Express Pharma June 1-15, 2013

Market Thinking green Management Sizing it up: Sustainability in pharma supply chain Pharma Ally Effluents: Treating it with technology

V O L 8 . N O . 1 5 J UNE 1 - 1 5 , 2 0 1 3

CONTENTS

Chairman of the Board Viveck Goenka

MANAGEMENT

Editor Viveka Roychowdhury*

Sizing it up: Sustainability in

BUREAUS

pharma supply chain

Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das

PAGE 21

Facebook: The amazing book to increase your face value!

Bangalore Neelam M Kachhap Delhi Shalini Gupta

PAGE 26

RESEARCH Personal genomics and its role in creating

MARKETING

lifelong wellness

Deputy General Manager Harit Mohanty

PAGE 28

Novartis drug significantly extends

Senior Manager Rajesh Bhatkal PRODUCTION

time without disease progression

PAGE 30

India develops $1 rotavirus vaccine

PAGE 31

General Manager B R Tipnis

PHARMA ALLY

Production Manager Bhadresh Valia

Sipra Labs records 30 per cent growth in

Asst. Manager - Scheduling & Coordination Arvind Mane

2012-13

Asst. Art Director Surajit Patro

PAGE 35

Industrial Equipwash launches

Chief Designer Pravin Temble

spray balls

Senior Graphic Designer Rushikesh Konka

Vacuum drying – Nothing works without drying

Photo Editor Sandeep Patil Layout Rakesh Sharma

Low hiring sentiments in

Circulation Team Mohan Varadkar

pharma sector

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 62

Dr Vijay Viswanathan to receive First Vivian Fonseca Scholar Award

PAGE 63

Wockhardt appoints V Suresh as President, Finance

MARKET Ayurveda is well versed with the toxic effects of Aristolochia indica

PAGE 12

Pharmexcil signs MoU with CCCMHPIE

PAGE 14

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Piramal Enterprises receives IND approval from the US FDA for its anti-diabetic molecule IPA to organise 6th Symposium on Nasal and Pulmonary Drug Delivery

PAGE 15

P-MEC India to showcase pharmaceutical machinery and equipment

PAGE 18

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PHARMA Pro&Pack Expo 2013 create global benchmark of Brand India for pharma industry

June 1-15, 2013

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PHARMA LIFE

C I R C U L AT I O N

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.

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EDITOR’S NOTE Coming clean for World Environment Day

BOTH INTERNATIONAL CLINICAL TRIALS DAY AND WORLD ENVIRONMENT DAY GIVE A CHANCE TO INDUSTRY TO DRUM UP SUPPORT FOR CHANGES IN REGULATORY POLICIES

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Ever since it was first celebrated in 1973, UNEP has used World Environment Day (June 5) to create awareness around environment-related challenges. Our June 1-15 issue attempts to provide a status check on the efforts of the pharmaceutical industry on this front. We are happy to report that there seems to be a genuine attempt among Indian pharma companies to come clean; never mind if its really their exports that are driving this change rather than any real concern for Mother nature.

In fact, Andhra Pradesh, one of the key defaulters on this front, bagged top honours in the Environmental Performance Index in 2012.

But pharma companies claim that while they have upgraded to some of the latest technologies, the regulators are still stuck in a time warp. (See stories, Thinking green, page 9 and Effluents: Treating it with technology, page 32).

Similarly, a TARI report (See Sustainability in pharma supply chain, page 21) on the regulatory mechanisms of two states — Maharashtra and Gujarat, two pharma hubs — shows that there are few efforts to monitor if such norms are followed by the small and medium enterprises (SME) in this sector. With Ranbaxy’s recent $500 million fine still in the news, it is all the more imperative for regulators to monitor pharma SMEs before larger companies who source from them fail global compliance norms.

Whether its rules for pollution control or clinical research and trials, industry has a common grouse. Regulators ignore the warning signs of shady practices until they are forced to react, thanks to activists’ PILs or parliamentarians who seize the opportunity to appease vote banks. Regulators then swing to the other extreme, drafting and releasing laws, without thinking them through.

Clinical research in India is presently going through one such phase and May 20, International Clinical Trials Day, saw yet another effort by industry to give clinical research a fresh context.

To mark the occasion, the Indian Society for Clinical Research (ISCR) chose to 'highlight the positive difference' made by clinical research at www.expresspharmaonline.com

a panel discussion held in the KEM Hospital campus. The audience was an assorted mix: mostly clinicians, clinical researchers, representatives of CROs, a few reporters. Going with the chosen theme, the panelists made the pitch that perceptions of clinical research and trials needed to change in India.

(See full coverage at this link: http://pharma.financialexpress.com/latestupdates/2181-a-positive-spin-to-clinicalresearch).

But beyond the usual rhetoric, the discussion served to further air some key issues. It was interesting to see how stakeholders at different ends of the process viewed the same crucial step: the informed consent. While a cancer survivor was OK with a filming of the consent process, others were wary of the logistical nightmare of archiving and transferring this audio visual documentation, what level of AV equipment doctors would need (an investigator seemed skeptical whether his clinic could ever morph into a studio), etc.

The compensation guidelines seemed to be the other big concern, leading to a lively debate on when compensation became inducement and who drew that line.

The consensus was that there needs to be India-centric guidelines and here may I add my two bits to the debate. As a representative of the media, I would like to see these same companies coax their parent companies to adopt India-centric guidelines when it comes to dealing with the lay public and media.

Whatever the mandated degree of separation between spokesperson and press/lay public followed by their global offices, if they can agree to more transparency, they will certainly inspire more trust.

At the panel discussion, the suggestions went back and forth, and it became clear that each stakeholder knew best what the other needed to do. But as is so often the case, any transformation has to start from within. We really have to be the change we want to see.

Viveka Roychowdhury viveka.r@expressindia.com June 1-15, 2013

MARKET

W H AT ’ S INSIDE

THE BUSINESS OF PHARMACEUTICALS

Ayurveda is well versed with the toxic effects of Aristolochia indica PG 12 Pharmexcil signs MoU with CCCMHPIE PG 14 Piramal Enterprises receives IND approval from the US FDA PG 15 IPM registers growth of 9.3 per cent in April 2013, valued at ` 6239 crores PG 16 IPA to organise 6th Symposium on Nasal and Pulmonary Drug Delivery PG 17

MANAGEMENT 21 RESEARCH 28 PHARMA ALLY 32 PHARMA LIFE 62 June 1-15, 2013

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The state of Andhra Pradesh (AP) has around 200 bulk drug and 530 formulation units including SMEs in the organised and unorganised sectors. About 30 per cent of the medicines exported from India to the US are from AP and recognising the importance, US FDA opened offices in New Delhi and Mumbai.

According to Captain VVSK Sastry, Assistant Secretary General, Bulk Drug Manufacturers Association (BDMA), Andhra Pradesh (AP), the bulk drug industry is expected to grow between 11 to 13 per cent in 2013-14.

The state is home to several leading pharmaceutical companies like Dr Reddy’s Laboratories (DRL), Aurobindo Pharma, Hetero Laboratories, Mylan Laboratories, Divis Laboratories, GVK Bio Science, Natco Laboratories, MSN Laboratotories, Andhra Organics, Virchow Laboratories etc.

Ban notification All active pharmaceutical ingredient (API) majors in AP have demonstrated the use of available and proven technologies for management of environmental factors. Today, Hyderabad is recognised globally as a ‘pharma hub’ along with its supremacy in the software industry as well.

However, the bulk drug manufacturing sector in the region is in a quandary,

EFFLUENT TREATMENT PLANTS AND SOLID WASTE MANAGEMENT PLANTS, USING THE LATEST TECHNOLOGY, HAVE BEEN ESTABLISHED IN AP FOR DISPOSAL OF WASTE, IN A SCIENTIFIC MANNER, UNDER THE SUPERVISION OF THE STATE POLLUTION CONTROL BOARD 10

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VVSK SASTRY Assistant Secretary General, Bulk Drug Manufacturers Association

despite its global recognition and its efforts in making exemplary improvements in environment management in general and waste water management in particular.

An industry expert, who did not wished to be named, comments, “Forget about growth, even survival itself is a big question mark.” This situation is due to the ban imposed in 1996 by a Government notification on certain categories of industries that include bulk drug manufacturing units. Till date, the worst affected sector is the bulk drug manufacturing sector as these units constitute more than 90 per cent of the total industrial establishments that come under the purview of the banned notification.

