Best printers for Home

Best Mixer Grinder

Best wired Earphones

Best 43 Inch TV in India

Best Wi Fi Routers

Best Home Theatre in India

Smart Watch under 5000

Best Laptops for Education

Best Laptop for Students

New Delhi, Jan 16 () Drug firm Wockhardt on Thursday said that it has received approval from the Drug Controller General of India for its two new antibiotics.
 "DCGI (Drug Controller General of India) has approved Wockhardt's two new antibiotics, EMROK (IV) and EMROK 0 (Oral), for acute bacterial skin and skin structure infections including diabetic foot infections and concurrent bacteraemia...," the drug firm said in a regulatory filing.
 The new drug will target superbug like Methicillin resistant Staphylococcus aureus (MRSA), which is a leading cause of rising antimicrobial resistance (AMR).
 "By virtue of its broad spectrum activity against widely prevalent pathogens including MRSA, superior safety over currently available anti-MRSA agents and its unique properties, I believe EMROK/EMROK-O has a strong potential to effectively address the unmet medical need of the clinicians in the country thereby helping to reduce the morbidity and mortality," Wockhardt Group founder chairman Habil Khorakiwala said.
 The size of Indian antibiotic market is around Rs 16,000 crore.
 AMR is a major public health problem globally. India carries one of the largest burdens of drug-resistant pathogens worldwide.
 Infections caused by drug-resistant organisms could lead to increased mortality and prolonged duration of hospitalisation, causing a huge financial burden to the affected persons, health-care systems, and hinder the goals of sustainable development.
 Two million deaths are projected to occur in India due to AMR by the year 2050, the company said.
 Currently available anti-MRSA agents have multiple side effects such as kidney damage, decrease in platelet cell counts and muscle pain, which limits their use for a longer period and compromise the safety of critically ill patients in the ICU. SID DRR

Wockhardt gets DGCI approval for 2 new antibiotics

The <keyword id="97393" type="ORGANIZATION" weightage="80" keywordseo="Competition-Commission-of-India">Competition Commission of India</keyword> (‘the Commission’) has found the <keyword id="69035" type="POSITION" weightage="80" keywordseo="chemist">Chemist</keyword> and Druggists Association, Goa (CDAG) to be in continued contravention of the provisions of the Competition Act, 2002 (‘the Act’). 
 
In an earlier case [MRTP-C-127/2009/DGIR (4/28)], the Commission had found the CDAG to be in contravention of the Act and thereafter, passed an order under section 27 of the Act on June 11, 2012 imposing a penalty of Rs 2 lakh on CDAG. 
 In a subsequent complaint filed by M/s Xcel Healthcare, it was brought to the notice of the Commission that the CDAG was restraining pharmaceutical companies such as M/s <keyword id="1997651" type="UNKNOWN" weightage="80" keywordseo="Glenmark-Pharmaceuticals-Limited">Glenmark Pharmaceuticals Limited</keyword> and M/s <keyword id="523713" type="COMPANY" weightage="80" keywordseo="Wockhardt-Limited">Wockhardt Limited</keyword> from doing business with non-authorized stockists and thereby, not complying with the order of the Commission. The Commission took suo-moto cognizance and ordered the <keyword id="123228" type="POSITION" weightage="80" keywordseo="Director-General">Director General</keyword> to investigate the matter. 
 
Following detailed investigation, the Commission found that CDAG was indulging in anti-competitive practices in complete disregard to the Commission order dated June 11, 2012. It was found that CDAG was continuing to exercise control on the supply chain through which drugs and medicines are made available in the market through the practice of requirement of LOC/NOC prior to appointment of stockists by pharmaceutical companies without having any legal or statutory authority in this respect. 
 
