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VOL 8. NO. 10 MARCH 16-31, 2013
CONTENTS
Chairman of the Board Viveck Goenka
MANAGEMENT
Editor Viveka Roychowdhury*
‘It only takes 2.1 treatment errors to convert
BUREAUS
a TB patient into an MDR patient’
Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das
PAGE 31
‘Engaging the private sector is important to prevent TB spread’
Bangalore Neelam M Kachhap
PAGE 32
Media and the TB control sector – time to
Delhi Shalini Gupta
build a relationship
MARKETING
Preventing drug-resistant TB in India PAGE 34
Deputy General Manager Harit Mohanty
'Pharmacists: an untapped potential in TB care and control'
Senior Manager Rajesh Bhatkal
PAGE 33
PAGE 36
Response to TB in India needs
PRODUCTION
bold policies
General Manager B R Tipnis
PAGE 37
TB diagnosis in India – Challenges and
Production Manager Bhadresh Valia
opportunities
Asst. Manager - Scheduling & Coordination Arvind Mane
Epidemiology of TB in India
Asst. Art Director Surajit Patro
RESEARCH
Chief Designer Pravin Temble
TB diagnosis: Beyond culture
Senior Graphic Designer Rushikesh Konka
PHARMA ALLY
Photo Editor Sandeep Patil
Indegene collaborates with Team Computers
Singapore
Circulation Team Mohan Varadkar
March 16-31, 2013
PAGE 42
PAGE 66
Waters opens new solution centre in
C I R C U L AT I O N
Copyright @ 2011 The Indian Express Ltd. All rights reserved throughout the world. Reproduction in any manner, electronic or otherwise, in whole or in part, without prior written permission is prohibited.
PAGE 39
to host exclusive ‘iPads in Pharma’
Layout Rakesh Sharma
Express Pharma Reg. No.MH/MR/SOUTH-77/2013-15 RNI Regn. No.MAHENG/2005/21398 Printed for the proprietors,The Indian Express Limited by Ms.Vaidehi Thakar at The Indian Express Press, Plot No. EL-208, TTC Industrial Area, Mahape, Navi Mumbai 400710 and Published from Express Towers, 2nd Floor, Nariman Point, Mumbai - 400021. (Editorial & Administra-tive Offices: Express Towers, 1st Floor, Nariman Point, Mumbai - 400021) *Responsible for selection of news under the PRB Act.
PAGE 38
PAGE 67
P-LIFE FDA vs Chemists: An ongoing battle
MARKET
PAGE 70
GACL bags ‘Best Corporate Social
Union Budget 2013—Dashed hopes
PAGE 18
Responsibility Practices’ award
PAGE 73
‘Any business model for TB can be successful only if it can be deployed till the very bottom of the health care chain’
PAGE 23
Pharmexcil urges DCGI to form committee for issues on EU Directives
PAGE 25
HSI/India lauds DCGI's direction to eliminate animal tests for cosmetics
PAGE 25
M&A activity in pharma sector shifts focus to emerging markets and generics
PAGE 26
CPhI in partnership with PMI India announce Pharma Project Management Conference PAGE 27 7th in-PHARMA JAPAN set to attract major pharma players from India
www.expresspharmaonline.com
PAGE 29
EXPRESS PHARMA
7
EDITOR’S NOTE
Terminating TB’s terror From the time of its discovery in 1882 by Robert
route. On the diagnosis and testing side, we do have
Koch, to the first World TB Day a century later, the
new tools but we need stronger policy intervention
tubercle bacillus has remained one step ahead of
to move beyond current screening practices (See
mankind.
story: TB diagnosis: Beyond culture, page 42).
Today, India has a high TB burden, with one in
The battle against TB and more so its Multi Drug
every four new cases of TB being from the country.
Resistant (MDR) avataar, involves orchestrating the
Drug resistant strains have added another dimension
efforts of multiple stakeholders: doctors (both in the
to the disease as well. As someone on the forefront
private and public space), pharma and diagnostic kit
of the TB epidemic in India, Dr Zarir Udwadia, a
manufacturing companies, global agencies like WHO
consultant chest physician and his team at Mumbai’s
and MSF; as well as health activists and the media.
Hinduja Hospital, were the first to describe Totally
The last two groups have emerged as the crucial last-
Drug Resistant TB (TDR-TB) from India, in October
mile crusaders, as both have a powerful impact on
2011. The knee-jerk reactions to this news was
changing the mindset of the patient. (See story:
typical: ignore the problem, sweep it under the
Taming MDR TB, page 30)
carpet, dispute the findings etc.
Unfortunately, today it seems to be a case of too
But Dr Udwadia’s team’s work was published
many cooks. Each stakeholder strives to work
and discussed both globally and within the country,
independently and therefore is often at cross
building up to a new sense of urgency. Today, India’s
purposes with other players. The patient has faded
national TB control plan, the Revised National
into the background noise, when in reality, s/he is
Tuberculosis Control Programme (RNTCP) may be
the most important piece of the puzzle. Let’s hope
hailed as a success story but policy makers are trying
that RNTCP’s revised goal of ‘universal access’ for
to bridge the gaps with better implementation. More
quality diagnosis and treatment for all TB patients in
pharma companies are researching new drugs (See
the community will be able to cover more of the
story: The TB armamentarium, page 11 of this issue)
country’s population. India has finally been declared
as they see increasing market potential but we also
polio-free; we need to fight TB with the same zest.
have irresponsible prescription patterns and patient non-compliance which is taking us down the TDR
8 EXPRESS PHARMA
www.expresspharmaonline.com
Viveka Roychowdhury viveka.r@expressindia.com
March 16-31, 2013
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MARKET THE BUSINESS OF PHARMACEUTICALS
W H AT ’ S INSIDE
Union Budget 2013Dashed hopes PG 18 Any business model for TB can be successful ... PG 23 Pharmexcil urges DCGI to form committee for issues on EU Directives PG 25 M&A activity in pharma sector shifts focus to emerging markets and generics PG 26 CPhI in partnership with PMI India announce Pharma Project Management Conference PG 27 7th in-PHARMA JAPAN set to attract major pharma players from India PG 29 FOPE's AGM held in Dehradun PG 29
MANAGEMENT 30 RESEARCH 42 PHARMA ALLY 66 PHARMA LIFE 70 March 16-31, 2013
www.expresspharmaonline.com
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11
DR MADHUKAR PAI
HITESH GAJARIA
Associate Professor, McGill Partner KPMG India University, Dept of Epidemiology and Biostatistics
T
Tuberculosis (TB) kills one person every two minutes in India and 750 people every day, says Dr Madhukar Pai, Associate Professor, McGill University, Dept of Epidemiology and Biostatistics. India has the world’s highest burden of tuberculosis, and accounts for nearly one-fifth of the new TB cases that occur in the world every year. According to Shakti Chakraborty, Group President – India Region Formulation and CIS, Lupin, “TB is a very serious disease in a developing country like India. It is estimated that annually around 330,000 Indians die due to the TB.” WHO’s Global Tuberculosis Report 2012 indicates that India has the most number of TB patients. In India, the prevalence is 3.1 million at best and 4.3 million at worst. Even in prevalence rate (per one lakh population a year), India is 249 (number in thousands) at best and 346 at high. Presently, there are a number of Indian and multinational companies producing drugs for the anti-tubercular portfolio. Lupin, Macleods Pharma, Cadila, Strides Arcolab, Svizera, Sandoz and Wockhardt are few companies that have impressive anti-TB drug portfolios. Amongst MNCs—Pfizer, Novartis,
12
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KAMBHAMPATI VALLY MAYA Research Manager, Cognizant Technology Solutions
We desperately need new TB drugs and therefore the FDA approval of Sirturo is great news. But I am concerned about introducing any new TB drug in the Indian market
TB is clearly indicating that the demand for drugs would be largely confined to economies where price control is deliberate and the scope for profits is much more limited
Anti-TB drug does not generate enough sales for pharma companies to consider it a worthwhile return on investment
Sanofi and Abbott have been manufacturing, marketing and researching anti-TB drugs. In India, especially anti-infectives have remained a major therapeutic category of focus for companies.
cent market share (IMS Health). We are global leaders in drugs like Rifampicin where we have close to 80 per cent global market share.”
tries —India, Indonesia, Pakistan, and Philippines – have a large private sector pharmaceuticals presence, capable of producing enough TB drugs to treat all incident TB patients with a full TB drug regimen.
Drugs availability WHO states TB as a major public health problem in India. Each year nearly two million people in India develop TB, of which around 0.87 million are infectious cases. This in turn has led to an increase in the production and marketing of TB drugs in India. Hitesh Gajaria, Partner KPMG India reveals the TB generic drugs availability in the Indian market, “R-Cinex ((Isoniazid / Rifampin – manufactured by Lupin) and Forecox (Ethambutol + Isoniazid Ethambutol – manufactured by Macleods) are the two of the most widely prescribed anti-TB drugs. Together, they capture close to 15 per cent of the market share in India. AKT-4, Combutol, Akurit -4, Pyzina are other majorly prescribed drugs for TB. Together these four brands capture ~20 per cent of the market sales of anti-TB drugs and are all manufactured by Lupin.” Chakraborty reiterates this and says, “There are numerous domestic and some international pharma firms manufacturing or marketing drugs in the country as well as globally. Lupin has been the trail blazer and still remains the undisputed global heavy weight in the anti-TB drugs space. Leave alone India, where we have close to 50 per www.expresspharmaonline.com
Treating TB Drug resistance in TB is a serious problem compromising both the treatment and control programmes. Poor usage of the available anti TB drugs has led to progressive drug resistance-multi drug resistance (MDR), extensively drug-resistance (XDR) and even total drug resistance (TDR). While drug sensitive TB is completely curable, MDR-TB is difficult to treat, XDR and TDR are often fatal. Non availability of new drugs to treat drug resistant cases further complicates the problem. The emergence of mycobacteria which are resistant to drugs used to treat TB has become a significant public health problem world over creating an obstacle to effective TB control. Its presence has been known virtually from the time anti-TB drugs were introduced for the treatment of TB but drug resistant TB is being encountered more frequently now in most countries including India. There have been a number of reports on drug resistance TB in India, but most studies were undertaken using nonstandardised methodologies with bias and small samples usually from tertiary level care facilities. Treatment of TB usually involves taking several antibiotic drugs for at least six months and sometimes for as long as 12 months. Four of the biggest high-burden coun-
MDR-TB treatment According to the WHO, Eastern Europe is in the midst of a MDR-TB disaster with 30 per cent of incident cases resistant to major therapies. Globally, five per cent of TB cases in developing countries are MDR compared to two per cent in developed countries. This is indicative of the fact that there is an urgent need to get the situation under control. The scale of the MDR-TB epidemic is massive, with 310,000 new cases reported in 2011. Globally, however, only 19 per cent of people thought to be infected are receiving treatment.
Types of treatments The drugs that are used for the treatment of drug resistant TB are grouped according to how effective they are, how much experience there is of their use and the drug class. All the "first line" anti TB drugs are in Group 1, apart from streptomcycin which is classified with the other injectable agents in Group 2. Group 1: First Line Oral Agents ◆ pyrazinamide ◆ ethambutol ◆ rifabutin Group 2: Injectable Agents ◆ kanamycin ◆ amikacin March 16-31, 2013
M|A|R|K|E|T
◆ capreomycin ◆ streptomycin
Udayasree Ovaldas— Associate Research Manager, Cognizant Technology Solutions suggests, “The first line drugs are those drugs that generally have the greatest bactericidal activity when used for TB treatment. New patients are those who have no history of prior TB treatment, or they have received less than one month of anti TB drugs. New patients are presumed to have drug susceptible TB (i.e. TB which is not drug resistant) unless there is a high level of isoniazid resistance in new patients, or the patient has developed active TB disease after known contact with a patient documented to have
Some biological drugs in development for MDR TB
March 16-31, 2013
rug resistant TB.” She continues, “It is recommended that patients take the TB drugs every day for the six months, although taking them three times a week is possible in some circumstances. It is essential that all the recommended drugs are taken. If only one or two drugs are taken, then the treatment probably won't work, because the TB bacteria that a patient has develops resistance to the drugs. Not only is the patient then still ill, but to be cured they then have to take drugs for the treatment of drug resistant TB, and these drugs are more expensive and have more side effects.”
New milestone in MDR TB treatment Kambhampati Vally Maya, Research Manager, Cognizant Technology Solutions informs, “A new class of drug specifically for the treatment of TB had not been developed for almost four decades after discovery of rifampicin. One important reason is that a
www.expresspharmaonline.com
novel anti-TB drug does not generate enough sales for pharma companies to consider it a worthwhile return on investment.” However, after more than four decades, recently Johnson & Johnson (J&J) received US FDA approval for Sirturo, a MDRTB drug which became a lead for success. Sirturo has been approved under the FDA’s accelerated approval programme for orphan drugs. While the FDA generally requires a lengthy three-stage testing process before any approval, Sirturo was given an approval after just two periods of study- the second phase is still ongoing. Inspite of a few untoward incidences that were observed, the FDA permitted its entry with a caution. The FDA warned that the drug carries risks of potentially dangerous heart problems and should be prescribed carefully by doctors. Gajaria feels that on an overall balance the FDA judged the benefits of accelerated approval process to outweigh the negative side effects, especially
when the medical fraternity has been put to notice of the possible negative side effects – necessitating due care in the prescription process. He highlights, “Sirturo is active against drug-resistant forms of the disease. In addition to Sirturo, another new drug that is active against MDR-TB called Delamanid, developed by Otsuka, is undergoing registration by the European Medicines Agency and is expected to be approved for use in 2013. It is likely that many more drugs will hit the market if the approval process is relatively relaxed in light of the prevalent emergency.” In order to maintain the quality and provide better drugs, United States Pharmacopeial Convention (USP) a scientific nonprofit organisation that sets standards for the identity,
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strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide works with the following 12 medications, which treat MDR-TB or extensively drugresistant TB (XDR-TB). They are as follows: ◆ Amikacin, 500 mg/2 ml solution for injection ampule or vial; 1 g powder for injection amp or vial* ◆ Capreomycin, 1 g powder for injection, vial* ◆ Cycloserine, 250 mg capsule ◆ Ethionamide, 250 mg tablet/capsule ◆ Kanamycin, 500 mg or 1 g powder for injection, vial* ◆ Levofloxacin, 250 mg tablet/capsule; 500 mg or 750 mg tablet ◆ Moxifloxacin, 400 mg tablet/capsule ◆ Ofloxacin, 200 mg or 400 mg tablet/capsule ◆ Para-Aminosalicylic Acid (PAS), 4 g granules, sachets ◆ Para-Aminosalicylic Acid (PAS) Sodium, 100 g granules, jar; 4 g or 9.2 g granules, sachets; powder for oral solution, sachets ◆ Prothionamide, 250 mg
SHAKTI CHAKRABORTY
UDAYASREE OVALDAS
PATRICK LUKULAY
Group President – India Region Formulation and CIS, Lupin
Associate Research Manager, Cognizant Technology Solutions
We are now looking at expanding our offerings in the AntiTB range to include APIs in the MDR TB category
New patients are presumed to have drug susceptible TB (i.e. TB which is not drug resistant) unless there is a high level of isoniazid resistance in new patients
Recently, it was reported that 40 per cent of TB cases in Belarus were MDR-TB—a shocking number
tablet/capsule “The Promoting the Quality of Medicines (PQM) programme, a US government-funded programme implemented by the US Pharmacopeial Convention
(USP), offers a free technical assistance to assist Indian manufacturers (and those worldwide) in achieving WHO pre-qualification. WHO pre-qualified medicines are comprehensively evaluated
for quality, safety and efficacy. Those that meet WHO’s standards are added to its list of pre-qualified medicinal products, which is a vital tool that today is widely used by United Nations agencies as
Vice President, Global Health Impact Programs and Director, PQM Programme, US Pharmacopeial Convention
Summary of drugs in development for MDR TB
14
Drug Candidate
Therapeutic Efficiency
Pros/Cons
Rifapentine(rifamycin)Phase III
High dose given intermittently or daily treatment improves the therapeutic efficacy
Pros: Shortens therapy when used with moxifloxacin and pyrazinamide or by replacing rifapmicin in first line treatment
Moxifloxacin(Flouroquinolone)P hase III
Active against non-replicating, drug resistant mycobacteria.Useful in latent TB
Pros: Acceptable side effect, shortening the duration oftreatment. Can be used with antiretroviral treatment Cons: Develops drug resistance quickly, Conflicting reviews about its ability to reduce the treatment duration has been observed.
TMC207(Diaryquinolines) Phase III
Bactericidal against dormant bacilli, inhibits drug-sensitive and drug-resistant M. tuberculosis
Pros: Acceptable side-effect profile; shortening duration in MDR- TB, has better action when combined with SQ109. Cons: Metabolised by cytochrome P450 isoenzyme hence unclear if it can be used with rifampicin. Variability in concentration with food intake
Linezolid(Oxazolidinones) Phase II
Good activity againstM. tuberculosis, including multidrug-resistant strains
Pros: Activity similar isoniazid, Can be used in MDR and XDR Cons: Prolonged use of linezolid has shown severe reversible bone marrow suppression, optic neuritis and peripheral neuropathy. Its safety profile does not warrant its use in cases for which there are other, safer, alternatives
PA-824(Nitroimidazole)Phase II
Activity against both drugsensitive and drug-resistant latent M. tuberculosis, no significant interactions with the cytochrome P450 enzyme system
Pros: Shortens the duration of therapy of second line treatment synergistic with pyrazinamide, rifampicin Can be used with antiretroviral, has narrow spectrum Cons: Definite role about reducing the duration of therapy when used with first line drugs is not available
OPC67683(Nitroimidazole) Phase II
Active against drug sensitive,drug resist- Pros: Quicker eradication when replaced with isoniazid in mice model. ant and latentmycobacteria. No signifi- Potential to reduce the duration of treatment. May be useful in HIV, has narcant action with P450 enzyme row spectrum of activity Cons: Inadequate trials in human trials
SQ109(Diaminecompound) Phase II
Activity against both drug sensitiveand drug-resistantM. tuberculosis. Potential of shortening duration oftreatment
Pros: Improves the bactericidal ability of TMC207 by 4-8 times and its action is significantly improved when used with rifmpicin. Bactericidal activity limited to mycobacterial species Cons: Inadequate trials in human trials
PNU-10080(Oxazolidinones) Phase I
Drug-susceptible as well asmultidrugresistantM. tuberculosis
Pros: Significantly shorten the duration of therapy Cons: Early satge of development
L-3858 (Pyrrole)Phase I
Drug-sensitive and drugresistant M. tuberculosis
Pros: Significantly shorten the duration of therapy Cons: Early stage of development
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March 16-31, 2013
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well as a range of groups involved in purchasing medicines in bulk. More information on this assistance is available at http://www.usp.org /around-world/pqm-uspusaid/increasing-supply-qamedicines,” shares Patrick
Lukulay, Vice President, Global Health Impact Programmes and Director, PQM Programme, US Pharmacopeial Convention. “Countries around the world are grappling with TB, but the Newly Independent
Trend of TB cases in India over the years Year
Population of India covered under RNTCP
Total TB cases
New extra pulmonary Retreatment TB cases cases
2005
1042000000
1294550
170783
224630
2006
1112000000
1400340
183719
260618
2007
1128000000
1474605
206701
276936
2008
1148000000
1517363
220185
289222
2009
1164000000
1533309
233026
289756
2010
1177000000
1522147
231121
292972
(Source: Cognizant Technology Solutions) The aim is to achieve the following targets by the end of 2015: Early detection and treatment of at least 90 per cent of estimated TB cases in the community, including HIV associated TB ◆ Initial screening of all previously treated (retreatment) smear-positive TB patients for drug resistant TB and the provision of treatment services for multi drug resistant TB ◆ The offer of HIV counselling and testing for all TB patients, and linking HIV infected TB patients to HIV care and support ◆ Successful treatment of at least 90 per cent of all new TB patients, and at least 85 per cent of all previously treated TB patients ◆ The extension of RNTCP services to patients diagnosed and treated in the private sector ◆
March 16-31, 2013
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States appear to be most in need at this point. MDR-TB is spreading fast in this part of the world, and is some ways is an epicenter for MDR-TB. Recently, it was reported that 40 per cent of TB cases in Belarus were MDR-TB—a shocking number,” informs Lukulay.
Sirturo- risks involved Sirturo (bedaquiline) is designed specifically for treating MDR TB. Bedaquiline inhibits the enzyme that Mycobacterium tuberculosis needs to replicate and spread throughout the human body. However, because the drug also carries some significant risks, doctors should make sure they use it appropriately and only in patients who don't have other treatment options. Despite nine patients receiving Sirturo in a clinical trial dying compared to two on placebo, the FDA approved Sirturo under its accelerated approval programme. J&J (Janssen Therapeutics), Sirturo's makers, is continuing additional studies to confirm its efficacy and safety.
