US FDA approves Allergan’s Avycaz to treat pediatric patients with cUTI and cIAI

Allergan plc, a global pharmaceutical leader, announced that the US Food and Drug Administration (FDA) has approved the company’s supplemental New Drug Application (sNDA) for Avycaz (ceftazidime and avibactam), expanding the label to include pediatric patients 3 months and older for the treatment of complicated intra-abdominal infections (cIAI) in combination with metronidazole and complicated urinary tract infections (cUTI). This is the first FDA approval of a pediatric indication for cUTI and cIAI in more than a decade.

“Difficult-to-treat gram-negative pathogens pose a significant health risk, particularly to the vulnerable and sensitive pediatric patient population with few options for treatment,” said David Nicholson, chief research & development officer at Allergan. “As resistance rises among the gram-negative pathogens that cause these serious infections, the expanded label for Avycaz provides a safe and effective treatment option now for pediatric patients with cIAI and cUTI. These expanded indications in pediatric patients with infections, including infants and those at a particularly young age, address an unmet need among this vulnerable population and underscore Allergan’s efforts in anti-infective research.”

The label expansion was approved based on results from two active-controlled clinical studies evaluating Avycaz in children or infants with cIAI or cUTI, as well as a single-dose pharmacokinetic study. In the cIAI study, the safety and efficacy of Avycaz (in combination with metronidazole) was compared with meropenem. In the cUTI study, Avycaz was compared with cefepime.

Across the trials, 128 pediatric patients 3 months to less than 18 years of age were treated with Avycaz. Overall, the findings from the pediatric studies were similar to the previous determination of safety for Avycaz for the treatment of adult patients with cIAI or cUTI, and no new safety concerns were identified in pediatric patients.

The primary objectives of the studies were to evaluate the safety and tolerability of Avycaz, and they were not powered for a statistical analysis of efficacy. The descriptive efficacy analyses in the pediatric studies were consistent with data from studies in adults with cIAI and cUTI. In the pediatric cIAI study, the clinical cure rate at the test-of-cure (TOC) visit in the intent-to-treat (ITT) population was 91.8% (56/61) in the Avycaz plus metronidazole group and 95.5% (21/22) in the meropenem group. Clinical cure rates for the predominant pathogens, Escherichia coli and Pseudomonas aeruginosa, were 90.5% and 85.7%, respectively for patients treated with Avycaz plus metronidazole, and 92.3% and 88.9%, respectively, for patients treated with meropenem. In the pediatric cUTI study, the combined favorable clinical and microbiological response rate at TOC in the microbiological-ITT population was 72.2% (39/54) in the Avycaz group and 60.9% (14/23) in the cefepime group. The microbiologic response rate for E.coli, the most common uropathogen identified in the study, was 79.6% for patients treated with Avycaz and 59.1% for patients treated with cefepime.

Avycaz was first approved by the FDA in February 2015 for the treatment of cUTI including pyelonephritis, and cIAI in combination with metronidazole, caused by designated susceptible bacteria including certain Enterobacteriaceae and P. aeruginosa, for patients 18 years of age and older. Avycaz was subsequently approved for the treatment of adults with hospital-acquired pneumonia / ventilator-associated pneumonia (HABP/VABP) caused by designated susceptible bacteria in February 2018.

Avycaz is a fixed-dose combination antibacterial indicated for the treatment of cIAI (in combination with metronidazole), and cUTI caused by designated susceptible Gram-negative microorganisms in patients 3 months or older. Avycaz is also indicated for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in adults. Avycaz consists of a combination of avibactam and ceftazidime.

Avibactam is a first-in-class non-beta-lactam beta-lactamase inhibitor which protects ceftazidime against degradation by certain beta-lactamases. Avibactam does not decrease the activity of ceftazidime against ceftazidime-susceptible organisms. Ceftazadime is a third-generation cephalosporin with a well-established efficacy and safety profile.

Avycaz has demonstrated in vitro activity against Enterobacteriaceae in the presence of some beta-lactamases and extended-spectrum beta-lactamases (ESBLs) of the following groups: TEM, SHV, CTX-M, Klebsiella pneumoniae carbapenemase (KPCs), AmpC and certain oxacillinases (OXA). Avycaz also demonstrated in vitro activity against P. aeruginosa in the presence of some AmpC beta-lactamases, and certain strains lacking outer membrane porin (OprD). Avycaz is not active against bacteria that produce metallo-beta lactamases and may not have activity against Gram-negative bacteria that overexpress efflux pumps or have porin mutations.

Ceftazidime and avibactam is being jointly developed with Pfizer. Allergan holds the rights to commercialize ceftazidime and avibactam in North America under the brand name Avycaz, while Pfizer holds the rights to commercialize the combination in the rest of the world under the brand name Zavicefta.”

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MDxHealth announces positive data from pan-European multicenter clinical validation and optimization study of SelectMDx

MDxHealth SA, a multinational healthcare company, announces that positive data from a pre-biopsy clinical validation and optimization study of SelectMDx were presented at the 34th Annual European Association of Urology (EAU) conference in Barcelona, Spain, March 15-19 2019.

This pan-European multicenter clinical study was designed to optimize and validate SelectMDx in assessing the risk of high-grade prostate cancer (PCa) in men with elevated prostate specific antigen levels (PSA). Data from the study showed that SelectMDx accurately predicts both low-risk as well as aggressive prostate cancer across all patient groups.

“This retrospective clinical validation study clearly confirms the value of the test to guide urologists to identify men at risk for aggressive disease, who may benefit from a biopsy or mpMRi procedure,” said Dr. Jack Schalken, Professor of Experimental Urology at the Radboud Medical Center in Nijmegen, The Netherlands. “The performance of SelectMDx in this multicenter study confirms previous published data for the intended use of the test.”

The study population consisted of 1,955 men from The Netherlands, France and Germany with suspected prostate cancer and who underwent initial prostate biopsies between December 2007 and December 2014.

Subjects were divided into training and validation cohorts. Post-DRE urine samples were collected from all subjects prior to biopsy and were evaluated with SelectMDx. The urinary RNA biomarkers were combined with other risk factors in a clinical model, and model coefficients were optimized for maximum sensitivity and negative predictive value (NPV) for > GG2 PCa in training cohort subjects with PSA <10 ng/mL. Version 2.0 of the Prostate Cancer Prevention Trial (PCPT) Risk Calculator was used for comparison.

For validation cohort subjects with PSA <10ng/mL (N=715), SelectMDx AUC was 0.82, sensitivity 89%, specificity 53% and NPV 95%, whereas the PCPTRC AUC was 0.70. SelectMDx performance for the full validation cohort (all PSA levels, N=916) was AUC 0.85, with sensitivity and NPV of 93% and 95%, respectively.

"These data provide further evidence of SelectMDx's ability to provide actionable results, which can help urologists making important clinical decisions," said Mike McGarrity, chief executive officer of MDxHealth. "In addition, we believe that routine implementation of SelectMDx could lead to substantial cost savings for healthcare systems and benefit patients by reducing the number of unnecessary invasive diagnostic procedures and treatments."

In France, Germany and The Netherlands combined, about 400,000 prostate biopsies are performed annually, resulting in about 115,000 newly diagnosed PCa patients per year. A recent cost-effectiveness study for SelectMDx in these countries where SelectMDx is used to stratify men for biopsy based on the probability of them harboring the aggressive form of PCa, showed cost savings per patient per year of $1,402 in France, $505 in Germany and $147 in the Netherlands.

On an annual basis the overall savings for the healthcare systems in these countries were respectively $184 million, $68 million and $3 million. In March 2018, SelectMDx was included in the EAU clinical guidelines, which assist clinicians in making informed treatment decisions. Since the introduction of SelectMDx in Europe in 2016, over 19,000 patients have been tested with SelectMDx.

Of the nearly 2 million prostate biopsies performed each year, less than a third identify cancer. Most of these men could have avoided a painful and invasive prostate biopsy procedure, with its associated complications and costs. SelectMDx for Prostate Cancer is a proprietary urine-based, molecular diagnostic test that offers a non-invasive liquid biopsy method to assess a patient's risk for prostate cancer. SelectMDx helps identify men at increased risk of harboring aggressive, potentially lethal, prostate cancer who may benefit most from a prostate biopsy and earlier detection. The test delivers a negative predictive value (NPV) of 98% for clinically significant disease, helping to reduce the need for MRI procedures and invasive prostate biopsies by up to 50%, thereby reducing healthcare costs. The test has been included in the 2018 European Association of Urology (EAU) clinical guidelines.

MDxHealth is a multinational healthcare company that provides actionable molecular diagnostic information to personalize the diagnosis and treatment of cancer.

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Annual SAARC diabetes conference discusses best practices, technical advancement to improve disease management

Leading endocrinologists from SAARC countries took part in the annual ‘SAARC Diabetes Conference’ held in New Delhi recently. The theme of the year’s conference was ‘Sharirmadyam Khalu Dharmasadhanam’ which emphasised on an individual’s responsibility to keep his body healthy.