Further the Commission also found that CDAG forced pharmaceutical companies to follow its mandate by threatening the other stockists in Goa to stop taking supplies or suspend receiving supplies from them till such time they stopped supplies to the unauthorised stockists such as M/s Xcel Healthcare. 
(Image: projectation.com) 
(Source: Press Information Bureau)

The Chemist and Druggists Association, Goa (CDAG) Faces A Penalty Of Rs 10,62,062

New Delhi, Dec 11 (IANS) The World Health Organization (WHO), national regulatory authorities and vaccine manufacturers in WHO South-East Asia Region discussed fast-tracking of Covid-19 vaccine rollout in member countries. "The vaccine manufacturing and regulatory sectors have a critical role to play inequitable and efficient deployment of vaccines," said Poonam Khetrapal Singh, Regional Director, WHO South-East Asia Region. Aimed at strengthening collaboration between national programmes, vaccine producers and regulators in the region for Covid-19 vaccine deployment, the meeting provided a platform for interaction and experience sharing for vaccine registration, deployment and regulation. According to Singh, all countries in the Region are now developing and finalizing national deployment and vaccination plans for Covid-19, of which regulatory preparedness is a core component. "Establishing expedited regulatory pathways for vaccine approval and adjusting regulatory pathways to the type of vaccine that is developed and filed for approval remains critical as emergency use authorization will precede full licensure," Singh said. "While vaccine licensure systems may need to be modified, having standard operating procedures and stipulated timelines for emergency use authorization would be vital," she added. The Regional Director emphasized on effective coordination, collaboration and information-sharing. From R&amp;D to production, and from information on country readiness to post-marketing surveillance, manufacturers, regulators, policy-makers and planners must continue to work together to optimize and refine vaccine deployment. Key global and regional partners such as GAVI and UNICEF participated in the meeting. Among the vaccine manufacturers, from India Bharat Biotech International Ltd, Biological E Ltd, Cadila Healthcare Ltd, Serum Institute of India Pvt. Ltd, Dr Reddy's Laboratories and Wockhardt Limited; from Indonesia Bio Farma Limited, and from Thailand Government Pharmaceutical Organization (GPO), Bionet Asia Co.Ltd and Siam Bioscience, participated in the meeting. The expert group also recommended that all countries should ensure availability of high-quality, complete and timely Covid-19 surveillance data on all risk groups, including migrants and remote or displaced populations, for decision-making related to vaccination. They highlighted the need for all countries to assess available cold chain space and meticulously plan cold chain requirement, including necessary improvements in storage, stock management, vaccine delivery strategy and waste management. --IANS bu/in