Chakraborty stresses, “There are many factors that must be taken into consideration for this. There is a fairly complicated process for procuring new drugs that are still being tested. Over the past four decades, the TB bacteria have also evolved. In fact, even J&J’s Sirturo drug was approved by the FDA under its accelerated approval programme — clearing innovative drugs based on promising preliminary results.” Maya, Research Manager, Cognizant Technology Solutions reminds, “All the deaths in the placebo arm of the human studies the FDA examined were linked to tuberculosis. Among the participants taking Sirturo, the causes of four deaths could not be identified, meaning that they might have been related to the drug.” However Pai feels, “We
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desperately need new TB drugs and therefore the FDA approval of Sirturo is great news. But I am concerned about introducing any new TB drug in the Indian market. The market is completely unregulated and anyone can purchase any antibiotic over the counter (OTC). Also, several studies have shown irrational and irresponsible antibiotic use in India, including for TB. So, if the new drug is abused widely, then we will rapidly lose the drug to drug resistance, and that will be a big setback in the race to develop better TB drugs. So, new TB drugs must be introduced very carefully and regulated. Doctors must be educated on how to use them as combinations, rather than single drugs.”
Nexus between TB and HIV As per the WHO Global TB Report 2011, there were an estimated 8.8 million incident cases of TB globally in 2010, 1.1 million deaths among HIV-negative cases of TB and an additional 0.35 million deaths among people who were HIV positive. Major challenges to control TB in India include poor primary healthcare infrastructure in rural areas of many states, unregulated private health care leading to widespread irrational use of first-line and secondline anti-TB drugs, spreading
HIV infection, poverty, lack of political will, and, above all poorly managed governmentdriven anti-TB programmes. In 2009, there were an estimated 9.7 million children who were orphaned as a result of parental deaths caused by TB. “While the HIV epidemic in India appears to have peaked, the total number of persons living with HIV/AIDS remains high, and with time the level of immune deficiency and TB vulnerability may increase. Malnutrition remains highly prevalent in India, and will remain a significant factor for years to come,” highlights Maya.
A call to eradicate TB India having the largest TB cases, a significant number of domestic pharma companies are engaged in manufacturing and marketing antiTB drugs. Lupin also partners with various agencies and organisations for their TB eradication programmes. “We supply anti-TB drugs to many Government agencies, the National TB programme, the Stop TB Partnership and various other international agencies. Lupin is pre-qualified as a preferred supplier to the Global Drug Facility (GDF). These formulations are being supplied to more than 50 countries through GDF procurement. The company also
Region wise global TB statistics
(Source: Cognizant Technology Solutions)
TB statistics of the 22 TB burden countries
(Source: Cognizant Technology Solutions)
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supplies to various international institutions like Pan America Health Organisation (PAHO), Medicines Sans Frontier (MSF) and the Damien Foundation. We are now looking at expanding our offerings in the Anti-TB range to include APIs in the MDR TB category. The areas of MDR TB and Paediatric TB provide additional opportunity for Lupin to strengthen its global leadership,” shares Chakraborty. He continues, “The majority of funding for RNTCP is from the Government of India (GoI) sources which includes a World Bank credit. The programme is also supported with funds from donor agencies including Department for International Development (DFID) of UK, the Global Fund and USAID. The Global Drug Facility (GDF) procures about half of the drug requirement of RNTCP using funds from DFID. Efforts have been made by the GoI to make TB treatment affordable to the poorer sections of the Indian society.” Maya feels, “The Indian government's Revised National TB Control Programme (RNTCP) was started in 1997 and was then expanded across India until the entire nation was covered by March 2006. The programme uses the WHO recommended Directly Observed Treatment Short Course (DOTS) strategy and reaches over a billion people in 632 districts/reporting units. In 2010 the RNTCP achieved a treatment success rate of 87 per cent of NSP patients and a detection rate of 71 per cent of the estimated NSP people in the community. In 2010 the RNTCP made a major policy decision that it would change focus and adopt the concept of Universal Access to quality diagnosis and TB treatment for all TB patients. This involves extending the reach of RNTCP services to all people diagnosed with TB, as well as improving the quality of existing services.” Maya shares the insight that the RNTCP plans to achieve these targets by using rapid diagnostics for the diagnosis of TB and drug resistant TB; expanding services for the management of multi drug resistant TB; strengthening urban TB control; strengthening public-private mix initiatives; improving the quality of basic DOTS services; aligning with National Rural Health Mission supervisory struc-
tures. ”The RNTCP has tried to involve non public health providers in promoting TB care, but it is believed that many patients continue to seek treatment elsewhere and currently go unreported. Surveys of TB prevalence including self reporting of TB prevalence have suggested that up to 46 per cent of patients may not be currently reported. There are many reasons why people may seek care outside the RNTCP. These include poor knowledge about TB, poor knowledge about services available through the national programme, the convenience of services, a desire for confidentiality and desire for personalised care. “With the aim of improving the collection of patient care information, in May 2012 India declared TB to be a notifiable disease, meaning that in future all private doctors, caregivers and clinics treating a TB patient must report every case of TB to the government, “adds Maya.
High burden countries TB has huge global impact, however, approximately 80 per cent of the global TB burden is concentrated in 22 high burden countries (HBCs). TB treatment has been considered primarily as a public health priority, because lengthy, supervised treatment is needed to maximise cure rates, reduce incidence, and minimise the development of resistance. A significant amount of private sector TB treatment is, however, known to exist. Of the 22 HBCs for drugsensitive TB, 11 countries were covered in an IMS study to assess the penetration of private sector in the TB drug market. One of these 11 HBCs, Brazil, is thought to have no private market for TB drugs. The remaining 10 HBCs (listed by 2009 HBC rank [14]) are: India (1), China (2), Indonesia (3), South Africa (5), Bangladesh (6), Pakistan (8), the Philippines (9), Russia (11), Viet Nam (12) and Thailand (18). Based on the estimated number of incident cases, these 10 countries include 60 per cent of the estimated burden of TB. IMS data were not available for other countries in sub-Saharan Africa including Nigeria (4), Ethiopia (7) and DR Congo (10). In the public sector, TB treatment policies are typically based on World Health Organization (WHO) recommendations, and for first line March 16-31, 2013
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treatment most countries adhere to a six month course denoted, in shorthand, as 2HRZE/4RH (2 months of isoniazid (H), rifampicin (R), pyrazinamide (Z) and ethambutol (E), followed by four months of isoniazid and rifampicin). Sales of standard dosages by the Global Drug Facility (GDF) reinforce these recommendations. For a given country, these treatment policies are usually decided centrally and are uniformly applied. Thus, estimating average treatment practices in the public sector is easier than in the private sector, where decision making is made at the healthcare provider or patient level. Four of the biggest highburden countries — India, Indonesia, Pakistan, and Philippines — have a large private sector pharma presence, capable of producing enough TB drugs to treat all incident TB patients with a full TB drug regimen. Gajaria notes, “The problem arises in the case of MDR-TB – very few patients receive MDR-TB treatment and data reveals that the private sector seems to be still finding it’s feet in bridging the gap. The RNTCP in India focuses on affordable and effective treatment of TB.”
ket responses, including expansion of Public-Private Mix (PPM) programmes, greater reach, flexibility and appeal of public programmes, regulatory and quality enforcement, and expansion of public MDR-TB treatment programmes. From a public health standpoint, understanding the private market is critical to ultimate-
ly improving overall outcomes in TB. In contrast to most national TB programmes (NTPs), the private markets operate in a decentralised and largely unregulated fashion, with few mechanisms in place to monitor and ensure evidenceinformed prescribing and patient adherence to a TB regimen, creating risks for
developing drug resistance.” According to Stop TB an arm of the WHO, there are close to around 15 new TB drugs which are presently in various stages of development. Soon after Sirturo there is an another new drug in the pipeline for active against MDR-TB, Delamanid, developed by Otsuka, targeted for this year. These drugs
provide more hope to both the industry as well as the patient, the end user, in the fight against TB. u.sharma@expressindia.com
PPP on TB drug development Private markets in four c o u n t r i e s — Pa k i s t a n , Philippines, Indonesia and India – had the largest relative sales volumes; annually, they sold enough first line TB drugs to provide 65–117 per cent of the respective countries' estimated annual incident cases with a standard 6–8 month regimen. Fixed drugs combination (FDC) markets were, however, more concentrated, with four companies capturing 69 per cent of FDC volume across the 10 countries (Sandoz, MacLeods and Lupin). Among second line drugs, fluoroquinolones were widely available, with significant volumes used for TB in India, Pakistan and Indonesia. Certain WHO-recommended drugs are not available and in general there are insufficient drug volumes to cover the majority of the expected burden of multidrug-resistant TB (MDR-TB). Private TB drug markets in several HBCs are substantial, stable, and complicated. “This calls for appropriate policy and marMarch 16-31, 2013
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Union Budget 2013- Dashed hopes Like last year, this year’s budget too has disappointed the Indian pharmaceutical sector. The industry feels that it did not get its rightful share of the budget pie. Usha Sharma presents the industry’s reactions
GST is critical to reduce waste
It is a responsible budget e were hoping the budget would breathe some life into the economy. The expectations of a big bang announcement to restart the economy were belied – expectations were high. Given what the market was grappling with there is a dearth of big ideas. On the other hand it is a responsible budget given the fact the fiscal deficit is being brought down from 5.3 per cent to 4.5 per cent. The allocation of ` 37,330 crore to the Ministry of Health and Family Welfare is welcome, particularly the increase of 24.5 per cent over the revised estimates for the new national health mission. Innovation seems to have got some attention with the setting up of the Indian Institute of Biotechnology at Ranchi and the allocation of ` 200 crore to the Ministry of Science and Technology to help scale up innovations and make them available to the people.
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RANJIT SHAHANI President OPPI and Vice Chairman and Managing Director, Novartis India
Impact is neutral on pharma sector
DR SWATI PIRAMAL Director, Piramal Healthcare
Proposals are conducive
he overall impact of this budget on the Indian pharma industry is neutral. We haven’t seen any changes announced in the excise or customs duties of formulations or bulk drugs. On an average, the excise duty is four per cent higher on APIs (active pharmaceutical ingredients or bulk drugs) than on formulations. Since APIs attract higher excise duty compared to the formulations, this leads to accumulation of credit which is a cost to companies. We were hoping that this budget would provide a solution by way of a refund mechanism for the unutilised credit. In addition, India is an attractive cost efficient destination for drug manufacturing and the government needs to provide an impetus to such activities in the form of tax and fiscal benefits. Currently, the only tax benefit available for R&D activities is in the form of weighted deduction for in-house R&D. The government could have helped the industry by expanding the tax benefit to all R&D expenses including contracted R&D.”
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KRISHNA PRASAD Managing Director, Granules India
he budget has promised Goods and Services Tax (GST) which is a good sign but that promise began five years ago. We should execute these policies quickly which reduces transaction cost and makes the economy efficient. For the pharma industry GST is critical to reduce waste. The investment in science and technology is a long awaited move. The lack or reference to retrospective tax was disappointing. Reducing the fiscal deficit is vital for the economy. The pharma industry looks forward to growth in the economy.
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welcome the Union Budget 2013-14, since it is growth and investment oriented. Increased expenditure on healthcare and healthcare infrastructure will boost our industry, create employment and benefit citizens. The budget proposals are conducive for the growth of India’s healthcare sector as they focus on inclusive and sustained development. Of particular benefit is the 24.3 per cent increase in the National Health Mission Programme. Commendable initiatives have been taken in critical areas such as investment in manufacturing and infrastructure, MSME growth and capital market development. Furthermore, the enhanced focus on investing in more AIIMS like institutions and increased skill development are positive initiatives which also increase opportunities for India’s youth.”
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KAIRUS DADACHANJI Managing Director, SCHOTT KAISHA
Not much has been allotted ot much has been allotted for the pharma or the healthcare sector in the budget. Directionally, the government has shown the commitment towards the healthcare sector by increasing the spend for National Health Mission by 24 per cent over the last year. Also the continued focus on medical education and training (including through AIIMS) is positive. Otherwise, no other direct support has been provided in the Budget to the sector. The increase in surcharge from five to 10 per cent
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HITESH SHARMA Partner and National Leader—Life Sciences, Ernst & Young
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and increase in royalty rates of tax from 10 to 25 per cent (subject to double tax treaty relief) will impact the pharma sector negatively. Finally the excise duty on MRP basis (with abatement of 35 per cent) for ayurvedic, unani, bio chem, siddha and homoeopathy medicines, aligns these areas with the present regime for the pharma sector. Most demands of the sector like tax holiday period increase for healthcare, GST roll out, service tax exemption for clinical trials activity, etc have not been
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addressed in the budget.
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Less attention towards healthcare sector n our pre-budget memorandum, OPPI proposed budgetary/ fiscal measures and support in the following five key areas: ■ Infrastructure building ■ Improving access to medicines ■ Reduction in transaction costs ■ Incentivising R&D ■ Reduction in tax burden and other measures Unfortunately, there is nothing significant in this budget for the healthcare sector, as such. ■ Setting up of Indian Institute of Biotechnology ■ Allocation of fund for products based on science and technology innovations The industry also expected that Government will take measures to make all imported life-saving drugs more affordable to the patients by eliminating the import duty. Unfortunately, this has not happened. Thus, in our view, the healthcare concerns of the country have not been given adequate importance in the Union Budget proposals for 2013-14 to help improving the healthcare needs of the nation.
No specific incentives
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TAPAN RAY Director General, Organisation of Pharmaceutical Producers of India
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GLENN SALDANHA Chairman and Managing Director, Glenmark
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he finance minister should be lauded for presenting a growth-oriented and balanced budget especially given the precarious state of the country’s finances. The focus on rationalising expenditure has definitely helped in controlling the fiscal deficit. Though we still remain on a sticky wicket, he has realised this fact and his effort has been to try and get us back to the six per cent plus GDP growth. While the direction seems right, it still remains difficult for India to achieve the high eight per cent GDP growth in the near future. For long the Budget has been a non event for the pharma sector in particular and Union Budget 2013-14 is no exception. Hence, we were not surprised when there were no specific incentives were announced for the sector. Even for the healthcare sector, there were no recommendations in particular.
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No specific measures for biotech industry
Nothing particular for pharma
he budget focuses on poverty alleviation, rural development and employment generation. It also focuses on increasing investments in the economy, which can alone drive development and growth. It aims to control fiscal and revenue deficits without resorting to higher taxation, which is really welcome. As far as the industry is concerned, the major benefit is the 15 per cent investment allowance on plant and machinery for investments above ` 100 crores. Increasing outlays for skill improvement for National Skill Development Corporation and more funding for SIDBI for MSME funding are practical measures. There are no specific measures to benefit the biotechnology industry or the vaccine industry in terms of tax exemptions or benefits. However, increased outlay for health and agriculture in general and specifically for the Rashtriya Krishi Vikas programme and the new National Livestock Mission will have spin off benefits for our industry.
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KV BALASUBRAMANIAM Managing Director, Indian Immunologicals
he Union Budget 2012-13 was more of a social budget. With majority of the reforms being targeted at three key sections of the society viz., women, youth and poor. Steps like ` 2000 tax credit available to tax payers in the slab of ` 2 lakh to ` 5 lakh and additional tax relief of ` 1 lakh for the first time home buyers who avail loan of ` 25 lakh would surely provide more disposable income in the hands of people. Finance Minister had very little to offer for the corporate sector and nothing for pharma sector in particular. Budget remained silent on reforms in pharma sector like reduction in tax and excise duties on life saving drugs and increase in the tax deduction for in-house R&D expenditure undertaken.
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DR B ARVIND SHAH Managing Director, Arvind Remedies
We welcome the Union Budget
Maintaining a healthy environment his budget is clearly a response to the prevailing socio-economic circumstances in the country. The Finance Minister has put forward a peoples’ budget. The most reassuring aspect of the budget today is the Finance Minister's acknowledgement of the criticality of continued inflow of foreign investments for augmenting the country's growth. The focus is clearly on the imperative of maintaining a healthy environment to mobilise it. The Finance Minister has also done well to place continued emphasis on the infrastructure sector, particularly, social infrastructure, which is really the need of the hour.
BLE-AG welcomes the Union Budget. We strongly believe as we sharpen our focus on sustainable food production and its supply, technology shall play a pivotal role. The Indian Institute of Biotechnology and National Institute of Biotic Stress Management are also steps in right direction and reflects commitment of government in investing in technology. The incubation projects in universities passing as CSR activities will encourage investments in biotech projects is also a step in the right direction.
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DEEPAK KAPOOR
RAM KAUNDINYA
Chairman, PwC India
Chairman, ABLE-AG
Nothing specific for pharma sector udget is indeed not on the expected lines as industry was waiting for impetus. However, it is heartening to note that the Finance Minister is able to maintain the fiscal discipline which may be healthy for the economy in the long run. Particularly appreciative is the fact that subsidy bill is curtailed. This should help in bringing the lower interest regime back in the country. There is nothing specific for pharma sector, however, a robust allocation of budgetary support to the healthcare sector shall augur well to improve healthcare in India. The
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PAWAN CHAUDHARY CMD, Venus Remedies
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actions imbibed in 24 per cent increase in budget allocation, separate allocation for medical education, training and research, national programme for healthcare for elderly and support for six AIIMS like institutions would pave a good path for healthcare. Being a research-driven company, it is pleasant to note that Finance Minister has also touched on science and technology and has initiated good allocations. We would like the innovation scenario in the country to improve at a much faster pace. The revival of investment
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allowance is welcome, however, it would have been better if a lower limit of investment would have kept. Investing ` 100 crores into plant and machinery may not be feasible for a mid-size firm.
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Pharma sector has received scant attention and fiscal prudence still remain a concern. Bolder measures could have been taken to kick start growth as projected in the National Economic Survey. The surcharge on high income earners was anticipated and is in fact, necessary. The focus on skill development through a
KIRAN MAZUMDAR SHAW
Nirbhaya fund are welcome but will have a limited impact on the overall economy. The manufacturing sector has not received the impetus it deserves — the 15 per cent investment allowance is inadequate. Food and fertiliser subsidies are underprovided. The
special fund for the youth along with the provision to recognise corporate investments in technology incubators as CSR, will favour selfemployment and entrepreneurship. The plethora of incentives for women and the proposed allocation for a women’s bank and the
pharma sector has received scant attention. Overall a positive budget which may not deliver the intended >6 per cent growth.
TURNKEY SOLUTIONS FOR BIOTECH & PHARMA INDUSTRY.
CMD, Biocon
he FM's directional intent is good and the investment signals are positive. However, implementation
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WARRINGTON FIRE ASTM BRI POLAND CERTIFIED
Small token to the SMEs and mid-cap companies
CE APPROVED
INTERNAL INFRASTRUCTURE (Modular Panels)
CONTAINMENT SOLUTIONS
CE APPROVED
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AIR STERILIZATION
OMKAR P HERLEKAR
CONTAINER STERILIZATION WITH PRE-INSULATED DUCTING
Whole-Time Director, Omkar Specialty Chemicals
am happy that the only proactive fiscal step towards the sector, as a small token to the SMEs and midcap companies like OSCL was that the Union Budget 201314 announced a petite entitlement of investment allowance of 15 per cent on companies investing ` 100 crores or more in plant and machinery between April 1, 2013 and March 31, 2015, in addition to the current rates of depreciation.
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PATENTED TECHNOLOGY PATENT NO. 541/MUM/2010
PLASWALL - OUTER CONSTRUCTION
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Excise duty has been increased
The wait shall be longer he pharma industry is under tremendous pressure in terms of costs. Moreover, there is inverted duty structure, representations have been made from many organisations to address the issue i.e. API's have 12 per cent and formulations have six per cent duty. In this budget we were looking at the issue been addressed by the Finance Minister but the wait shall be longer. Many units have crores of rupees stuck which could have been used as working capital in order to reduce the interest load burden.
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BHAVIN M MEHTA Director, Kilitch Drugs
n first reading and understanding, I feel it is a detrimental budget for the Ayurveda, Yoga ,Unani, Siddha, Homeopathy (AYUSH) sector as excise duty has been increased from earlier base of whole sale price less 40 per cent post manufacturing expenses to six per cent on MRP. This will result in increase in the prices of AYUSH products which are consumed by mostly rural masses in our country.
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SHASHANK SANDU Executive Director, Sandu Brothers
Overall impression of the budget is not path breaking he Union Budget for 2013-14 is not encouraging for the biotech sector as proposed by ABLE on behalf of the industry. Although some measures are announced, overall impression of the budget is not path breaking and is not sending the right pointers for quick growth of this sector as there are no major incentives announced by the government. While the finance minister has recognised the importance of venture capital and tax incentives, the measures announced are far from being adequate to build strong venture cap-
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PM MURALI President, Association of Biotechnology Led Enterprises (ABLE)
ital funds for the sector. We have to study the implications of the tax rebates and funds allocated for advanced skills development. From outside one is not able to put any numbers on to this. Exemption from excise/custom duties on life saving medicines, as well as on their raw materials and exemption on capital goods and consumables, CRO’s, diagnostic kits have not been considered. Somebody has to realise that these are important parts of healthcare sector. Also, there has been no measures providing tax holidays or soft loans to this sector.