The two-day annual conference, organised under the aegis of Dept. of Endocrinology and Metabolism at Sir Ganga Ram Hospital, is the only platform that brings leading medical experts from SAARC countries together to exchange best practices, update on latest products and other technical advancements that can aid in improving the overall management of diabetes.

Opened by Prof Surender Kumar, President of SAARC Diabetes Association, the conference was attended by leading endocrinologists from across the country including Dr V Mohan, Dr Nikhil Tandon and Dr Ambrish Mittal amongst other dignitaries. It was also attended by like-minded stakeholders and practitioners from SAARC countries who highlighted the progress made over the past year towards tackling diabetes in their respective regions as a result of focused awareness programmes undertaken.

“SAARC countries are among the highest populations of people with diabetes. This conference enables us to exchange key notes, progress and developments on improving the way diabetes is managed currently. In India specifically, ‘IMPACT India the 1000-Day Challenge’ provides a clear goal and direction for improving diabetes care by reducing HbA1c by 1 per cent over a 3-year period. This is the primary programme that can serve as a guide for other countries to learn from”, said Prof Surender Kumar, chairman, Department of Endocrinology and Metabolism, Sir Ganga Ram Hospital.

As per the 8th edition of IDF Diabetes Atlas, the incidence of diabetes in South East Asian countries was found to be over 82 million in 2017 which is expected to grow up to 151 million by the end of 2045. This clearly indicated that worldwide, there is a steady increase in the diabetes population owing to ignorance and sedentary lifestyle. Especially in the Indian sub-continent, the high incidence rate of diabetes, has led to a significant health burden. The lack of awareness and undiagnosed diabetes has paved way for the rise of various heart, kidney, eye and limb diseases.

“In India alone, 1 in 12 adults suffer from diabetes and over 11.2 lakh succumb to its complications. To combat this growing burden, the need of the hour is to burst myths and improve awareness on the need to manage diabetes betterby adopting a healthy lifestyle and being aware”, adds Dr Sudhir Tripathi, senior consultant, Department of Endocrinology and Metabolism, Sir Ganga Ram Hospital.

Under IMPACT India, the 1000 Day challenge, Novo Nordisk Education Foundation has taken an initiative to improve awareness and education amongst 150,000 practitioners and 10,000 paramedics through over 6,000 medical meetings and continuous medical education (CMEs) programmes. Novo Nordisk Education Foundation has also developed India Diabetes Care Index, a tool to track progress of diabetes care in India that provides a first ever real-time data on the state of diabetes care and the average blood sugar found in people living with diabetes. Currently, as per this index, the three-month average HbA1c level of people with diabetes in key cities is high against the recommended target of <7 per cent. Delhi is found to be at 8.53 per cent, Mumbai at 8.13 per cent, Chennai at 8.41 per cent and Kolkata at 8.24 per cent. India on the whole is found to be at an average HbA1c of 8.51 per cent.

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Rajasthan HC pulls up health ministry for delaying implementation of revised Clinical Establishments Amendment Rules 2018

The Rajasthan High Court has pulled up the Union ministry of health and family welfare for delaying the implementation of revised Clinical Establishments (Central Government) Amendment Rules, 2018 setting minimum standards for diagnostic laboratories.

The bench of justice Goverdhan Bardhar and justice Mohammad Rafiq on March 5, 2019 asked the ministry to notify revised Rules within four weeks and listed the matter for further hearing on April 8, 2019.

The bench ordered joint secretary of health ministry to appear in person before the court on the next hearing, if the ministry fails to implement the modified Rules.

On November 14, 2018 RD Rastogi, additional solicitor general, appearing for the ministry submitted that the revised draft notification on the basis of suggestions of a high power committee is under publication in gazette for inviting comments from public within a period of thirty days after which the notification will be finalised.

He appealed to the court to grant at least eight weeks’ time to place before it the amendments introduced to the aforesaid Rules.

Despite additional solicitor general’s submission, the ministry has not yet come out with a notification on revised Rules.

The ministry had on August 14, 2018 set up a committee to suggest modifications to the amended rules in compliance with the High Court order on May 30, 2018.

The High Court ordered the ministry to furnish reason why minimum qualification has not been prescribed for basic composite (small) laboratories in Clinical Establishments (Central Government) Amendment Rules, 2018 notified on May 18 last year.

The panel comprising principal scientific advisor to government of India as chairman, secretary (health), secretary (health research) and secretary (biotechnology) as members has already submitted its recommendations to the ministry.

As per the panel’s suggestion, medical tests should be undertaken on advice of a doctor. Interpretation of lab results or opinion there on when required, registered MBBS medical practitioner is essential. The authorized signatory will be liable for authenticity of the laboratory test report only, it recommended.

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Industry, regulator interaction needed for clarification on BA/BE submission norms

Even as the Central Drugs Standards Control Organisation (CDSCO) has set the ball rolling for BA/BE (bioavailability/ bioequivalence) submissions, the pharma and biotech industry in the country sees the need to re-engage with drug regulatory authority to clarify the said rules, said Dr. BR Jagashetty, former National Adviser (Drugs Control) to Union ministry of health and family welfare & CDSCO and former Karnataka Drugs Controller.

It was in January 2014, the CDSCO had released the draft guidance document to streamline the approval process for conducting BE and BA studies with human participants in India for export purposes. Later vide Gazette Notification No. GSR 327 dated April 3, 2017 amendment to various rules of Drugs and Cosmetics Rules have been carried out incorporating biopharmaceutical classification system (BCS) based on solubility & permeability and also making it mandatory for industry to submit the results of BE studies referred to in Schedule Y along with application for grant of a license of oral dosage form specified in Category II & IV of BCS.

But the issue is that although the State Licensing Authorities (SLAs) are empowered to approve the drugs, they are not trained in this specific area. Hence without training, the issuing of such amendments is of no use, Dr Jagashetty told Pharmabiz.

It is important that notifications coming from the CSDCO should be comprehensive and complete. In the instant case for grant of license by SLA, it is essential to classify the oral dosage form of drugs into Class II and IV drugs as per BCS and it is understood that the same is to be released yet. Also the inclusion of these drugs in the Indian Pharmacopoeia is also important with details of its testing methodologies etc, said Dr. Jagashetty.

Stating that there are also decision discrepancies on the BA/BE studies between DCC and DTAB, he said that a consensus was much-needed. For instance, during the 47th DCC meeting in July 2014, it was recommended as “BA/BE studies in respect of drugs manufactured in the country shall be insisted whenever there are issues relating to patient safety and variable bio-availability. As the infrastructure to conduct such studies is not uniformly available, it cannot be implemented as rule”.

However at the 72nd DTAB meeting of June 2016, it was recommended that submission of BE data should be made mandatory prior to grant of license for the manufacturing of drugs in the country and to begin with it may be made mandatory for Category II & IV drugs after classification as per BCS. For the drugs already marketed in India, three years time may be given of submission of BE studies. It was also mentioned to form a group to suggest modalities to identify the reference drug to conduct of BE studies, which is yet to be done it is learnt.

Therefore though CDCSO sets the momentum for BE submissions by notifying in the Gazette, the industry needs to re-engage with state regulators with proper training, to clarify rules, for proper list of Category II & IV, reference substances, test methods etc, said Dr. Jagashetty.

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Govt should frame healthcare mechanism to link clinical pharmacists with doctors and paramedics: Dr Mohan Kale

The Union government should frame a healthcare mechanism to link clinical pharmacists with doctors and other paramedical staffs. For this, the authorities need to take a policy decision which should suggest for engaging Pharm D qualified pharmacists to work as clinical pharmacists and look after pharmacovigilance (PV) activities.

There are PV centres in almost all the states which are currently controlled and the programmes are monitored and supervised by medical professionals. Pharm D pharmacists learn pharmacology, pathology and pharmacovigilance more than the MBBS graduates.

Therefore, the Pharm D pharmacists who are experts in the mechanism of drugs and their actions, need to be appointed as PV officers, commented Dr Mohan Kale, principal of Konkan College of Pharmacy, Mumbai.

In an interaction with Pharmabiz in Nagpur, Dr Kale has pointed out the drawbacks prevailing in the healthcare institutions with regards to medicine distribution and medication advice. He said without any knowledge in drugs or pharmacology, the nurses are giving medications to patients. In emergency cases also they are allowed to give medicines and that include scheduled category drugs also. The nurses have no knowledge about pharmacology or drug management. Such therapeutic anomalies happen in the institutions when qualified pharmacists are at hand.

“Except medical diagnosis, all other subjects in the medical sciences are learnt by a Pharm D student. The course is absolutely a patient oriented program and its syllabus is pharmacology based. A student of this doctoral program learns pharmacology and pathology more than a medical graduate. How do the nurses know pharmacology? Why they are allowed to give medicines even in emergency situations? They give even the scheduled drugs in some cases. It is high time for the healthcare managers stopped this practice when there are adequate number of qualified pharmacists who are drug experts. Today Pharm D pharmacists are available in our country and their knowledge and potential should be utilised in the healthcare system. A clinical pharmacist should be in every hospital to supervise medications and monitor adverse reactions,” said Dr Kale.

