,vaccum and continuous distillation process handling. Active participation in project activities, plant operation and start up. Process ....
Read more: Chemical Engineering walk in Interview

Pharma Reviews: Exclusive | New labelling norms: Drug companies to have larger fonts for generic names

The move will help the government break the unholy nexus between doctors and pharma companies. This will also promote use of generic drugs in market to reduce burden on patients, in a country where healthcare expenses are met out-of-pocket by patients. As of now, drug makers in India ...
Read more: Exclusive | New labelling norms: Drug companies to have larger fonts for generic names

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., on efforts to reduce tobacco use, especially among youth, by exploring options to address the role of flavors ‒ including menthol ‒ in tobacco products

FDA takes steps to reduce tobacco use, especially among youth, by exploring options to address the role of flavors ‒ including menthol ‒ in tobacco products.
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., on efforts to reduce tobacco use, especially among youth, by exploring options to address the role of flavors ‒ including menthol ‒ in tobacco products

Pharma Reviews: Dangerous doses

Due to this price control, many pharma companies prefer to manufacture non-essential drugs which are mostly FDC and earn a good margin of profit,” says a senior doctor at AIIMS-Delhi, requesting anonymity. According to the Drugs and Cosmetics Act, FDC is treated as a new drug in India because ...
Read more: Dangerous doses

Pharma Reviews: 'Time right for India to reduce its dependence on API imports from China'

The Pharmaceuticals Export Promotion Council of India (Pharmexcil) along with national research institutes are drawing up plans to reduce the dependence on China and Italy for import of active pharmaceutical ingredients (APIs) and intermediates, according to the Director-General of Pharmexcil, ...
Read more: 'Time right for India to reduce its dependence on API imports from China'

Pharma Reviews: Asia Pharma Expo to boost Bangla pharma manufacturing standards

According to experts, the expo will help take the pharma manufacturing standards of Bangladesh to newer heights. ... Its State Minister - Zahid Maleque, Drug Administration Directorate General Director General – Mustafizur Rahman, Indian Deputy High Commissioner in Bangladesh – Dr. Adarsa ...
Read more: Asia Pharma Expo to boost Bangla pharma manufacturing standards

Pharma Reviews: 'Right time for India to promote APIs'

A strategy is being worked out by Pharmaceuticals Export Promotion Council of India (Pharmexcil) in association with national research institutes to reduce the dependence on China and Italy for import of Active Pharmaceutical Ingredients (API s) and intermediates, Director General of Pharmexcil Ravi ...
Read more: 'Right time for India to promote APIs'

US FDA News: Alka-Seltzer Plus Products: Recall - Ingredients on Front Sticker May Not Match Product in Carton

Consumers may ingest a product to which they may have an allergy or anaphylactic reaction, an ingredient which may be contraindicated for their condition or they intend to otherwise avoid, with potential for serious health consequences.
Read more: Alka-Seltzer Plus Products: Recall - Ingredients on Front Sticker May Not Match Product in Carton

Pharma Reviews: Efforts on to rely less on China, Italy for pharma ingredients

“India is largely dependent on China for API imports. Until recently, China used to sell APIs at lower prices due to their lower labour costs. The profit margin on APIs used to be low, and Indian drug manufacturers thought it wise to import APIs, make formulation drugs and export them,” said Bhaskar.
Read more: Efforts on to rely less on China, Italy for pharma ingredients

Pharma Reviews: Health NGOs seek removal of professional body members from committee tasked to review FDCs

The All India Drug Action Network (AIDAN) - a group of healthcare-focused NGOs - has expressed dismay over government appointing representatives of professional bodies such as Indian Pharmaceutical Association (IPA) and Indian Medical Association (IMA) as members of Sub-Committee of Drugs ...
Read more: Health NGOs seek removal of professional body members from committee tasked to review FDCs

Pharma Reviews: ChrysCapital may return to Mankind with $400m deal

Mumbai: Indian private equity posterboy ChrysCapital along with its global sponsors have made a surprise late-stage bid to buy a stake of $350-400 million in Mankind ... The fund's partner and pharma industry veteran Sanjiv Kaul has strong ties with Indian pharma entrepreneurs, including the Junejas.
Read more: ChrysCapital may return to Mankind with $400m deal

Pharma Reviews: Indian logistics sector to reach $215 bn by 2020. Here's what will drive growth