The heartening fact is that the plan outlay for science and technology has increased and there are some announcements in the agriculture area where two new biotech institutes are coming up. More outlay to AYUSH is certainly a good step in the right direction.
working capital and affecting competitiveness in international market and this needed to be addressed urgently. Considering the long-term benefits of R&D to the economy at large, all excisable goods used for R&D purposes should have been exempted from excise duty as also import of all Capital Goods to boost our R&D activities to produce and provide our people with the latest more therapeutic medicines, exemption of physician samples from central excise duty, and reduction of customs duty on all life-saving drugs, etc. The Indian pharma industry has always responded to the urgent calls of our Government, both in Centre and in States, in times of disaster and natural calamities by providing free medicines anywhere in India, without minding the production costs and expenses involved in reaching the medicines to those affected victims. It is sad that despite our repeated requests and representations, the Government continues to tax these voluntary free medicines by imposing excise duty and sales tax on them. It has been a very lopsided budget, in that investment allowance @ 15
per cent has been allowed to manufacturing companies that invest more t h a n ` 100 crores in plant and machinery in the next two years. Most of the manufacturing industries in India are small scale driven, with even our Prime Minister calling them ‘engines of growth’. How many companies can invest ‘more than ` 100 crores’? It effectively blocks lakhs of MSME units in India, not to mention over 10,000 units in the pharma industry from availing of this benefit. The 12th Five Year Plan in the report on MSME sector states that it is the “major base of manufacturing sector in India, with its contribution of over 45 per cent in the overall industrial output and calls for “substantial enhancement of plan allocation for the sector during the 12th Plan to address major bottlenecks facing the sector.” No wonder many in the Indian pharma industry now feel that it is a futile exercise to spend time and effort providing our pre-Budget proposals for drafting the Union Budget year-afteryear, as the Finance Ministry has been ignoring the industry time and again in the last few budgets.
It has been a very lopsided budget n industry that has grown from being fully dependent on foreign companies a few decades ago to being an indigenous entrepreneur-driven industry with over ` 64,000-crore market today, an industry that has over 10,000 small and medium enterprises and about 300 large enterprises all over India, an industry that provides over 64,000 safe and efficacious medicines at affordable prices, an industry that provides employment to over 40 lakh people, an industry that has contributed significantly in improving the standard of life and life expectancy, bringing down the death rate and infant mortality rates etc. of our people, an industry that our Government is very proud to showcase to the world as ‘Pharmacy of the World’, an industry that has earned the respect, admiration and dependence of all countries of the world for providing safe, efficacious, affordable quality medicines – has been completely ignored in the Budget. The pharma industry has been facing problems of huge CENVAT accumulation due to the inverted duty structure resulting in blockage of
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DAARA B PATEL Secretary-General, Indian Drug Manufacturers’ Association
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March 16-31, 2013
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‘Any business model for TB can be successful only if it can be deployed till the very bottom of the health care chain’ Even as the Xpert test approved by WHO is all set to revolutionise TB diagnosis, Bangalore- based Molbio Diagnostics, a JV between Bigtec Labs and Tulip Group, is setting out to test the waters this month with a unique point of care test that can diagnose a host of infectious diseases including TB. Chandrasekhar Nair, Director and Chief Executive Officer, Bigtec Labs, and N Sriram, Director, Tulip Group, reveal more in an interview with Shalini Gupta Tell us about the inception of Molbio diagnostics. Molbio Diagnostics is a joint venture (JV) company between Bigtec Labs and Tulip Group. Bigtec focuses on R&D infrastructure to develop indigenous market-ready innovative diagnostic tools specifically for countries like India where infectious diseases are prevalent and the health infrastructure is resource-limited, while, Tulip, a leader in the Indian diagnostics space, has the extensive manufacturing and marketing expertise since it caters to both to Indian and international markets. Molbio
March 16-31, 2013
INTERVIEW
enables us to deliver the Truelab Real Time micro PCR System to the global markets in the most effective way. Tell us something about the product, its technology and advantages vis-a-vis sputum smear test. Also, how does it rank on sensitivity, specificity, duration of the test, clinical outcomes, its ability to detect MDR TB, TB in children and extra pulmonary TB. The Truelab Uno is a MEMS-based (Micro ElectroMechanical Systems-based) real time micro Polymerase Chain Reaction (PCR) device.
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Chandrasekhar Nair, Director and Chief Executive Officer, Bigtec Labs PCR is fast becoming the gold standard in infectious disease diagnosis since it’s very sensitive and specific. However, traditional PCR equipment is very expensive and inaccessible to the people most afflicted by infectious diseases since it requires extensive laborato-
N Sriram, Director, Tulip Group ry infrastructure and skilled operators. Truelab Uno is portable and battery operated, and is designed to be used by minimally skilled technicians. It also offers rapid detection time of 45-60 minutes. We conducted a study with Hinduja Hospital,
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Mumbai, the results of which were published in PLoS One. It reveals that the test has a sensitivity greater than 99 per cent in sputum positive (S+), culture positive (C+) as well as a specificity of 100 per cent versus a composite reference standard (CRS). Not only this, it was also able to detect all strains on a panel from WHO/TDR that contains over 220 geographically diverse strains of tuberculosis (TB) in an evaluation done recently. While our current test does not detect drug resistance, we are working on a test that not only detects TB but also detects resistance to first line anti-TB medication like isoniazid and rifampicin. We are also in the process of designing studies to evaluate the test performance vis-a- vis TB in children and extra pulmonary TB. When is Truelab expected to hit the market? What is it priced at? How much investment has been made so far? Marketing will start from March 2013. The TB test would be priced between ` 800 to ` 1000 to the lab. The workstation comprising the Truelab analyser, Trueprep Mag device, printer and a set of pipettes will be priced at about ` 4.5 lakhs, which is an one-time investment. We have spent close to ` 50 crores on the development of technology and setting up manufacturing facilities. Although the Revised National TB Control Programme (RNCTP) programme has achieved 100 per cent coverage, India's TB burden is not showing any signs of improvement. This is predominantly because of poor case detection owing to poor diagnosis of suspected TB patients. Two people die every three minutes in India due to mismanagement and misdiagnosis of TB patients. While mismanagement can and is being addressed to some extent by policy makers, misdiagnosis is largely due to the fact that the existing tests are not good enough and better tests are not available. The existing smear microscopy test, which is most prevalent, has a low sensitivity of 40 to 50 per cent which in turn means that it misses half of the positive cases. In the meantime, the patient is commonly treated with ineffective antibiotics, continues coughing and spreading the dis-
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ease. Performing a culture for TB diagnosis, can take over a month, a huge disadvantage when it comes to diagnostics purposes. Hence, current diagnostic tools have been inadequate owing to poor sensitivity and specificity, poor deployability, high cost, long lead time from test to result and the need for specialised infrastructure and skilled man power. Worldwide, India leads in providing access to ARVs and is the largest producer of generic TB drugs. TB diagnostics is one area where Indian companies are yet to innovate. Your comments TB was largely considered a public sector domain with strained resources even to provide treatment, leave alone diagnostics. While a number of companies were involved in the manufacture of serological tests and microscopic reagents, it was long felt that molecular tests would not be able to compete with the former owing to high price points. Hence companies generally did not see a market for innovative products in this segment. Lack of a unified algorithm for diagnosis and treatment, an evolving regulatory environment and constraints in support for research and innovation in the private sector have also been responsible, although things are changing in the recent times. There needs to be an ecosystem for technology innovation. That said, with the realisation of the inadequacy of smear microscopy and the ban on serological tests, the market is now open for adopting newer technologies. Is funding hard to come by for companies focusing on TB diagnostics? Yes and no. The Indian Government is very supportive of industry through schemes like New Millennium Indian Technology Leadership Initiative (NMITLI), Biotech Industry Partnership Programme (BIPP), Small Business Innovation Research Initiative (SBIRI) and Technology Development and Demonstration Programme (TDDP). However, the government needs to be more involved in ensuring that products developed successfully by Indian companies are available to the Indian population. India has a poor manufacturing set-up for cuttingedge diagnostics, which could www.expresspharmaonline.com
benefit tremendously by infrastructure development support by the government. Else, we are forced to rely on developed countries, which in turn, drives up costs. While BIPP helped us validate the tests, the NMITLI took a leap of faith in us and provided us with a soft loan that helped us invest in cutting edge technology and develop the platform. What was the driving force behind the Truelab test? How did you arrive at such a solution? Uncertainty in the causative agent leads to misuse of anti-microbials and consequently a build-up of drug resistance. Faster and better diagnosis leads to automatic reduction in patient suffering and the spread of infectious diseases. It has been felt that molecular diagnostic technology could close all these gaps; however, high cost and paucity of trained technicians and labs has been a constraint. Our attempt was to make a product that brings TB diagnosis to the patient such that it could be used by low level technicians as well. We also realised that any business model for TB can be successful only if it can be deployed till the very bottom of the health care chain. Years of assembling multi-disciplinary teams of engineers, chemists and biologists while building sustained partnerships with prestigious institutions like AIIMS, CMC, IISc, IIT, NIMHANS, NIMR, NIV, SJRI etc have helped us realise our vision. How huge is the market for TB diagnostics in India? What is the marketing strategy going to be like? Estimate for market size have varied from 20 million tests per year to over 40 million tests per year. However, considering the reported number of TB suspect patients presenting to RNTCP, one can say that approximately at least 25 million tests are done per year on suspected TB patients in India. The marketing strategy is to promote our technology to even the smallest of labs and Primary Health Centres (PHCs) all over the country who could otherwise not even dream of doing a PCR test. We will highlight the 'Any Time, Any Where PCR' capability to motivate even field level testing. At the same time, we shall be engaging
the RNTCP for their adoption of our system in the programme. We plan to take the platform to our 70 plus distributors worldwide for deployment in their countries. What is the procedure to be followed before such a test comes to the market? Once the test is ready, we conduct internal validation at our company followed by an external validation that is totally independent and is conducted by hospitals and labs, for instance the study conducted at Hinduja hospitals. The test now needs a drug-manufacturing license issued by the state drugs controller. If imported, an import license from the DCG(I) is necessary. Tests like HBV, HCV and HIV (categorised as critical) need further evaluation by the central laboratory (NIB). WHO does not have a pre-qualification for TB, however, they do endorse tests based on peer review of reported performance. We are working on evaluations by national TB labs towards engaging RNTCP for further adoption. Tell us something about the validation studies of chips for malaria, dengue, chikungunya, H1N1, typhoid and Hepatitis B. We have performed extensive in-house studies on the precision, reproducibility and other analytical parameters. While some of the tests have already been thoroughly validated, multi-centre studies evaluating the performance of Molbio’s newer tests on the Truelab platform are underway. The performance compares well in terms of turnaround time, sensitivity, specificity and ease of use with existing tests in the market. While a point of care test is much called for, regulatory policy goes a long way and integrating such tests in the diagnostic algorithm. Your comments. India needs to first have a national policy for TB that would also cover the private sector with clear algorithms. The regulatory system must be beefed up to ensure implementation of the policy. There should also be a clear and transparent mechanism for monitoring the quality of diagnostic tests prior to introduction and also post market. shalini.g@expressindia.com March 16-31, 2013
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COMPANY WATCH Pharmexcil urges DCGI to form committee for issues on EU Directives DCGI likely to act on the basis of the committee's comment Usha Sharma Mumbai harmaceuticals Export Promotion Council of India (Pharmexcil) has mooted the idea of a committee, constituted by the Drug Controller General (India) (DCGI), under the chairmanship of the joint secretary, Department of Commerce and Industry, Government of India to help the DCGI decide on issues related to the EU Directive on Falsified Medicines, due to come into effect from July this year. The committee will comprise of a representative each from both the DCGI and Pharmexcil. Government of India had officially deputed the DCGI as the competent authority in India for issuing written certificates on API export consignments, as required by the EU Directive 2011/62/EU of June 8, 2011 with amended Directive 2001/83/EC. In line with this, DCGI had shared drafted guidelines for issuing written confirmation on EU Directive with Pharmexcil
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and Pharmexcil had requested Indian pharma companies to share their concerns and suggestions on the checklist issued by the DCGI. Giving more details of this meeting, Dr PV Appaji, Director General, Pharmexcil said, “We recently conducted a meeting with the DCGI and
Union. We expect to get a final confirmation by the end of this month for issuing written certificates to the exporters.” He highlighted, “The committee may review all representations from the exporters from time to time and DCGI will act on the
GOVERNMENT OF INDIA HAD OFFICIALLY DEPUTED THE DCGI AS THE COMPETENT AUTHORITY IN INDIA FOR ISSUING WRITTEN CERTIFICATES ON API EXPORT CONSIGNMENTS Additional Secretary, Department of Commerce and Industry, Government of India and discussed issues relating to the EU Directive on Falsified Medicines. We shared our comments and concerns over the draft guidelines prepared by DCGI and to a large extent, the DCGI agreed to the points we shared. We have suggested that DCGI should form a new committee which will mainly see to issues related to exports to the European
basis of the committee's comments.” In the same meeting, Pharmexcil also raised major issues related to the EU Directive and asked DCGI to consider simplifying the documents which need to be submitted to the DCGI. Like other regulatory agencies, inspections by DCGI officers can be carried out based on the site master plan to be submitted to DCGI. It has also suggested to consider critical data verification from
the original documents which can be done at the site itself. Based on valid certificates held by individual companies issued by various regulatory agencies like US FDA, UK MHRA, EDQM, TGA or COPP under WHO-GMP, DCGI may consider the issue of confirmation certificates for a limited period. Appaji said, “We have suggested that the DCGI should conduct inspection after issue of limited validity certificate. We want to ensure that all the issues related to the EU Directive will be resolved and the Government has also given us an assurance on this issue. Hopefully we will receive the final confirmation from the DCGI.” Pharmexcil has asked DCGI to upload all the government notifications and competent authority communication on the Central Drugs Standard Control Organisation website. He was also asked to upload draft guidelines on the CDSCO website urgently and DCGI has assured that it will upload the guidelines very soon. u.sharma@expressindia.com
HSI/India lauds DCGI’s direction to eliminate animal tests for cosmetics Marks the beginning of the end of acute oral toxicity and oral mucosal irritation animal testing for cosmetic purposes in India umane Society International/India has praised a direction given by the Drug Controller General of India (DCGI) to fast-track deletion of the final two animal tests from India’s cosmetics safety standard. The directive was issued during an emergency meeting of the Bureau of Indian Standards’ PCD19 Cosmetic Sectional Committee, to which
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March 16-31, 2013
HSI/India was a special invitee. It marks the beginning of the end of acute oral toxicity (lethal poisoning) and oral mucosal irritation animal testing for cosmetic purposes in India. Alokparna Sengupta, Be Cruelty-Free Campaign Manager, HSI India said, “Humane Society International/India applauds the foresight and compassion of Drug Controller General Dr GN Singh’s direction in this progressive move. It’s unthinkable that in this day and age, animals are still www.expresspharmaonline.com
choking on cosmetic chemicals in decades-old poisoning tests while companies choke on their own inertia in switching to a cruelty-free business model.” From now on, companies in India wishing to test cosmetic products or ingredients for these specific effects will have to submit a non-animal testing proposal to the DCGI for approval. Eventually, it is expected that the Indian cosmetic standard IS4011 will be amended to reflect the changes as directed by DCGI. The BIS has the responsibili-
ty of setting up safety standards for cosmetics by the Central Drug Standards Control Organisation (CDSCO), through the Drugs and Cosmetics Act of 1945. HSI's Be Cruelty-Free campaign, the largest-ever global effort to end animal testing for cosmetics, has worked with various Legislative Assemblies and Members of Parliament in India who have written to the CDSCO and BIS in support, asking for an end to cosmetics testing on animals. EP News Bureau-Mumbai EXPRESS PHARMA
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M&A activity in pharma sector shifts focus to emerging markets and generics February 2013 registers decrease in both volume and value terms M&A (including private equity) trend analysis
&A activity in the pharmaceutical sector was focused on emerging markets and generics as companies were looking at new high-growth geographic markets. According to IMS, the global generic injectables market is expected to grow at a compounded annual growth rate of 13 per cent from 2011-2017, driven by patent expiries outpacing most other dosage forms. In line with the above trend, US-based Mylan agreed to acquire Agila Specialties, an India-based developer and manufacturer of high-quality generic injectable products, for approximately $1.85 billion. This transaction will significantly expand and strengthen Mylan's global injectables platform and provide entry into new highgrowth geographic markets such as Brazil. With this acquisition, Mylan will gain access to a broad product portfolio of more than 300 filings approved globally and marketed through a network covering 70 countries, including 61 abbreviated new drug applications (ANDAs) approved by the US Food and Drug Administration (FDA). Mylan will also gain access to nine high-quality manufacturing facilities in India, Brazil and Poland, eight of which have been approved by the FDA. Agila's manufacturing capabilities include vials, pre-filled syringes, ampoules, lyophilisation, cytotoxics and antibiotics. M&A activity in the pharma sector decreased in both volume and value terms, when compared to the average of previous six months’ (August 2012–January 2013). According to Datamonitor's Medtrack database, the pharma sector recorded 20 M&A transactions in February 2013, against the previous six months’ average of 37.8 transactions. In value terms, the sector recorded deals worth $2.5 billion against the previous six months’ average of $3.3 billion. The Indian pharma sector witnessed three deals during February 2013, against the average of 0.8 deals over the previous six months. Apart from Mylan’s acquisition announcement of Agila Specialties, Vivimed Labs’ acquisition of Finoso Pharma, a pharma development services company for $2.79 million, is notable.
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Source:
Top M&A deals (Feb 2013) Rank
Date
Target
Acquirer
Deal value ($m)
1
02/27/13
Agila Specialties Private Limited (IN)
Mylan, Inc. (US)
1850
2
02/08/13
3SBio, Inc. (CN)
Decade Sunshine Limited (KY)
340
3
02/01/13
Velcera Inc. (US)
Perrigo Company (US)
160
4
02/20/13
Ipsen & Inspiration assets
Cangene Corporation (CA)
55.9
5
02/10/13
Algatechnologies, Ltd. (IL)
Grovepoint Capital LLP (GB)
50
6
02/01/13
Productos Medix SA de CV (MX)
WAMEX Private Equity (MX)
32
7
02/07/13
Flamel Technologies SA (FR)
Deerfield Management Company L.P (US)
15
8
02/28/13 Spring Bank Pharmaceuticals, Inc. (US) Brock Securities, LLC; Gilford Securities Incorporated
10.5
9
02/25/13
Cuattro Veterinary USA, LLC (US)
Heska Corporation (US)
7.65
10
02/14/13
Finoso Pharma Private Limited (IN)
Vivimed Labs Limited (IN)
2.79
Source:
Venture financing trend analysis
Venture funding Companies in the pharma sector raised $123.1 million during February 2013, against the previous six months’ average of $360.1 million. In terms of volume, the sector recorded 16 venture funded deals, compared to the previous six months’ average of 25.8 transactions.