He said the Pharm D course was introduced in India for providing quality pharmacy services to the patient community. But government do not understand this fact. Government of India should frame a healthcare mechanism common to all states and union territories and in which the role of clinical pharmacists should be earmarked and linked with doctors, nurses and other paramedical staffs. He said the patients of today are very sensitive and they need reports of pharmacovigilance.

Regarding opportunities for Pharm D pharmacists, Dr Kale said the multinational companies should stop engaging medical professionals for writing and preparing literature on medicines. Most of the MNCs select MBBS graduates to look after their department of product management/medical affairs. The ideal candidates for preparing medical literature are Pharm D pharmacists.

He said he will give one representation to the next government to identify specific areas of services for Pharm D pharmacists in the healthcare system.

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NPPA reviews data from coronary stent makers, importers to revise ceiling price in accordance with WPI; current rates valid till March end

The National Pharmaceutical Pricing Authority (NPPA) has started reviewing sales data from coronary stent manufacturers and importers ahead of revising prices in accordance with the wholesale price index (WPI) of the previous year. The current ceiling prices are valid only till the end of this month.

In a circular issued last week, the national drug price regulator had directed firms to furnish details such as price to distributor or stockiest, category-wise maximum retail price (MRP) and the quantity sold in the last calendar year. Once finalised, the ceiling prices will be applicable to all coronary stents available for sale in the country’s trade channel including bare metal stents (BES) and drug eluting and bioresorbable vascular scaffold. After reviewing the sales data, the government is expected to hold discussions with industry stakeholders before arriving at the ceiling price for the next one year.

Last year, the government had marginally hiked the MRP of BES from Rs.7,260 to Rs.7,660 and slashed the price of drug-eluting stents (DES) and biodegradable stents to Rs.27,890 from Rs.29,600. After examining market statistics, the regulator was of the view that “cardiac stents, being an essential drug under Schedule I of DPCO 2013 and part of NLEM 2015 having paramount importance on public health, need to continue to be kept under price regulation in larger public interest”. The regulator has also refused to provide separate sub-category and higher ceiling price for latest-generation biodegradable stents despite several requests by multinational manufacturers. Biodegradable stents now have the ceiling price of DES only. The manufacturers are allowed to add goods and services tax and no other charges in the calculation of MRP, if they have actually paid such taxes or if it is payable to the government on the ceiling price specified.

The NPPA is considering stent price revision just weeks after a decision by the US administration to revoke its Generalised System of Preferences (GSP) tax concessions to India citing “trade barriers that create serious negative effects on United States commerce”. The Central government slashed prices of medical devices such as knee implants and coronary stents by up to 75 per cent to make them more affordable. The US has been pressing India not to extend these price caps. Last year, following petitions filed by US medical device manufacturers, the office of the USTR initiated a GSP benefits eligibility review of India, which has resulted later in withdrawal of concessions. Three US medical device majors – Abbott, Boston Scientific and Medtronic – had petitioned the US government through the industry association AdvaMed for withdrawing GSP benefits over the medical device pricing policy.

According to minister of state for chemicals and fertilisers Mansukh L. Mandaviya, the decision to fix stent ceiling prices has helped 10 lakh heart patients in India save around Rs.8,000 crore. Moreover, 1.5 lakh patients saved about Rs.2,000 crore since the price fixation of knee implants in August 2017.

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US FDA approves expanded indication for Abbott’s MitraClip device used to repair leaky mitral valve without open-heart surgery

Abbott announced it received approval from the US Food and Drug Administration (FDA) for a new, expanded indication to its leading MitraClip device used to repair a leaky mitral valve without open-heart surgery. Supported by the results of the landmark COAPT Trial, MitraClip is the first transcatheter mitral valve intervention therapy approved to treat select heart failure patients with clinically significant secondary, or functional, mitral regurgitation (MR).

The MitraClip transcatheter clip-based therapy, available in the US since 2013 and now on a third generation of product innovations, has been used to treat more than 80,000 patients worldwide over the last 10 years. The new, expanded indication addresses the secondary form of MR and significantly increases the amount of people with MR able to be treated with MitraClip. Based on this approval, Abbott will begin discussions with the Center for Medicare and Medicaid Services (CMS) and physician specialty societies to request a revision to the national coverage determination (NCD) that would expand Medicare coverage to include secondary MR patients.

“Since severe secondary MR is extremely difficult to manage and associated with a poor prognosis, people have historically had few options,” said Neil Moat, MD, chief medical officer of Abbott’s structural heart business. “The expanded indication of MitraClip opens new doors for these ailing patients and can improve their quality of life and chance of survival despite their complex condition.”

Approximately four million Americans suffer from MR, specifically one in 10 adults age 75 and older. It’s estimated two to three times as many patients may benefit from MitraClip treatment for secondary MR as a result of underlying heart failure than those treated for the primary (or degenerative) form of the disease associated with the structure of the valve.v People with heart failure may develop secondary MR when the left chamber of the heart becomes enlarged, preventing the mitral leaflets from closing normally and allowing blood to flow backwards through the heart.

Significant secondary MR can lead to reduced quality of life, recurrent hospitalizations and decreased survival. Medication alone is the current standard of care for most heart failure patients with secondary MR, but this approach only helps manage the symptoms and does not address the underlying cause. MitraClip is now an effective treatment option for these ailing patients.

The MitraClip device repairs MR without open-heart surgery and is delivered to the heart through a small incision in the leg. The device clips portions of the leaflets, or flaps, of the mitral valve together to reduce the backflow of blood, restoring the heart’s ability to pump oxygenated blood more efficiently. MitraClip provides almost immediate symptom relief and patients are released from the hospital on average after two days.

“Over the past decade, we have made significant and consistent investments to lead the development of novel treatments for mitral valve disease,” said Michael Dale, vice president of Abbott’s structural heart business. “The expanded indication for MitraClip is a direct result of the dedication of our employees as well as our remarkable clinical investigators.”

Abbott is the global leader in developing transcatheter mitral valve technologies as alternatives to open-heart surgery. Building upon its success with the MitraClip device and many years of mitral valve experience and clinical evidence, Abbott is leading the way in novel, transcatheter devices by investing in the development of new mitral valve replacement options with its Tendyne and Cephea valve technologies.

The COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) Trial investigated MitraClip for treating secondary MR, and the data add to more than 10 years of evidence on the use of MitraClip for treating both primary and secondary MR. While the secondary MR indication has just been received in the US, the device has treated patients outside of the US with both forms of the disease. COAPT met both primary and all 10 secondary endpoints as presented during the TCT cardiology meeting in Sept. 2018, showing a 47 per cent relative reduction in hospitalizations and a 38 per cent relative reduction in mortality.

The meaningful results showed that MitraClip was superior to medical therapy in reducing hospitalization and death for patients with severe secondary mitral regurgitation. In the COAPT Trial, 614 symptomatic heart failure patients with moderate-to-severe or severe secondary MR were randomized to receive treatment with MitraClip plus guideline-directed medical therapy or guideline-directed medical therapy alone at 78 sites in the US and Canada. The primary efficacy endpoint was all heart failure hospitalizations through two years, and the primary safety endpoint was freedom from device-related complications at one year compared to a performance goal of 88 per cent.

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CTMR to conduct series of workshops to identify qualified siddha practitioners & recognize bona fide method of treatment

In order to identify and recognize bona fide method of Siddha treatment and filter factitious healing by quacks claiming traditional methods, the Centre for Traditional Medicines and Research (CTMR), an NGO working for the welfare of Siddha system in Chennai, is starting a series of workshops across the state from March 23.

The first in the series will be conducted at CPR convention centre in Alwarpet in the city on Saturday, 23rd March. The program is conducted in association with CPR Environmental Education Centre, Chennai. The workshops are conducted mainly to educate those who do not understand Tamil language and wish to follow Siddha system.

CTMR, which was in a dormant state for the last two-three years, has revived its activities recently with multiple programs with the support of central and state ayush ministries, sources informed. According to Dr. T Thirunarayanan, secretary of the Centre, advertisements by quacks in print and visual media make it difficult for the common man to identify the qualified and registered Siddha physicians. Very often people are misguided by advertisements making fake claims. Against this, CTMR has decided to provide right understanding about Siddha medicines, registered centres and qualified practitioners.

“Siddha system of medicine is an ancient system of well codified indigenous system of medicines practised over 2000 years in India. Its literature is only in Tamil. People from other states and countries living in the metro city of Chennai find it difficult to understand its basics, its approach to disease free life, health promotion and for what clinical conditions the system can be used. The workshops are meant for their benefits”, said Dr. Thirunarayanan.

He said even people living in Tamil Nadu have confusion between home remedies and Siddha system, which has a strong basic concept on which it was built on. The flooding of information on the benefits of various herbs, food and practices and tall claims in the social media further confuse people.