Sastry informs, “The issue of the ban notification was a result of a short term and immediate measure proposed in a Joint Action Plan by Andhra Pradesh Pollution Control Board (APPCB) and Central Pollution Control Board (CPCB) for a PIL filed in the Supreme Court of India by the Indian Council for Enviro Legal Action, a NGO. The Joint Action Plan proposed

by APPCB and CPCB contains short, medium and long-term plans. It is noteworthy that in its orders dated May 12, 1998, the Supreme Court, in fact, ordered to declare the temporary ban, on its expiry, as permanent for new industries only. But, subsequently, the temporary ban issued initially was made a blanket permanent ban for all identified categories of existing and new units. Industry associations report that if one looks into the rationale under which the ban was imposed almost two decades ago, it is clear that the allegation at that point of time is mainly discharge of industrial waste waters, consequent damage of crops and endangering biota. Given the circumstances and technological limitations of industry, imposition of a restriction was justified at that time but as said, it was 16 years back.” www.expresspharmaonline.com

DR VILAS DAHANUKAR Vice-President, Global Process R&D Head, Dr Reddy's

Innovations and advancements in process technologies and waste treatment technologies have made bulk drug manufacturing processes more clean and environment friendly

The state government has put forth more stringent laws and also provided common waste treatment plants in few industrial clusters

He further said, “Times have now changed.

Innovations and advancements in process technologies and waste treatment technologies have made it possible for bulk drug manufacturing processes to be clean and environment friendly. In fact, the embracing of newer technologies by bulk drug manufacturing sector is not solely by choice but due to a compulsion to compete and be sustainable in the international market; to meet expectations of environment, health and safety competency standards of global customers and most importantly to make the manufacturing processes viable.”

companies in these four districts. These committees recommended the relaxation of the restriction imposed on API companies. The API companies are hopeful of a positive and favourable decision by the Government of Andhra Pradesh in this regard,” reveals Sastry.

Subsequent to imposing the restriction in 1997 on expansion and modernisation of industries in four districts, the Government of AP ensured that the action plan submitted by APPCB and CPCB to the Supreme Court was implemented in totality with respect to air, water and hazardous waste management with establishment of common effluent treatment plants (CETPS) and common secured landfill facilities (TSDF). The management of organic wastes generated in API companies has gone to a superior level due to the utilisation of these wastes as ‘auxiliary fuel’ by cement units located in different parts of the state. This has resulted in MoEF delisting the Patancheru-Bollarum industrial cluster from the critically polluted areas.

Sastry predicts, “The Government of AP is likely to consider the reports and recommendations of the two expert committees constituted in 2012 to look into the improvements made by API companies in environmental management and the industry is hopeful of a favourable decision in this regard.”

Learning curve Effluent treatment plants and solid waste management plants, using the latest technology, have been established in AP for disposal of waste, in a scientific manner, under the supervision of State Pollution Control Board.

API units located only in the four districts of AP, viz., Hyderabad, Rangareddy, Medak and Mahaboobnagar are faced with a restriction imposed by the Government of AP on certain categories of industries which include API units.

“However, in the recent past, there were two independent studies and recommendations by two expert technical committees constituted by Appellate Authority, AP and APPCB and improvements were made by API

June 1-15, 2013

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State initiatives Today, AP-based pharma companies manufacture the maximum number of APIs and are currently facing waste disposal related issues, which is causing harm to the environment to a large extent. Sastry agrees with the fact that the maximum number of APIs are produced by AP-based companies but avers that the state also has a proper waste management system in place.

He replies, “Pharma companies in AP are manufacturing the maximum number of APIs. It is a misrepresentation that the companies are currently facing waste dis-

posal related issues.

Technically, AP is leading the way in industrial waste management. The state topped the Environmental Performance Index (EPI) during 2012 for adopting best green practices to maintain quality of air, water and forest cover.”

“The state government has put forth more stringent laws and also provided common waste treatment plants in few industrial clusters.

But, the implementation of the law in spirit is lacking. A few months ago, some polluting units were closed down but they were again given permission to operate. As

Challenges faced by pharma companies: a) b) c) d) e)

June 1-15, 2013

Acute power shortage Impact of GATT-TRIPS agreement on pricing of pharma products Presence of more unorganised players than the organised ones Countries like China and Israel affecting outsourcing demand for pharma products Entry of foreign players with well-equipped technology-based products

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usual, the government rules, regulations and schemes are sound on paper put lack proper implementation due to inadequate will, vision and resources,” informs Dr Vilas Dahanukar, Vice-President, Global Process R&D Head, DRL.

Remedial measures Increasing competition from China, pricing pressures and increasing environmental regulations are some of the challenges faced by AP pharma companies. Dahanukar feels, “The companies need to change their mindset and think of long-term solutions.

Innovation based on green chemistry and green engineering principles is one way of addressing these issues.”

Shastry says, “The investment on environment management infrastructure

by API manufacturing companies in AP during 2008 – 2012 is estimated at ` 250 crores against an estimated investment of ` 350 crores upto 2008.”

Water treatment plants, an important part of pharma facility, while being set up requires huge investments. Dahanukar suggests, “There should be some incentives given to smaller industries to reduce waste generation and promote treatment of waste in the right manner. A well maintained industrial effluent treatment plant should be set up to serve the needs of smaller companies. Smaller companies should pay for the service provided.”

“It is really a matter of concern that small companies cannot afford to invest in high strength waste water treatment. However, common effluent treatment established for low strength waste water are operating for many years. It is a requirement of significant investment on waste water treatment to comply with the regulations in vogue.

However, BDMA, with support from APPCB and Continued on page 13

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‘Ayurveda is well versed with the toxic effects of Aristolochia indica’ Indian herbal medicines garnered the spotlight some time back with Aristolochic acid content in them tied to increasing risk of renal failure. Chandrakant Bhanushali, General Secretary, Ayurvedic Drug Manufacturers Association (ADMA), clears the air on this myth in an interview with Shalini Gupta What is the recommended dosage of Aristolochic acid in herbal medication in India?

In Ayurveda, Aristolochic acid (AA) is not used directly as a constituent; but in a few Ayurvedic drugs the herbal sources of AA, especially Aristolochia indica (Ishvari /Nakuli) root is used.

Aristolochia indica is used in a very small quantity (around two per cent) in these products when prescribed for internal use.

Ayurveda is well versed with the toxic effects of Aristolochia indica (Sanskrit: Nakuli, Ishwarmool). It is clearly mentioned that this herb, if taken in very high doses, causes inflammation of stomach and kidney, leading to nausea, vomiting, colic and even coma or death due to respiratory failure, if not treated immediately.

In Ayurveda, Aristolochia indica is indicated in fevers, as a pain killer in arthritic and colic pains and to induce labour pains. It is also indicated in snake poisons. The dose is very low (0.625 to 1.875 gm of whole plant powder) compared to the dose of routine herbal powders (which varies from 3 to 15 gm) in most of the Ayurvedic formulations. Aristolochia indica is only recommended for short durations.

Joelle LN, et al (N Engl J

INTERVIEW

Med 2000; 342:1686-92), in their publication, mention that Aristolochia with total doses of more than 200 gm taken for mean duration of 15 months was associated with a higher risk of urothelial carcinoma. This dose is almost more than 100 times the dose recommended in Ayurvedic texts and that too for quite a long duration.

What are some of the medications being sold in India?

Ayurvedic medicines that contain Aristolochia indica include: Mahavishagarbha Taila (for external application): Percentage not worked out as decoction of many herbs is processed with oil.

Poogakhanda (for internal use in debility, gastricpeptic disorders patients): Used in approximately 0.5 per cent as processed with ghee, sugar, herbal juices and milk. Market sale (turnover) of this product is negligible.

WE COULD NOT FIND KIDNEY FAILURE PREVALENCE THAT CAN BE ATTRIBUTED TO AA IN HERBAL MEDICINES, AS THERE ARE VERY FEW HERBAL DRUGS IN THE INDIAN MARKET WHICH CONTAIN AA OR ARISTOLOCHIA SPECIES 12

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Gorochanadi Vati (for internal use in fever): Used in quantity of two per cent of the whole formulation.

Market sale (turnover) of this product is negligible.

Since when have these products been banned in the US and why?

Aristolochic acid nephropathy (AAN), also known as Balkan endemic nephropathy, was evident in 1992 in a Belgian cohort of more than 100 patients after the intake of slimming pills containing a Chinese herb, Aristolochia fangchi.