Notes and definitions
Source:
Top venture financing deals (Feb 2013) Rank
Date
Target
Investors
Deal value ($m)
1
02/14/13
Jounce Therapeutics, Inc. (US)
Third Rock Ventures, LLC (US)
47
2
02/26/13
Glide Pharma (GB)
Invesco Perpetual; Undisclosed Investors
21.19
3
02/14/13
Elcelyx Therapeutics, Inc. (US)
GSM Fund LLC; Morgenthaler Ventures; Kleiner Perkins Caufield & Byers; Technology Partners
20
4
02/28/13
Kala Pharmaceuticals, Inc. (US) SaskWorks Venture Fund Inc.; Lux Capital Management ; Polaris Venture Partners; Third Rock Ventures, LLC
5
02/26/13
Brickell Biotech, Inc. (US)
AMOREPACIFIC Ventures ; Palisade Concentrated Equity Partnership II, L.P.; Undisclosed Investors
11.5 7
Medtrack is a comprehensive, fully integrated, global biomedical database providing information on companies, products, patents, deals, venture financing, and epidemiology. It is a live database, constantly updated with news, milestones, trial information, etc. Medtrack’s unmatched coverage is supported by a user-friendly, highly dynamic set of decision support tools and analytics. Inhouse analysts and researchers add key insights and conclusions to provide you with the primary and secondary information you need. Key uses of the database include competitive intelligence, target identification, screen potential licensing and investment opportunities, patent assessments, product due diligence, royalty valuations, and developmental benchmarking. Deal value trend is based on transactions where associate values have been disclosed. Trend analysis excludes rumoured and terminated deals. Value and volume analysis excludes private equity exits. For more information, visit us at www.medtrack.com
Source:
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EXPRESS PHARMA
www.expresspharmaonline.com
March 16-31, 2013
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Strides Arcolab to sell Agila Specialties division to Mylan To sell it for an aggregate sum of $1,600 million in cash and potential additional consideration of up to $250 million trides Arcolab has entered into a definitive agreement for the sale of its specialties subsidiary, Agila Specialties, and simultaneously its overseas specialities subsidiary, Agila Specialties Asia, Singapore, has entered into a definitive agreement for the sale of its subsidiaries to Mylan. Under the terms of the agreement, Strides and its subsidiary will receive an aggregate sum of $1,600 million in cash on closing and a potential additional consideration of up to $250 million subject to the satisfaction of certain conditions by Strides. The transaction has been
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independently approved by the respective Board of Directors of Strides and Mylan. Following successful closing of the transaction, Strides proposes to utilise proceeds towards, inter alia, retiring debt, providing a pretax return of approximately $700 million to $800 million to shareholders, and costs related to the satisfaction of contingent conditions. Arun Kumar, Executive Vice Chairman and Group Chief Executive Officer, Strides Arcolab, said, “The sale of Agila demonstrates our commitment to maximising value to our shareholders. Our investments in the business, together with the operational excellence of our employees, have led to the creation a global, high-quality specialty injectables busi-
ness with an industry-leading pipeline and best-in-class infrastructure. I am excited by the combination of our Agila business with Mylan as it allows Mylan to leverage its operational base to become a leading global injectables company in the coming years and offers great opportunities to the employees who have made Agila what it is today. ” VS Iyer, Chief Executive Officer, Agila Specialties, said “This transaction is an endorsement of the worldclass capabilities the Agila team has created and serves as a perfect bolt-on strategy for the future of Agila and its employees.” Heather Bresch, Chief Executive Officer, Mylan said, “The addition of Agila to Mylan’s existing injecta
bles platform will immediately create a new, powerful global leader in this fastgrowing, attractive market segment and accelerate our target of becoming a topthree global player in injectables. ” The transaction is subject to customary conditions, including receipt of required regulatory approvals. Jefferies International is acting as sole financial advisor to Strides Arcolab. Herbert Smith Freehills is acting as lead international counsel, supported by DSK Legal, Haynes and Boone, and Pinheiro Neto Advogados. EP News Bureau-Mumbai
PRE EVENT CPhI in partnership with PMI India announce Pharma Project Management Conference Event to be held in Mumbai on May 8-10, 2013
PhI in association with PMI India will hold Pharma Project Management conference from May 8-10, 2013 in Mumbai, customised specifically for pharmaceutical industry’s high end project needs around cost, quality and time. This strategic conference aims on discussing best practice strategies to implement project management from the leaders of the industry who have successfully handled complex projects themselves. This distinctive conference
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has received a lot of interest and has already confirmed industry leaders to present including Sanjit Singh Lamba, Managing Director India, President, Global Brands Business Unit Eisai Knowledge Centre; Swaminathan Srinivasan, Director Project Management, Dr Reddy’s Laboratories (UK); Sanjay Bhanushali, Director International Operations, Cipla; Mohan Pandey, Director R&D operations, Bristol-Myers Squibb; Dr Varada Bapat, Head-Project Management,
Wockhardt and many more. The event will feature indepth discussions on streamlining end-to-end product life cycle management, minimising project risk management, overcoming application challenges in R&D, clinical research, engineering, SCM and manufacturing. It will also help in understanding application of theory of constraints specific to complex pharma projects, best strategies for critical path identification and innovative strategies for effective time management.
Industry experts to discuss enforcement at DIA India’s 6th Regulatory Conference Event to be held at I Ahmedabad from April 5-6, 2013
March 16-31, 2013
ndia’s initiatives to encourage the enforcement of regulations will be discussed by prominent industry experts at DIA India’s sixth Regulatory Conference, to be held in Ahmedabad, Gujarat. The two-day event from April 5-6, 2013 will bring together local and multinational pharmaceutical companies, clinical research professionals, acade-
micians, regulators, and key stakeholders in health authorities to share the knowledge they’ve gained from decades of experience and note-worthy contributions to the development of the Indian pharma industry. The conference will feature Rajiv Gulati, President Global Pharmaceuticals Business, Ranbaxy Laboratories, speaking on the www.expresspharmaonline.com
theme 'India, the Upcoming Economy: Encouraging Enforcement of Regulations.' Dr GN Singh from the Drug Controller General of India (DCGI) will also participate. Programme co-chair, Dr Hemant Koshia, Food and Drug Commissioner of Gujarat, said, “DIA India’s sixth Regulatory Conference will focus on the challenge of
Hands-on training workshop on MS-Project 2010 and brief on MS-Visio will be held on May 10, which will help project managers in developing plans, assigning resources to tasks, tracking progress, managing budgets and analysing workloads. It will be taken up by Vijayalakshmi who is Microsoft Office Certified Master having obtained over 25 certifications in MS Office products plus GreenBelt Certification from Benchmark SixSigma. EP News Bureau-Mumbai
keeping the Indian pharma industry competitive in the world market despite everevolving regulation. Attendees will discuss current issues in the regulatory field, deliberate how to be prepared to face up to these complexities by learning from the past, and decide proactive measures that could be taken by the industry.” EP News Bureau-Mumbai EXPRESS PHARMA
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EVENT BRIEF Microbiological control of compendial articles: A workshop on current status and future directions of compendial standards Date: March 18-19, 2013 Venue: USP- Rockville Summary: USP (US Pharmacopeia) will be hosting a workshop on USP standards for microbiological control of compendial articles. The workshop will present information on current USP Microbiology Expert Committee chapters and potential and draft chapters in the areas of bio-burden control of non-sterile products, sterilization and sterility assurance, validation of alternate microbiological methods, and rapid/modern microbiological methods. The breakout sessions will solicit discussion and input from stakeholders. The workshop will provide an overview of recent and current work of the USP General Chapters Microbiology Expert Committee vis-a-vis new and revised chapters and chapter proposals in order to solicit feedback on the committee’s current and future standardssetting activities. It will foster conversation that focuses on better understanding the needs of stakeholders. Microbiology laboratory supervisors and microbiologists, contract microbiology laboratory staff responsible for testing pharmaceuticals, biologics, dietary supplements, food ingredients, and medical device products and regulatory QA, QC, and compliance personnel will participate in the workshop. Contact details: Dr Radhakrishna Tirumalai Principal Scientific Liaison General Chapters Department Global Science and Standards Division Tel: (301) 816-8339rst@usp.org
DIA India's 6th Regulatory Conference Date: April 5-6, 2013 Venue: Ahmedabad, Gujarat
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EXPRESS PHARMA
Summary: India’s initiatives to encourage the enforcement of regulations will be discussed by prominent industry experts at DIA India’s 6th Regulatory Conference. The two-day event will bring together local and multinational pharmaceutical companies, clinical research professionals, academicians, regulators, and key stakeholders in health authorities to share the knowledge they’ve gained from decades of experience and note-worthy contributions to the development of the Indian pharma industry. The conference will feature Rajiv Gulati, President Global Pharmaceuticals Business, Ranbaxy Laboratories, speaking on the theme ‘India, the Upcoming Economy: Encouraging Enforcement of Regulations.’ Dr GN Singh from the Drug Controller General of India (DCGI) will also participate. Contact details: Laura Hollis Tel: +1-215-442-6154 Email: Laura.Hollis@diahome.org
iPHEX 2013 Date: April 24-26, 2013 Venue: Bombay Exhibition Centre Summary: The Pharmaceuticals Export Promotion Council of India (Pharmexcil), has announced the launch of iPHEX 2013, India’s own pharmaceutical show under the support of Ministry of Commerce and Industry, Department of Commerce, and Government of India. Over 400 leading Indian companies are expected to showcase the best of pharma products at the event. The organisers claim that iPHEX 2013 will see the presence of 5,000 business visitors including overseas buyers and drug regulators. Huge business opportunities are expected to emerge during the event. Further, the presence of large number of drug regulators from overseas market is expected to help Pharmexcil and its members to promote the quality and affordability aspect as envis-
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aged in ‘Brand India’ pharma campaign. The campaign has been initiated by Ministry of Commerce and executed by Pharmexcil in association with IBEF. Contact details: Sanika Patil ProjectManager – IPHEX 2013 Tel: 91.11.23324288 M: 91.9582758812 E-mail: sanika@falconmail.com
PHARMA Pro&Pack 2013 Date: April 24—26, 2013 Venue: Mumbai Exhibition Centre, Goregaon Summary: PPPE 2013 is an initiative of the Indian Pharma Machinery Manufacturers’ Association (IPMMA), jointly with GPE Expo. The event will offer a single platform for more than 200 exhibiting companies from India and across the world to showcase their products. Contact details: Paresh Jhurmurwala GPE EXPO Global, Opp. Priyadarshini Tower, Near Judges’ Bungalows, Bodakdev, Ahmedabad 380015, Gujarat Tel: +91 79-2687 1390 +91 79-4000 8253 +91 79-4000 8233 Email: contact@pharmapropack.com
ly handled complex projects themselves. This distinctive conference has received a lot of interest and has already confirmed industry leaders to present including Sanjit Singh Lamba, Managing Director India, President, Global Brands Business Unit Eisai Knowledge Centre; Swaminathan Srinivasan, Director Project Management, Dr Reddy’s Laboratories (UK); Sanjay Bhanushali, Director International Operations, Cipla; Mohan Pandey, Director R&D operations, Bristol-Myers Squibb; Dr Varada Bapat, Head-Project Management, Wockhardt and many more. The event will feature indepth discussions on streamlining end-to-end product life cycle management, minimising project risk management, overcoming application challenges in R&D, clinical research, engineering, SCM and manufacturing. It will also help in understanding application of theory of constraints specific to complex pharma projects, best strategies for critical path identification and innovative strategies for effective time management. Contact details: Tel: (022) 61727001Email: conferences-india@ubm.com (Promo Code: EXP-DISC10) Website: http://www.pharmaprojectmanagement.com?utm_campaign=MEDIAPARTNER &utm_medium=EVENTLISTING&utm_source=EXPRESS PHARMA
Pharma Project Management conference Date: May 8-10, 2013 Venue: Mumbai Summary: CPhI in association with PMI India will hold Pharma Project Management conference, customised specifically for pharmaceutical industry’s high end project needs around cost, quality and time. This strategic conference aims on discussing best practice strategies to implement project management from the leaders of the industry who have successful-
March 16-31, 2013
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POST EVENT 7th in-PHARMA JAPAN set to attract major pharma players from India Expected to attract more visitors than the previous year
Sachin Jagdale Mumbai th in-Pharma Japan, the international pharmaceutical ingredients expo and conference, will be held in Tokyo Big Sight, Japan from July 10-12, 2013. Reed Exhibitions Japan, the organiser of the conference, along with Indian Drug Manufacturers Association (IDMA) briefed senior Indian pharmaceutical professionals about the key highlights of the conference. 7th in-Pharma Japan is expected to attract more visitors than the previous year. During the event, exhibitors can make their products more visible through presentation sessions. An exclusive venue for exhibitors to hold a private presentation is available inside the exhibition hall. It is a cost effective way to publicise product to target buyers. Chief executive officers, chief technical officers, presidents, vice presidents, and directors from major pharma
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companies across the globe will take part in the conference. Over 810,000 invitation tickets will be sent out to industry executives and professional in Japan and all over the world. Special support services for exhibitors also includes exclusive VIP customer registration system, VIP networking reception party, e-guidebook and web link service, press release services etc. Indian pharma manufactures could expect
special benefits out of this conference as organisers have arranged for special counters for Indian delegates. On the sidelines of briefing in Mumbai, Daara Patel, Secretary General, IDMA, presented the analysis of Indian and Japanese pharma market. “As India has an advantage of great breed of pharma talent, Indian pharma manufacturers need to capitalise on opportunities
that Japanese pharma market offers,� he said. Japan is the second largest pharma market in the world. About 70 per cent pharma ingredients for generic market in Japan are imported. This huge requirement also opens a gate of opportunity for Indian pharma manufacturers. Japan already has a few Indian pharma players operating on their soil. Sachin.jagdale@expressindia.com
FOPE's AGM held in Dehradun More than 110 delegates from Himachal Pradesh and Uttarakhand participated in the meeting ederation of Pharma Entrepreneurs (FOPE), a registered body catering to the needs of manufacturers of pharmaceutical segments in Himachal Pradesh and Uttarakhand, recently held its annual general body meeting in Dehradun. Under the
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March 16-31, 2013
Chairmanship of BK Gupta, more than 110 delegates from both the states and other areas participated in the meeting. One of the key agendas was to elect a new team to take FOPE towards greater heights. A new trend was set by electing the entire team without going into formal election. RC Juneja, Chairman and Managing Director, Mankind Pharma, was unani-
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mously elected as the Chairman of FOPE. BK Gupta accepted the responsibility of Co-Chairman, BR Sikri was appointed as CoChairman, Vinod Kalani as the General Secretary and NS Bhatia as the treasurer. Vinod Gupta, SL Singla, JS Sudan, Charanjit Atreja and Sandeep Jain took the responsibilty as the Vice Chairman and others took the responsibilty as Secretary, Joint Secretaries and Executive members. The delegates participated in detailed discussions on fixed drug combinations, (FDC), Generic versus Brands under section 33(P), bar code matter, uniform code of marketing practices and CBDT circular on gift to doctors. A presentation was also given by Singh Associates on Labour related issues. Yes Bank was the sponsor for the event and gave a presentation about
their services with regards to mainly pharma segment. It was also decided to make FOPE as a national body expanding its presence beyond the states of Himachal Pradesh and Uttarakhand. Sub committees on excise and taxation, marketing, MSME, Pricing/DPCO, Publication, regulatory and technical, quality management, membership drive and international trade were also formed to give more positive services to the members. FOPE will be starting distributing new awards to its members under various categories. Established six years ago, FOPE's contribution to the members has created a positive impact and image in the market, such that the government has also started recognising its services to its members. EP News Bureau-Mumbai EXPRESS PHARMA
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MANAGEMENT INSIGHT FOR MANAGING PHARMA
W H AT ’ S INSIDE
'Engaging the private sector is important to prevent TB spread' PG 32 'It is important to listen to, respect the patient's voice' PG 32 Media and the TB control sector – time to build a relationship' PG 33 Preventing drug-resistant TB in India PG 34 ‘Pharmacists: an untapped potential in TB care and control’ PG 36 Response to TB in India needs bold policies PG 37 TB diagnosis in India – Challenges and opportunities’ PG 38 Epidemiology of TB in India PG 39
RESEARCH 42 PHARMA ALLY 66 PHARMA LIFE 70 30
EXPRESS PHARMA
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March 16-31, 2013
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‘It only takes 2.1 treatment errors to convert a TB patient into an MDR patient’ Dr Zarir F Udwadia, Consultant Chest Physician feels irresponsible prescription patterns and rampant self-medication are the main cause of MDR TB and explains to Viveka Roychowdhury why a ban on the prescription of TB drugs by all except a few approved doctors is the need of the hour ulti drug resistant TB (MDR TB) is a result of the way we treat TB. For instance, in public hospitals, Category II cases (consisting of retreatment cases including patients with relapse, failure and those who return after default. Such patients are generally sputum positive and have longest duration of treatment) treatment is given in two phases. The intensive phase consist of two months (24 doses)of isoniazid, rifampicin, pyrazinamide, ethambutol and injection streptomycin followed by one month (12 doses) of isoniazid, rifampicin, pyrazinamide and ethambutol all given under direct observation thrice weekly on alternate days. In total the intensive phase in category II is three months. This is immediately followed
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by continuation phase, which consists of five months (22 weeks, 66 doses) of isoniazid, rifampicin and ethambutol given thrice daily on alternate days, the first dose each week directly observed. If the sputum smear is positive after three months of treatment, the four oral intensive phase drugs are continued for another one month (12 doses) before starting five months of continuation phase. In normal circumstances, the total duration of treatment is of eight months. Instead of using sputum smears, we should in fact be using the latest testing technologies, i.e. the Gene Xpert test kit, first along with sputum smear testing at more frequent intervals to detect TB. In the private sector, bad/irresponsible prescription
patterns are fuelling the MDR TB epidemic and it only takes 2.1 treatment errors to convert a TB patient into an MDR patient. Patients/lay public are also to at fault. Today anyone in India can walk into a chemist and buy a week's supply of TB drugs, not realising that they have taken the first step towards developing MDR TB. Such self medication is harmful because if such a person does contract TB later, the infection will be already resistant to the first lot of drugs he has consumed unsupervised. Why can't the Drug Controller (India) pass an order banning the prescription of TB drugs by all except a few approved doctors? This has been done in Brazil with very good impact. Such a ban will cut short the drain of precious medicine resources as well as curb the spread of MDR TB. I expect this is not being done thanks to opposition from vested interests like the pharmaceutical companies as
well as the doctor community, especially private practitioners, who would see it as a loss of business. But such a ban is really the need of the hour. Better access, more affordability are of course required but more judicious use of the resources that we already have currently will also have a major impact. (Dr Zarir F Udwadia is a consultant chest physician at the Hinduja Hospital, Breach Candy Hospital and Parsee General Hospitals, Mumbai. Dr Udwadia and team were the first to describe Totally Drug Resistant TB (TDR-TB) from India, in October 2011, and published a report on these cases and their treatment in January 2012. In February this year, the PD Hinduja National Hospital and Medical Research Centre received the first TB Champion Award from Global Health Strategies (GHS), an international consulting company, in recognition of the importance the organisation has given to accurate diagnosis and treatment and to optimally manage TB patients, provide reliable diagnostics and develop techniques for rapid diagnosis of TB and drug susceptibility testing.)
‘For the first time in 50 years, there is hope’ Leena Menghaney, Manager (India), Access Campaign, Medecins Sans Frontieres feels that the Health Ministry and Drug Regulatory Authority have to provide leadership and develop a plan to prevent the misuse of new TB drugs édecins Sans Frontières has been grappling with the limitations of drugresistant TB medicines in India since 2007 when it began treating some of the most marginalised and severely ill patients in Mumbai for multi drug resistant TB/HIV co-infection. Today 120 coinfected patients are treated, including 11 children. To con-
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trol DR TB, India should begin adopting in the DOTs programme fixed-dose combinations for first line TB treatment that increase adherence, develop clear plans to regulate the sale, prescription and use of TB drugs in the private sector and most importantly strengthen lab capacity across the country so that treatment providers can adjust the treatment regime according to the
POLICY MAKERS MUST ENSURE THAT COMPASSIONATE USE PROGRAMS FOR NEW TB DRUGS ALLOWS SOME OF THE SICKEST DR TB PATIENTS TO RECEIVE THESE NEW MEDICINES March 16-31, 2013
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resistance pattern of each patient as the 'standard, onefits-all' MDRTB treatment regime is not a medically correct approach to treating DRTB. For the first time in 50 years, there is hope. New drugs, effective against drugresistant forms of TB, are becoming available. Policy makers must seize this opportunity and ensure that compassionate use programs for new TB drugs allows some of the sickest DR TB patients to receive these new medicines. India must participate in the research required to find the best treatment regimens incorporating these new medicines. New regimens must be shorter, more effective and less toxic than the current twoyear regimen for DR TB. Drug manufacturers must make new drugs available for clinical research, register them in India and ensure they are
affordable. Most importantly India must have a plan to prevent the misuse of new TB drugs and here the Health Ministry and the Drug Regulatory Authority have to provide leadership. EXPRESS PHARMA
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'Engaging the private sector is important to prevent TB spread' Dr Evan Lee, Vice President of Global Health Programs, Eli Lilly talks to Viveka Roychowdhury about the role of private players to create awareness, detect TB early and provide support to those affected in all its forms e cannot point a finger at one institution or organisation for the blame of drugresistant TB. Government must set standards, but we also need to engage private medical practitioners, pharmacists, NGOs, patient groups and the like. Stakeholders need to work together to leverage one another’s unique skills and competencies. TB is a complex disease, managed by complex processes. These range from the technical challenges associated with drug susceptibility testing, to training of healthcare providers to manage the required complex treatment regimens, to ensuring appropriate adherence to treatment and managing side effects and a myriad of socio-economic issues, to adequate follow up to be sure the patient has taken the last dose of medicine and is in fact free of the disease. The complex healthcare system in India further adds challenges, with most people with cough or other TB symp-
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toms visiting a private practitioner. Skills here range from international standards to low levels of TB-specific training. TB in lungs is most common form, which is diagnosed by microscopy. But this technique does not show TB in other parts of the body. TB is a difficult to detect disease also because the frontline test most commonly used – smear microscopy - does not show whether TB is drug sensitive or drug resistant. So it is assumed the patient has drug sensitive TB and is put on the standard directly observed therapy, short course (DOTS) regiment. Therefore there is a need for capacity to test drug susceptibility- but this can take weeks to get a result. The new diagnostic device, GeneXpert, provides an alternative to the lengthy drug susceptibility testing process, but it tests for resistance to only one medicine (Rifampicin) not to the others. It is being introduced in selected sites in India. The directly observed treatment-shortcourse DOTS
regime requires that a patient must go to a certified DOTS provider, usually at a hospital three times a week to take medication under the supervision of a healthcare provider. Last year, the (Indian) government stated some pharmacists could be DOTS providers. If people go to the private sector, they might not get the right treatment for the right duration, so engaging the private sector is important to avoid creating resistance. Treatment of MDR-TB is carried out under DOTS-Plus guidelines, requiring administration of up to six different medicines for 24 months. All these medicines can have side effects, further complicating the management of the patient and creating the risk of treatment default. Preventing this situation, and ensuring that patients complete their treatment for MDR-TB therefore requires the engagement of several levels of the health system, from the community up to the referral hospital, and across the public and private sectors.