The workshops will cover the basic principles of siddha, health promotion practices, cultivation of medicinal plants and utility, healthy food and lifestyle, safe and natural personal care products. There will be four sessions from 9 AM to 6 PM. Siddha experts with exposure to various ethnic groups’ lifestyle and health issues will conduct the workshops.

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European Commission approves Roche’s MabThera (rituximab) for a rare autoimmune disease

Roche announced that the European Commission has approved MabThera (rituximab) for the treatment of adults with moderate to severe pemphigus vulgaris (PV), a rare condition characterised by progressive painful blistering of the skin and/or mucous membranes. Extensive blistering can lead to serious, life-threatening fluid loss, infection and/or death.

MabThera is the first biologic therapy approved by the European Commission for PV and the first major advancement in the treatment of the disease in more than 60 years. Following approval by the US Food and Drug Administration (FDA) in June 2018 and today’s decision, MabThera is now approved to treat four autoimmune diseases in the US and Europe.

“We’re pleased to bring the first biologic medicine to the more than 50,000 people in Europe suffering from pemphigus vulgaris,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “This MabThera approval provides a much needed new treatment that has been shown to provide higher remission rates than corticosteroids alone, which can cause debilitating side effects.”

The European approval is based on data from the phase III Ritux 3 trial, a Roche-supported randomised controlled study, conducted in France, which evaluated MabThera plus a tapering regimen of oral corticosteroids (CS) compared to a standard dose of CS alone, as a first-line treatment in patients with newly diagnosed moderate to severe pemphigus. The primary endpoint of the study was complete remission at month 24 without the use of CS for two or more months. The study demonstrated that 89.5% of people with PV treated with MabThera, in combination with short-term oral CS treatment, achieved complete remission without the use of CS for two or more months, compared to 27.8% of people with PV receiving CS alone, the current standard of care. The results of the Ritux 3 trial were published in The Lancet in March 2017.

The Roche-sponsored phase III multicentre, randomised, double-blind PEMPHIX study, evaluating the efficacy and safety of MabThera compared with mycophenolate mofetil (MMF), an immunosuppressant, in patients with moderate to severe PV, is ongoing.

Recently, an international panel of experts, the International Bullous Disease Group, published new recommendations on the diagnosis and management of pemphigus in the Journal of the American Academy of Dermatology, and recommended the use of an anti-CD20 monoclonal antibody, such as MabThera combined with a tapering regimen of oral CS, as a first-line therapy option for moderate to severe pemphigus.

Pemphigus vulgaris is an autoimmune, blistering disease, occurring within the epidermis, affecting the skin and mucous membranes. It is the most common type of a group of autoimmune disorders collectively called pemphigus. It is estimated that around three in every 100,000 people are diagnosed with this disease globally.

Ritux 3 is a Roche-supported phase III, prospective, multicentre, parallel-group, open-label randomised trial (NCT00784589), conducted in France by the French Study Group on Autoimmune Bullous Diseases. It was designed to evaluate MabThera plus a tapering regimen of oral corticosteroid (CS) treatment compared to a standard dose of CS monotherapy as a first-line treatment in patients with newly diagnosed moderate to severe pemphigus. The primary endpoint of the study was complete remission at month 24 without the use of corticosteroids for two or more months.

A phase III, randomised, double-blind, double-dummy, active-comparator, parallel-arm multicentre study (PEMPHIX, NCT02383589), designed to evaluate the efficacy and safety of MabThera compared with mycophenolate mofetil (MMF), an immunosuppressant, in patients with moderate to severe active pemphigus vulgaris requiring 60-120 mg/day oral prednisone (or equivalent).

MabThera (Rituxan in the US) in combination with methotrexate is indicated for the treatment of adults with severe active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs (DMARD) including one or more tumour necrosis factor (TNF) inhibitor therapies. MabThera/Rituxan, in combination with glucocorticoids, is indicated for the treatment of adults with severe, active granulomatosis with polyangiitis (Wegener’s, GPA) and microscopic polyangiitis (MPA). People with serious infections should not receive MabThera/Rituxan. It is not known if MabThera/Rituxan is safe or effective in children.

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Ayush ministry’s plan to introduce Aadhaar-based attendance system for ASUH college staff faces legal wrangle

The Ayush ministry’s move to introduce an Aadhaar-based attendance system in Ayurvedic, Siddha, Unani and Homoeopathic (ASUH) colleges has run into legal wrangle. The Delhi High Court has issued a notice to the ministry on a petition filed by Uttranchal Ayurvedic College challenging the move. The court has also sought the ministry’s response over a decision to make local recruitment of staff mandatory.

The petitioner argued that the ministry had passed several directions, including the conduct of inspections in ASUH colleges, which have been granted permission for five years. The ministry is bound to comply with the minimum standard regulation notifications, which provided a detailed procedure for granting permission to medical colleges in the country. It was further argued that the said notifications could not have been circumvented by way of an administrative order. As per law, colleges which have been granted permission for five years cannot be inspected unless there is a serious complaint against them.

It was also argued that the ministry’s direction to implement Aadhaar-enabled geo location-based bio-metric attendance system for faculty of the colleges was in clear violation of the Constitution bench judgment passed in KS Puttaswamy Vs Union of India.

The government’s innovative Aadhar-based geo-location enabled attendance system for teaching and non-teaching staff has not been going well as planned over privacy and security issues. Since Aadhaar is linked across databases, the step could give any company building database an insight on someone’s daily activity, its critics say.

The ministry sought time while submitting that the directions under challenge were tentative in nature and no final decision was taken on the same. The next hearing in the matter is listed for March 27.

It may be noted that the Central government has been tweaking norms to promote education in traditional systems of medicine. Apart from the Adhar-based attendance system, the new initiatives include National Eligibility Entrance Test for admission to all Ayush educational institutions for undergraduate and post-graduate courses and Ayush National Teachers Eligibility Test to select qualified teachers.

For the academic year 2018-19, the ministry has revised the timeframe to fast-track the permission process for opening new Ayush colleges. Henceforth, applications under 12A of Homoeopathy Central Council Act 1973 and 13A of Indian Medicine Central Council Act should reach the government for approval between July 1 and August 31 of any year. The government should forward eligible applications to Central Council of Homeopathy or Central Council of Indian Medicine for technical scrutiny by September 30. The councils should provide its recommendations by March 31 and the ministry will arrive at a final decision by May 31.

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Ascent Meditech embarks on Rs.70 crore expansion plan to achieve four times growth in next five years

Aiming to grow four times in the next five years, Ascent Meditech, a Mumbai-based leading player in orthopedic soft goods (OSG), mobility, wound-care and healthcare products, has embarked on a Rs.70 crore expansion plan to set up a state of the art integrated manufacturing plant spread over 15-acre land in South Gujarat.

The plant will be operational by Q1 in fiscal 2020-21 and is expected to increase the production of orthopedic soft goods, mobility, wound-care and healthcare products to around 2 lakh units from the existing 40,000 pieces at five plants in Daman to cater to the growing demands in domestic and global markets, said Rajiv Mistry, founder and managing director, Ascent Meditech Limited.

The company, which currently has more than 350 products under the Flamingo brand, has raised growth capital of Rs.70 crore from the UK-based private equity player LeapFrog which will be utilized to set up advanced manufacturing facility, he informed.

The plant will comply with regulatory norms governing all medical devices from April 2020 and help the company overcome the capacity constraints, he said, adding that as of now certain products in wound care segment are regulated under Medical Devices Rules 2017 but orthopaedic soft goods are unregulated.

The orthopaedic soft goods market is highly unorganized in the absence of regulations thus hampering the growth of the segment.

Currently, OSG industry in India is estimated to be worth Rs.2,000 crore growing at a rate of 15-18% annually but we are growing at 35% CAGR over last 27 years. Our current turnover stands at Rs.140 crore. Of them, export constitutes 20% of the turnover. The company exports products to 47 countries including UK, Canada, Australia, he stated.

Talking about changing trend in OSG segment, Mistri said “Earlier critical patients used OSG on the advice of medical practitioners. Now people started buying OSGs for pain management on their own thus fueling the growth of the segment. An OSG can be used in injuries caused by fractures, muscle pain, and other orthopedic complications. The industry is at a nascent stage and that awareness can help increase user base.”

Shedding light on business prospects, he said “The aim of the company is to make product affordable and exploit the untapped potential of Asian, African markets. We want to reach out to emerging markets having higher population to reap benefits. We will soon foray into sports, fitness and mobility products in a big way.”

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NR Group opens mindfulTMS Neurocare centre in Bengaluru to treat mental illnesses; to invest Rs.25-cr for expansion in India & abroad

The Mysuru-based NR Group has recently opened its mindfulTMS Neurocare centre in Bengaluru which will offer the US FDA-approved Transcranial Magnetic Stimulation (TMS) to treat and control depression, Obsessive Compulsive Disorder (OCD), anxiety, mood syndrome and addiction.

The Bengaluru centre is the second facility of the NR Group Rangsons Healthcare which brought to India the much-needed holistic approach to treat mental illnesses with the US FDA-approved TMS. Its first facility in New Delhi reported 100 patients accessing for the treatment protocol.