In April 2001, the Food and Drug Administration in the US issued a consumer health alert warning against consuming botanical products, sold as 'traditional medicines' or as ingredients in dietary supplements, containing AA. The agency warned that consumption of AA-containing products was associated with “permanent kidney damage, sometimes resulting in kidney failure that has required dialysis or transplantation. In addition, some patients have developed certain types of cancers, most often occurring in the urinary tract.”

What percentage of people in India suffer from kidney failure and is there any clinical evidence of it being attributed to AA in herbal medicines?

There are more than 20,00,000 patients with renal failure in India as of 2010, and 100,000 new patients with end-stage renal failure (ESRD) every year who require treatment.

Of these patients alone, 9,00,000 patients will require dialysis, apart from the already existing patients.

We could not find kidney failure prevalence that can be attributed to AA in herbal medicines, as there are very few herbal drugs in the Indian market which contain AA or Aristolochia species.

What is the current export of Indian herbal medicines with its CAGR? Indian herbal medicines

worth ` 1730.41 crores were exported with an annual growth rate of 31.22 per cent. The biggest markets by sale include CIS and the African countries.

We expect the exports to touch ` 2000-crores figure this year.

What are the current standards being followed in order to ensure safety of the drugs?

Currently in India, standards as laid down in Ayurvedic Pharmacopoeia of India are being followed. A majority of adverse events (AEs) reported in relation to the use of herbal products and herbal medicines can be attributed to poor quality of the product and uneducated administration of the herbal drugs. In order to promote the safety and effective use of herbal medicines, internationally recognised guidelines for assessing their quality are established.

The World Health Assembly — in resolutions WHA31.33 (1978), WHA40.33 (1987) and WHA42.43 (1989) — has emphasised the need to ensure the quality of medicinal plant products by using modern control techniques and applying suitable standards. Today, the herbal medicines are by and large manufactured in GMP setups, and quality of the raw material as well as the finished products is assessed using the best methods currently available.

The analysis of herbal medicines is done at various levels, be it in view of the standard raw material based on the contamination limits or the qualitative and quantitative analysis of the active principles. The endeavour doesn't end here, rather many techniques similar to those used for the analysis of synthetic drugs are also frequently employed (e.g. volumetric analysis, gravimetric determinations, gas chromatography, column chromatography, high performance liquid chromatography and spectrophotometric methods). shalini.g@expressindia.com June 1-15, 2013

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Thinking Green Continued from page 11 Government of AP, are trying to establish common waste water treatment facilities for high strength in different industrial estates,” informs Shastry.

Shastry emphasises, “All major API companies have invested heavily in such systems, viz., strippers, multieffect evaporators, bio-ETPs, reverse osmosis systems and achieved zero liquid discharge or zero process liquid

ous waste after treatment is recycled. Any potent drugs manufactured are neutralised at the source. Innovation based on green chemistry and green engineering principles will help in addressing

these issues. The chemicals and pharma manufacturers should form a local chapter to share best practices and adopt green technologies.

The government's support for such an initiative is

required. In a way, the environmental challenge can offer a great opportunity to develop a sustainable future,” adds Dahanukar Given these comments, it is evident that major players

in the API industry in AP are hopeful of overcoming environmental issues; technical, administrative or regulatory; within the next six months or a year. u.sharma@expressindia.com

IF INDUSTRIAL WASTE IS NOT TREATED AND DISPOSED IN THE RIGHT MANNER, IT IS BOUND TO HARM THE ENVIRONMENT AND POPULATION. ORGANIC WASTE IS INCINERATED IN CEMENT MANUFACTURING PLANTS AS A FUEL AND THE AQUEOUS WASTE NEEDS TO UNDERGO CHEMICAL AND BIOLOGICAL TREATMENT discharge. As on date, API manufacturing companies are able to treat entire waste water generated from manufacturing of products and recycle the treated waste water. The solid waste derived out of such treatment is also disposed off to scientifically designed TSD facilities. That is how, the process waste water, in any form, is controlled from being in contact with ground or surface water. Hence, the possibility of hazardous chemicals entering into surface or ground water is remote.”

If industrial waste is not treated and disposed in the right manner, it is bound to harm the environment and population. “First of all, no untreated industrial waste should be discharged in any water bodies. Organic waste is incinerated in cement manufacturing plants as a fuel and the aqueous waste needs to undergo chemical and biological treatment. All aqueJune 1-15, 2013

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COMPANY WATCH Pharmexcil signs MoU with CCCMHPIE To promote cooperation and trade between India and China for pharma and healthcare industries

Usha Sharma- Mumbai ith an aim to promote cooperation and trade between members companies of India and China and facilitating development of pharma and healthcare industries, Pharmaceuticals Export Promotion Council of India (Pharmexcil) recently signed a Memorandum of Understanding (MoU) with China Chamber of Commerce for Import and Export of Medicines and Health Products (CCCMHPIE). The MoU was signed during the visit of Li Keqiang, Prime Minister, China to India. Raghuveer Kini, Executive Director signed on behalf of Pharmexcil and Dr Xu Ming on behalf of CCCMPHIE at a recently held event in New Delhi. The MoU was signed in the presence of Minister of Commerce, Industry and Textile Minister, Anand Sharma and Gao Hucheng, Commerce Minister of People's Republic of China.

In an exclusive interaction with Express Pharma, Raghuveer Kini, Executive Director, Pharmexcil said, “Our recently signed MoU will enhance our existing capability and will give us better reach to the Chinese

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market. At present our exporters are not exposed to the entire Chinese market. It will also help Indian pharma companies to showcase and visit many more international events in China.”

Kini further informed about the hassles in regulatory registrations. “We have also discussed about the delay in the registration process which our companies face a number of times.

In future if any critical issues crop up regarding the registration process, Pharmexcil will consider and try to

resolve them as early as possible which is also the same for CCCMHPIE.” Under the agreement as specified in the MoU, both the countries need to work for long-term cooperation.

Information should be mentioned in English for smooth understanding and a list of websites need to be provided. Assistance should be provided for seminars, exhibition and other related activities. Both parties would make efforts to ensure that the fee structure and timelines taken by drug regulato-

ry authorities of both countries for granting product registrations would be reasonable and appropriate. A mechanism needs to be established for coordination, consultation, mutual understanding and communication with regard to any concerns regarding market access in the other.

Kini commented, “We are happy to sign this agreement with CCCMHPIE and certainly it will accelerate the growth in Indian pharma companies. u.sharma@expressindia.com

Countries must fix critical access to medicines flaws in Trans-Pacific Trade Pact: MSF Access to medicines issues finally back on negotiators’ agenda after being sidelined for more than a year

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s negotiations for the Trans-Pacific Partnership (TPP) restart in Lima, Peru, tomorrow, countries must prioritise fixing critical flaws in the agreement that could leave millions of people in developing countries with limited access to affordable generic medicines, international medical humanitarian organisation Doctors Without Borders/Médecins Sans Frontières (MSF) said.

“Substantive discussions on access to medicines have languished for more than a year, with negotiating countries and many other groups, including MSF, voicing concerns about the damaging impacts of the proposed

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rules. The Lima round offers a key opportunity for TPP negotiators to remove harmful provisions from this trade agreement before it’s too late,” said Judit Rius Sanjuan, US Manager, MSF Access Campaign.

Negotiations on the TPP — a far-reaching trade agreement between 11 Pacific Rim countries — continue to be shrouded in secrecy, but leaked copies of the agreement reveal that the US is demanding the most harmful package of intellectual property protections ever proposed for a trade agreement with developing countries.

These rules would make www.expresspharmaonline.com

it extremely difficult for generic competitors to enter the market, keeping prices unaffordably high, with devastating public health consequences.

The proposed provisions would, for example, lower patentability standards, making it much easier for pharma companies to obtain secondary patents and extend product monopolies for existing drugs; prohibit challenges to weak or invalid patents until after they have been granted; and grant back door monopolies by locking up clinical data needed to approve generic drugs.

“The TPP threatens to

constrain countries’ ability to limit abusive patenting and to ensure timely access to the affordable generic medicines that are so critically important to treatment providers like MSF. Alarmingly, the TPP is slated to become the ‘gold standard’ for future trade agreements across the globe, which means that unless these provisions are rejected now, they will be replicated and imposed on many more developing countries in the coming years,” said Dr Jonathan Novoa Cain, President, MSF Latin America.