(The Eli Lilly and Company Foundation is responsible for the Lilly MDRTB Partnership, an initiative started in 2003 to support the response to MDR-TB in India and other high-burden countries. In India, the company works with NGOs and associations representing medical professionals to train and support healthcare workers, including doctors, nurses, pharmacists, rural healthcare providers and community volunteers. Additional programmes engage journalists and communities to create awareness, detect TB early and provide support to those affected by TB in all its forms.)
'It is important to listen to, respect the patient's voice' Blessina Kumar, Delhi-based health activist and public health consultant spoke to Viveka Roychowdhury on the crucial need to make the TB patient's voice heard and ensure that it forms the basis of all decisions pertaining to TB control programmes. She is also the Community Representative and Vice Chair- Stop TB Partnership (WHO, Geneva) and Global TB CAB (Community Advisory Board) Member here has been an increasing number of MDR TB cases in India, which is more complicated to treat and takes longer than the usual six month treatment for drug susceptible TB. This becomes very complex for the patient and the provider with issues of adherence and severe side effects of the drugs. There is need for support and counselling to the patient in order to ensure treatment adherence and success. The first thing that needs to be done is to acknowledge,
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whether in the private or public sector, that there is a huge problem (of MDR TB). You cannot keep hiding things under the carpet. Secondly, just the RNTCP cannot address India's MDR TB issue, it takes all stakeholders to come together and work together. More than 50 per cent of our patients go to the private sector for treatment. A major challenge is to ensure that the private sector is brought in, with some flexibility, so that both systems (the private as well as the public health care systems) www.expresspharmaonline.com
can work together. An understanding of what this would mean and how it would work at the ground level is crucial. If there is no connection and the two sectors work in parallel it is the patients who will suffer. Thirdly, we have to realise that patients are not
just recipients of care; they too have a voice. We need to respect and listen to that voice and ensure that this forms the basis of all our decisions. We tend to forget that at the end of the line there is actually a patient, who is being affected. We cannot dump rubbish on to a patient and expect the problem to be solved. Empowering patients is something that is really not looked at seriously in India. To be a TB patient in India is the most dis-empowering experience. Patients perspectives need to be respected and reflected into whatever we do. How do we do this? That's where patient representatives, patient advocates, health activists, civil society groups are becoming very important as they are much closer to the patient. March 16-31, 2013
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Media and the TB control sector – time to build a relationship Bharathi Ghanashyam, from Journalists against TB outlines the reasons why TB ranks very low with the media his is an invited piece and I cannot but express the sense of relief I feel. I did not have to chase editors or send multiple reminders in order to get it published. I did not have to anxiously wait for weeks and then realise my story had been killed. And yet, this is not the story with every piece I write. The very same editors who accept with ease, the articles I write on other health issues such as HIV/AIDS or primary healthcare, or whatever, outright reject my stories on TB without leaving any room for negotiation. I have heard a multitude of reasons for this. As my usually encouraging editor friends tell me, readers are not interested in TB as they don’t identify with it. It affects only the poor and the underprivileged; it is an old disease and doesn’t make news anymore. There are no developments in the TB sector; there is no new research or advancement. TB also makes for news that is lacklustre when compared with HIV for instance. It is not a health condition (unlike HIV), which lends itself to drama and sensation. HIV stories, while they should not, can be projected through very colourful lens, considering the HIV infection spreads chiefly through the sexual route. That probably explains the reader interest bit. Be that as it may, on all fronts, TB ranks very low with the media. But here’s why the media should be telling its readers and viewers about TB. It has been and continues to be a lethal, killer disease despite it being entirely preventable and curable. According to the Revised National TB Control Programme (RNTCP), 1.8 million persons develop the disease annually, of which about 800,000 are infectious; and, until recently, 370,000 died of it annually. There are also data to indicate that India has the highest TB burden in the world.
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About 1,000 people die of TB every day. To quote an oft repeated simile, this is the equivalent of four airbuses crashing on a single day. It does not take much to imagine the amount of airtime and column space that kind of news would get. But news about 1000 people dying of TB everyday passes by without a whimper. To bust a myth, TB is not only a disease of the poor; rather it is a disease of the immune compromised. For sure TB is caused by the bacterium Mycobacterium tuberculosis and is spread from person to person through the air and people living in unhygienic and congested conditions, read that as ‘poor’ are more vulnerable to it. But there is now evidence to prove that people living with diabetes are also vulnerable to TB. More people living with HIV die of TB than any other coinfection. There’s more. The only vaccine we have for TB (i.e. BCG) is over 90 years old. TB treatment has hardly changed in more than 40 years. The only reliable diagnostic tool we had for TB till very recently was the sputum microscopy test which is also over a century old and which misses more than half of all positive cases. So we have problems on all three fronts – prevention, diagnosis and treatment. But that’s only half the problem. We now have amidst us an increasing number of drug-resistant TB cases, which is far more difficult to cure and requires long, intensive and expensive medication that is extremely toxic and causes severe, almost crippling side effects. Drug resistant TB, also called DR TB, MDR TB or XDR TB is caused when the patient drops out of treatment for primary TB before completing the entire course or the patient has been wrongly managed. If he/she gets a relapse, or actually gets TB, it is resistant to the first line of drugs. MDR-TB therefore is a manmade phenomenon arising out of poor treatment, poor drugs and poor adherence. According to the WHO www.expresspharmaonline.com
Global TB Report – 2012, India has an estimated 66,000 notified cases of MDR TB, of which only 16,820 were initiated on treatment as of September 2012. The emphasis here is on the word notified. There is good reason to suspect that there is a much higher number of cases which have not come to the notice of the official RNTCP. This is because India’s private health sector does not notify all cases to the RNTCP. Each of these cases is capable of spreading the disease to 15 others. The RNTCP acknowledges that TB is a major barrier to social and economic development. An estimated 100 million workdays are lost due to illness annually. Society and the country at large also incur a huge cost due to TB—nearly $ 3 billion in indirect costs and $ 300 million in direct costs. So, do we or don’t we have a case here for the media to take up? Shouldn’t the above situation be the reason enough for the media to give it more attention regardless of whether it is the rich or the poor that are infected/affected? Shouldn’t all this information be out in the open rather than held closely within the TB sector alone? Why is this not happening? Why is TB control staff not holding media workshops to engage them? Why are good ad campaigns like BulgamBhai not getting air time? The blame for this lies least with the media. Unlike HIV where governments, funding agencies, networks of positive people and other stakeholders came together, and invested time and effort to address the media and build their knowledge and capacity on reporting on HIV, no such efforts have been made in the TB sector. It is a known fact that there is very little investment even in the core areas such as research and development of diagnostic tools and drugs. So investment in awareness generation activities is really on the farthest burner. While India has taken several steps that can lead to more efficient prevention of
primary as well as MDR TB, we have a long way to go with regard to enforcement. To name a few, India is the first country to ban the use of serological tests to diagnose TB. India has also made it mandatory for the private sector to notify every case of TB to RNTCP. We also have one of the world’s most successful, government-run TB control programmes in RNTCP. It may be possible for India to eliminate TB if only we had vigilant enforcement, good private sector cooperation to ensure early diagnosis and rapid treatment. Every person with chronic cough for more than two weeks must be investigated for pulmonary TB, because diagnostic delays can prove costly. More importantly, we have to bolster these efforts with a massive campaign that can spread awareness on TB and the correct way to treat it. The quickest route for building such awareness is obviously through the mainstream media. But that’s not going to happen until we invite the media to partner with TB control efforts and impress on them that the situation warrants more attention than it currently gets. Is the TB sector listening? EXPRESS PHARMA
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Preventing drug-resistant TB in India Madhukar Pai, Professor, McGill University, Montreal, Canada says a transformational change in the relationship between the public and private health sectors is critical for TB control in India arch 24 is World TB Day, and a good time to take stock of progress in tuberculosis (TB) control in India, the country with the largest number of TB cases. Yet, most people in India probably think that TB is a disease from their grandparents’ era. They are seriously mistaken. TB is an enormous problem, even today. Every year, India reports over 2 million TB cases, although the true numbers may be much higher. It is only in 2012 that the Government of India made it mandatory for the private healthcare sector in India to notify all TB cases to local health authorities. So, the true magnitude of the TB problem in India will become clear only when we precisely count the number of TB cases managed in the private sector which accounts for a majority of healthcare delivery in the country. The scary truth about TB is that everyone is at risk. TB is an airborne infection that is spread when infected people cough and release droplets with TB bacteria in the air. As in the case of any airborne infection, we are all vulnerable. TB anywhere is TB everywhere! As India witnesses increasing cases of multidrugresistant (MDR) TB, the disease is now becoming increasingly difficult to diagnose and treat. A 2011 Global TB Report by the World Health Organization estimated that approximately 64,000 cases of MDR-TB emerge annually from the notified cases of pulmonary TB in India. This number may not seem large. However, for a moment, consider the TB burden of India. Then consider the quality of care that is accessible to most patients. Now consider the possibility that many more can become drug resistant in India in the coming years. TB control in India is at a decisive juncture. Unless we invest more in TB control, we will see an increasing number of cases in the future. What is MDR-TB? If TB strains become resistant to isoniazid (INH) and rifampicin (RMP), the most critical first-line TB
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drugs, this is called MDR-TB. If the treatment of people with TB is incorrect, interrupted or not completed, the TB bacteria can become resistant to the common TB drugs that are used. Also when doctors prescribe the wrong treatment, the incorrect dose, or duration of treatment, the patient can easily become drug resistant. Counterfeit TB drugs can also result in drug-resistance and poor outcomes, and this is a growing concern with all drugs in India. Why should we be concerned about MDR-TB? The answer is simple. MDR-TB requires extensive treatment (for two years) with multiple, toxic drugs and outcomes are poor. Treatment of MDR-TB is also very expensive. And MDR-TB can progress into even worse forms of TB such as extensively drug-resistant TB (XDR-TB). The rise of MDR-TB in the recent past in India is worrying. Recently, Hinduja Hospital in Mumbai reported cases of ‘totally drug-resistant tuberculosis’ (TDR-TB) – suggesting that this form of TB was incurable because of resistance to all the TB drugs tested. WHO has not accepted or endorsed the definition of TDR-TB. How has India controlled the problem of TB? India’s Revised National Tuberculosis Control Programme (RNTCP) is a globally lauded success in the area of TB control. It expanded basic diagnostic and treatment services to cover 100 per cent of the Indian population. And yet, TB continues to be a huge public health challenge. It is important to consider what we can do to go beyond extending basic TB services. Early diagnosis and treatment of patients with MDRTB is one area that RNTCP needs to improve. Currently, most TB patients in the public sector receive only sputum smears as the diagnostic test (see image: Analysis of sputum smears of TB patients). While most patients eventually get free TB treatment in the public sector, they first seek care at chemist and drug shops and visit informal and unqualified providers. All of www.expresspharmaonline.com
this can result in long delays before TB treatment is started. While sputum smears are rapid, inexpensive and do help identify the most infectious cases, the technology lacks sensitivity, and cannot detect MDR-TB. So, unless patients fail first-line TB drug therapy or have been previously treated for TB, they generally do not get tested for
MDR-TB in the public sector. The RNTCP needs to consider providing a large section of the patients with adequate drug-susceptibility testing and second-line drug treatment. New, fast and WHOapproved molecular tests such as Xpert MTB/RIF (GeneXpert platform by Cepheid Inc, Sunnyvale, California) can now give drug-susceptibility results within hours and such technologies need to be urgently scaled-up to detect more MDR-TB cases and initiate
Analysis of sputum smears of TB patients
Xpert analysis in progress
Bulgam Bhai ad campaign, Source: Project Axshya
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Reproduction of RNTCP ad released in newspapers
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them on second-line drug therapy. A Cochrane systematic review, published on January 31, 2013, showed that the Xpert assay (see image: Xpert analysis in progress) is highly accurate with a sensitivity of 88 per cent and specificity of 98 per cent, when compared to culture. The test is significantly more sensitive than sputum smear microscopy. Furthermore, the Xpert assay can detect resistance to rifampicin with as sensitivity of 94 per cent and specificity of 98 per cent. Recent initiatives by donors have successfully reduced the price of Xpert test cartridges to under $10 for the public sector, but the test continues to be expensive for the private sector in India. This may soon change with the impending launch of a Consortium of private labs in India that will offer WHO-endorsed tests like Xpert at affordable prices. We need many more such efforts to engage the private sector. India’s private sector, which diagnoses and treats more than half of all TB patients, has been a source of mismanagement of TB and hence, drug resistance. This includes the use of incorrect
diagnostics, incorrect regimens and lack of supervision to ensure all TB patients complete treatment. What can patients do to prevent drug-resistant TB? To begin with, all individuals with cough for more than two weeks must get their sputum tested for TB. Sputum testing is available free via thousands of microscopy centres run by the RNTCP, and ad campaigns such as Bulgam Bhai (see image:Bulgam Bhai ad campaign, Source: Project Axshya) have been focused on encouraging patients with chronic cough to seek sputum testing. If patients seek care in the private sector, they must demand sputum testing over blood tests for TB. There is no accurate blood test for TB. If TB is diagnosed, the most important thing a person can do to prevent MDRTB is to take medications exactly as prescribed. No doses should be missed and treatment should not be stopped early, even if symptoms improve. Patients who cannot afford to buy drugs must seek treatment in the public sector where TB drugs are given free. Initiatives are also underway to provide free TB drugs to patients in the
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private sector, and such an effort can make a big difference in India, where even the really poor patients often seek care in the private sector and pay out-of-pocket for medical care. Doctors, healthcare providers, pharmacies, and laboratories have a critical role to play in preventing MDR-TB. They must ensure quick and accurate diagnosis, follow recommended treatment guidelines, monitor patients’ response to treatment, and make sure therapy is completed is the key to prevention. If TB is confirmed, they should start treatment promptly and follow WHO or RTNCP guidelines. Efforts are underway to develop the 'Indian Standards for TB Care' that both public and private sectors can agree on and adhere to. The Indian government recently banned the use of antibody blood tests for diagnosing TB, and leading newspapers carried ads on the ban (see image: Reproduction of RNTCP ad released in newspapers). This is a welcome development as blood antibody tests are known to be highly inaccurate and misleading (see story “Beyond the
Ban” published in Express Pharma, 1-15 July, 2012 : http://bit.ly/11KFsOz). Other blood tests such as QuantiFERON-TB Gold (marketed in India as 'TB-Gold') are not meant to diagnose active TB. They are meant to detect latent TB infection and one in three Indians is latently infected. So, doctors should not use such blood tests to start treatment for active TB. Laboratories should stop the use of inaccurate blood tests for TB and instead prioritise sputum tests. Also, it is critical that pharmacies and drug stores do not dispense TB drugs without a valid allopathic doctor’s prescription. This is mandated by law (i.e. Schedule H) but rarely implemented or enforced. It’s important to remember TB is not an ordinary cough and TB drugs are not cough syrups that can be handed out. Overthe-counter use of TB antibiotics without adequate supervision can foster drug resistance. Indeed, prescription audits have shown widespread use of irrational TB drug prescriptions which might partially explain the emergence of MDR and XDRTB in India. The Indian government must do a better job of regulating the sale of TB drugs in India. Indeed, all antibiotics must be regulated to prevent their widespread abuse. As the lead agency for TB control in India, the RNTCP’S role is pivotal in preventing MDR-TB. The RNTCP has just announced its National Strategic Plan (NSP), for the period 2012 – 2017, with its new objective of ‘universal access’ for quality diagnosis and treatment for all TB patients in the community. A transformational change in the relationship between the RNTCP and the private health sector is critical for the success of all the major areas of the NSP (universal access, early diagnosis, interruption of transmission, prevention or management of MDR-TB). While the RNTCP must work harder to partner with the private sector, the private sector also has a responsibility towards public health in India. TB control in India cannot succeed without both sectors joining forces. EXPRESS PHARMA
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‘Pharmacists: an untapped potential in TB care and control’ INTERVIEW
Manjiri Gharat, Vice-President and Chairperson, Indian Pharmaceutical Association-Community Pharmacy Division (IPA CPD) speaks to Viveka Roychowdhury about the reforms needed to counter tuberculosis (TB) India has the world's largest population of TB-infected individuals and MDR TB is on the rise. What role can pharmacists in India play to tackle this problem? TB has been our major public health problem. Pharmacists who come in direct contact with the patients , i.e. community (retail) pharmacists, have a tremendous role to play in TB care and control. Being the first point of contact for patients, they come across several undiagnosed, untreated TB patients. Thus, it provides great opportunity to detect the people with symptoms of TB, counsel them to go for diagnosis and try to bring them on treatment. One untreated case of Pulmonary (Lung) TB can infect 10 to 15 individuals in a year. So when a pharmacist detects even one such case, he is safeguarding the life of 10 to 15 individuals. This is a tremendous opportunity for early case detection. The Government of India has the Revised National Tuberculosis Control Programme (RNTCP) to fight against TB and under RNTCP, diagnosis and treatment is given free of charge under direct observation. This is known as DOTS (Directly Observed Treatment, short course) which is mainly delivered through Government hospitals, health posts and through some private providers. But till recently, retail pharmacies were never roped in this programme or rather in any national health programme. If DOTS is made available through pharmacies, it can certainly increase the access to free anti-TB medicines. The long opening hours of pharmacies and convenient location makes it a perfect patient-centric DOTS setup. Another important point to be noted is that 50 to 60 per cent TB patients go to private sector even though there is free treatment available in the public sector. One of the several reasons is lack of awareness about DOTS. Also, an important issue is TB treatment is a lengthy
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process which takes a minimum of six to eight months or more. Many patients from the private sector leave the treatment halfway. This nonadherence is one of the major contributors to drug resistant TB. There is no monitoring mechanism in private sector treatment. Thus, counselling the patients and monitoring treatment is very important to improve the adherence. And pharmacists are in the best position to offer such services. Thus, with this background,you realise that pharmacists can play a very important role. Community awareness about TB and about DOTS, case referral of TB symptomatic cases, provision of DOTS medicines through pharmacies, supervision of treatment, patient counselling and rational use of antibiotics are some of the key areas where pharmacists can contribute effectively. Through Indian Pharmaceutical AssociationCommunity Pharmacy Division (IPA CPD), you have spearheaded initiatives to engage pharmacists in the Revised National TB Control Programme (RNTCP). What are the goals and objectives of these initiatives? At IPA, we realised that pharmacists’ potential has largely remained untapped and the situation in India urgently demands that this unutilised human resources be engaged in TB services. We should not leave any stone unturned when it comes to fight against TB. With this objective, from 2006, we started training pharmacists in Mumbai with the support of RNTCP and Maharashtra State Chemists and Druggists Association (MSCDA). Pharmacists were trained for the roles and responsibilities discussed earlier. Starting with seven pharmacists in 2006, now there are 350 plus pharmacists in Mumbai, Thane district, Nagpur in Maharashtra who are working for this social cause. Central TB Division, MoH, GoI took note of this DOTS TB www.expresspharmaonline.com
Pharmacists project work and in April, 2012, CTD signed a MoU with IPA, AIOCD, SEARPharm Forum and PCI for engaging pharmacies in RNTCP pan India. This was a great satisfying milestone for us at IPA to see that a small initiative went to the national scale to benefit thousands of TB patients in the country. Also, this marked the first footprints of pharmacists in any national health programme. This project has turned out to be an innovative public private partnership model and Indian pharmacists’ work is appreciated world over. IPA is invited to share these experiences in several of international conferences. Also, some high TB burden countries are in touch with us for this purpose. Recently; delegates from Ministry of Health, Vietnam visited DOTS pharmacies in Mumbai and as per the latest news, now they are replicating this model back home. Central TB Division and IPA jointly have developed training module for community pharmacists. It has been uploaded on the www.tbcindia.nic.in/ website. On February 18, Director General of Health Services Dr Jagdish Prasad released this module. This module is for the pharmacists, as well as for the trainers. So using this module, the project will be implemented in Jharkhand, Delhi, Madhya Pradesh, Gujarat and West Bengal and later on to other states. Have these initiatives resulted in any changes by way of better patient compliance, better public awareness of TB prevention and control, etc? Yes, we have some data. Pharmacists have reached out to more than 7,000 people to create awareness. In the last two years, more than 400 patients have been cured at DOTS pharmacies under the supervision of the pharmacists.10 to 15 per cent of the cases referred by the pharmacists have been positive TB
cases. Thus they are very well contributing to RNTCP and are strengthening the programme. Apart from the statistics, I can give you some real life examples by which we can understand how significant the pharmacist’s contribution is. This is a case from Mulund, Mumbai. A pharmacist displayed the board outside the pharmacy about free anti-TB medicines (DOTS) appealing to enquire about TB diagnosis and free treatment at the pharmacy. The very next day, one patient approached the pharmacist after reading this board. The patient was recently diagnosed in the private sector and had just started the treatment. The patient was poor and was very unlikely to complete the full course of treatment. After interacting with the pharmacist, he went back to his physician and informed that he wished to switch to DOTS. He went to the nearby Corporation hospital as guided by the pharmacist where his diagnosis was confirmed by RNTCP TB authorities and DOTS treatment was started and his DOTS box was kept at the pharmacy. Now the patient has completed the treatment under the supervision of the pharmacist. See, such patient would have been possibly a likely case of DR TB later as he would have left the treatment in a few days or few months, because of unaffordability. Pharmacists’ intervention proved to be very useful to get such patient under the purview of DOTS. There are several such case studies and pharmacists are doing a wonderful job. Let me tell you that there are no much financial incentives for the pharmacists to do this work. I really appreciate and salute the socio-professional work of the pharmacists. What remains to be achieved and implemented? (future plans, roadmap on this project) Well, there is a lot to do. As I said earlier, now RNTCP will be expanding this pharmacist’s model in other states. IPA will extend support for this roll out. I see that it will take around next three to five March 16-31, 2013
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years of efforts for this roll out and we have a clear road map for the same. With support of all stakeholders, we wish to sensitise all the pharmacists in the country for this public health issue. Every pharmacist should be aware of TB symptoms and should be able to detect as many TB cases as possible from the community. Is IPA CPD engaging with pharmaceutical companies as well? If so, what is the scope of this engagement and which pharma companies are involved? Lilly MDR TB Partnership (of Eli Lilly and Company Foundation) is the one who is supporting us throughout this journey. In fact with Lilly’s support, we were able to expand our work in Maharashtra since 2010. Apart from funding, Lilly always
provides support for work such as, follow up for some work with Govt TB authorities. So it is a true collaborative partnership that we have with Eli Lilly for this pharmacists TB work. Participating in the annual Lilly Summit is also an excellent opportunity to showcase our work, network with other stakeholders and to know the latest happenings in the globe. Lilly MDR-TB Partnership is further expanding this engagement with pharmacists by supporting partners /NGOs to implement the initiative in other states of India. The RNTCP has announced its National Strategic Plan (NSP), for the period 2012 – 2017, with its new objective of ‘universal access’ for quality diagnosis and treatment for all TB patients in the community. What are the
broad contours of the NSP and how is IPA CPD planning to be part of it? I would say that we will offer all our services for this noble cause. In NSP, we can see that retail pharmacies will play a crucial role in Universal access plan. Things are yet to become clear but IPA CPD is always there wherever RNTCP needs us. What are IPA CPD's plans for World TB Day 2013? Every year, CPD conducts TB awareness programme for the community through pharmacists. Also IPA Students Forum conducts awareness campaigns all over the country. We will continue the same. We also felicitate the DOT provider pharmacists on the TB day. Are there any alignment / partnerships with WHO,
global initiatives like the Stop TB Partnership, etc.? I have been enrolled by TB TEAM Expert in publicprivate mix (PPM) for TB care and control by WHO STOP TB Partnership. We have also worked with Partnership to develop draft tool for 'Engaging pharmacies in TB care and Control' for PPM tool-kit and participated in 8th PPM subgroup meeting of WHO. The draft is being finalised and once it is included in the tool-kit, the pharmacist’s model will more easily spread across the globe. It is always a great feeling and great opportunity to work with WHO.