“We at NECC foresee an overall growth in the Indian market, especially in the automobile, textile, pharma and steel sector. We feel that there is a big market potential for logistic sector, waiting to be tapped. We understand that logistics and supply chain play a key role in the development and growth of ...
Read more: Indian logistics sector to reach $215 bn by 2020. Here's what will drive growth

Pharma Reviews: `IQVIA' to focus on digital healthcare and human data science

MUMBAI: Over a year after Quintiles, a contract medical research provider merged globally with healthcare information company IMS Health, a new brand IQVIA has been formed to focus on digital healthcare and human data science. The contours of the merger are now being firmed up here in India, ...
Read more: `IQVIA' to focus on digital healthcare and human data science

Pharma Reviews: India's leadership in cost-efficient generics is unchallenged: Sanjiv Kaul

ChrysCapital invested $20 million in dermatology product maker Curatio Healthcare early this week, making it the 10th investment of the homegrown PE firm into Indian Pharma. Sanjiv Kaul, partner at the PE firm, has spent over 40 years in Indian pharma, including a 27-year stint in various leadership ...
Read more: India's leadership in cost-efficient generics is unchallenged: Sanjiv Kaul

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., on pivotal public health step to dramatically reduce smoking rates by lowering nicotine in combustible cigarettes to minimally or non-addictive levels

FDA takes pivotal public health step to dramatically reduce smoking rates by lowering nicotine in combustible cigarettes to minimally or non-addictive levels.
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., on pivotal public health step to dramatically reduce smoking rates by lowering nicotine in combustible cigarettes to minimally or non-addictive levels

Pharma Reviews: Torrent may raise Rs 15 bn via QIP as it readies to bid for Sanofi assets

While Torrent is working actively to integrate Unichem's business, it had earlier turned around Elder Pharma's domestic business, which it had acquired in 2014. Torrent has more than doubled the portfolio it had acquired from Elder. Indian pharmaceutical companies are weighing opportunities in ...
Read more: Torrent may raise Rs 15 bn via QIP as it readies to bid for Sanofi assets

US FDA News: Neurovascular Embolization Coils: Healthcare Provider Letter - Potential for Increased Image Artifact When Using Magnetic Resonance Angiography For Follow-Up

Reduced quality of MRA image from increased artifact can result in inaccurate clinical diagnoses (e.g., occlusion status) and subsequent inappropriate medical decisions.
Read more: Neurovascular Embolization Coils: Healthcare Provider Letter - Potential for Increased Image Artifact When Using Magnetic Resonance Angiography For Follow-Up

US FDA News: Kratom-containing Powder Products by PDX Aromatics: Recall - Potential for Contamination with Salmonella

Salmonella contamination can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
Read more: Kratom-containing Powder Products by PDX Aromatics: Recall - Potential for Contamination with Salmonella

Pharma Reviews: Indian investors urged to explore biz opportunities in Venezuela

Addressing a business round-table with Indian Industry organized by the Federation of Indian Chambers of Commerce and Industry (FICCI), here on ... reputed Indian pharma companies such as Sun Pharma, Dr. Reddy's, Glenmark and Claris are operating in Venezuela, providing basic medicines in the ...
Read more: Indian investors urged to explore biz opportunities in Venezuela

Pharma Reviews: India braces for Donald Trump's reciprocal tax, may fight it in WTO

But the situation may go out of control if tariffs are raised across the board. India's export exposure to the US in sectors such as diamond jewellery, pharmaceuticals and marine products remains far higher than steel and aluminium. The US alone consumes about 30 per cent of India's annual jewellery ...
Read more: India braces for Donald Trump's reciprocal tax, may fight it in WTO

Pharma Reviews: 'Opportunities galore in pharma industry'

Indian Pharmaceutical Association national president V.S.V. Vadlamudi on Friday said the pharmaceutical industry had been providing ample opportunities for the students pursuing related courses. They could prove themselves only when they were able to convert their theoretical information into ...
Read more: 'Opportunities galore in pharma industry'

Pharma Reviews: 'Pharma Bro' Martin Shkreli gets 7 years in prison in securities fraud case

NEW YORK: The smirk wiped off his face, a crying Martin Shkreli was sentenced to seven years in prison for securities fraud Friday in a hard fall for the pharmaceutical-industry bad boy vilified for jacking up the price of a lifesaving drug. Shkreli, the boyish-looking, 34-year-old entrepreneur dubbed the ...
Read more: 'Pharma Bro' Martin Shkreli gets 7 years in prison in securities fraud case

US FDA News: FDA warns duodenoscope manufacturers about failure to comply with required postmarket surveillance studies to assess contamination risk