EP News Bureau– Mumbai June 1-15, 2013

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Piramal Enterprises receives IND approval from US FDA for its anti-diabetic molecule Will enable to initiate a phase I clinical trial of P11187 iramal Enterprises has received approval from the US FDA for its Investigational New Drug (IND) P11187. This approval will enable to initiate a phase I clinical trial of P11187 in healthy volunteers in the US. P11187 is an orally active, small molecule New Chemical Entity (NCE), discovered and developed by the NCE Research Division of Piramal Enterprises. It selectively acts on GPR40; a potential therapeutic target for Type II Diabetes Mellitus (T2DM).

T2DM is an emerging worldwide health crisis with an incidence rate of 300 million by 2025 as predicted by the WHO and accounts for about 90 per cent of the diabetic population.

P11187 will be tested for safety and its glucose-lowering properties for the first time in humans; both properties having been well-established in our preclinical studies.

Currently, the T2DM treatment space has limitations in

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Suven secures three product patents Patents received for the treatment of disorders associated with neurodegenerative diseases uven Life Sciences has received grant of two product patents from Canada (2672190 and 2703157) and one product patent from Eurasia (17154) corresponding to the New Chemical Entities (NCEs) for the treatment of disorders associated with neurodegenerative diseases.

These patents are valid through 2028. The granted claims of the patents include the class of selective 5-HT compounds discovered by Suven and are being developed as therapeutic agents and are useful in the treatment of cognitive impairment associated with neurodegenerative disorders like Alzheimer’s disease, attention deficient hyperactivity disorder (ADHD), Huntington’s disease, Parkinson and schizophrenia.

EP News Bureau – Mumbai

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June 1-15, 2013

terms of efficacy and adverse side-effect profiles. The advantage of P11187; as a GPR40 agonist, is the stimulation of

insulin secretion in a glucosedependent manner, thus reducing the potential risk of excess insulin production.

Dr Swati Piramal, Vice Chairperson, Piramal Enterprises said, “The NCE

Research division of PEL is dedicated to finding new cures for metabolic disorders. It focusses upon nurturing innovation and break-through thinking to impact the lives of millions of people. P11187’s

IND approval by the US FDA; recognises our untiring efforts to identify candidates that would translate into more efficacious drugs for the effective management of diabetes.”

EP News Bureau – Mumbai

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Offers various pack sizes to support formulation development from discovery to full-scale production

Avantor Performance Materials India Limited 1201-1206, 12th Floor, Pinnacle Business Tower, Shooting Range Road, Surajkund, Faridabad - 121009 Avantor Performance Materials India Limited Tel: +91-129-4267000, 4267100, 4267200 1201-1206, 12th Floor, Pinnacle Business Tower, Fax: +91-129-4267299, 4267199 Shooting Range Road, Surajkund, Faridabad - 121009 e-mail: pharma.india@avantormaterials.com Avantor Performance Materials Tel: +91-129-4267000, 4267100, 4267200India Limited web: www.avantormaterials.com 1201-1206, 12th Floor, Pinnacle Fax: +91-129-4267299, 4267199Business Tower, Shooting Range Road, Surajkund, Faridabad - 121009 e-mail: pharma.india@avantormaterials.com Tel: 4267100, 4267200 web:+91-129-4267000, www.avantormaterials.com Fax: +91-129-4267299, 4267199 e-mail: pharma.india@avantormaterials.com web: www.avantormaterials.com

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GROWTH TRACKER IPM registers growth of 9.3 per cent in April 2013, valued at ` 6239 crores In therapeutic segment, 10 therapies have outgrown With Bonus Units at Full Value Val in Crs CORPORATE

Rank MAT

MAT Apr -13 MTH

IPM

Apr-13

Val (Cr)

MS%

GR%

Val (Cr)

MS%

GR%

71264

100.00

11.2

6239

100.00

9.3

Abbott + Abbott HC + Novo

1

1

4747

6.66

6.8

411

6.59

5.4

Sun Pharma

2

2

3550

4.98

21.0

331

5.31

25.8

Cipla

3

3

3543

4.97

6.2

323

5.17

4.8

Glaxo

4

6

3214

4.51

8.8

249

3.99

-9.0

Zydus + Biochem

5

4

3177

4.46

21.2

283

4.54

28.0

Ranbaxy

6

5

2940

4.13

6.7

253

4.05

4.9

Mankind

7

7

2582

3.62

21.6

219

3.51

8.9

Alkem + Cachet + Indchemie

8

8

2420

3.40

11.7

213

3.42

16.8

Pfizer + Wyeth

9

10

2231

3.13

10.7

180

2.88

-2.5

Lupin

10

9

2186

3.07

14.2

193

3.10

14.3

Macleods

11

12

1829

2.57

19.4

151

2.42

9.1

Intas

12

11

1763

2.47

18.9

166

2.67

21.6

Emcure + Zuventus

13

13

1674

2.35

12.6

146

2.34

9.8

Aristo

14

14

1642

2.30

10.4

144

2.31

11.3

Dr. Reddys

15

16

1567

2.20

12.2

135

2.16

9.0

Sanofi-Aventis + Universal

16

15

1546

2.17

9.5

136

2.18

6.8

Glenmark

17

17

1415

1.99

18.1

128

2.05

17.7

Micro + Bal

18

21

1292

1.81

6.3

107

1.72

4.3

Ipca

19

19

1283

1.80

16.3

119

1.91

26.1

USV

20

18

1265

1.78

21.2

120

1.93

22.1

he Indian Pharma Market (IPM) is valued at ` 6239 crores in April 2013.

It has seen a growth of 9.3 per cent for the same month. Amongst the top 10, Zydus has registered a growth of 28 per cent, Sun Pharma at 25.8 per cent and Alkem at 16.8 per cent. 22 corporates have crossed the growth of IPM for the month of April 2013 amongst top 50. Sun Pharma has moved to number two position amongst corporates on MAT basis.

Amongst the top 50 corporates, Zydus has the highest growth of 28 per cent followed by Bharat Serums at 22.7 per cent and Ipca at 26.1 per cent. Amongst the 1120 ranked companies Ipca shows high growth at 26.1 per cent followed by USV at 22.1 per cent and Intas at 21.6 per cent.

Fourrts & Albert David moved up one rank over last time amongst the corporates in April 2013.

Amongst upcoming corporates Corona Remedies has grown at 153.5 per cent, Akumentis at 28.3 per cent and Eris at 20.5 per cent. Ordain breaks into top 100.

From the therapy perspective, 10 therapies have outgrown the IPM growth. The anti-infective market has a growth of six per cent whereas respiratory market has seen an eight per cent growth. The anti-diabetic market has grown at 11.1 per cent and cardiac at 10.4 per cent in chronic business.

Amongst the top 10 therapies, Neuro/CNS market has shown the highest growth at 13 per cent.

T

Val in Crs

16

Super Group

MAT Apr 13

GR%

Mth Apr 13

GR%

IPM

71264

11.2

6239

9.3

ANTI-INFECTIVES

12587

9.0

1012

6.0

CARDIAC

8743

13.5

797

10.4

GASTRO INTESTINAL

8125

12.7

751

8.9

VITAMINS / MINERALS / NUTRIENTS

6327

12.1

569

8.9

RESPIRATORY

5406

7.7

429

8.0

PAIN / ANALGESICS

5272

8.4

464

9.1

GYNAECOLOGICAL

4637

8.8

408

6.9

ANTI DIABETIC

4625

15.4

417

11.1

NEURO / CNS

4345

11.3

398

13.0

About PharmaTrac PharmaTrac is a the secondary sales data audit conducted by AIOCD Pharmasofttech AWACS, a pharmaceutical market research company formed by All Indian Origin Chemists & Distributors (AIOCD ) in a joint venture with Trikaal Mediinfotech.

AWACS in AIOCD AWACS stands for Advanced Working, Action & Correction System – reflecting the underlying philosophy behind AIOCD AWACS' research tools to reduce time to information by 50 per cent or more and to significantly improve on accuracy of information. Accurate and faster information flows from the market will help clients grow topline and bottom-line.