Response to TB in India needs bold policies Dr Suvanand Sahu, Team Leader for TB-REACH, Stop TB Partnership presents seven points important to address TB and prevent further emergence of drug resistant forms of TB in India he response to TB in India needs to be set at an unprecedented level with bold ambitions of getting to near zero levels of death and with resource commitments from both the public and private sector that is commensurate with the scale of the problem. The Government has recently taken a few steps in the right direction, e.g. increasing the budget for Revised National Tuberculosis Control Programme (RNTCP), launch of a mandatory notification policy and a vision to provide universal access. These are important steps, but will need more efforts and partnership with all stakeholders to effectively implement in a diverse country like India. In my view the following seven points are important to address TB and prevent further emergence of drug resistant forms of TB in India: 1. Adoption of bold policies, proposed and driven by the civil society and key stakeholders, including the TB-affected communities and the private business sector. Policies should promote universal access to
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care for all forms of TB in adults and children, including drug-resistant TB and HIV-associated TB. This should include provision of universal access to drug susceptibility testing for all TB patients and access to rapid diagnostics for TB for all those that require it. This should also include access to free, or affordable, and quality assured TB medicines, including childfriendly medicine formulations. 2. Effective implementation of the policy of mandatory notification of all TB cases (including their treatment outcome), using e-Health and m-Health approaches, and a combination of incentives as well as punitive action. In this process it is important to learn from the progress made in polio eradication related to notification and investigation of all cases of paralysis in children. 3. Improvement of TB care across the country both in the public and private sector, among care providers in RNTCP, as well as those who have remained outside RNTCP. This should include strict adherence to www.expresspharmaonline.com
the Indian and International Standards of TB Care which should include the prescription and use of the most appropriate diagnostics and treatment regimen. Majority of Indians approach the private sector for their health care needs and TB is no exception. As new diagnostics become available and new treatment regimens are likely in the future, there is an opportunity for the private health care sector to demonstrate its leadership and entrepreneurship. Health insurance, both by public and private sector, and the future plans on moving towards universal health coverage, are important opportunities to promote quality of care in TB and weed out sub-optimal care. 4. Improvement in drug regulations and its implementation to improve the quality of anti-TB drugs and prevent irrational dispensing of such drugs. Implementation will require policies that will incentivise WHO prequalification and use of fixed-dose combination formulations with kits that have the entire course of medicine for individual patients. 5. To promote early and enhanced TB case detection actively screen people who are at high risk, or who belong to vulnerable groups
that are unlikely to access early care and in whom the impact of the disease can be catastrophic. In addition, care must be taken to make patients complete the diagnostic process and start treatment – currently too many patients either do not complete the diagnostic process, or do not start treatment after diagnosis. To achieve this it is important to change policies towards use of rapid and more accurate tests and faster algorithms that can diagnose most forms of TB in one patient visit to the healthcare facility. 6. The civil society and affected communities need to get organised for greater advocacy, monitoring of care provision, and actual participation in the provision of TB diagnosis and treatment to patients. The experience of the HIV and polio responses in India successfully mobilised the civil society and TB has much to learn from these examples. 7. India needs to use the full potential of the research capacity in the country to develop new diagnostics, new drugs and vaccines for TB. This will require increased commitment from both the public and private sector stakeholders engaged in research and health product development. EXPRESS PHARMA
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TB diagnosis in India – Challenges and opportunities Dr Sanjay Sarin, Regional Director, Global Health (Central & South Asia Pacific), BD elaborates on the challenges and opportunities of TB diagnosis in India ndia ranks #1 in the world and constitutes 1/5th of the global TB burden. Every year, in India close to two million people develop the disease with nearly 40 per cent of them being infectious. Almost 1,000 people die of this curable disease in India every day. TB primarily affects people in their most productive years of life with almost 70 per cent of the patients being in the 1554 years age group. The disease continues to be a key deterrent to social and economic development with a staggering annual economic burden in excess of $ 3 billion in direct and indirect costs1. It is estimated that about 170 million workdays are lost annually in the country due to this disease2. India along with China contributes nearly 50 per cent to the global burden of Multiple Drug Resistant TB (MDR-TB). The rate of MDRTB infections in India in new and retreatment cases is 2.1 per cent and 15 per cent respectively. Out of nearly 65000 notified MDR-TB infections in 2011, only 3,384 patients have been put on treatment3. According to the WHO’s MDR-TB and XDR-TB report (2011), though significant efforts are being made, more needs to be done to achieve the goal of universal access by 2015. In India also, the government is taking significant steps to curb the menace of TB. In fact the DOTS programme in India has been a major success and is cited as a best case example across the world. However, the scourge of drug resistant TB and HIV-TB co-infection is threatening to reverse these gains. It is therefore imperative to have a comprehensive strategy inclusive of both diagnostic and therapeutic interventions to fight this epidemic. Improvements in existing approaches and implementation of new diagnostic tools for rapid and improved diagnosis of TB, MDR/XDR-TB and HIV-TB co-infection are needed. The
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strategy should include all the key stakeholders such as national TB programmes (NTPs), technical partners, civil society representatives, product developers, donors as well as the corporate sector. The last few years have seen the introduction of many new WHO diagnostic technologies starting with the liquid culture in 2007, followed by the line probe assay, LED microscope and more recently cartridge-based nucleic acid amplification technology such as the GeneXpert. Efforts are also being made to ensure the introduction of these technologies into the country TB diagnostic algorithms. It is important to note that all these technologies are complementary and are not necessarily substitutes for each other. In fact, WHO has developed new diagnostic algorithms which have appropriately included the above mentioned newly approved diagnostic technologies from a screening and treatment monitoring perspective. In addition to this, WHO recently issued a negative guidance on serology-based TB tests and subsequent to that Government of India has banned the sale and manufacturing of these tests in India4. According to the WHO TB serodiagnostics tests policy statement5, “It is strongly recommended that these commercial tests not be used for the diagnosis of pulmonary and extra-pulmonary TB as currently available commercial serodiagnostic tests (also referred to as serological tests) provide inconsistent and imprecise findings. There is no evidence that existing commercial serological assays improve patient outcomes, and high proportions of false-positive and false-negative results may have an adverse impact on the health www.expresspharmaonline.com
of patients.” Serology-based TB tests have been a big bane in India and a major reason behind delayed diagnosis and subsequent unfavourable treatment outcomes of TB patients. The banning of these tests is a big step in the positive direction and should certainly be helpful in the introduction of WHO approved diagnostic technologies in the private sector. In view of the fact
that more than 70 per cent of the Indian population seeks treatment in the private sector it is critical to engage the private sector to not only utilise the available capacity but to also build meaningful linkages with the national TB program. In addition to engaging the laboratories in the private sector, it is also important to align the physician community on the benefits of WHO approved technologies, as prescribing the approved TB diagnostic tests will be key to improving the lot of TB suspects in the country. BD through its Global Health Initiative is helping create long-term health solutions to fortify overburdened and under-resourced healthcare systems in three primary ways: 1. Increasing access to critical and state-of-the-art disease monitoring technologies 2. Building capacity and improving quality of care in resource constrained settings and 3. By investing in new
and market appropriate technologies for the developing world BD has been actively engaged in building publicprivate collaborations, as well as partnerships with the industry to advance the cause of improved TB diagnosis in India. BD is working with key stakeholders to build a platform for wider private sector participation in TB disease management. BD is instituting a mechanism of sustainable pricing coupled with technical assistance for capacity building in TB diagnosis through good laboratory practices programmes, developing centres of excellence and participating in industry forums to strengthen the voice for improved TB diagnosis and better patient outcomes. BD is working with both Revised National TB Control Programme and FIND (Foundation of Innovative New Diagnostics) to develop capacity for TB culture and drug susceptibility testing in 33 laboratories across India. BD also worked with FIND and Alliance Biosafety to establish a centre of excellence in biosafety in Bangalore to address biosafety issues associated with laboratory diagnosis of drug-resistant TB. BD believes that improvements in laboratory technologies are critical towards strengthening the continuum of TB care including diagnosis and monitoring in the country eventually leading to overall strengthening of healthcare systems. These improvements will not only address current crises, but can also support future healthcare needs in emerging economies such as India.
References: 1 RNTCP annual status report, 2011. 2.Tuberculosis situation in India – www.tbassnindia.org (accessed feb 2013), 3. WHO Global Tuberculosis Report, 2012. 4. TB: Centre bans ‘inaccurate’ serology tests, The Indian Express, Pune, June 20, 2012 5. WHO, Tuberculosis Serodiagnostics Tests, Policy Statement, 2011 March 16-31, 2013
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Epidemiology of TB in India Dr Giridhar R Babu, Associate Professor, Public Health Foundation of India discusses the imminent need for improved diagnostics and universal coverage of TB treatment ndia has one fifth of the world's burden of tuberculosis (TB) found and has a huge economic impact. According to recent
I
estimates, TB caused India to lose an estimated $23.7 billion. In addition, 42 per cent of the total population in the country is classified as poor and hence TB can lead to catastrophic out-ofpocket expenditure. It is imperative to ensure overall oversight, management systems. Ensuring political will at all levels of government is also a key determinant of
the initiative's success. It has to be acknowledged that extreme times such as this require extreme actions. India started its National Tuberculosis Programme (NTP) from 1962. The Revised National Tuberculosis Control Programme (RNTCP) adopted DOTS in 1997. RNTCP expanded in several phases to cover the entire popula-
tion by 2006 and is the largest TB programme providing anti tubercular treatment for more than 1.5 million people annually. The programme has over 13,000 peripheral laboratories with smear microscopy services and has examined more than 36 million persons through sputum-smear microscopy and detected more than 7.5 million TB
(Table-1) Estimates of TB in India - 2011 Number (thousands)
Rate (per 100000 population)
Mortality (excludes HIV+TB
300 (190-430)
24 (15-35)
Prevalence (includes HIV+TB)
3100 (2100-4300)
249 (168-346)
Incidence (includes HIV+TB)
2200 (2000-2500)
181 (163-199)
Incidence (HIV+TB)
94 (72-120)
76 (5.8-9.6)
Case correction, all forms (%)
59 (54-65)
TB case notifications 2011 New cases
%
Treatment cases
%
Smear positive
642321
-53
Relapse
112508
-37
Smear negative
340203
-28
Treatment after failure
17304
-6
Treatment after default
72787
-24
Other
101832
-33
Smear-unknown/not done Extra-pulmonary
226965
-19
Other
1952
(<1)
Total new
1211441
Total retreatment
304431
1323949
Total cases notified
1515872
Other (history unknown) Total new and relapse
Source: WHO GLOBAL TUBERCULOSIS REPORT 2012
New cases Smear positive
Smear negative/unknown/not done
Extrapulmonary
M:F Ratio
2.2
35573
34025
Age <15
12985
Laboratories:
2011
Smear (per 100000 population)
1
Culture (per 5 million population)
0.1
Drug susceptibility testing (per 5 million population)
0.1
Is second-line drug susceptibility testing available?
Yes, in country
Is there a national reference laboratory?
Yes
Source: WHO Global Tuberculosis Report 2012
March 16-31, 2013
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patients in the past five years. This mammoth programme screens nearly 25000 chest symptomatic persons per day for TB and detects, on an average, 3000 smear-positive TB cases and registers 4800 TB cases of all forms for treatment. Out of the estimated 8.8 million new TB cases worldwide, 2.3 million occur in India. Over the last few years, India has been reporting about 1.5 million cases of TB annually and of them a little over 1.3 million are new (and relapse) cases. (Table-1) The gap in notification is about one million people with TB that either do not receive care or
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receive it under sub-optimal conditions with unknown treatment outcomes. This is a major challenge in the fight against TB in India. In addition, the gap between the smear positive TB cases diagnosed and those treated and notified is about 100,000 per year. It is important to include all the cases of tuberculosis and bring them into the ambit of national programme. Here, I describe the epidemiological steps of detection to identify opportunities of TB case detection and suggests steps to be taken to improve detection at each of these steps and provide a roadmap for implementation
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of the steps.
Epidemiological basis of TB Control The estimated detection of new cases in India is falling short by at least one million per year. For a period of five years, this would result in a backlog of five million patients to be treated. In addition, approximately 100,000 patients are not diagnosed as TB even within the network of RNTCP hospitals. That means they add up 5,00,000 in the last five years. In effect, this means over 4.5 million people would be potentially transmitting the disease to the uninfected population in the
last five years. The rate at which the Indian programme is detecting new cases has remained stable. There are few possible reasons why this possibly might indicate detrimental effects. First, even if we were to assume TB transmission has really been reduced and only old cases are present in greater proportion; but this cannot explain the missing one million new cases per year. Second, there might be more deaths from TB that they donâ&#x20AC;&#x2122;t survive till diagnosis. Third, the proportion of people who are getting diagnosed for TB is same as proportion of TB cases being missed by the system. Realistic estimations of TB burden will provide the credible evidence for policy formulation and program implementation. To aid this, the Government of India can consider conducting nationwide population-based surveys of the prevalence of TB. These surveys would provide a direct measurement of the number of TB cases and their resistant forms, while repeat surveys conducted few years apart can allow direct measurement of trends in disease
March 16-31, 2013
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burden. There is abundant evidence that surveys are helpful in curbing TB burden in low and middle-income countries. Additional challenge in poor detection of TB cases is compounded by rampant and irrational use of antibiotics to treat undiagnosed TB cases. This results in the patients to become resistant for second and third line of anti-tubercular drugs, generally reserved for those who do not respond to first line of treatment. This is one of the biggest contributor for burden of multi drug resistant (MDR) TB case. According to the WHO Global Tuberculosis report of 2012, the estimated MDR TB cases among the notified cases are around 21000 patients per year. Extending the same proportion of MDRTB to missed cases; India will have an additional 21000 cases annually. In total, with 42000 MDR TB cases annually, India should have had more than two lakh cases of MDR TB in the last five years. In contrast, the cases of MDR TB cases reported in India are only around 4000 cases.
Way ahead The first pragmatic step is to enhance sputum specimen collection and transportation systems to full coverage by pro-actively establishing sputum collection and transportation from all public and private health facilities where TB symptomatics seek care, even if it costs significantly. It might be better to efficiently engage the services of NGOs, Anganwadi, ASHA, and the private sector laboratory specimen transport systems. This will ensure reduction in burden of primary TB and will greatly contribute towards prevention of drug resistance. Hence, the immediate priority is to bring the missed TB patients in the ambit of diagnosis and treatment. The challenge is exploring the attributes of finding around one million additional cases annually in terms of where they are missed, who is missing them and including all vulnerable sections as target beneficiaries for treatment. The next immediate requirement is to address the need of innovative new diagnostics and improve their quality to not to miss the opportunities of treating the infected individuals due to March 16-31, 2013
false nega t i v e results. Keeping in line with this logic backed by epidemiological principles, the possible actions to be taken are therefore based on the epidemiology of tuberculosis. The objective of RNTCP has so far been to detect smear positive TB cases by monitoring the number of TB symptomatic, which are tested with sputum smear microscopy. Though this indicator has been steadily increasing showing continued and successful effort for detecting TB cases. The Indian programme has done tremendous progress in improving the case notification rates. However, good case notification rates need not necessarily lead to early and rapid diagnosis of all persons with TB. Delays in detecting cases could in turn allow the spread of infection in the community before such cases are detected. It is only realistic to think that there are several steps at which we miss TB diagnosis. Any delays before diagnosis can spread the TB infection in families, public places, and other overpopulated places. In India, this is expected since most of these delays are inherent to access issues with health centres. The next challenge is to resolve treatment failure after diagnosis of TB. The immediate precedence is to uphold the objectives of RNTCP, as highest scientific and epidemiological gains will come from prompt diagnosis and effective treatment. This can be followed through a combination of accurate diagnosis and actively seeking TB cases in high-risk and vulnerable populations. The next step would be to use newer technology driven diagnosis and detect greater proportion of cases for treatment. There is a role for public health researchers and professionals. There should be greater evidence from the field in terms of how to integrate the existing private practitioners including the traditional healers into the ambit of TB case detection and treatment. It would be useful to generate evidence from the existing national health programs on motivating factors and enablers for private practitioners to report and treat TB cases as per national policy. www.expresspharmaonline.com
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RESEARCH EXPERTISE FOR DRUG DEVELOPMENT
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DR MADHUKAR PAI Associate Professor, Dept of Epidemiology & Biostatistics, McGill University
An accurate antibody or antigen detection test will make a big difference to TB control, especially if it can be introduced as a rapid, dipstick or lateral flow test. Much more basic research and biomarker work is needed to make that happen long eluded both patients and clinicians, with developing countries relying predominantly on sputum smear microscopy, a centuryold technique that has outgrown its use. Plagued by low sensitivity that further drips in field settings, arduous time to obtain results (up to a month since it is culture based) the inadequacy of smear test has also been enhanced by the increasing HIV pandemic coupled with its inability to detect drug March 16-31, 2013
resistance. It is only pertinent then that the research community and organisations engaged in finding new and better methods for TB diagnosis look at other approaches to solve this problem.