WHO, vaccine makers discuss fast-tracking of Covid vax rollout

<ul><li>Over 40 states in the US have filed a lawsuit against 20 drugmakers led by Teva Pharmaceuticals, an Israeli firm, for allegedly conspiring to raise prices of drugs. </li><li>Seven Indian drugmakers - <keyword id="44642" type="CITY" weightage="20" keywordseo="Sun-Pharma">Sun Pharma</keyword>, Dr Reddy’s Laboratories, Glenmark Pharma, Lupin Wockhardt, Zydus Pharma and Aurobindo Pharma - have been named in the antitrust lawsuit. </li><li>The lawsuit alleges that the concerned pharmaceutical firms colluded to raise the prices of over 100 medicines.</li></ul> Over 40 states in the US have <a href="https://www.livemint.com/industry/manufacturing/top-indian-drug-makers-accused-of-fixing-prices-1557774708125.html">filed a lawsuit</a> against 20 drugmakers led by Teva Pharmaceuticals, an Israeli firm, for allegedly conspiring to raise prices of drugs in the US market. Seven Indian drugmakers - Sun Pharma, Dr Reddy’s Laboratories, Glenmark Pharma, Lupin Wockhardt, Zydus Pharma and Aurobindo Pharma - have been named in the antitrust lawsuit, which was filed at the end of last week following the culmination of a multi-year investigation into the US pharma industry. Sun Pharma’s share price on the Bombay Stock Exchange <a href="https://www.google.com/search?q=sun+pharma+share+price&amp;rlz=1C1GCEU_enIN820IN820&amp;oq=sun+pharma+share+price&amp;aqs=chrome..69i57j0l5.4788j1j4&amp;sourceid=chrome&amp;ie=UTF-8">fell 13% </a>yesterday before recovering. The lawsuit alleges that the concerned pharmaceutical firms colluded to raise the prices of over 100 medicines and divide up the addressable market for the medicines as opposed to competing normally against each other. Teva is said to be <a href="https://www.philly.com/business/generics-teva-pennsylvania-new-jersey-drugs-price-fixing-20190513.html">the driving force </a>behind the collusion. Between 2013 and 2015, the Israel drugmaker reportedly fixed prices on 86 medicines, the complaint from the states alleged. The price increases on some drugs were as high as 1,000%. The drugmakers have to deal with more than just the lawsuit from the states. Even the US Department of Justice is investigating the companies for antitrust violations. Speaking on the matter, a spokesperson for Sun Pharma told <a href="https://www.livemint.com/industry/manufacturing/top-indian-drug-makers-accused-of-fixing-prices-1557774708125.html">Mint</a>, ““We believe the allegations made in these lawsuits are without merit and we will continue to vigorously defend against them." If successfully argued, the lawsuit could result in billions of dollars worth of fines for the concerned companies. The fines for Indian pharma firms are expected to be in <a href="https://timesofindia.indiatimes.com/business/india-business/7-indian-pharma-cos-face-lawsuits-from-over-40-us-states/articleshow/69315711.cms">the tens of millions of range</a>, since their participation was reportedly limited. For their part, the drugmakers have argued that the price increases were a result of market factors like supply shocks and consolidation among rivals. SEE ALSO: <a href="https://www.businessinsider.in/generic-drugs-are-americas-solution-to-high-branded-drug-prices-but-recent-events-suggest-the-markets-not-working/articleshow/67200320.cms">Generic drugs are America's solution to high branded drug prices. But recent events suggest the market's not working</a>

Seven Indian pharma companies are being dragged into a US lawsuit over high drug prices

Drug maker <keyword id="63358" type="PERSON" weightage="20" keywordseo="Cadila-Healthcare">Cadila Healthcare</keyword> Limited has clarified that its drugs in the US have been recalled by its US subsidiary, Zydus Pharma USA; it was a class III type recall. The company gave the clarification following a news report that stated that the company had to recall one of its drugs in the US market. 
	 "The recall by our US subsidiary was voluntary and a class-III type recall, which means that the use of the product is not likely to cause any adverse health co<keyword id="6354646" type="CITY" weightage="20" keywordseo="NSE">nse</keyword>quences. There is no material impact”, said the company in a letter to the National Stock Exchange (NSE). 
	 The NSE on December 31, 2014, had sought clarification from the pharma major after a news report suggested that along with Wockhardt and Hospira, Cadila too has voluntarily recalled 58,920 bottles of Benzonatate Capsules—these medicines are used to treat coughs. The US Food and Drug Administration (<keyword id="6354656" type="ORGANIZATION" weightage="20" keywordseo="FDA">FDA</keyword>) had published this information on its website. 
	 
	Representational Image

Cadila Clarifies Voluntary Recall Of Drugs In
The US Market

Watching the Sensex can be misleading-- India's mid and small cap stocks have lost ₹2.4 trillion of investor wealth this year alone