DERMA

3737

11.9

328

11.9

OPHTHAL / OTOLOGICALS

1280

12.5

120

12.2

HORMONES

1230

16.9

108

14.6

Terminologies used

OTHERS

966

16.0

89

21.1

BLOOD RELATED

873

8.3

78

-1.5

ANTI-NEOPLASTICS

871

15.0

87

27.2

VACCINES

868

6.3

74

2.7

MAT – Moving Annual Total MTH – MonthVal (Cr) – Value in Crores MS per cent – Market Share in Percentage GR per cent – Growth in percentage For more information, visit http://www.aiocd.net

ANTI MALARIALS

655

15.1

45

12.5

SEX STIMULANTS / REJUVENATORS

402

15.4

37

10.5

STOMATOLOGICALS

316

11.8

28

7.5

EXPRESS PHARMA

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June 1-15, 2013

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PRE EVENT IPA to organise 6th Symposium on Nasal and Pulmonary Drug Delivery Symposium will be held in Mumbai on October 24 and 25, 2013 he Indian Pharmaceutical Association will organise the 6th Symposium on Nasal and Pulmonary Drug Delivery, which will be held in Mumbai on October 24 and 25, 2013. The theme for the symposium is â&#x20AC;&#x2DC;Global Regulatory Trends.â&#x20AC;&#x2122; The twoday scientific symposium will be tailored specifically to nasal and pulmonary drug delivery and will reportedly welcome a panel of highly renowned scientists and technical experts for sharing knowledge about orally inhaled and nasal drug products (OINDPs).

The Indian pharmaceutical industry is showing increasing interest in developing orally inhaled and nasal products compared to conventional dosage forms as they provide significant benefits to patients including minimal systemic exposure, faster onset of action and broader options for disease management. Nasal and pulmonary drug delivery is used for local and systemic treatment of diseases such as asthma, chronic obstructive pulmonary disease (COPD), rhinitis, migraine and many more.

New inhalation products are also being developed for non-respiratory disease indications, e.g diabetes, which would allow patients to avoid more intrusive medical treatments.

Inhalation science and technology is a rapidly growing field. In the US, for many years, the industry had no formal guidance for OINDP. However, between October 1998 and June 1999, the FDA issued three draft guidances and the industry commended the FDAâ&#x20AC;&#x2122;s efforts in preparing these drafts. However, in recent times, the regulatory hurdles facing OINDP developers have become more stringent as the global mar-

T

June 1-15, 2013

ketplace has extended the impact of the US FDA. Patents are expiring at an accelerated rate without a compensating flow of new innovations, allowing cheaper generics to expand their reach in the US and Europe. By 2015, many of the products will go off patent in the US and the launch of generics would result in the brand drug sales to decrease by 60 per cent. The developed markets are forecasted to be characterised by low growth, a stricter regulatory environment and increasing levels of patent litigation. The pressure to reduce drug prices would be even more pronounced in Europe due to high government deficits.

Most of the pharma companies are, therefore, seeing emerging markets as the key to their growth.

Most emerging markets are in a far better financial condition, with rising personal incomes, minimal entitlement exposures and lower levels of public debt.

Rising levels of healthcare access and funding as well as the changing mix between generic and innovative products are contributing to market realignment.

Alongside the importance of emerging markets as sources of revenue growth, over the past decade several of them have also become major providers of low-cost contract R&D resources, spanning the full breadth of activities, from discovery chemistry and biology to API manufacture and clinical trial management.

The winners in the emerging markets, therefore, would be those companies that know how to balance their global competences with tailored approaches for local markets.

EP News Bureau-Mumbai www.expresspharmaonline.com

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PRE EVENT P-MEC India to showcase pharmaceutical machinery and equipment Event to be held in Mumbai from December 3 to 5, 2013 -MEC India 2013, India's leading machinery, equipment and technology event, will be held at Bombay Exhibition Centre in Mumbai from December 3 to 5, 2013. Decision makers from all over the world are increasingly looking at India for sourcing pharmaceutical machinery and equipment. At P-MEC India, exhibitors will reportedly have the unique opportunity to showcase their products in front this audience, building brand aware-

P

ness and gaining new leads from over 85 countries.

Key decision makers in the pharma industry from these 85 countries, including India, China, the US, the UK, France and Italy will take part in the event. Exhibitors’

profile include analytical equipment, automation and robotics, batching systems/ equipment, cleanroom equipment, filling equipment, filtration/separation/purification, health and safety products, instruments, laboratory

AT P-MEC INDIA, EXHIBITORS WILL REPORTEDLY HAVE THE OPPORTUNITY TO SHOWCASE THEIR PRODUCTS, BUILD BRAND AWARENESS AND GAIN NEW LEADS FROM OVER 85 COUNTRIES

products and equipment, machinery, packaging equipment and supplies, plant/ facility equipment, process automation and controls, processing equipment, RFID, tabletting/capsule fillers, testing and measurement, validation.

P-MEC India is co-located with CPhI India, a sister brand of CPhI Worldwide.

Into its sixth year, P-MEC India and its co-located events are the largest and most comprehensive pharma industry events in South Asia.

EP News Bureau-Mumbai

EVENT BRIEF Govt. College of Pharmacy, Bangalore (Golden Jubilee Celebrations) Date: June 1-2, 2013 Venue: Government College of Pharmacy (GCP), Bangalore Summary: The Government College of Pharmacy (GCP), Bangalore will celebrate the 50 years of beginning of pharmacy education in the state of Karnataka.A local organising committee has been formed with Professor S Shashidhara, Principal of the college, Shiva Hiremath, President of the Alumni association, GCP, and KP Ravindra, President of American Association of GCP Alumnae, US. Dr S Ramachandra Shetty, Professor in the college is the organising secretary. Sessions will be held on – Remembering 50 Golden Years (Reminiscence); Pharmacists: Professional Challenges for better service to patients; Challenging Technologies – with moving times; and Bridging the Generation Gap: Present and Past in pharmacy.

Apart from honouring the retired professionals and fac-

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ulty members of the college, the two-day celebrations will have group discussions led by the distinguished alumni of the college. It will also involve talks about how professional pharmacists can serve the patients and consumers better.

Contact details: Email: goldengcp@gmail.com

science, Teva Pharmaceuticals, Bristol-Myers Squibb, Orchid Pharmaceuticals will attend the event.

Contact details: Tel: (022) 61727001 Email: Conferencesindia@ubm.com Website url: http://pharmaqbd.com/?utm_campaign= MEDIAPARTNER&utm_medi um=EVENTLISTING&utm_so urce=EXPRESSPHARMA

Pharma Quality by Design Date: June 12-14, 2013

Innopack Pharma Conference

InnoPack India 2013 will gather a host of packaging experts including Laura Bix, Associate Professor, School of Packaging - Michigan State University, Robert Winter, Director Materials Management, Pfizer, Gautama Buddha, Senior Director Packaging Development, Dr Reddy's Laboratories, Santanu Chowdhury, Associate Director Packaging Development, Ranbaxy, Prashant Kane, Senior General Manager Packaging Development, Sun Pharma Advanced Research Centre and others who all are at the centre stage of developing innovative packaging for pharma globally.

Venue: Mumbai Summary: The 2nd Annual Pharm QbD Forum will have case study sessions on various dosage forms (pulsatile drugs, solid oral dosage, lyophilised products), on API synthesis and scale up, on various analytical sciences and development. Workshop on DOE covering all the basic statistical approach all supported with different case studies will be held. Speakers who have been implementing and working on the QbD principles for their respective organisations like Dr Reddys Laboratory, Emcure, Lupin, Jubilant Life www.expresspharmaonline.com

Date: June 27-28, 2013

Contact details:

Venue: Mumbai, India Summary: InnoPack India 2013 focuses on innovation in pharma packaging for compliance and safety. A contentbased conference with high level keynotes, exciting learning formats and unparalleled networking sessions covering a host of topics like, innovations in patient compliance packaging, packaging materials and drug delivery devices, effective anti-counterfeiting measures and packaging regulatory compliance, will be held.

Tel: (022) 61727001 Email: Conferencesindia@ubm.com Website url: http://www.innopackindia.com/?utm_campaign=M EDIAPARTNER&utm_medium=EVENTLISTING&utm_so urce=EXPRESSPHARMA

4th Annual Pharma Supply Chain Summit Date: July 11-12, 2013 Venue: Mumbai June 1-15, 2013

M|A|R|K|E|T

Summary: Now in its 4th year, CPhIâ&#x20AC;&#x2122;s Annual Pharma Supply Chain Summit would be focusing on practical case studies and open discussions on important topics like Government Policies - GST Act, extensive use of IT for visibility and automation of supply chain, optimising international logistics and the critical debate on 3PL for effective outsourcing of supply chain. The topics will be discussed in innovative networking formats like speed geeking, i3 centre, clash of the titans and the end of the conference by a relaxing cocktail reception.