Molecular diagnostics: Setting a new paradigm Culture tests have been
the gold standard for TB diagnosis despite the time it took for results to be obtained. While scientists have worked at obtaining faster results in even a weeks time, an increasing approach now is to rely on molecular diagnostics. The Bill and Melinda Gates Foundation has been instrumental in its support of research, devel-
opment, and delivery of new TB diagnostics by distributing grants worth $150 million since towards this cause. Elaborates Gene Walther, Deputy Director for Diagnostics, Bill & Melinda Gates Foundation, “Molecular testing for TB, has been transformational, it is the first real advance in TB diagnosis since the 1880s
with an improved performance, allowing us to detect disease earlier, thereby permitting the initiation of treatment, as well as the reduction and spread of TB.” He
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ndia recently decided to roll out a unique test across 18 sites in the country to diagnose and confirm MDR TB. Hailed as a breakthrough in TB diagnosis, the Xpert test, developed by the Foundation for Innovative New Diagnostics (FIND), US-based Cepheid Corporation and the University of Medicine and Dentistry of New Jersey has been endorsed by WHO. It has several firsts to its credit including its ability to detect multi-drug resistant TB in less than two hours demonstrating both high sensitivity (88 per cent), as well as high specificity (98 per cent),a feat unaccomplished by its predecessors till now. An accurate test that can offer rapid detection along with reliable diagnosis had
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stresses that this is not end of the road, there is still room for further improvement in molecular diagnostics to improve access to state-of-the-art diagnostic technologies. Back in India, a company in Bangalore is determined to prove Walther right. Molbio Diagnostics, a joint venture between Bigtec Labs and Tulip group has developed a point-of-care test, Truelab, a real time PCR assay which hits the market this month. The battery operated test uses state-of-the-art Micro Electro-Mechanical Systems(MEMS) technology and can give results in an hour. “We conducted a study with Hinduja Hospital, Mumbai, the results of which were published in PLoS One. Truelab has a sensitivity greater than 99 per cent in smear positive (S+) and culture positive (C+) cases and a specificity of 100 per cent (versus a composite reference standard (CRS)). It was also able to detect all TB strains in an evaluation study using a panel from WHO/TDR that contains over 220 geographically diverse strains of TB,” asserts, Chandrasekhar Nair, Chief Executive Officer, Bigtec labs. While the sputum smear test showed a low sensitivity of 40-50 per cent with the rate further declining in countries with high prevalence of pulmonary TB and HIV infection, tests such as Xpert and Truelab rank high on both specificity and sensitivity and are the need of the hour. Detecting drug resistance is also a critical factor in which Xpert scores over Truelab, an area the latter is working upon. High specificity coupled with high sensitivity and detecting drug resistance, thus, have emerged as three important parameters to determine the efficacy of a test for TB diagnosis. This is further con-
firmed by studies over the past few years which blame the failure of TB diagnostics on either the disease being underdiagnosed (thus increasing the risk of transmission), or overdiagnosed (utilising resources of the healthcare system) or worse delayed diagnosis of drug resistance with the patient acquiring resistance and spreading the infection further.
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CEO, Bigtec labs
GENE WALTHER Deputy Director for Diagnostics, Bill & Melinda Gates Foundation
Fitting into the big picture Priced at $9.98 per cartridge Xpert MTB/RIF is already being scaled up in over 20 countries, with 1,900,000 cartridges procured in the public sector in 77 of the 145 countries eligible for concessional pricing. Price reduction was facilitated by Gates Foundation, UNITAID and other donors. While funding for TB diagnostics research by donor institutions is gaining momentum, the figure has remained far below that of drugs and vaccines for TB. Reluctance on the part of companies to invest in product development fearing market dynamics and a low return of interest does not help the cause either. Most of them are scared to test the waters after the government imposed a ban on serological tests for TB diagnosis citing their inaccuracy. “An accurate antibody or antigen detection test will make a big difference to TB control, especially if it can be introduced as a rapid, dipstick or lateral flow test. Much more basic research and biomarker work is needed to make that happen,” chips in Dr Madhukar Pai, Associate Professor, Dept of Epidemiology & Biostatistics, Mcgill University. Finding validated, accurate biomarkers then is the key. “Biomarkers offer next generation diagnosis of TB by helping identify the DNA of the bacterium rather the cellular wall (smear
THE GATES FOUNDATION HAS INVESTED $11 MILLION IN NEW GRANTS TO IDENTIFY BIOMARKERS FOR THE DEVELOPMENT OF NOVEL TB DIAGNOSTICS. USE OF ACCESSIBLE SAMPLES SUCH AS URINE, SALIVA, BREATH AND PERHAPS BLOOD AND THE EASE OF DOING THESE TESTS OUTSIDE OF A FORMAL LAB SETTING WOULD ENABLE HEALTH CARE PROVIDERS TO SCREEN AND DIAGNOSE PATIENTS MORE QUICKLY 44
CHANDRASEKHAR NAIR
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Truelab has a sensitivity greater than 99 per cent in smear positive(S+) and culture positive(C+) cases and a specificity of 100 per cent (versus a composite reference standard (CRS). It was also able to detect all TB strains in an evaluation study using a panel from WHO/TDR that contains over 220 geographically diverse strains of TB
Molecular testing for TB, has been transformational, it is the first real advance in TB diagnosis since the 1880s with an improved performance, allowing us to detect disease earlier, thereby permitting the initiation of treatment as well as the reduction and spread of TB
microscopy) which not only helps increase sensitivity, but also enables rapid diagnosis and detection of drug resistance,” adds Walther. The Gates Foundation has invested $11 million in new grants to identify biomarkers for the development of novel TB diagnostics. Use of accessible samples such as urine, saliva, breath, and perhaps blood and the ease of doing these tests outside of a formal lab setting would enable healthcare providers to screen and diagnose patients more quickly, he feels. An effective test that is affordable and accessible could, however, lose out in absence of a proper diagnostic algorithm. An algorithm is a recommended sequence in which procedures such as symptom screens can be combined with tests in a diagnostic pathway. An efficient algorithm would integrate procedures and tests to ensure the most rapid, accurate, and rational diagnosis and treatment for all patients. India’s failure in this area can only be revealed by the fact that even after achieving 100 per cent DOTS coverage TB still remains a huge burden. While the Revised National
TB Control Programme (RNTCP) has shown a lot of leadership by banning inaccurate TB blood antibody tests, making TB case notification compulsory, increasing its budget to support introduction of new innovations, including the scale up of the recent Xpert test, much more needs to be done. “Most TB patients in India first seek care in the private sector where subsidised prices for WHO-endorsed tests like Xpert, line probe assay and liquid culture are not available. So, there is no affordable alternative to TB serology, hence the government should consider ways to make WHOendorsed tests more affordable in the private sector,” exhorts Pai. Initiatives such as IPAQT – Initiative to Promote Affordable and Quality TB Tests are the path bearers in this regard, he feels. Meanwhile it remains to be seen how both Xpert and Truelab would be implemented in peripheral microscopy centre labs and primary health centres where they would impact clinical outcomes even as the hunt for an innovative test that can possibly rise above all limitations is on. shalini.g@expressindia.com March 16-31, 2013
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PHARMA ALLY VENDOR NEWS W H AT ’ S INSIDE
Waters opens new solution centre PG 67 EMBL Hamburg researchers PG 68 Malvern launches new imaging ... PG 69
Indegene collaborates with Team Computers to host exclusive ‘iPads in Pharma’ Attended by over 40 senior sales, marketing, training, commercial, and business executives from leading global and Indian pharmaceutical companies ndegene in partnership with Team Computers, an enterprise IT solution provider and Apple Inc’s authorised reseller in India, hosted an exclusive executive briefing for senior pharma leaders on ‘Driving Efficiency and Effectiveness in Pharma with Enterprise Mobility’. The event hosted
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recently was attended by over 40 senior sales, marketing, training, commercial, and business executives from leading global and Indian pharmaceutical companies. Manish Gupta, Chief Executive Officer, Indegene Lifesystems said, “Our new enterprise mobility frame-
work allows clients to assess and deploy mobility solutions intelligently across multiple brands and teams. We expect this approach to be transformational in areas such as detailing, CLM, sales force training, and physician and patient engagement.” As pharma marketing continues to transform, consumers and stakeholders have changed the way they create and assimilate information. For instance, a recent study by Manhattan
Research suggests that physicians interacting with med-reps using iPads are 35 per cent more likely to request a sample; and 29 per cent of physicians surveyed are more likely to prescribe the drug. Another study estimated that remote training could save a company approximately $1000 per year per rep, and with an enterprise solution, the saving could be significantly higher. EP News Bureau-Mumbai
Sigma-Aldrich Corporation announces expansion of its global shared services centre in India Opens new GSS Centre in Bangalore, to span across 45,000 sq ft when fully operational
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Sigma-Aldrich Corporation, a life science and high technology company, announced the expansion of its Global Shared Services (GSS) centre in India which supports the company globally by offering value-added capabilities to drive business growth and accelerate operational excellence. The GSS Centre in Bangalore, spans across 45,000 square feet and is fully operational. The opening of the new GSS facility closely follows the recent celebration of Sigma-Aldrich’s 20th anniversary conducting business in India. Says Karen Miller, Senior Vice President of Corporate Development and Corporate Communications, Sigma-Aldrich Corporation, “India remains a major focus for Sigma-Aldrich. With GSS, we will leverage our capabilities, talent and infrastructure in India to better serve our global customer base.” Miller added, “Our highly educated colleagues in GSS are supporting many of our global functions, including strategic marketing, sales support and business analytics. From transactional to highly strategic responsibilities, our GSS India employees
are helping to support our global business growth and accelerate operational excellence.” S i g m a - A l d r i c h Corporation has showcased noteworthy Asia Pacific investments in the last few years, including opening of a new packaging facility in Bangalore, opening of a new facility in Wuxi, China, which is now fully operational and completion of a new SAFC Hitech precursor manufacturing facility in Taiwan. “APAC remains a key area of focus for our company not only from a growth perspective but also in terms of infrastructure support for our global franchise,” said Jason Apter, Vice President and Managing Director, Media Announcement, Asia Pacific, Sigma -Aldrich. The company recently reorganised to enhance focus on core market segments to better attune solutions and services to meet the needs of a diverse customer base. The company defined three new strategic business units Research Markets, Applied Markets and SAFC Commercial. Each intends to tailor product innovation programmes, sales and marketwww.expresspharmaonline.com
(L-R) Michael Kanan, Vice President and Corporate Controller; Karen Miller, Senior Vice President Corporate Development and Corporate Communications; Silji Abraham, Chief Information Officer and Jason Apter, Vice President and Managing Director, Asia Pacific, Sigma-Aldrich Corp ing channels, and customised solutions in a manner that best suits the specific needs of the customer segments they serve from research to manufacturing. “In challenging economies, successful companies are those that are best able to meet their customer needs and our markets in Asia Pacific are no exception. We need to continue getting closer to our customers, increasing service level and launching more local products,” said Apter. “To reinforce this commitment, we will bring the Vetec
brand of products to Asia Pacific and an expanded consumables offering to provide more complete solutions for various research and applied market segments. We continue to leverage our global capabilities and customise them for the needs of our local markets.” The expanded product portfolio is expected to be available in India by the second quarter of the year and already is being distributed in other regions within Asia Pacific. EP News Bureau-Bangalore March 16-31, 2013
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Waters opens new solution centre in Singapore Is equipped with advanced analytical application development and demonstration capabilities and training facilitie
ilford, Massachusettsheadquartered Waters Corporation has opened a new Solution Centre in Singapore. Housed in Singapore Science Park II, Waters Solution Centre is equipped with advanced analytical application development and demonstration capabilities and training facilities dedicated to addressing the needs of laboratory scientists throughout South East Asia. “The scientific challenges our customers face in South East Asia are unique to this part of the world and Waters’ new Solution Centre is designed to address these challenges to ensure our customers are successful. Comprising a team of skilled analytical scientists, many at post-doctoral levels, who will offer technical advice and/ or develop applications to solve analytical issues, the Solution Centre will serve the increasing important markets of South East Asia along with Singapore and Australia,” said Mike Harrington, Vice
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President Europe and Asia Pacific, Waters Division. In addition to establishing Waters R&D facility for Engineering in Singapore, the new Waters Solution Centre is an extension of Waters’ commitment to promote R&D in Singapore in support of the development of Singapore’s biomedical sciences sector. “The opening of Waters Solution Centre marks another milestone in our commitment to Singapore. Singapore is a key strategic location for us in Asia and in particular South East Asia, at two levels – business and talents. Not only does it bring us closer to our customers in this region, Singapore as a research hub is also where international and local research talents and minds gather,” said, Mathieu Laouenan, General Manager, South East Asia & Pacific Operations, Waters Corporation. The Solution Centre will offer customers the Waters Omics Research Platform Solutions, the best-in class
instrumental systems for those in the pharmaceutical and life sciences, food, and clinical research areas. With the world’s growing emphasis on medical care, these solutions will help the medical community in South East Asia realise the promise of personalised medicine with a ‘bench to bedside’ approach to optimising the drug discovery process. “Through development of applications to address the challenges faced by scientists in this part of the world, Waters hopes to leverage its momentum in food safety analysis and life sciences innovation and expand its capability in traditional medicine research and the development of new tools for the chemical industry,” said Mark Ritchie, Senior Manager of Waters Solution Centre. The new centre will also be equipped with one of Water’s state-of-the-art separation science and mass spectrometry technology, the ACQUITY Ultra Performance
Convergence Chromatography (UPC2). ACQUITY UPC2 is a new category of separations science that is proving to be a reliable complementary chromatography platform with unique workflow, application and environmental impact benefits compared to either liquid or gas chromatography platforms. This revolutionary technology replaces the use of organic solvents with safe, green CO2, while increasing analytical performance. Customers from all market segments throughout South East Asia are encouraged to contact the Solution Centre to better understand and appreciate the features and benefits of Waters Omics Research Platform Solutions, ACQUITY UPC2 or any of Waters’ advanced separation science and mass spectrometry technologies. EP News Bureau-Mumbai
POST EVENT Siemens launches SIMATIC S7-1500 Updated version of its TIA Portal also launched
March 16-31, 2013
iemens Industry Sector’s Industry Automation division has launched SIMATIC S7-1500 recently in Mumbai. SIMATIC S7-1500 are next generation controllers for medium to high-end machine and plant automation. The new generation of controllers is characterised by high performance and efficiency and offers numerous benefits such as integrated motion control, plant security, and safety applications that are easy to implement. Greater efficiency is represented in particular by the innovative design that enables simple commissioning and safe operation, by the configurable diagnostic functions that provide the plant status and by the integration into the TIA Portal for simple engineering and low project costs. Commenting on the new product S7-1500, Bhaskar Mandal, Executive VicePresident, Industry Sector, South Asia, Siemens, said “Being in the Indian market for decades, Siemens has a thorough understanding of the
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industry needs and has continuously designed products and solutions that help our clients maximise productivity and increase efficiency. The new SIMATIC S7-1500 controller sets new standards for maximised productivity. This benefits small-series machines, as well as complex installations that place high demands on speed and deterministic communication. The SIMATIC S7-1500 is seamlessly integrated in the Totally Integrated Automation Portal (TIA Portal) for maximum engineering efficiency.” With regard to overall performance, the technology, security, safety and system performance have been considerably improved. In order to increase efficiency, further developments have been made specifically in the areas of design and handling, system diagnosis and engineering with the TIA Portal. The Siemens Industry Sector’s Industry Automation division also announced the enhancement of its 'Totally Integrated Automation Portal' www.expresspharmaonline.com
(TIA Portal) engineering framework with numerous new functions. Version 12 enables all Siemens drives of the Sinamics G converter series to be parameterised via the TIA Portal, and additional diagnostic functions have also been integrated. Among other things, the safety functionalities have been extended for SIMATIC S7-1500 and the Profinet communication performance has been expanded. The programming languages have been trimmed for even greater efficiency and new security functions provide improved protection of knowhow, and better security against copying and access. Within the framework of the new version of the TIA Portal there are also updates for engineering tools for the configuration, programming, commissioning and servicing of the Siemens automation devices and drive systems. These include, for example, the following engineering systems: SIMATIC Step 7 V12 for SIMATIC controllers, SIMATIC WinCC V12 for HMI systems
(SIMATIC HMI) and Sinamics Startdrive V12 for the Sinamics G converter family. Mandal adds, “Integration of automation platforms in a manufacturing environment is vital to avoid automation islands. While our current version of Totally Integrated Automation portal performs automation and drive tasks quickly and intuitively, the new version provides seamless drive integration, integrated system diagnostics and safety functionality along with a powerful Profinet communication.” The Siemens TIA Portal is designed for high efficiency and user-friendliness, and it is suitable for both first-time users and experienced users. It offers a standardised operating concept for controllers, human machine interface (HMI) and drives, for shared data storage and automatic data consistency, for example during configuration, communication and diagnosis. It also offers powerful libraries covering all automation objects. EP News Bureau-Mumbai EXPRESS PHARMA
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PRODUCTS EMBL Hamburg researchers use Viscotek TDA for enhanced protein characterisation by SAXS esearchers at the European Molecular Biology Laboratory (EMBL) in Hamburg, Germany, have incorporated a multi-detector array size exclusion chromatography (SEC) system from Malvern Instruments (Viscotek TDA –Triple Detector Array) at the laboratory’s small angle X-ray scattering (SAXS) beamline to improve the productivity and quality of detailed protein characterisation work. Use of the Viscotek TDA triple detector array system prior to analysis provides complementary biophysical data and simultaneously purifies samples for measurement. This results in more information and better quality data from each experiment. This innovative set-up is not only
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limited to the institute itself, but is widely accessible to structural biology researchers via BioStructX, a European Commission initiative that creates a single gateway to Europe’s leading synchrotron facilities. SEC produces a fractionated sample for measurement, separated on the basis of hydrodynamic size. The Viscotek TDA incorporates refractive index, UV and light scattering detectors which in combination provide concentration and absolute molecular weight measurement for these eluting fractions. Integrating this system with the SAXS beamline provides it with purified samples for measurement that give enhanced signal-to-noise ratios and high quality data.
Waters updates Alliance HPLC designs W aters Corporation has reinforced its commitment to High Performance Liquid Chromatography (HPLC) users through new design improvements to the Waters Alliance HPLC System. Per customer demand, the updated system will maintain key alliance performance specifications and control algorithms to ensure that analysts can seamlessly replicate their existing methods. Ian King, Vice President of Separation Science for the Waters Division, “The
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Alliance HPLC System has been the benchmark for HPLC in the laboratory for nearly two decades. Because of its dependability, high quality and flexible operation, tens of thousands of these systems are used every day to run methods varying from USP monographs to polymer analyses. Since its introduction, the Alliance HPLC System has been continually enhanced accommodating an enormous range of separation challenges. Waters will continue its commitment to upgrading the Alliance HPLC System with the assurance that any changes will not affect established, validated HPLC methods.” Beyond updated electronics and user interface, the Alliance HPLC system is ideally suited to help scientists enhance their HPLC methodologies through use of Waters eXtended Performance [XP], 2.5 µm columns. These columns belong to Waters’ platform of scalable particle size www.expresspharmaonline.com
In combination with the biophysical information from the TDA these data provide detailed information about the internal shape and structure of proteins that advances understanding of their behaviour. In particular SAXS data is valued for the determination and monitoring of the low resolution structures and conformational changes that proteins exhibit. Both Malvern Instruments and EMBL Hamburg are partners in the BioStructX project which brings together facilities from across Europe to establish a state-of-the-art coordinated and multi-site infrastructure to support access for key methods in structural biology. The new integrated SECSAXS set-up was developed by a number of experts within
EMBL, and with input from Malvern Instruments to enhance the department’s offering to BioSAXS users transnationally. The automated multi-pronged characterisation it offers has already demonstrated its significant advantages to the first users and is expected to be in considerable demand as the BioSructX project advances.
chemistries, which includes our patented surface charged column chemistries, which due to their wide selectivity range can seamlessly reproduce existing HPLC methods and simultaneously provide a pathway to UPLC compatibility for the future. Waters’ HPLC to UPLC method transferability strategy differentiates us from other competitors. Additionally, the ability for Alliance HPLC to seamlessly integrate with customers’ existing Empower software network for instrument control and data processing significantly expands the impact of the system. Empower 3 Software, Waters’ flagship chromatography data software, makes it easier than ever to run samples and produce meaningful results without extensive training, re-engineering workflow, or adding new software to support instruments or advanced chromatographic techniques. Analytical laboratories depend on the Alliance HPLC System to meet the rigorous requirements ranging from routine analyses to the performance standards of newproduct research and development. The Alliance HPLC system offers: Integrated solvent and
sample management to ensure consistent system-to-system performance and high reproducibility; Alliance HPLC features with Automated Solvent Compressibility, users do not have to select from calibration or look-up tables, and risk accidental errors in selection; Full integration with either Empower or MassLynx Software for instrument control and data processing; a large, intuitive LCD-based user interface for rapid system setup and daily start-ups; Easy, tool-free maintenance resulting in maximised uptime; Waters complete line of detection technologies – from routine UV/ Vis detectors to single, tandem and triple quadrupole mass spectrometers extend application capabilities; supported by Waters 50 years of HPLC expertise and global reach in every country where Waters is represented.
Contact details: Soloni Gosalia Malvern Aimil Instruments Naimex House, BSEL Tech Park, B Wing – 906 Sector 30A, Opp Vashi Railway Station, Vashi, Navi Mumbai 400 705, India Tel: + 91 22 3918 3596 Fax: +91 22 3918 3562 Email: soloni.gosalia@ malvernaimil.com
Contact details: Dayamani Santosh, Administrative Officer, Waters India Pvt Ltd. 36A, II Phase Peenya Industrial Area Bangalore 560 058 India website: www.waters.com email: dayamani_santosh @waters.com March 16-31, 2013
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Cognex launches new series of compact barcode readers ognex Corporation announced a new series of compact barcode readers designed for 1-D-oriented barcode reading. Small in size but exceptional in barcode reading performance, the DataMan 50L measures just 23.5 mm x 27 mm x 43.5 mm and features an IP65-rated housing. It is ideal for mounting in very tight spaces on production lines and in machinery. The DataMan 50L is equipped with Hotbars, a proprietary image analysis
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technology that delivers the highest read rates in the industry. The DataMan 50L includes all of the features
that make Cognex the premier barcode reading brand, including: Hotbars, which provides the highest read rates of 1-D linear barcodes, including those that are damaged, distorted, blurred, scratched, low height or low contrast. The ability to analyse 'no reads' by letting the user see what the reader sees, either live on a monitor or through image archiving. Designed with no moving parts that can become worn out and require replacement.