<ul><li>Generic drugs from India and China may clash with a campaign in US led by former Ranbaxy whistleblower Dinesh Thakur.</li><li>In an exclusive interview with Business Insider, Thakur revealed his plan to force regulatory changes in US.</li><li><keyword id="7651171" type="UNKNOWN" weightage="20" keywordseo="katherine-ebans-new-book">Katherine Eban's new book</keyword>, <keyword id="7651172" type="UNKNOWN" weightage="20" keywordseo="bottle-of-lies">Bottle of Lies</keyword>, raises alarming concerns about generic drugs in the US.</li><li>This will be an added challenge for Indian drug makers already faced with pricing pressures in US.</li></ul>These are not the best of times for Indian pharma companies. Recently, a US lawsuit alleged that Sun Pharma’s Taro amongst other generic drug makers colluded with each other to <a href="https://www.businessinsider.in/seven-indian-pharma-companies-are-being-dragged-into-a-us-lawsuit-over-high-drug-prices/articleshow/69318841.cms">keep prices high</a>. The news spooked pharma stocks and lost nearly 10% of their value in less than a month. But, there is more bad news to come. A <a href="https://www.businessinsider.in/business/us-generic-drugs-risk-rises-for-indian-pharma-after-new-book-launch/articleshow/69332570.cms">frightening new book</a> called ‘Bottle of Lies’ by Katherine Eban accuses generic drugs of poisoning. This exposé sounds a death knell to Indian generic drug makers, who sell off-patent drugs to US and Europe. At the heart of this ‘cheap generics’ argument is a man called Dinesh Thakur who was a director at Ranbaxy ten years back. He blew the lid off of illegal practices by Indian pharmacos cutting corners and compromising on quality, <a href="https://dineshthakur.com/about-2/">before quitting the company in 2005</a>. Now, he is going a bit further to bring in a law where a consumer can know “where” the medicine in manufactured. Will he win the campaign to make drugs safer? Business Insider caught up with the man at the centre of this freshly brewing storm. Here are the edited excerpts. Katherine’s book and the whole conversation around it, is it coming across as something that is targeting Indian companies? The issue of data integrity is not unique to India. We see these problems here in the US as well. We see these problems in China, we have seen similar problems in Europe. The issue is what is it that we are going to do differently. Up until now, the people who really talked about this were people who worked in the industry or policymakers. A book like this puts the issue in the hands of common people who are patients and consumers. So, the conversation is much broader. To answer the question that you are asking, you know, does this mean we are trying to bash India, absolutely not. There is discussion about a big US manufacturer in there. It’s not just limited to India. What will be your next step in the US? In the US context, there is clearly a model that the FDA has followed. In 2012, the US Congress broadened the remit of the FDA, which was a local agency until then. It did not have offices outside of the country (US). Now we are pushing Congress to look at the data and see if the model works. If it’s not, what do we need to do differently. We are asking the House Energy and Commerce Committee, which oversees the Department of Health and Human Services, under which FDA comes, we are asking the committee to hold public hearings and have this discussion. That’s on the regulatory side. There are things that can be done from the patient’s side. For example, there is no legal requirement right now for the retail medicine to disclose where a certain product is manufactured. One of the things we are pushing for is for the Congress to make a law to disclose this. What it does is to put the power in the hands of the people. When I go and buy my medicines from a local pharmacy here, I can look it up and say this medicine was made in Shanghai in China, or this was made in a facility in India, and I can then decide whether I want to buy that medicine or not. Today, we don’t have that information. Do you have any political backing for this? We have a bunch of like-minded people trying to create some public awareness and in the Congress. Isn’t this against the tone taken by the Trump administration, which wants to make medicines affordable. Adding compliance costs might not help. Do you the government will go for this? The discussion on price, especially in the US, is centered around patented medicines, because those are really, really expensive. Most of the medicines made in India and China have very low price points -- typically between $10-$15 for a 30-day course. A part of what we are trying to do is highlight, that you can only cut the bone only so thin. After a point, there is not going to be any meat on it. The discussion is also about how low can you go before you stop manufacturers from cutting corners. This argument again plays into the hands of the multinationals, as we call them here. It takes the argument away from the cost of drugs to the quality and safety. My answer was in the US context. In India, the context is completely different. We have price controls. We