Venue: Bombay Exhibition Centre, Mumbai

bring pharma professionals from all over the world to Mumbai and facilitates initiating and closing business deals. Take this opportunity to showcase your products and services while enhancing your brand at South Asia's leading pharma industry event.

Summary: Reflecting the continued growth in the API, generics, fine chemicals and bio-pharmaceuticals industries on the Indian sub-continent, CPhI India and related pharma services events saw an increase in visitors and exhibitors. CPhI India will

Contact details: Chaitali Patil UBM India Times Square Unit No 1 and 2, B Wing, 5th Floor, Andheri Kurla Road, Marol,Andheri (East) Mumbai - 400 059 T +91 22 61727162 F +91 22 61727273 E chaitali.patil@ubm.com

Your production process for tomorrow Integrated and tailored solutions for your process

Contact details: Tel: (022) 61727001 Email: Conferencesindia@ubm.com Website url: http://www.pharmasupplychainindia.com?utm _campaign=MEDIAPARTNER&utm_medium=EVENTL ISTING&utm_source=EXPRE SSPHARMA

with

Glatt Engineering Consulting Process Engineering General Planning

Pharmac India 2013

Implementation Date: September 5-7, 2013

Validation/Qualification

Venue: Hitex, Hyderabad Summary: Pharmac India 2013 is 4th International pharma machinery, equipment, bulk drugs, API and material exhibition going to be held in Hyderabad, Hitex.

It has successfully brought together manufacturers and buyers on a common platform and contributed substantially towards the growth of the industry. Pharmac India 2013 is jointly organised by Orbit Exhibitions and IDMA (GSB) and actively supported by BDMA and CIPI.

GMP-Compliance Services Training

From the idea to turnkey production in the pharmaceutical and biotech industries

Headquarters: Glatt Ingenieurtechnik GmbH Nordstrasse 12, 99427 Weimar / Germany phone: +49 -3643 -47-0 fax: +49 -3643 -47-1271 eMail: info@glatt-weimar.de Indian Office: Glatt (India) Pharma Engineering Pvt. Ltd. 13 Ground Floor Palam Marg, Vasant Vihar New Delhi - 110057 / India phone: +91 -11 - 460 529 60 / 61 / 62 fax: +91 -11 - 460 529 64 eMail: info@glatt-india.com

Contact details: Varsha Surve Manager - Exhibitions Orbitz Exhibitions 101, Navyug Industrial Estate TJ Road, Siwree (W) Mumbai - 400015 Mob: 9322037955 Email: info@pharmacindia.com

CPhI India Date: December 3-5, 2013

June 1-15, 2013

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POST EVENT PHARMA Pro&Pack Expo 2013 create global benchmark of Brand India for pharma industry Event organised by IPMMA and GPE Expo HARMA Pro&Pack Expo 2013, an international exhibition on pharmaceutical manufacturing technologies was recently held at Mumbai Exhibition Centre.

The event was organised by Indian Pharma Machinery Manufacturers’ Association (IPMMA) and GPE EXPO. It was co-located with iPHEX 2013 – an international exhibition for pharma and healthcare (organised by PHARMEXCIL) and supported by more than 14 national and international pharma and trade associations.

The Chief Guest for the event was Prithviraj Chauhan, Chief Minister, Maharashtra, who inaugurated the twin exhibitions, PHARMA Pro&Pack Expo 2013 and iPHEX 2013.

The Special Guest was Rajeev Kher, IAS, Additional Secretary, Department of Commerce & Industry, Government of India and the Guest of Honour was Dr GN Singh, Drug Controller General (India).

227 exhibitors from 16 countries of PHARMA Pro&Pack Expo 2013 and 400 exhibitors of iPHEX 2013 exhibition were visited by 19,500 pharma professionals from 104 countries.

The Advisory Board of the PHARMA Pro&Pack Expo 2013 had eminent pharma professionals from the Indian pharma industry.

They were Dr Vinay Naik, President -Intl Operations, Alembic; Kumarswamy MS, Head Projects, Strides Arcolab; Pratul Singh, General Manager, Biocon; Sanjay Singh, Sr VP – Operations, Aurobindo Pharma; SK Sinha, President – Manufacturing, Cadila Pharmaceutical; Anjani Kumar, Cipla, Sanjit Singh Lamba, Managing Director, President - Global Brands Unit, Head - Global Procurement Strategy, Eisai India; Mahesh Shah, Technical Director, Emcure

P

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Prithviraj Chauhan, Chief Minister, Maharashtra inaugurating the twin exhibitions, PHARMA Pro&Pack Expo 2013 and iPHEX 2013

EXHIBITION GAVE THE BEST OPPORTUNITY TO THE INDUSTRY TO PROMOTE ‘BRAND INDIA’ CONCEPT Pharmaceuticals, BVR K Srinivas, General Manager Manufacturing, Granules India; AM Jawle, Managing Director, Knexir Consultants, Alok Ghosh, President – Manufacturing, Lupin; SM Mudda, Executive Director - Tech and Operations, Micro Labs; Mohit Kumar, Head – Engineering Projects (Pharma), Ranbaxy Laboratories; Arvindkumar Thakker, Vice President – Manufacturing, Wockhardt, SG Belapure, President, Zydus Cadila Healthcare.

The exhibition gave the best opportunity to the industry to promote the Brand INDIA concept. As the show was initiated, promoted and organised by industry itself, it helped to share a common platform for even a micro-scaled entrepreneur to exhibit alongside the industry giants and promote their skills and services.

EP News Bureau-Mumbai www.expresspharmaonline.com

Rajeev Kher inaugurating the event

Exhibitors at the venue June 1-15, 2013

MANAGEMENT INSIGHT FOR MANAGING PHARMA

W H AT ’ S INSIDE

Facebook: The amazing book to increase your face value! PG 26

RESEARCH 28 PHARMA ALLY 32 PHARMA LIFE 62

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S KSHAMA V KAUSHIK

ROSANNA M VETTICAD

Small and medium enterprises are the backbone of any developing economy, contributing to its social and economic development. They contribute a large proportion of the industrial base and significantly to exports as well.

In India, according to the 2012-13 annual report of the Ministry of Micro Small and Medium Enterprises (MSME) there were a total of 361.76 lakh MSME units (registered and unregistered) in the country employing 805.24 lakh people as of 2006-07.

MSMEs contribute eight per cent of the country’s GDP, 45 per cent of the manufactured output and 40 per cent of our total exports. The mission of the Ministry is to achieve a cumulative growth of 40 per cent in the number of registered enterprises and to enhance this sector’s contribution to GDP from the present eight per cent to 10 per cent by the end of 12th Plan.

Structure of Indian pharmaceutical companies The Indian pharmaceutical industry consists of approximately 10,500 units, most of which are in the small sector. 300-400 of these fall in the medium to large organised sector. It is estimated that 36.5 per cent of the total market share is contributed by the top 10 manufacturers. The medium and large domestic companies in

fact have been the drivers of growth, contributing 75 per cent of domestic sales and over 90 per cent of exports.

Table 1 presents a clearer picture of the fragmentation in the industry.

While 70 per cent of the units earn revenues of only up to ` 10 crores, only two per cent of the total number of units generates revenue of more than ` 500 crores.

In terms of geographical distribution, almost 45 per cent of the total pharma manufacturing units are located in two states alone – i.e.

Maharashtra and Gujarat.

Refer to Table 2: Considering the fragmented nature of the industry we can safely conclude that a large number of the pharma manufacturing units in the states of Gujarat and Maharashtra are likely to be medium or small in nature, which primarily supply to the larger units. While sharing sustainable practices is crucial to the relationship between a company and its stakeholders (including suppliers), the government should also take steps to help and encourage the smaller units in their endeavour towards sustainable development. Considering that contract manufacturing is a growing element in the pharma industry, none of the top 10 pharma companies (barring one), studied in a report prepared by TARI2 had detailed discussions on their suppliers and how they ensure sustainable practices at the supplier end. With India emerging as a global player in the pharma indus-

try, it will have to comply with globally accepted standards such as Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP) and Good Clinical Practices (GCP).

For the purpose of this report, we look specifically at the states of Maharashtra and Gujarat (since they have the largest number of manufacturing units) to understand, what (if any) regulatory mechanisms exist in these states to help small and medium pharma companies in improving their commitment to their stakeholders towards long-term and sustainable development.