The DataMan 50L features a three-position lens and an integrated aimer for easy setup at different working distances. The incredibly small form factor enables the reader to integrate into virtually any new or existing installation. Contact details: Sunil Vaggu Cognex Sensors India Email: vaggu.sunil@cognex.com Phone: +91 9881466003
Telstar launches pre-engineered modular aseptic facilities elstar in association with its sister company KeyPlants has developed a pre-engineered modular aseptic facility for manufacturing of small-volume parenterals (SVP). This installation is designed to be adapted to pharmaceutical/biopharmaceutical processes areas requiring to be operated both in aseptic conditions for product protection and/or under contained conditions for operator protection. The facility, which is designed for either lyophilised powder or solutions, allows handling either vials or pre-filled syringes with a range from 2 to 20ml. Furthermore, this installa-
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tion is conceived to be flexible with the ability to add lyophilisation modules and a second line without interruption to existing operations. The line speed is to be from 200 (20 ml) to 400 vials (2 ml) per minute, with either manual or, if required, automatic loading systems. The modular concept is an innovative trend in the construction of critical facilities for the pharma/ biopharma industry, offering fast track, cost efficient alternatives to conventional design. Furthermore, the modular design provides standardisation and repeatability, which further
simplifies pre-fabrication and enhances the cost certainty of the project. The modular concept significantly reduces time to market for lifesaving products, such as pandemic vaccines
and new cytostatics. Contact details: Telstar Tel: +34 93 736 16 00 Web: www.telstar.eu Email: marketing@telstar.eu
Malvern launches new imaging masterclass webinar series alvern Instruments’ has introduced new series of web-based Imaging Masterclasses. The series will then continue through the year and will cover a
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March 16-31, 2013
broad range of imaging topics. Alongside this will run the laser diffraction Masterclass series which will discuss subjects including wet method develop-
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ment, dry method development, optical property selection and specification setting. The opening ‘introduction to imaging’ webinar is designed to provide a basic understanding into the theory behind making particle characterisation measurements using imaging-based techniques. In line with Malvern’s established Masterclass concept, the whole series will deliver information on topics of specific interest to a broad audience and to people with varied levels of particle characterisation experience and technical expertise. Intended to serve as a non-commercial, educational series, the new Imaging Masterclass programme is the most recent in
Malvern’s extensive webinar Masterclass collection. The series will be presented by Malvern’s technical and applications experts and is aimed at operators looking to get the most from their analytical techniques as well as those who simply wish to expand their understanding of the subject area. Contact details: Soloni Gosalia Malvern Aimil Instruments Naimex House, BSEL Tech Park, B Wing – 906 Sector 30A Opp Vashi Railway Station, Vashi, Navi Mumbai 400705, India Tel: + 91 22 3918 3596: Fax: +91 22 3918 3562 soloni.gosalia@malvernaimil.com www.malvern.com EXPRESS PHARMA
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March 16-31, 2013
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It seems an extension of controversy that started a few months back between Food and Drug Administration (FDA) Maharashtra and chemists in the state. A few months back, FDA’s objection to entertain prescriptions from non allopathy doctors met with strong protest from chemists as well as non allopathy doctors. Moreover, this controversy caught both the FDA and chemists in a dilemma of choosing between ethics and rules. Even the Maharashtra Government struggled to find out an amicable solution. Now, perhaps the same old story is getting repeated. But the location hasn’t changed, characters are the same too, only the script is different. FDA's recent raids on chemist shops that were working without a registered pharmacist are justified. However, on the other hand, industry experts are also surprised at the sudden and desperate response of FDA to such chemist shops. A stitch in time saves nine, goes an old saying. Unfortunately, the FDA didn't understand this sooner and perhaps woke up late to an emergency. Raid rampage FDA raids are as per the laid down rules and should be supported by any law abiding individual. However, fingers have been pointed towards FDA’s approach and not at the rules. How come so many illegal chemist shops have cropped up and survived for so many years in the first place? What had stopped FDA from raiding such shops before, which have now grown become a major problem? Sudhir Deshpande, Legal Consultant, Pharmalex, doesn’t find FDA's raids sudden. According to him it is not correct to say that this is FDA’s sudden outburst against chemist shops in Maharashtra. “This is an ongoing process and FDA, Maharashtra State has been taking penal action against the chemist shops for violaMarch 16-31, 2013
tion of conditions of licenses especially selling Schedule H drugs without supervision of a registered pharmacist,” says Deshpande, while backing his opinion. He adds, “It appears, FDA decided to resort to the campaign and concerted action as the instances of selling drug without supervision of the registered pharmacist, selling drugs without prescription, diversion of habit forming drugs for non medicinal use etc. have become major problem over last few years.” One reason that is been put forward for not conducting raids before was the lack of drug inspectors. Dilip Kadam, Executive Member, All India Organisation of Chemists & Druggists (AIOCD) and Maharashtra State Chemists and Druggists Association (MSCDA) says, “Basically there were no sufficient drug inspectors earlier and hence the law could not be implemented even if anybody wanted to do so. The period of lack of inspectors was too long, therefore there was nobody to keep any control on the chemists.” Kadam stressed that there was no dispute between the chemists' association and the FDA. Everything was working in cordial relations as a very few inspectors were in the FDA who could not make regular inspections as per the law till Mahesh Zagade, FDA Commissioner, Maharashtra State, came into the picture. Kadam informs, “Very recently 92 inspectors have been recruited.” According to Subramanian Vaidya, an industry expert, there were a lot of complaints about unauthorised stocking and sales of some products in the hormonal segment and that too without prescriptions. Drug inspectors also noticed that the sale of such products were being effected by unqualified staff at the pharmacy outlets. “The entire move seems to have been mooted after this episode. This was because a lot of complaints and sufferings in the form of adverse effects at the patients' level. www.expresspharmaonline.com
There could be other reasons too. However the main one could be that such sales and consumption of these products were harmful to customers at large and that too without any monitoring of the sales,” says Vaidya.
To be or not to be However, there always two sides to a story. The problem that arises while cutting the tablet strip is one of the many examples where
SUDHIR DESHPANDE Legal Consultant, Pharmalex
with the rules. However explaining the chemists' point of view, Kadam points out the dilemma associated with the cut tablet strip. He says, “After giving the loose tablets, the remaining strip should have the requisite batch number and its expiry date. FDA should address this issue by giving guidelines to the manufacturers. The rules are very clear but they should go hand in hand with other
SUBRAMANIAN VAIDYA An industry expert
Raids are an ongoing process and FDA, Maharashtra State has been taking penal action against the chemist shops for violation of conditions of licenses especially selling Schedule H drugs without supervision of a registered pharmacist
The pharma companies have also erred to a certain extent. This is by increasing the number of capsules in a strip in order to swell the one time purchase by the customer, thus looking for a larger turnover of the product and thus the revenue
this fact gets clearly underlined. As per Deshpande, the provisions of Rule 65(9) of the Drugs and Cosmetics Rules, 1945 are clear and there is no ambiguity as to whether tablets strips should be cut or not. If the prescription of schedule H drugs is for six tablets, it is mandatory for the chemist to sell only six tablets by cutting the tablets strip. The ability of compliance of conditions of licenses and Rule 65 depends on the mindset of the chemists. Over the period of last few years, under the pretext of practical difficulties, chemists have developed a tendency of not complying
related acts and rules.” Vaidya brings pharma companies into the picture. According to him, pharma companies also have a role to play in this scenario and discusses some critical issues associated with the pharma industry. He stresses, “The pharma companies have also erred to a certain extent. This is by increasing the number of capsules in a strip in order to swell the one time purchase by the customer, thus looking for a larger turnover of the product and thereby the revenue. There are many examples on this at the chemist front. Obviously when the doctors prescribe medicines to the patients, they are not well EXPRESS PHARMA
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informed of the packaging by the company and this leads to miscommunication.” He adds, “Besides daily wage earners and weaker sections of the society would like to buy bare minimum as one time purchase. This calls for cutting of strips at the chemists' level.” However Vaidya argues, “Strip cutting results in not being able to track and trace batch numbers and expiry dates and dispensed. Rules are existing in FDA , but they have not been progressively reviewed and changed so as to meet the changed circumstances. Hardly any governance has been done in this area. Companies do all sorts of tricks and manage to get the maximum out of a prescription and rightly so.”
Lack of resources A large number of chemist shops in Maharashtra, working without proper license or registered pharmacists, had to pull down their shutters due to FDA raids. A move applauded by many but in several cases, the chemists have their own justifications. There was just one pharmacist in many chemist shops because the shop owner couldn't afford to employ two pharmacists to work in different shifts. So, chemists who tried to run shop in two shifts had to go without a pharmacist in one of the two shifts. To make the situation worse for chemist shop owners, Maharashtra doesn't have a sufficient quantity of registered pharmacists. So in this scenario, where there is a demand supply gap, can the raids by FDA be justified? “It is true that to run
shop in two shifts, a chemist shop would require two pharmacists and that Maharashtra does not have sufficient registered pharmacists to work in the chemists shops. No accurate data is available as to how many of registered pharmacists have left for a career in countries out of India, how many are working in government and railway hospitals, how many are working in the pharma industry or any other field,” opines Deshpande. However he also cautions, “Notwithstanding the problem of non availability of sufficient registered pharmacists, FDA cannot allow shops to run without supervision of registered pharmacists.” He emphasises, “The problem has become chronic not because of the non availability of pharmacists but because of entry of large number of shopkeepers in the profession by appointing registered pharmacists only for the name sake. FDA’s action will result in driving such elements out of the profession and it will be certainly beneficial to the law abiding chemists.” Kadam provides statistical count of the number of pharmacists. He says, “There are 1,30,000 registered pharmacists in the state and around 50,000 retail shops in every nook and corner of the state. Almost 10,000 pharmacists come out of the colleges every year. Maharashtra is second in number, with the maximum pharmacy colleges. So, there should not be a scarcity of pharmacists. However today the position is such that looking at the state population, behind every 2000 people there is one retail shop.” Dr Laurence J Peter, a
FDA'S ENDEAVOUR TOWARDS STRICT IMPLEMENTATION OF RULES IS COMMENDABLE. HOWEVER,THE ISSUES GENERATED OUT OF FDA'S RAIDS ARE ALSO THE OUTCOME OF FDA'S OWN LETHARGIC ATTITUDE. ITS EFFORTS TO IMPLEMENT THE LAID DOWN RULES CAN ALWAYS BE JUSTIFIED BUT WITH SUCH SUDDEN OUTBURSTS, FDA ITSELF IS MAKING ROOM FOR THESE RAIDS TO GET QUESTIONED 72
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world known educator, describes bureaucracy“Bureaucracy defends the status quo long past the time when the quo has lost its status.” Vaidya explains, “Any raid cannot be justified by FDA at this moment. FDA could have been more transparent while granting licenses. Unfortunately in some cases licenses have been given when there was actually no need of it. FDA indeed has a very good batch of officers. FDA commissioner's intentions are noble too and cannot be questioned. However, in some exceptional cases loopholes were being thoroughly exploited by the subordinate authorities for giving away licenses. There could be built in gains in this in terms of convenience and money exchange. Needless to point out that the employed pharmacists, as they are less in number, sign up with more than one outlet allowing malpractices to seep in.”
Will budding pharmacists get demoralised? Pharmacist usually do not get good salaries at the chemist shops. There is a question mark over job satisfaction as well, as chemist shops are not identified as an industry. Now recent controversies associated with this profession must have added to the worries of the budding pharmacists. Will such frequent fights associated with this profession make aspiring pharmacists look for other jobs? Vaidya provides critical and realistic views, “Pharmacy degree holders are not interested in this type of work and they consider this below their dignity. They always lean towards white collar jobs in a pharma company in various departments like marketing, production, regulatory, R&D, clinical research and so on. These jobs also bring considerable increased amount of wages and incentives along with perks. This leads to a gigantic gap in terms of emoluments drawn by a pharmacist degree holder and diploma pharmacist in a chemist shop. There is hardly any social esteem for a diploma pharmacist in a pharmacy outlet.” However Deshpande disagrees and does not think that it will be difficult to attract good pharmacists.
DILIP KADAM Executive Member, All India Organisation of Chemists & Druggists (AIOCD) and Maharashtra State Chemists and Druggists Association (MSCDA)
Basically there were no sufficient drug inspectors earlier and hence the law could not be implemented even if anybody wanted to do so. The period of lack of inspectors was too long, therefore there was nobody to keep any control on the chemists
“In fact, the campaign by FDA will create better opportunities for pharmacists keen to work in chemists shops as full time pharmacists. Closure of shops not employing full time registered pharmacist will also create an opportunity for self employed pharmacists,” says Deshpande, while showing the silver lining to the controversy. So the bottom line is that FDA's endeavour towards strict implementation of rules is commendable. However, the issues generated out of FDA's raids are also the outcome of FDA's own lethargic attitude. Its efforts to implement the laid down rules can always be justified but with such sudden outbursts, FDA itself is making room for these raids to get questioned. As far as patients are concerned, they are more bothered about the delivery of the right medicine, at the right time. FDA and chemist shop owners should ensure that they would not stoop to the level that would degrade their credibility in the eyes of patients by becoming a source of entertainment. sachin.jagdale@expressindia.com March 16-31, 2013
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AWARDS GACL bags ‘Best Corporate Social Responsibility Practices’ award YK Shishode, Public Relations Officer, GACL receives the award
Exchange) 7th Social and Corporate Governance Awards celebration on World CSR Day in Mumbai. YK Shishode, Public Relations Officer, GACL received the coveted honour from Dr Alok Bhardwaj,
ujarat Alkalies and Chemicals Ltd (GACL) was recently honoured for ‘Best Corporate Social Responsibility Practices’ during BSE's (Bombay Stock
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Executive Vice President, Canon India. The social and corporate governance awards was instituted six years back to recognise the best practices in corporate and social responsibility and to spread the knowledge about corporate and social responsibility. EP News Bureau-Mumbai
XCODE Life Sciences receives ISBA 2013 Promising Venture Award Award presented in conjunction with the seventh edition of the Annual Incubator Conference on Business Incubation
hennai-based biotechnology company XCODE Life Sciences has received ISBA 2013 Promising Venture Award presented by The Indian Science and Technology Entrepreneurs Parks (STEP) and Business Incubators Association
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(ISBA). ISBA is a professional body sponsored by the National Science and Technology Entrepreneurship Development Board (Ministry of Science and Technology, Government of India). This award was presented in conjunction with the seventh edition of the Annual Incubator Conference on Business Incubation. Held at KIIT University, Bhubaneswar, the conference theme focussed on 'INCUBATION: Adding Dimensions, Spurring Growth' which witnessed the participation of nearly 500 delegates from different communities such as policy makers, incubation managers and academia. An important part of the conference was the 5th ISBA Innovation and Entrepreneurship awards to recognise outstanding startups and entrepreneurs who gained from the Indian
Incubation Network. XCODE was chosen among several Indian start-ups to receive the Promising Venture Award for its outstanding performance and innovative business model. XCODE was closely evaluated based on several criteria that included innovation in technology, product offering, potential impact and its ability to succeed in the market. The eminent jury panel was headed by Prof YS Rajan, who is a professor at ISRO, Department of Space, Bangalore and Chairman, National Institute of Technology (NIT), Manipur, besides holding advisory roles at apex boards for several other institutions. In July 2012, XCODE launched its signature product Lifelong Wellness, a scientific, personalised wellness programme for individuals based on an individual DNA
PD Hinduja National Hospital and Medical Research Centre, Mumbai bags award Conferred with the first D Hinduja National diagnostics and develop tech- could fix some root problems Hospital and Medical niques for rapid diagnosis of which had been plaguing the P TB Champion Award by Research Centre, Mumbai has TB and drug susceptibility society till now.” Global Health Strategies
March 16-31, 2013
been conferred the first TB Champion Award by Global Health Strategies (GHS), an international consulting company. Hinduja Hospital was recognised for the importance the organisation has given to accurate diagnosis and treatment and to optimally manage TB patients, provide reliable
testing. The research report by Hinduja Hospital was published in January 2012. On winning the award, Pramod Lele, Chief Executive Officer, Hinduja Hospital said, “Hinduja Hospital has always been known for its cutting edge research. TB is a sensitive topic and we are glad that the outcome of our research www.expresspharmaonline.com
Dr Camilla Rodrigues, Consultant Microbiologist and Chairperson Infection Control Committee said, “Hinduja Hospital has always shown corporate social responsibility for a noble cause, and has invested in both rapid TB diagnostics and research for over 15 years.” Hinduja Hospital was the
analysis. Today, the company has a growing customer base of over 100 satisfied customers. Commenting on the award, Dr Saleem Mohammed, Chief Executive Officer and Co-founder, XCODE Life Sciences, said “XCODE is both proud and honoured to receive this award and it comes in recognition of what we have already achieved in the field of personalised healthcare and what we are working towards - making a difference in the lives of the Indian population. This award is not only a great motivator for us but for all the other entrepreneurs in the country to do something different and stand out. I look forward to leading XCODE in the next stages of the company’s development.”. EP News Bureau-Mumbai
first hospital in India to have come out with a research report that found 12 TB patients to be resistant to most anti TB drugs. The certificate credits Hinduja Hospital for bringing out the report resulting in a major restructuring of the National TB Control Programme in Maharashtra state and Bombay Municipal Corporation to enhance case detection. EP News Bureau-Mumbai EXPRESS PHARMA
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APPOINTMENT Frank Heinricht appointed Chairman of the Board of Management of SCHOTT Will join office on June 1, 2013
he Supervisory Board of SCHOTT has unanimously appointed Dr Frank Heinricht to the position of its new Chairman of the Board of Management. Heinricht is currently the Chairman of the Board of Management of Heraeus Holding. He completed a degree in physics and a doctorate in engineering at the Technical University of Berlin and began his professional career at TEMIC
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Semiconductors. After holding positions as the General Manager and Chairman of the Integrated Circuits Division, he was appointed the Chief Executive Officer of TEMIC Semiconductor Group, in 1998. In 2003, Heinricht joined Heraeus Holding as Member of the Board of Management. He was appointed as the Chairman of the Board and Labor Director in 2008. Chairman of the
Supervisory Board of SCHOTT, Dr Dieter Kurz said, â&#x20AC;&#x153;We are pleased that we were able to recruit Heinricht, an outstanding manager, as the new
Chairman of the Board of Management. His experience in managing a company with a complex portfolio makes him ideally suited to lead SCHOTT. He looks back on a proven track record in expanding the market presence of a global company, particularly in Asia. We are confident that the necessary re-orientation at SCHOTT is in excellent hands with him.â&#x20AC;? Heinricht will take office on June 1, 2013. EP News Bureau-Mumbai
CAMPUS BEAT NIPER celebrates Indian National Science Day Appreciate the contributions of Indian scientific community to the society
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ational Institute of Pharmaceutical Education and Research (NIPER) SAS Nagar celebrated Indian National Science Day to appreciate the contributions of Indian scientific community to the society. NIPER celebrated this in the presence of the delegates of 3rd IndoGerman Conference on Modeling Chemical and Biological (Re) Activity. Prof KK Bhutani welcomed the guest for this special session of the conference. He added that the
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influence of Raman Effect is more relevant today especially in the field of nano technology and nanoscience. Prof DVS Jain eminent professor from Punjab University who had the personal experience of interacting with Sir CV Raman, introduced the great contributions made by Raman to the young audience. He mentioned the influence of Raman Effect and how the idea was generated. Prof G Frenking, Philipps University, Marburg, Germany delivered the sci-
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ence day special lecture. The topic of discussion was 'chemistry with the computer'. Prof G Frenking also lauded the contributions of Indian scientists to the general growth of scientific field. He deliberated on the relevance of computer technology to all sciences chemistry in particular. He pointed out the difficulties experienced in the interaction between chemistry and computational fields during the initial days. Those initial efforts lead to tremendous growth. Today every aspect of chemistry
can be handled using computers. The reliability of results is 100 per cent in some topics of chemistry and it is sufficiently high in the topics related drug discovery, material science and nano technology etc. A group of scientists (Alexander Von HumboldtChandigarh Chapter) met the German delegates and joined the Science Day celebrations. Petit, Science Councillor from German Embassy, New Delhi, also visited NIPER on this occasion. EP News Bureau-Mumbai
March 16-31, 2013
REGD.WITH RNI NO.MAHENG/2005/21398 REGD.NO.MH/MR/SOUTH-77/2013-15, PUBLISHED ON 5TH & 20TH EVERY FORTNIGHLY & POSTED 6-7-8 & 21-22-23 OF EVERY FORTNIGHLY. AT IND.EXP.PSO.