The Bengaluru centre was inaugurated by Dr. Ajit Bhide, past president, Indian Psychiatry Association. He said that entry of corporate players into the mental healthcare space and coverage of TMS for depression, OCD and addiction coming in from Ayushman Bharat and Oriental Insurance with many more health insurance players to enter the fray indicates a significant transformation in the space.

By 2020, mindfulTMS Neurocare centre plans to have 12 clinics in India and 22 clinics globally. “Going by the success at the New Delhi clinic, we are confident to replicate a similar effort in Bengaluru. Our future growth is envisaged in 3 phases. There will be six clinics in the first phase. The second will have 25 centres and our game-plan for the third phase is to opt for a franchisee model. Efforts to duplicate the model in the EU, UAE are also on the cards. For these an investment between Rs.25-30 crore is being allocated from internal accruals. At a later stage, assistance from venture capitalists and private equity could be considered,” Pavan Ranga, MD, Rangsons and Managing Partner, NR Group told Pharmabiz on the sidelines of the clinic opening event.

Going by the technology’s capability and the research papers that endorse TMS customized treatment protocols that have yielded successful results to treat mental illnesses over time, we will create awareness about mental illnesses and help patients to bounce back to their normal self. There are several clinical studies conducted in India across NIMHANS, Bengaluru, Central Institute of Psychiatry, Ranchi and AIIMS, New Delhi which have proved TMS as an effective non-drug based treatment option or an adjunct therapy for depression with no side-effects, said Dr Vijay Mehtry, Consultant Psychiatrist, mindfulTMS Neurocare.

Our psychiatrists and psychologists are trained in best practices to develop personalized treatment plans for each patient. A TMS session which lasts about 19 minutes and the accelerated version lasts about 9 minutes enables patients resume their normal daily activity immediately. Globally, TMS has evolved and is prescribed to Parkinson’s disease, post-stroke and post-natal depression. It has also been effective in patients where antidepressants may have worked only partially, added Dr. Mehtry.

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Pharmexcil to organise India Pavilion at Korea Pharm & Bio to explore market for APIs, chemicals, lab & packaging materials

The Pharmaceuticals Export Promotion Council of India (Pharmexcil) is all set to explore the Korean pharmaceutical markets for securing new sources of API imports and at the same time giving a boost to the Indian exports of generic drugs, laboratory equipments and packaging materials to the Korean market. As part of this initiative, the Council is planning to organise an India Pavilion at Korea Pharm & Bio event to be held at Korea International Exhibition Centre (KINTEX) in Goyang, South Korea from 16-18 April, 2019.

Korean Pharm & Bio is mainly focused at exhibiting Active Pharmaceutical Ingredients (APIs), chemicals, laboratory related agents and equipments and packaging materials. After China and Japan, South Korea is the next very important market having great potential for improving pharmaceutical businesses in the Asia Pacific region and therefore Pharmexcil wants to take this opportunity to help its members explore the South Korean Peninsula.

“Not just exploring the export potential to the South Korean markets, we are also looking at our members to be able to build a strong business networking with Korean players who would be supplying us with high end advanced laboratory and packaging materials for the Indian markets. This apart we feel Korea is a having a strong potential for Indian players to supply affordable high quality generics,” said Udaya Bhaskar, Director General of Pharmexcil.

Pharmexcil is organising an India Pavilion at Korea Pharm & Bio with an objective to create more awareness about the Korean industry and local pharmaceutical associations among the Indian players and at the same time exhibit various innovative Indian pharmaceutical products to the Korean markets. This is the only exhibition supported by KFDA and Korea pharmaceutical industry.

The council is also offering the member participants to avail assistance through the Marketing Assistance Initiative (MAI) scheme of government of India. To avail this the eligibility condition is that the members should have an export turnover less than Rs.30 crore for the previous financial year and they should have also completed one year of membership period with Pharmexcil. “As part of MAI scheme member players having a turnover of less than Rs.30 crore in the previous year will be eligible to have assistance of Rs.70,000 towards air fare,” informed the Pharmexcil DG.

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Merck gets European approval for Keytruda in combo with chemotherapy to treat adults with metastatic squamous NSCLC

Merck, announced that the European Commission has approved Keytruda, the company’s anti-PD-1 therapy, in combination with carboplatin and either paclitaxel or nab-paclitaxel, for the first-line treatment of adults with metastatic squamous non-small cell lung cancer (NSCLC). This approval is based on data from the phase 3 KEYNOTE-407 trial, which demonstrated that Keytruda in combination with chemotherapy significantly improved overall survival (OS) in adults with metastatic squamous NSCLC regardless of PD-L1 tumour expression status, reducing the risk of death by 36 percent compared to chemotherapy alone (HR=0.64 [95% CI, 0.49-0.85]; p=0.0008).

“In KEYNOTE-407, first-line treatment with Keytruda in combination with chemotherapy resulted in significant improvements in overall survival for patients with metastatic squamous non-small cell lung cancer, regardless of PD-L1 expression,” said Dr. Luis Paz-Ares, chair of the medical oncology department, Hospital Universitario Doce de Octubre, Madrid, Spain. “Lung cancer is the leading cause of cancer death in Europe, so this approval marks an important milestone for the patients and families facing this difficult-to-treat type of lung cancer.”

The approval allows marketing of the Keytruda combination in all 28 EU member states plus Iceland, Lichtenstein and Norway, at the approved dose of 200 mg every three weeks until disease progression or unacceptable toxicity.

In NSCLC, Keytruda is also approved in Europe for the: First-line treatment of metastatic nonsquamous NSCLC in combination with pemetrexed and platinum chemotherapy in adults whose tumours have no EGFR or ALK positive mutations (KEYNOTE-189); First-line treatment of metastatic squamous or nonsquamous NSCLC as monotherapy in adults whose tumours have high PD-L1 expression (tumour proportion score [TPS] =50%) with no EGFR or ALK positive tumour mutations (KEYNOTE-024); and Treatment of locally advanced or metastatic NSCLC in adults whose tumours express PD-L1 (TPS =1%) and who have received at least one prior chemotherapy regimen (KEYNOTE-010).

“Keytruda provides a foundation for the treatment of lung cancer in Europe, and this approval expands our first-line combination indications to include adults with metastatic squamous non-small cell lung cancer,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “This is a meaningful treatment advance as an anti-PD-1 combination therapy is now approved in Europe for this type of non-small cell lung cancer. With this approval, more patients with non-small cell lung cancer may have the opportunity to benefit from combination therapy with Keytruda.”

In KEYNOTE-407, Keytruda in combination with carboplatin and either paclitaxel or nab-paclitaxel significantly improved OS, reducing the risk of death by 36 percent compared to chemotherapy alone (HR=0.64 [95% CI, 0.49-0.85]; p<0.0008). The Keytruda combination also demonstrated improved PFS, with a reduction in the risk of progression or death of 44 percent compared to chemotherapy alone (HR=0.56 [95% CI, 0.45-0.70]; p<0.0001). Among patients who received the Keytruda combination, the ORR was 58 percent (95% CI, 52-64) compared to 38 percent (95% CI, 33-44) for patients who received chemotherapy alone (p<0.0001). The median DOR was 7.7 months (range, 1.1+ to 14.7+ months) for patients who received the Keytruda combination compared to 4.8 months (range, 1.3+ to 15.8+ months) for patients who received chemotherapy alone.

Lung cancer, which forms in the tissues of the lungs, usually within cells lining the air passages, is the leading cause of cancer death in Europe and worldwide. In 2018, there were nearly 388,000 deaths from lung cancer in Europe. The two main types of lung cancer are non-small cell and small cell. NSCLC is the most common type of lung cancer, accounting for about 85 per cent of all cases. There are several subtypes of NSCLC, including adenocarcinoma (accounting for 40% of lung cancers), squamous cell carcinoma (25 to 30%) and large cell carcinoma (10 to 15%).

Keytruda is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumour cells. Keytruda is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumour cells and healthy cells.

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Researchers find therapeutic efficacy of leaf extracts of senna, radish in tackling type-2 diabetes

A new study conducted by two Gujarat-based researchers has shown that leaf extracts of senna and radish have therapeutic potential to tackle type-2 diabetes and substantially reduce hyperglycemia. The research, done successfully on animal models, would be a boost to global efforts to develop an effective anti-diabetic herbal medication.

While the World Health Organisation (WHO) has declared that type-2 diabetes will be the seventh leading cause of death by 2030, the adverse effects associated with currently available synthetic anti-diabetic drugs are a matter of concern for researchers worldwide. Against this backdrop, traditionally used herbal medicines are getting increased attention globally. The experimentation, conducted by Deepti Kaushalkumar Jani of Barbaria Institute of Pharmacy and Sunita Goswami of LM College of Pharmacy, has proved that leaves of senna (cassia angustifolia) and radish (raphanus sativus) possess antioxidant, antihyperlipidemic and antihyperglycemic properties. The results were published last week in an international peer-reviewed journal for traditional and complementary medicine.