FDA has issued warning letters to Olympus, FujiFilm and Pentax, for failing to comply with section 522 orders on postmarket surveillance studies for duodenoscopes
Read more: FDA warns duodenoscope manufacturers about failure to comply with required postmarket surveillance studies to assess contamination risk

Pharma Reviews: Japan to recruit 200000 IT professionals from India to fill manpower gap

According to Maeda, who was speaking at the India-Japan Business Partnership Seminar in Bengaluru, the Japanese government is also looking to collaborate with companies specifically from Hyderabad. ... Apart from the IT industry, Maeda said Japan was looking to invest in India's pharma industry.
Read more: Japan to recruit 200000 IT professionals from India to fill manpower gap

US FDA News: Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for oral testimony before the U.S. House Committee on Energy and Commerce Subcommittee on Oversight and Investigations hearing “Examining U.S. Public Health Preparedness for and Response Efforts to Seasonal Influenza.”

Commissioner remarks as prepared for testimony at the hearing “Examining U.S. Public Health Preparedness for and Response Efforts to Seasonal Influenza.”
Read more: Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for oral testimony before the U.S. House Committee on Energy and Commerce Subcommittee on Oversight and Investigations hearing “Examining U.S. Public Health Preparedness for and Response Efforts to Seasonal Influenza.”

Pharma Reviews: Japan eyes India to fill manpower gap in its information technology sector

Japan is looking to hire human resources from India to fill the manpower gap in its information technology sector caused due to a fall in the country's ... “The pharma industry is big here and our government is also looking at promoting generic drugs,” said Maeda, who was in Hyderabad along with other ...
Read more: Japan eyes India to fill manpower gap in its information technology sector

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., on effort to help bolster U.S. shellfish market by taking mutually beneficial steps to resume shellfish trade with the EU

FDA announces proposed shellfish equivalence determination with the EU that will create new market access for U.S. exporters as well as make a wider selection of healthy and safe shellfish options available to consumers. It will also assure American consumers that imported molluscan shellfish from Europe is as safe as what we produce in the U.S.
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., on effort to help bolster U.S. shellfish market by taking mutually beneficial steps to resume shellfish trade with the EU

Pharma Reviews: India emerging as a global pharma assistant

In the past three years, India is not only growing as a net donor but also as a preferential player in the pharma industry in terms of trade, manufacturing and R&D. India has made its mark not just in these areas but has established itself as the tenth largest pharma exporter in the world. While earlier the ...
Read more: India emerging as a global pharma assistant

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA activities related to the ongoing post-market review of Essure and FDA’s commitment to keep women informed

The FDA is actively evaluating a significant increase in the number of medical device reports submitted to the agency on the Essure device from October to December 2017
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA activities related to the ongoing post-market review of Essure and FDA’s commitment to keep women informed

Pharma Reviews: Paytm founder Vijay Shekhar Sharma youngest Indian billionaire in Forbes list

Meanwhile, 92-year-old Samprada Singh, who is the chairman emeritus of Alkem Laboratories, is the oldest Indian billionaire. He was ranked 1,867th on the list with a fortune of USD 1.2 billion. Singh founded the pharma firm Alkem Laboratories 45 years ago. Singh worked in a chemist's store before ...
Read more: Paytm founder Vijay Shekhar Sharma youngest Indian billionaire in Forbes list

Pharma Reviews: Healthcare M&A outlook bright for 2018: Analysts

In October, we saw the GL Capital-lead consortium takeover of SciClone Pharmaceutical, a specialty small-molecule company, for about USD$600 million. Chinese, Indian and Australian biopharmas also had a busy year. Fosun Group (China) acquired a 74% stake in Hyderabad-based Gland Pharma ...
Read more: Healthcare M&A outlook bright for 2018: Analysts

Product Recall Alerts: Breathe easy: Malaysia not affected by faulty asthma inhalers recall in the UK

The Medicines and Healthcare products Regulatory Agency (MHRA) in UK issued a patient level drug alert, and recalled two specific affected lots of faulty inhalers manufactured by Glaxo Wellcome UK Limited. Due to manufacturing issues, experts warned that a small number of the devices were not ...
Read more: Breathe easy: Malaysia not affected by faulty asthma inhalers recall in the UK

Pharma Reviews: Price crash ahead? Key diabetes, cancer drugs to go off-patent in India

The next three to five years would see some of the most important cardio-vascular, diabetic and oncology molecules going off-patent in the Indian market. This could trigger launches of generic versions by local pharma players, and thereby a major drop in their prices. Industry experts expect the sharpest ...
Read more: Price crash ahead? Key diabetes, cancer drugs to go off-patent in India