Regulatory environment in the pharmaceutical industry - Maharashtra and Gujarat The Drugs & Cosmetics Act, 1940 regulates the import, manufacture, distribution and sale of drugs and cosmetics through licensing in India. Among other things it stipulates that the manufacture and sale of drugs and cosmetics shall be undertaken only by qualified persons.

It also contains stringent provisions to keep a check on the manufacture of spurious

and sub-standard drugs.

Under the act, the regulation of manufacture, sale and distribution of drugs is primarily the concern of the state authorities while the Central Authorities are responsible for approval of new drugs, clinical trials in the country, laying down the standards for drugs, control over the quality of imported drugs, coordination of the activities of State Drug Control Organisations and providing expert advice with a view to bringing about the uniformity in the enforcement of the Drugs and Cosmetics Act. The Drug Controller General of India is responsible for approval of licenses of specified categories of drugs such as blood and blood products, I. V. fluids, vaccine and sera.

Maharashtra3 The Food and Drug Administration (FDA) of Maharashtra is the focal point for consumer protection (with respect to drugs, cosmetics and food) in the state of Maharashtra. It is designated as the licensing authority for the grant of the drug manufacturing licenses under the Drugs and

Table 1: Turnover-wise distribution of Units1 Turnover (Rs Crores)

% Distribution

0-10 Cr.

70%

10-50 Cr.

20%

50-100 Cr.

5%

100-500 Cr.

3%

500 + Cr.

2%

FOR INNOVATION,TECHNICAL UPGRADATION, GROWTH AND SUSTAINABLE DEVELOPMENT, THE SME SECTOR WOULD NEED ADEQUATE FUNDING TO MAINTAIN ITS COMPETITIVE ADVANTAGE AT THE DOMESTIC AND INTERNATIONAL LEVELS 22

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Cosmetics Act, 1940 for the entire state. The FDA, as a part of its mandate, is also required to analyse drug samples at its Drug Control Laboratories at Mumbai and Aurangabad. Maharashtra is the first state to set up an independent Intelligence Branch with a separate police wing to assist in investigations under Acts enforced by FDA. Apart from granting or renewing licenses for drug manufacturing units, it issues various certificates, including WHO GMP (good manufacturing practices) certificates.

The role of the FDA is to ensure safety, efficacy, purity and quality of drugs and to ensure availability of drugs at reasonable prices. Its objects include: ● To ensure safety, efficacy, purity and quality of drugs; ● To ensure availability of drugs at authorised prices; ● To create an awareness about the importance of proper storage of drugs; ● To eliminate irrational combinations /banned drugs; ● To study the problems and suggestions made by the stakeholder; ● To collect the information in general about the drug trade and take necessary steps; and ● To prepare policy regarding drug matter.

The Drug Control Laboratory which operates under the administrative control of the Commissioner, FDA employs qualified, experienced and trained staff for the analysis of, among other things, bulk drugs, drug formulations (like tablets and capsules), antibiotic formulation, and vitamins, in its laboratories at Mumbai and Aurangabad, equipped with modern, sophisticated, computerised and analytical instruments. All activities from the receipt of samples to final dispatch of reports are computerised using software developed by HCL in accordance with FDA & Drugs Control Laboratory requirements.

■

February 2010 (168 units).

Details of items ‘not of standard quality’ (NSQ) with reasons, found by the FDA from samples of drugs and cosmetics drawn for testing and analysis by the Drug Controls Laboratory.

There are around 150 items declared NSQ

between July 2012 to January 2013.

Gujarat4 The Food and Drugs Control Administration (FDCA), Gujarat has been in existence for the past 53 years. As in Maharashtra, it is primarily entrusted with the implementation of the Drugs & Cosmetics Act – 1940 &

Rules 1945 and is the licensing and controlling authority for drug manufacture and sales. According to the FDCA website, Gujarat is the first state to initiate online software for sales and manufacturing licenses in January 2007.

The Food & Drug Laboratory (FDL) set up at Vadodara is the first NABL

accredited government laboratory in the country. In addition the FDCA has two other regional food laboratories for testing of food samples, one at Rajkot and one at Bhuj. It is setting up one more stateof-the-art Food & Drug Laboratory at Dethali, in Patan district of North Gujarat. This new FDL lab is designed according to the lat-

FDA Maharashtra has: ■

■

USFDA approved units (60 units as per the list provided, having US FDA, MHRA, Health Canada, TGA & other certifications).

List of WHO GMP certificates issued as of

June 1-15, 2013

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est GLP norms, with the latest equipment and instruments. Constant upgradation of facilities and equipment in laboratories have always been a priority of the FDCA. The FDCA lays great emphasis on training its officers new and in service with the objective of sharpening their knowledge, not only to maintain the performance of the FDCA but also to achieve newer landmarks.

Drugs inspectors regularly draw samples of allopathic drugs and raw materials used to manufacture them from dealers, manufacturing units, doctors, hospitals, CHC, PHC etc. and send them to FDL, Vadodara for testing and analysis. If the sample is declared as ‘Not of Standard Quality’, action is initiated as per policy and report to head office.

As in the case of the Maharashtra FDA, the FDCA also grants certificates including WHO GMP and State GMP. The Intelligence Branch (IB) takes prompt action on any information related to manufacturing / selling of spurious, misbranded or drug / cosmetics manufactured without licenses. ◆ There are 3,164 drug (allopathic, homoeopathic, ayurvedic) and cosmetic manufacturing units in Gujarat as of June 16, 2012. ◆ In the year 2012, 5,333 samples were drawn by the FDCA for testing of which 463 or 7.99 per cent were found to be Not of Standard Quality. ◆ The details of sample declared as ‘Not of Standard Quality’ (NSQ) is sent through SMS to all retailers, wholesalers, District Health Officers (DHO), PHC / CHC, CMSO and State Drugs Controllers of India. This is the first ever initiative taken by any Drugs Controller to ensure effective recall of NSQ medicines. ◆ There are 460 units who are WHO GMP holders and 191 units that are State GMP holders.

The FDCA periodically undertakes informative programmes, interviews / demonstration of testing kits on Doordarshan, other television channels and All India Radio.

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Table 2: State-wise distribution of pharma manufacturing units S.No.

State

Number of Manufacturing Units Formulation

Bulk Drugs

Total

%age to total

1

Maharashtra

1,928

1,211

3,139

30%

2

Gujarat

1,129

397

1,526

14%

3

West Bengal

694

62

756

7%

4

Andhra Pradesh

528

199

727

7%

5

Tamil Nadu

472

98

570

5%

6

Others

3,423

422

3,845

36%

Total

8,174

2,389

10,563

Programmes and policies towards sustainable development of the SMEs-initiatives undertaken including 12th Plan strategy While the drug control authorities at the state level have a strictly laid out mandate, there are no programmes and policies in place to assist the SMEs in the pharma industry to grow into sustainable business units that are able to meet the competitive standards set by domestic and global players. However, there are various measures undertaken or planned to be undertaken at the central level.

These are too recent to assess whether they have been/will be implemented and the actual impact they will have on the small and medium companies.

Department of Pharmaceuticals National Institute of Pharmaceutical Education & Research (NIPER) set up in 1984, has among its primary objectives the nurturing and promotion of quality and excellence in pharma education and research, toning up the level of pharma education and research by training future teachers, research scientists and managers for the industry and profession, colwww.expresspharmaonline.com

laborating with Indian industry to help it meet global challenges and study the sociological aspects of drug use and abuse and rural pharmacy etc.

According to the 2011-12 Annual report of the DoP, NIPER started conducting training programmes at the newly established Small and Medium Pharmaceuticals Industry Centre (SMPIC) for the small and medium pharma industry on the aspects of GMP and GLP, instrumental analysis and manufacturing of APIs and formulations.

However, no information is available on the number of such programmes actually conducted. The centre also plans to provide a focal point for industry academia interaction.

Apart from the above, the DoP as part of its capacity building measures towards providing support to the SME pharma industry for quality manufacturing, has, with the help of Ministry of MSME, expanded the Credit Linked Subsidy Scheme (CLCSS) being operated by the Ministry of MSME for providing financial assistance for technical upgradation of Schedule-M standards. More than 140 items of plant and machinery have been added to the eligible list of equip-

ment for which assistance can be provided. The department has also proposed a scheme of financial assistance to MSMEs for WHOGMP, US FDA and other international standard manufacturing compliances. The vision of the DoP is to make India the largest global provider of quality medicines at reasonable prices. It has set the upgradation of SMEs to WHO-GMP and training of professionals therein, as one of its goals for the 12th Plan.