“Our study has successfully evaluated the anti-diabetic activity of senna and radish leaf extracts in high-fat diet and low dose streptozotocin-induced diabetes mellitus”, Jani told Pharmabiz in a telephonic interview. “Many studies have done in the past in search of new herbal drugs to treat diabetes. However, the lack of sufficient research on the effectiveness of raphanus sativus and cassia angustifolia leaf extracts as treatment option in diabetes indicates need for evaluation of anti-diabetic potential of these herbs”, she pointed out.

The study, conducted on female Sprague-dawley rats, was in accordance with the Committee for the Purpose of Control and Supervision of Experiments on Animals guidelines issued by the government of India. The leaves were procured by field collection and authenticated at KNK College of horticulture in Madhya Pradesh. “Our phytochemical analysis revealed the presence of various bioactive phytoconstituents in both extracts. Both contain flavonoids, plant pigments that possess antihyperglycemic, antiobesity and antioxidant activity. Presence of these constituents in the extracts of study plants strongly supports their synergistic effect for the treatment of diabetes,” Jani said.

Type-2 diabetes is often associated with dyslipidemia or abnormal amount of blood lipids. Chronic dyslipidemia leads to lipid deposition and pancreatic lipotoxicity, thus impairing insulin secretion and promoting the progression of the disease. According to the present research paper, reviewed by Pharmabiz, supplementation with leaf extracts is observed to reduce dyslipidemia significantly. The treatment also showed trend of increase in High Density Lipoprotein level in a dose dependent manner.

According to the researcher, there is enough evidence that extracts of these leaves can retard the risk of complications due to chronic hyperglycemia. “The beneficial effects of both the extracts in diabetes can be attributed to the synergistic effects of its bioactive compounds. Now we need to further explore the efficacy and toxicity of these extracts during long-term use,” Jani added.

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UP DCA makes linking of Aadhaar of pharmacists with sale licences mandatory to prevent renting out of certificates

Aiming to end the malpractice of renting out of certificates by pharmacists to medical shop owners who operate their outlets without engaging pharmacists in the shops, the Uttar Pradesh drugs control administration (UP DCA) has made it mandatory to link Aadhaar number of pharmacist with sale licences. The UP DCA’s decision comes in the wake of an order from Allahabad High Court in this regard last year.

With this, no pharmacist can rent out his certificate to another shop and no shop owner can run a medical store without engaging a pharmacist.

While applying for fresh licenses or for retention, the medical shop owner/applicant must mention the Aadhaar number of the pharmacist in the application form. Even as it has been made mandatory for fresh licenses, the existing licence holders must also share their pharmacists’ Aadhaar with the concerned office of the department within the specified time limit, says AK Jain, state controlling and licensing authority of UP DCA.

“It was made effective soon after the order came and the process is on the portal. Within a specified time, the existing shops too need to register the Aadhaar numbers of their pharmacists. But it is difficult to identify and collect all of them. We are giving instructions to all. There are 76,933 retail pharmacies in the whole state,” said the DC.

The association of pharmacists had earlier filed a case with the court against running pharmacies without pharmacists and renting out certificates by pharmacists to medical shop owners who operate their outlets without engaging pharmacists in their shops. In the judgment, the court ordered the drug control department to ensure presence of pharmacists in the medical shops and link their Aadhaar numbers with the sale licence register. This will help to stop renting out one’s certificate to other medical stores.

Jain said the department has already started the process of including Aadhaar numbers and it is included in all applications receiving online and offline. Instruction has been given to the existing retail shop owners to follow the process at the earliest.

Talking about the enforcement activities, he said the department has issued 3,815 restricted retail licenses, 20 A and 21 A, under Schedule K and in these premises presence of pharmacists is not required always. The shop can sell a selected list of medicines. Along with the licence, the list of medicines is also given.

Regarding digital services, Jain said applications for fresh sale licence and for retention are accepted online and certificates are issued within 24 hours by the ADCs. In the next three months, manufacturers can also apply online, for that a software is being developed. In the case of medical devices, all registration processes are done paperless.

Talking to Pharmabiz, the UP DC claimed that Uttar Pradesh is the state with highest number of Jan Aushadhi Stores which are run by registered pharmacists only. Medicines to these stores are supplied by BPPI. He said Jan Aushadhi Stores can develop much more provided other manufacturing companies are also allowed to supply for them.

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CDSCO issues draft notification to notify inland container depot Dhannad, Indore for drug imports

Close on the heels of addition of Kamrajar Port and Mundra Port to the list of ports earmarked for import of drugs, the government has notified inland container depot Dhannad, Indore for this purpose which will significantly reduce the cost and time of drug companies importing pharmaceutical products in Madhya Pradesh.

Currently, only export of pharmaceutical products are allowed from this inland container depot. With this, pharmaceutical products which will be imported to India can be transported to the inland container depot, Dhannad from sea ports such as Nhava Sheva port, Kamrajar Port and Mundra Port etc for clearance.

The inland container depot is expected to generate Rs. 5,000 crore business annually in coming years.

As per a draft notification issued by CDSCO on March 11 after consultation with the Drugs Technical Advisory Board, the words “Inland Container Depot Dhannad, Indore in Madhya Pradesh” have been inserted after the words “Mundra Port in Gujarat” in rule 43A in Drugs and Cosmetics Rules, 1945. This would enable import of drugs by inland container depot into Madhya Pradesh.

Welcoming the draft notification designating inland container depot Dhannad for import of drugs, Himanshu Shah, president of MP Small Scale Drug Manufacturers Association, said “We have been demanding this for a long time. This will benefit around 400 drug companies located in MP especially MNCs in Pithampur special economic zone. The drug units can import vaccines, pharmaceutical raw materials in small quantity at comparatively lesser cost”.

Besides the drug industry, traders will also be benefited from this initiative. We have also demanded that Indore international airport which currently handles air cargo of pharmaceutical products meant for exports should also be allowed to handle imported drug consignments, he said.

Earlier on January 10 this year, CDSCO had issued gazette notification adding Kamrajar Port and Mundra Port in rule 43A.

Rule 43A states that no drug shall be imported into India except through one of the following places, namely: Ferozepore Cantonment and Amritsar Railway Stations: In respect of drugs imported by rail across the frontier with Pakistan.

Ranaghat, Bongaon and Mohiassan Railways Stations: In respect of drugs imported by rail across the frontier with Bangladesh.

Petrapole Road in West Bengal, Sutarkandi in Assam, Old Raghna Bazar and Agartala in Tripura: In respect of drugs imported by Road from Bangladesh.

Raxaul: In respect of drugs imported by road and railway lines connecting Raxaul in India and Birganj in Nepal

Chennai, Kolkata, Mumbai, Cochin, Nhava Sheva, Kandla and Inland Container Depots at Tuglakabad and Patparganj in Delhi and Tuticorin in Tamil Nadu and Marmugao port in Goa and Visakhapatnam in Andhra Pradesh: In respect of drugs imported by sea into India.

Chennai, Kolkata, Mumbai, Delhi, Ahmedabad, Hyderabad, Goa, Bengaluru and Visakhapatnam: In respect of drugs imported by air into India.

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Healthium Medtech scouts for frugal engineering driven start-ups to spur future growth; gets fund infusion of US$ 5 mn

Healthium Medtech is setting up a network to collaborate with start-ups by giving them commercial access and working with them to build ideas into products. The company, known for its wound closure Sterispon in the surgical market, has now envisaged expansion in the consumable space to increase its presence in urology after it slated a specific investment of US$ 5 million. Plans are underway to set new line at its existing plant in Kunigal, on the outskirts of Bengaluru.

“India is the hub of frugal engineering. We are looking at tie ups with International and European firms to start importing energy devices in the next six months. The process of evaluating some joint ventures with international companies for technology transfer to bring their inventions to Indian market and provide patients with a larger variety of products is on,” Anish Bafna, CEO, Healthium Medtech told Pharmabiz.

The country today is still heavily reliant on imports for over 80% of its medical device needs. It is here, we see that the medical device policy 2018 will play a critical role to give a fillip to domestic manufacturers and reduce imports. In addition, the policy also encourages high quality manufacturing with a specific focus on innovation, he added.

Dedicated hubs like the Andhra Pradesh Med Tech Zone would help create a larger ecosystem for medical devices companies to collaborate in launching new products, increase access to new geographies and enable synergistic product development. Moreover, the country has over 100 start-ups in the medical devices space focused on launching on innovative technologies/products in the local market. Developments in the space of bio-enhancement, Robotics, 3D printing are likely to be the key drivers going forward. We are actively nurturing such start-ups to develop new technologies/products, said Bafna.

It is here Ayushman Bharat takes the centre-stage in the government healthcare space. This along with the Make in India policy will see a lot of Indian companies be able to provide effective and accessible med-tech solutions, he said.

The company has three product categories: wound closures, consumables and minimally invasive solutions. Specific to urology is the Urilite range for intermittent to long term urine drainage. The silicone catheter is designed for long term in-dwelling period and superior patient comfort. The Suprapubic Catheterization Kit is for urine drainage from bladder during urethral infections. The TUR Set is for irrigation during endoscopic TUR procedure and the Nelaton Catheter for intermittent urine drainage.