Pharma Reviews: New Government Report Affirms India's Patient-First Commitment on Pharma Patents

Significantly, the report makes multiple comments about the protection of public rights on pharmaceutical patents via the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement of the World Trade Organisation (WTO). India signed up to TRIPS in 1995, and following a 10-year transition ...
Read more: New Government Report Affirms India's Patient-First Commitment on Pharma Patents

Pharma Reviews: Forbes World's billionaire list: India billionaire count soars to 121; but US and China have way more

It is intriguing to note that the Indian pharmaceutical sector has produced the most number of billionaires, with 16 business tycoons including Sun Pharmaceuticals founder Dilip Shanghvi, chairman of Poonawalla group Cyrus Poonawalla, and Piramal's founder Ajay Piramal making it to the list.
Read more: Forbes World's billionaire list: India billionaire count soars to 121; but US and China have way more

US FDA News: FDA approves first tests to screen for tickborne parasite in whole blood and plasma to protect the U.S. blood supply

FDA approves first tests to screen for tickborne parasite in blood donations
Read more: FDA approves first tests to screen for tickborne parasite in whole blood and plasma to protect the U.S. blood supply

US FDA News: Methylprednisolone Sodium Succinate for Injection 40mg, 125mg, and 1g by Sagent Pharmaceuticals: Recall - High Out of Specification Impurity Results

An elevated impurity has the potential to decrease effectiveness of the product in patients. Posted: 03/06/2018
Read more: Methylprednisolone Sodium Succinate for Injection 40mg, 125mg, and 1g by Sagent Pharmaceuticals: Recall - High Out of Specification Impurity Results

US FDA News: FDA expands approval of replacement heart valve, smallest mechanical valve size approved in the world

FDA expands approval of replacement heart valve, smallest mechanical valve size approved in the world
Read more: FDA expands approval of replacement heart valve, smallest mechanical valve size approved in the world

US FDA News: FDA approves new HIV treatment for patients who have limited treatment options

The FDA approved Trogarzo (ibalizumab-uiyk), a new type of antiretroviral medication for adult patients living with HIV who have tried multiple HIV medications in the past (heavily treatment-experienced) and whose HIV infections cannot be successfully treated with other currently available therapies.
Read more: FDA approves new HIV treatment for patients who have limited treatment options

Pharma Reviews: Traders in export-focused sectors wary of Donald Trump's tariff threats

Traders across export-focused sectors with a significant business presence in the United States say they are apprehensive of growing noises from Washington DC for higher import tariffs. India's export exposure in sectors such as diamond jewellery, pharmaceuticals and marine products with regard to ...
Read more: Traders in export-focused sectors wary of Donald Trump's tariff threats

US FDA News: FDA authorizes, with special controls, direct-to-consumer test that reports three mutations in the BRCA breast cancer genes

FDA has authorized 23andMe to market a consumer test that reports only 3 out of more than 1,000 known mutations in BRCA genes
Read more: FDA authorizes, with special controls, direct-to-consumer test that reports three mutations in the BRCA breast cancer genes

Pharma Reviews: The tightrope walk of India's drug-price regulator

The tightrope walk of India's drug-price regulator. By ... May 15, 2013: DPCO 2013 announced; considers market-based ceiling price formula against industry wish; NLEM expanded to 628 formulations from 74 ... Apr 22, 2016: Indian Pharmaceutical Alliance files a petition with DoP against NPPA's move
Read more: The tightrope walk of India's drug-price regulator

Pharma Reviews: What is data integrity in Pharmaceutical industry?

Over the last two years, Indian companies like USV, Hetero and Sri Krishna Pharmaceuticals (all unlisted), Agila Specialties (Mylan's subsidiary), etc. ... Recently, Sun Pharma, Aurobindo, Biocon, etc. received form 483 observations, but there was no data integrity related observations, hence stocks did ...
Read more: What is data integrity in Pharmaceutical industry?