have the National Pharmaceutical Pricing Authority (NPPA), which determines the prices of essential medicines. There is no equivalent of that in the US. But Indian companies are also focussed more on the US. They are more worried about what’s happening in the US. I agree with you completely. The advocacy we do in India will be very different from what we do in the US. What has been the political response in the US so far? The book has just come out. We are just starting this campaign. We had a similar campaign in 2015, after the Ranbaxy case broke. But at that time, the response was---we have this new law and we have to give it some time for it to take effect. We have an election next year. The price of prescription drugs is a big issue. When the Ranbaxy case came to light, one of the arguments as that the standards cannot be the same for US, a developed market, and India, where providing medicines itself is a big challenge. Will that challenge remain in India? I believe so. Unfortunately, the big difference between India and the US is that we have a lot of data here (US). The institutions here make decisions based on data. Unfortunately, India doesn’t do that. The Central Drugs Standard Control Organisation (CDSCO) is the most opaque of organisations. I have been dealing with them for six years right now. Having said that, how do you make the case that someone who is making Rs 500 a day and has to spend Rs 200 on medicines, and if the medicine doesn’t work, what system do we have capture that information? In India, we don’t even a system to recall drugs. Your next few months of advocacy will be focussed on the US. Is there another Ranbaxy kind of incident that you have come across in the recent months, which will be a part of your campaign? In the book, there are two or three companies that there is a deep dive into. So, the book does a deep dive into Ranbaxy on what really happened there. There is also a deep dive into Wockhardt. Now that the book is public, I can talk about it. There is also a deep dive into Mylan, which is a West Virginia, US-based company. On the question of regulations, do you think there is a need to revisit the settlement process? The book goes into detail about jurisdiction. While the FDA has the mandate to inspect a foreign facility, how do you prosecute in a foreign jurisdiction? Who will serve a subpoena in a foreign country? I think that’s a discussion that has to happen at the Congressional level but I am not qualified to answer that. Can the FDA have a SEC kind of approach while dealing with violations? There are examples in the book that will make your hair stand. Why is it that the penalties we impose on serial wrong-doers are purely financial? That’s a good question. To what extent can we hold individuals accountable, not just impose financial penalties, which is cost of doing business. You take a risk and if you get caught, you just pay money and move on. Unless you hold individuals accountable, some of this behaviour won’t change. Hopefully, this book will create that level of awareness among people so that we can demand, when it comes to healthcare, it should not be a SEC kind of settlement. Do you think Indian companies have come a long way in the last six years? I think so…. But we really have to change the attitude that we have one set of standards for the local market and another for the export market. Unless that changes, all the improvements we are trying to make… What have we spent money doing? We have upgraded our plants, we have made them clean, sterile, and we got new equipment. We have invested a lot in third-party training. We have hired consultants who charge $8,000 a day. That’s what we have been doing for the last five years. Right? But the real problem is where do send the people you hire at the bottom for training? You train them to make products for India and you train them to cut corners. Two years later, when they ask for a promotion, where do you promote them to? Export market. You think all that you taught them in the first 3-4 years, they are going to forget it the moment they work on an export market? It doesn’t work like that. SEE ALSO: <a href="https://www.businessinsider.in/us-generic-drugs-risk-rises-for-indian-pharma-after-new-book-launch/articleshow/69332570.cms" data-type="tilCustomLink" target="_blank">A frightening new book on the safety of generic drugs could send India’s pharma industry into an even deeper pit</a>

You Searched For "Wockhardt Limited" and got 7 results

Wockhardt gets DGCI approval for 2 new antibiotics

PTI

The Chemist and Druggists Association, Goa (CDAG) Faces A Penalty Of Rs 10,62,062

BI India Bureau

WHO, vaccine makers discuss fast-tracking of Covid vax rollout

IANS

Seven Indian pharma companies are being dragged into a US lawsuit over high drug prices

BI India Bureau

Cadila Clarifies Voluntary Recall Of Drugs In The US Market

Purba Das

Watching the Sensex can be misleading-- India's mid and small cap stocks have lost ₹2.4 trillion of investor wealth this year alone

Sriram Iyer

The man who brought Ranbaxy to its knees is pushing for ‘Made in India’ tag on drugs sold in US

Sriram Iyer

Popular Keywords

Buying Guides