The Bengaluru-based company is known for its Sterispon an off-white, non-elastic, porous and pliable gelatin sponge is most sought after by surgeons. Due to the sponge’s porosity, blood platelets are trapped which controls further bleeding. The sponge is known to expand. So special care is required when placing in a cavity or in closed tissue spaces. Therefore it is recommended to be used only by surgeons across neurology, orthopaedics and dental among others. Sterispon complies with US pharmacopoeia standards. It is neutral pH, bio-compatible, non-toxic and non-allergic in nature.

The company already sells Haemostats in the global market where its product CliniCel is sold across multiple geographies, said Bafna.

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Centre approves continuation of NACP-IV beyond 12th Plan for 3 years from April 2017 to March 2020

The Central government has given its approval for continuation of National AIDS Control Programme-IV (NACP-IV) beyond 12th Five Year Plan for a period of three years from April, 2017 to March, 2020. The total outlay will be Rs. 6,434.76 crore.

The benefit of this programme will be that more than 99% of population will be kept HIV free; more than 70 lakh of key population covered annually through a comprehensive HIV prevention programme; and around 15 crore of vulnerable population (including five crore pregnant women) will be tested for HIV in three years of project. Besides, two crore 32 lakh units of blood will be collected at NACO’s supported blood banks during this three-year project. Two crore 82 lakh episodes of sexually transmitted infections will be managed under this project during three years of the project and seventeen lakh of PLHIV will be put on free anti-retroviral treatment by the end of project period.

The main objectives of NACP IV included reduction of new infections by 50 per cent (2007 Baseline of NACP III) and providing comprehensive care and support to all persons living with HIV/AIDS and treatment services for all those who require it.

The strategies worked out to achieve these goals include intensifying and consolidating prevention services with a focus on high-risk groups and vulnerable population and general population. Other strategies are expanding Information, Education and Communication (IEC) services for general population and High-Risk Groups (HRGS) with a focus on behaviour change and demand generation, increasing access and promoting comprehensive care, support and treatment (CST), building capacities at national, state, district and facility levels, and strengthening Strategic Information Management Systems.

In 1992, the Government launched the first National AIDS Control Programme (NACP I) and in 1998 NACP II was initiated. Based on the learning from NACP I and II, the government designed and implemented NACP III (2007-2012) with an objective to “halt and reverse the HIV epidemic In India” by the end of the project. There is a steady decline in overall prevalence and nearly 50 per cent decrease in new infections over the last ten years. NACP IV aims to consolidate the gains of NACP III.

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US FDA approves Roche’s Ventana PD-L1 Assay as first companion diagnostic to identify TNBC patients eligible to treat with Tecentriq in combo with Abraxane

Roche announced US Food and Drug Administration approval of the Ventana PD-L1 (SP142) Assay as the first companion diagnostic to aid in identifying triple-negative breast cancer (TNBC) patients eligible for treatment with the Roche cancer immunotherapy Tecentriq (atezolizumab) 3 plus chemotherapy (Abraxane [paclitaxel protein-bound particles for injectable suspension (albumin-bound); nab-paclitaxel]). Assessment of PD-L1 biomarker status on tumour-infiltrating immune cells with the assay is essential for identifying those patients most likely to benefit from the treatment.

A diagnosis of triple-negative breast cancer means that the three most common proteins associated with breast cancer growth – estrogen receptor, progesterone receptor and HER2/neu – are not expressed on the tumour.

“Triple-negative breast cancer is an aggressive disease that, until now, has had limited treatment options,” said Michael Heuer, CEO of Roche Diagnostics. “This assay plays a pivotal role in helping physicians identify patients that can benefit from Tecentriq therapy, providing better patient care. At Roche, we build on our capacity to research both targeted medicines and companion diagnostics under one roof, so we can provide the right treatment to the right patient at the right time.”

The Ventana PD-L1 (SP142) Assay was developed to enhance visual contrast of tumour-infiltrating immune cell staining. In triple-negative breast cancer, PD-L1 is primarily expressed on tumour-infiltrating immune cells rather than on tumor cells themselves.

Launched in 2016, the Ventana PD-L1 (SP142) Assay is the primary diagnostic assay within the Tecentriq clinical development program and was used to enroll and stratify patients in Tecentriq clinical trials. The assay was the first to evaluate patient PD-L1 biomarker status using immune cell staining and scoring within the tumor microenvironment.4

The IMpassion130 study is a phase III, multicenter, randomized, double-blind study evaluating the efficacy, safety and pharmacokinetics of Tecentriq plus nab-paclitaxel compared with placebo plus nab-paclitaxel in people with unresectable locally advanced or metastatic triple-negative breast cancer who have not received prior systemic therapy for metastatic breast cancer (mBC).

Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T cells. Tecentriq has the potential to be used as a foundational combination partner with cancer immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers.

Tecentriq is already approved in the European Union, United States and more than 85 countries for people with previously treated metastatic NSCLC and for certain types of untreated or previously treated metastatic urothelial carcinoma (mUC). Tecentriq was also recently approved in the United States for the initial treatment of people with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumour aberrations and for the treatment of PD-L1 positive, metastatic triple-negative breast cancer.

Karnataka to conduct CBT again on March 25 despite case being subjudice in Supreme Court

With around 160 candidates already having passed out the competency based test (CBT), the Karnataka Department of Medical Education (DME) would again be conducting CBT again on March 25, 2019 much against the wishes of radiologists in the country under Indian Radiological and Imaging Association (IRIA).

Karnataka chapter of IRIA had made representation recently to the state health ministry to take reasonable action on the ongoing Union health ministry mandated six months training (SMT) course followed by CBT in the state as the matter is still subjudice in the Supreme Court (SC).

As per SMT rules, CBT is conducted after the registered medical practitioner (RMP) undergoes six months SMT training course as mandated.

Union health ministry has mandated SMT course for RMPs to carry out ultrasound procedures in the state as per SMT Rules, 2014. A notice to this effect was circulated in medical colleges across Karnataka .

The Directorate of Medical Services (DMS) Madhya Pradesh has also issued an order saying that registration of all sonologists in the state will be renewed subject to results of CBT. DMS Madhya Pradesh is the state authority to implement the Pre-Conception and Pre-Natal Diagnostic Techniques (Prohibition Of Sex Selection) Act (PCPNDT Act) in the state.

SMT Rules 2014 stipulate RMPs to be eligible for performing ultrasound test after undergoing a SMT course known as the Fundamentals in Abdomino- Pelvic Ultrasonography- Level one for MBBS doctors.

Radiologists across the country under IRIA have been contesting that the training of radiology including ultrasound can only be given best in the Department of Radiology, which has qualified teachers in the radio diagnosis specialty and Instrumental Physics as well as the required infrastructure of many high end colour doppler ultrasound machines and teaching materials, as per Medical Council of India (MCI) Act. Only radiologists are qualified to teach and practice radiology and ultrasound as per MCI affidavit in Delhi High Court (HC).

Following the Delhi HC verdict in February 2016 to strike down SMT and CBT, the matter is now sub judice in SC as IRIA and Union health ministry have filed special leave petition (SLP).

Meanwhile, Directorate of Medical Education (DME) in Kerala has also sent a circular to all medical colleges in the state to conduct CBT against which the Kerala Chapter of IRIA has also contemplated legal action.

Earlier, the Madurai bench of Madras High Court (HC) had also directed the Dean of Madurai medical college in Tamil Nadu to prove the veracity of SMT course for RMPs conducted in the institution from November 2015 to May 2016, as per SMT Rules, 2014, with records of attendance and details of faculty and logbook. So far, the state government and the Dean of Madurai Medical College have not filed their responses, leading to the court adjournment twice.

New ICMR initiative aims at reducing use of antibiotics in adolescents with AUF; partner institutions to get fund backing

In an effort to take on the growing menace of antimicrobial resistance (AMR) in the country, the Indian Council of Medical Research (ICMR) is launching a novel initiative to reduce inappropriate use of antibiotics in children and adolescents with acute undifferentiated fever (AUF).

AUF is one of the leading causes of hospital stay in India among youngsters. The ailment, also known as acute febrile illness, lacks an international consensus and has been traditionally defined as fever lasting less than two weeks in duration without organ-specific clinical features. AUF poses a diagnostic and therapeutic challenge to clinicians as a number of viruses, bacteria, protozoa and rickettsia can cause it. The non-specificity of symptoms and lack of accurate diagnostics often lead to irrational use of antibiotics and antimalarials.

The new programme will be organised jointly by the ICMR and Foundation for Innovative New Diagnostics (FIND), a Geneva-based global healthcare non-profit group. It aims at studying how adding commercially available, point-of-care tests and decision-aid tools to clinical guidelines used in outpatient clinics or health centres can improve care while reducing inappropriate use of antibiotics.