US FDA News: Hydromorphone HCL Injection USP by Hospira: Recall - Potential For Empty Or Cracked Glass Vials

Use of or exposure to cracked units may be associated with adverse events such as sharps injury to healthcare professionals.
Read more: Hydromorphone HCL Injection USP by Hospira: Recall - Potential For Empty Or Cracked Glass Vials

Pharma Reviews: Innovations in pharma packaging can check fake drugs : Yogesh Mudras

The Indian pharma economy has witnessed rapid growth in recent decades and is known as one of the global pharma hubs, ranking fourth in the world in ... Similarly, with the advent of a number of expensive and delicate biosimilars, the pharma packaging industry is experiences unexpected challenges ...
Read more: Innovations in pharma packaging can check fake drugs : Yogesh Mudras

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s commitment to modernizing food and nutrition programs

FDA announces commitment to modernize and streamline our food and nutrition programs to make sure that our investments of new and existing resources achieve their intended public health goals.
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s commitment to modernizing food and nutrition programs

Pharma Reviews: Indian pharma companies correcting mistakes in manufacturing standards

The Indian pharmaceutical industry, reeling under the regulatory scanner of the US Food and Drugs Administration (FDA) for the past few years, is learning from their mistakes. Out of the 192 inspections held by the US FDA in India in 2017, only eight were referred for Official Action indicated (OAI) or ...
Read more: Indian pharma companies correcting mistakes in manufacturing standards

Pharma Reviews: Branching Out

Earlier the OTC market in India was dominated by FMCG companies such as Dabur, Unilever, Henkel and Reckitt Benckiser among others. In the last few years though, drug companies such as Cipla, Dr. Reddys, Lupin, Sun Pharma have created separate divisions for OTC drug sales. Zydus Cadila ...
Read more: Branching Out

Pharma Reviews: India, Sri Lanka join hands to boost healthcare at Medicare 2018

FICCI, the apex industry chamber of India, in partnership with Government of India organised an 'India Pavilion' at the Medicare Show. Over 50 Indian companies specialising in healthcare services, medical tourism, pharmaceutical and medical equipment devices and suppliers participated. Moreover ...
Read more: India, Sri Lanka join hands to boost healthcare at Medicare 2018

Pharma Reviews: India, Netherlands to partner for innovative vaccine solutions

Dutch Lifesciences majors Philips, DSM are important players in the Indian healthcare industry. Key Indian pharma players have active and growing investment in the Netherlands; companies including Serum Institute of India, Dr. Reddys, Lupin, and Sun Pharma are leveraging the Dutch life sciences ...
Read more: India, Netherlands to partner for innovative vaccine solutions

Pharma Reviews: ​​Pharma to return to Gujarat, print impacted

The Indian Drug Manufacturers Association (IDMA) has shared an interesting bit of information. The state of Gujarat which contributes to 33 per cent of India's pharmaceutical production, is expected to be boosted by 40 per cent by 2020.
Read more: ​​Pharma to return to Gujarat, print impacted

Pharma Reviews: IDMA, UK-based NSF to equip pharma industry in attaining global quality standards

To help quality control heads of Indian pharma companies enhance audit-readiness, the Indian Drug Manufacturers Association (IDMA) and the UK-based agency NSF International have collaborated to jointly start Advanced Programme In Pharmaceutical Quality Management (APPQM) for ...
Read more: IDMA, UK-based NSF to equip pharma industry in attaining global quality standards

Pharma Reviews: Odyssey of Courage: The Story of an Indian Multinational by Habil Khorakiwala: Review

The book is a concise presentation on the pharmaceuticals industry in modern India; of the fast changing economic-legal-professional environment in which the young Habil operated and flourished; the comfort he drew from such apparently disparate matters as the Indian Patents Act of 1970, a drugs ...
Read more: Odyssey of Courage: The Story of an Indian Multinational by Habil Khorakiwala: Review

Pharma Reviews: Tax breaks on R&D: DIPP, Finance Ministry not on the same page

These statements were tabled during the closed door session between Union Chemicals and Fertilisers Minister Ananth Kumar and senior executives of pharmaceutical companies in Bengaluru at 'India Pharma 2018' on February 15. During this session, an action taken report — which contained the ...
Read more: Tax breaks on R&D: DIPP, Finance Ministry not on the same page

Pharma Reviews: Pharma Cos not under MCI, hence can claim deductions on promotion to doctors: IT Tribunal

During the arguments, the AR for the pharma company submitted that the circular issued by the Medical Council of India (supra) does not indicate the violations of any code of conduct when it comes to the Pharmaceutical industries (the donor). The same is applicable only to the Doctors in medical ...
Read more: Pharma Cos not under MCI, hence can claim deductions on promotion to doctors: IT Tribunal

Pharma Reviews: IPC urges industry to take up skill development of pharmacovigilance personnel on high priority