AMR has serious implications for a country like India where the misuse of last-resort antibiotics for common health conditions is rampant. “Our Antimicrobial Stewardship Programme (AMSP) calls for judicious use of life-saving antibiotics. The ultimate goal is to address the rising issue of AMR and to bring about a change in the antibiotic prescription pattern,” said Dr Murali Chakravarthy, Chairman, Central Infection Prevention and Control Committee, Fortis Healthcare, at a health conclave in Delhi last week.

According to official sources, the ICMR is currently seeking submissions from government and non-government institutions to take part in the 18-month programme. The partner institutions to be funded will be identified using a competitive selection process on the basis of site eligibility and institutional capacity. The selected ones will get two to three awards of up to $200,000 each. The project is part of the AMR Diagnostics Use Accelerator launched by FIND. The accelerator is a platform to help low- and middle-income countries tackle the AMR problem.

As per the project call document, a copy of which has been reviewed by Pharmabiz, the study protocol will be developed by ICMR, FIND and the selected institutions in collaboration with the World Health Organisation Special Programme for Research and Training in Tropical Diseases. Patient enrollment is expected to start by October 15 this year and be completed by October 15, 2020. Final report should be ready by January 15, 2021.

Study sites include outpatient departments of primary healthcare units, hospital clinics and pharmacies. Only Drug Controller General of India-approved commercially available diagnostics such as simple haematology, biomarker-based tests and locally relevant pathogen-specific examinations could be used in the study.

Considering the AMR issue as a national priority, the ICMR has been trying to widen the range of its AMSP to smaller in-patient centres in a phased manner. It is currently supporting surveillance, infection control and antimicrobial stewardship through a network of 20 tertiary care hospitals across the country.

“We are scouting for a project management consultant to scale up the programme. The surveillance activity will be implemented in at least two states to begin with and gradually expand it. The geographical locations and hospitals would be decided as the programme progresses,” said Dr Kamini Walia, Senior Scientist at Epidemiology and Communicable Diseases Division of ICMR.

Recently, the council has also issued a new set of guidelines for its AMSP. Expected to be followed voluntarily by all hospitals and clinicians, the guidance document noted that irrational prescription of broad-spectrum antibiotics, poor sale regulations, self-medication and lack of education regarding responsible use are driving the AMR problem. Available data supports this view. A study conducted in the intensive care units of 20 tertiary care hospitals in India had showed that 7 per cent of critically ill patients were resistant to antibiotics. Drug resistance to first-line antibiotics also results in 58,000 neonatal deaths each year.

Pharma SMEs seek year-long deadline extension for implementation of new labelling norms

With the April 1 deadline for implementation of labelling change for drug packs approaching fast, the small and medium pharma industries have called upon the Union health ministry to defer its implementation by a year to salvage them from incurring more than Rs.300 crore losses due to huge buildup of packing material stocks.

The labelling changes will not have any impact on product efficacy, patients safety and product quality, they stated.

The ministry has already extended the implementation of a label change for bigger font size of generic names from September 13, 2018 to April 1, 2019 through a gazette notification on December 3, 2018.

In another draft notification on December 7, 2018, it extended implementation of new labelling norms for Schedule H, H1, G and X drugs from November 1, 2018 to April 1, 2019. However, the ministry is yet to come out with final notification in this regard.

Said Amit Chawla, vice president of Laghu Udyog Bharati Indore unit and secretary of Madhya Pradesh Small Scale Drug Manufacturers Association, “Though the above changes do not reflect on the medicines quality and prices, the pharma industry has already started taking measures to move over to the new packing. However looking at the huge buildup of packing material stocks, we request that the final implementation dates should be deferred by one year at least i.e. voluntary basis change over till March 31, 2020 and on mandatory basis from April 1, 2020.”

We generally keep one year stock of packing materials in advance, the materials get consumed during peak season ranging from April to September. Hence we are looking for year long extension of deadline for implementation of the said packaging changes to avoid losses, said a representative from drug industry.

Last month a Laghu Udyog Bharati delegation had called on Mandeep Bhandari, joint secretary, Union health ministry urging him to defer the implementation of both labelling changes till April 1, 2020 as the changes in drug packs will not have any impact on efficacy and quality of drugs.

We hope that our request for extension will get accepted by the ministry to streamline the implementation of the above notifications, said Chawla.

Said Rajesh Gupta, president of Himachal Drug Manufacturers Association, “We have already appealed to the ministry to consider the extension of deadline for implementation of changes in packing norms till March 31, 2019. Our request was accepted by the ministry. Considering the huge packing materials piled up at manufacturers, we further requested the ministry to defer implementation of labelling changes till March 31, 2020 as changes in packs hardly have any effect on drug quality and patient safety.”

Indian Pharma Market grew by 10% in February to Rs.10,762 cr

The Indian Pharmaceutical Market has achieved a double digit growth of 10 per cent during the month of February 2019, slightly lower than the growth in January 2019 of 11.3 per cent as the respiratory and dermatology segments shown lower growth of 3.8 per cent and 9.8 per cent respectively. According to AIOCD-AWACS report, anti-infectives achieved growth of 4.6 per cent and Vitamins sales moved up by 9.9 per cent. All the chronic therapies including anti-diabetic notched up a high double digit growth of 16.1 per cent while Cardio grew by 15.9 per cent and CNS by 13.6 per cent during February 2019. Indian companies grew by 10.2 per cent and MNCs are growing slightly lower at 10 per cent.

The volumes are not showing encouraging upward trend for last three months. Growth Driver’s (GD) as volumes remained at 2.7 per cent and price increase of 4.9 per cent. Based on MAT GDs volumes worked out to 4.2 per cent and prices at 3.1 per cent. FDC related market showed negative growth of 50.5 per cent while the non FDC market showed a growth of 10.6 per cent. The single molecules grew at 10.3 per cent during February 2019. Price component of GD for the FDCs is 1.7 per cent, other GDs in terms of volumes are at negative 52.4 per cent while new products contributed only 0.1 per cent. The non FDC component growth drivers see volumes at 2.3 per cent, prices at 5.8 per cent while new products are growing at 2.6 per cent.

Among the top 50 corporate, 46 registered positive growth of IPM. Amongst the top 10 corporates, Torrent has the highest growth at 19.8 per cent followed by Lupin at 16.6 per cent and Intas at 15.3 per cent. Further, Ipca Laboratories registered growth of 32.5 per cent, followed by Micro growth at 16 per cent ans Sanofi moved up by 14 per cent. Abbott HC clocked growth of 3 per cent and Abbott India achieved growth of 15.9 per cent. Sun Portfolio has shown a growth of 7.4 per cent, while Ranbaxy also slower at 6.8 per cent. Emcure got a double digit growth of 10.5 per cent while Zuventus moved up faster at 16.7 per cent. Total 8 companies launched during last three years. Amongst the top 60 MNCs Boehringer Ingelheim achieved highest growth of 28.6 per cent followed by Bayer Zydus at 20.1 per cent and Sanofi at 14 per cent.

The NLEM 2013 containing molecules market showed growth at 6.2 per cent to Rs.1055 crore whereas the non NLEM market grew at 10.4 per cent to Rs.9,245 crore resulting in an overall growth of 10 per cent during February 2018.

From the therapy perspective, 19 therapies have shown a positive growth during February 2019. During the month Respiratory market moved up by 3.8 per cent, Derma at 9.8 per cent, Gastrointestinal by 8.7 per cent. Pain and analgesics achieved growth of 10.8 per cent and VMN 9.9 per cent. All the 31 regions have posted positive growth. Bihar market grew the highest by 22.3 per cent followed by MP growing at 19.4 per cent and Odissa growing at 19.3 per cent.

Amoxycillin plus clavulanic acid market grew by single digit growth of 8.1 per cent to Rs.189 crore and glimepiride plus metformin market achieved double digit growth rate of 12.1 per cent. Glimepiride plus metformin was pegged at 185 crore. Azilsartan plain market is now valued at Rs.73 crore on MAT basis. Sofosbuvir and its combination market has reached at Rs.760 crore on MAT basis. The luliconazole market is worth Rs.388 crore and tenegliptin and its combinations are valued at 880 crore on MAT basis. The market of paracetamol plain registered a double digit growth rate of 14.7 per cent on monthly basis and plain atorvastatin has posted a growth of 9.4 per cent. Montelukast polus levocetrizine has slowed down at 6.9 per cent. Voglibose plus metformin plus glimepiride has posted a double digit growth of 23.9 per cent.

Maxtard has posted monthly sales of Rs.41 crore, followed by Glycomemt GP at Rs.36 crore, Lantus at Rs.42 crore and Galvus met at Rs.35 crore. Liv 52 market reached at Rs.32 crore and that of Janumet capture sales of Rs.41 crore. Augmentin reached at Rs.37 crore. New launches Azilsartan and combinations are now valued at Rs.27 crore with launch of total 34 brands. There are 64 brands launched in last 24 months in the Luliconazole segment and these new launches are worth Rs.99 crore on MAT basis. Among the VMS category total 12 brands were launched during February 2019 and within cardiac there have been 4 brands.