Having produced around 400 trained pharmacovigilance personnel last year, the Indian Pharmacopoeia Commission (IPC) which is also the national coordination center (NCC) for Pharmacovigilance Programme of India (PvPI), has urged the pharma industry to take up skill development of ...
Read more: IPC urges industry to take up skill development of pharmacovigilance personnel on high priority

Pharma Reviews: Capping of stent price irrelevant, when govt launched Ayushman Bharat: Experts

But now the environment for medical devices is turning positive, stated Das at the sidelines of the recently concluded Indian Pharma and India ... But the recommendation of the industry is that if and when it happens, then the entire value chain of diagnostics should be brought under the same ambit.
Read more: Capping of stent price irrelevant, when govt launched Ayushman Bharat: Experts

Pharma Reviews: Why transfer NPPA chief, asks doctors' forum

Questioning the decision to transfer Bhupendra Singh, chairman of National Pharmaceutical Pricing Authority (NPPA), the Alliance of Doctors for Ethical ... IAS officer of UP cadre, had played an important role in exposing the true colours of private healthcare in India, especially of the corporate hospitals.
Read more: Why transfer NPPA chief, asks doctors' forum

US FDA News: FDA warns of fraudulent and unapproved flu products

FDA warns of fraudulent and unapproved flu products
Read more: FDA warns of fraudulent and unapproved flu products

Product Recall Alerts: FDA Alerts Professionals, Patients Not to Use Compounded Drugs from Cantrell Drug Company

The U.S. Food and Drug Administration is alerting health care professionals and patients not to use drug products produced by Cantrell Drug Company of ... In response to the FDA's recommendation, in July 2017, Cantrell recalled all drug products marketed as sterile and ceased sterile compounding.
Read more: FDA Alerts Professionals, Patients Not to Use Compounded Drugs from Cantrell Drug Company

Product Recall Alerts: Serious Deficiencies In Cantrell's Compounding Operations Prompts FDA Recall

FDA is alerting health care professionals and patients not to use drug products produced by Cantrell Drug Company of Little Rock, Arkansas, including opioid products and other drugs intended for sterile injection, that were produced by the company and distributed nationwide. The agency is concerned ...
Read more: Serious Deficiencies In Cantrell's Compounding Operations Prompts FDA Recall

US FDA News: Compounded Drug Products from Cantrell Drug Company: FDA Warning - Serious Deficiencies in Quality and Sterility Assurance

Administration of contaminated or otherwise poor quality drug products can result in serious and life-threatening injury or death.
Read more: Compounded Drug Products from Cantrell Drug Company: FDA Warning - Serious Deficiencies in Quality and Sterility Assurance

US FDA News: FDA alerts health care professionals and patients not to use compounded drugs from Cantrell Drug Company; agency seeks action to stop production and distribution

FDA is alerting not to use drug products produced by Cantrell Drug Company that were distributed nationwide.
Read more: FDA alerts health care professionals and patients not to use compounded drugs from Cantrell Drug Company; agency seeks action to stop production and distribution

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new efforts to advance implementation of the new consumer Nutrition Facts label for foods

Americans rely on the U.S. Food and Drug Administration to ensure that food labels contain updated nutritional information to help them make more informed food choices that lead to better health for themselves and their families. I’ve made nutrition one of my top priorities, and ensuring that consumers have accurate and science-based information concerning the link between diet and chronic diseases like diabetes, obesity and heart disease is part of that commitment. We need to advance new ways to use the science we’re learning about diet and nutrition as tools for reducing the burden of disease. Our update to the iconic Nutrition Facts label includes significant changes to help consumers make more informed dietary choices, and we are already seeing the new label on many products.
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new efforts to advance implementation of the new consumer Nutrition Facts label for foods

Pharma Reviews: As a contra play, huge value in select pharma stocks: Sanjiv Bhasin, India Infoline

Coming to pharma, it has been a dog of a sector. It has been all over the place but like you rightly pointed out, if there is now one alibi, the headwind of rupee becomes a tailwind and like you pointed out we are extremely positive about stocks like Aurobindo Pharma or Dr Reddy's or Cipla, where we think ...
Read more: As a contra play, huge value in select pharma stocks: Sanjiv Bhasin, India Infoline

Pharma Reviews: Cipla's U-turn: Happily ever after?

In a foes-turn-friends move announced on February 27, the Mumbai-based drug maker announced that it will partner Swiss biotech company Roche to promote Actemra (tocilizumab, used in chronic arthritis) and Syndyma (bevacizumab, an anti-cancer drug used in multiple indications) for the Indian ...
Read more: Cipla's U-turn: Happily ever after?