12th Plan initiatives The Working Group set up for the 12th Five Year Plan has recommended several schemes and initiatives targeted towards the SME sector of the pharma industry. India being a signatory to the WHO certification protocol on the quality of pharma has accepted the WHO-GMP standards as an integral part of the standards for exports of pharma products. Since export of generics to the high growth emerging markets is to be a key strategy for growth of the pharma industry in India, the up-gradation of SMEs to WHO-GMP standards would enable them to export their products and thereby increase profitability. The 12th Plan target is to have at least 2000 WHO-GMP stanJune 1-15, 2013

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●

❖

with the unplanned growth of the industry.

Among the industry development schemes, the working group has suggested: Opening a National F o r m u l a t i o n Development Centre (NFDC) to assist the SMEs for the development of new formula-

tions which are the source of increasing production in the domestic and export market. This is primarily due to the fact that development of generic formulations from patent products for small and big molecules (biosimilars) is a challenge for the SMEs.

® Trademark of The Lubrizol Corporation © 2011 The Lubrizol Corporation

dard units by the end of 2017 so as to enable the SME sector to increase and sustain its participation in the pharma industry growth process According to the report of the Working Group, there are currently about 800 units that are certified by the Central Drugs Standard Control Organization for WHO-GMP production. Given the ambitious target of achieving $ 100 billion production by 2020, 1000 - 1200 units will have to be assisted in raising their manufacturing standards to WHO-GMP levels. It also envisages a need to upgrade at least 250 units to US FDA/EDQM/TGA and other International Standards by 2017 and training of 5,000 working professionals in WHO-GMP and other International Standards GMP requirements.

As stated above, the ministry has devised schemes for the upgradation of SMEs to WHOGMP, USFDA/EDQM/TGA and other international standards which include: ● Interest-based subsidy scheme at the rate of about ` 1 crore per unit of assistance to be implemented in partnership with IDBI/SIDBI for upgrading SMEs to WHO-GMP manufacturing standards to capitalise on the generics opportunity - about 1,200 units out of 10,563 SMEs in the country ● Specific assistance for standards higher than WHO-GMP to selected SMEs – 250 units, to build competitiveness of very high standards and second line of internationally capable industry for high value pharma products for strong regulated but high value markets ● Infrastructure building for pharma industry particularly for SMEs – building on the strength of existing clusters so as to provide infrastructure gaps for higher production including taking care of environmental concerns, power and labs testing, etc. Providing financial and technical assistance to improve financial sustainability of SMEs on one hand and also safeguard the environment from the hazards associated

❖

Develop a software, under the technical guidance of Drug Controller General (India), for helping the SMEs in achieving various regulatory compliances which would be distributed by the department to the industry free of cost.

Conclusion The Indian pharma industry has grown from an almost non-existent entity to a force to be reckoned with in the production of high quality generic drugs in India due to the low cost of production and high quality facilities. It is one of the fastest growing sectors in the Indian economy and grew at 14 per cent5

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M|A|N|A|G|E|M|E|N|T in revenue terms in 2011-12 vis-à-vis 2010-11. The growth can be attributed to legislative reforms, growth in contract manufacturing and outsourcing, foreign and domestic acquisitions and joint ventures and India’s efforts to comply with the World Trade Organization (WTO) Trade Related Intellectual Property Agreement (TRIPs) obligations.

A significant feature of the Indian pharma industry is that the current fragmented structure is changing as a result of consolidation through mergers, acquisitions, brand takeovers etc.

The main drivers of this trend have been: ● to widen therapeutic coverage thereby diversifying and reducing the risk of being active in limited segments; ● increasing the sales base, as increase in sales can support larger R&D budgets which are essential to remain competitive; ● strengthening the marketing and distribution reach and network; and ● realising savings in costs.

However, the focus of such transactions now is likely to move to the actual quality of operations in the manufacture of these generic drugs, particularly in light of the recent cases eg: US-FDA and Ranbaxy, Sun Pharma, Dr Reddy’s Laboratories etc.

The bans on these firms have been

lifted over the last year as the companies have taken corrective actions and are improving manufacturing processes. While it is pertinent to note here that India is the only country with the largest number of USFDA compliant plants (more than 100) outside the US, 793 WHO-GMP approved plants, and 153 European Directorate of Quality Medicines (EDQM) approved plants with modern state-of-the-art technology6, the need for large and small players to continue to improve and maintain good manufacturing processes is more important now than ever before.

While the drug control administrations of Gujarat and Maharashtra are required to perform all the functions mentioned earlier, they do not appear to specifically target the small and medium units that operate within the pharma industry. Particularly in the case of compliance with GMPs, there is no specific effort/guideline provided to the SMEs in complying with these strict regulations put in place by WHO and the US FDA. According to WHO, its GMP are that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorisation. Above all, manufacturers must not place

patients at risk due to inadequate safety, quality or efficacy; for this reason, risk assessment has come to play an important role in WHO quality assurance guidelines.

Furthermore, no specific direction is given towards helping these units in meeting environmental standards including conservation of water and energy, waste management and managing effluents and greenhouse gas emissions, or adoption of norms for the overall health and safety of employees in the manufacturing process, sustaining and retaining talent, etc. While the contribution of the SME sector in the pharma industry in terms of its economic and social impact is phenomenal, the sector still does not receive due credit in some areas, particularly in terms of financial assistance. For innovation, technical upgradation, growth and sustainable development, the SME sector would need adequate funding to maintain its competitive advantage at the domestic and international levels.

The pharma industry is set to grow at a phenomenal rate; stringent demands from the international community and multi-national companies on the impact the sector has on environment, economy and human resources will inevitably be focused on SMEs that operate on a large scale in the industry. In such a scenario, the government has to take some

proactive steps and ensure implementation of the schemes it proposes.

Unless actionable suggestions are implemented under the aegis of the various regulatory authorities in existence at the state and central levels, the sustainable growth of the SME sector may be affected, thereby impacting the overall growth the sector as well.

About TARI Kshama V Kaushik and Rosanna Vetticad are Chartered Accountants and founding members of Thought Arbitrage Research Institute, a not for profit research think tank working in areas of sustainability , corporate governance and public polices

References 1. Annual Report 2011-12, Government of India Ministry of Chemicals & Fertilizers Department of Pharmaceuticals 2. http://pharma.financialexpress.com/s ections/management/2020-sustainability-reporting-in-the-pharmaceutical-sector-prescription-for-pharma 3. http://www.fdamah.com/Home.aspx 4.http://gujhealth.gov.in/food_drug_c ommissioner.htm 5. http://pharmaceuticals. gov.in/ 6. http://pharmaceuticals.gov.in/

DIGITAL DOSE Facebook: The amazing book to increase your face value!

Dinesh Chindarkar, Co-founder, MediaMedic Communications, in the series of articles titled ‘The Digital Dose for Indian Pharma’ elucidates how creating a page on Facebook can help pharma companies to initiate a responsible communication with their target audience and benefit the brand

acebook, launched in the year 2004, is the most popular social networking website in India with 400 plus million users which makes India #2 in the ranking of all Facebook users by

F

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country. Facebook has revolutionised the way people look at and feel about social media. Through this platform people can now stay connected, share photos and information like never before. The usage of Facebook is not restricted only to common people. Celebrities, politicians, sportsmen and also businessmen can exploit Facebook to increase their popularity and social gains.

With such perks, how can this media benefit our pharma industry?

With a massive user base, it is definitely a place where the industry can leverage their corporate and/or brand presence through a Facebook page. If you have an OTC www.expresspharmaonline.com

brand, you must have a Facebook presence. This may sound compulsive, but in reality, it is compulsory if you want to be seen! People have such easy Internet access these days that social media is the first place they look for further information on any product. A recent study from PWC’s Health Research Institute has established that 40 per cent of consumers have used social media to find health-related brand reviews. As a result, if pharma companies want to earn the attention of modern day consumers, then they need to connect with them through Facebook in order to influence their decisions.

Since pharma brands come under regulations, it is clear that they cannot be advertised. But category building and disease awareness are critical issues that can be addressed using this route. With so much igno-

rance about health, Facebook opens up a media to reach out to people. Having patient communities on Facebook where one can engage patients, communicate directly with them, share their views and opinions can prove to be an excellent outcome on Facebook for the pharma industry.

Creating a page on Facebook and having a responsible communication for generating disease awareness can indirectly benefit the brand. But before one chooses this path, they ought to be sure that what information they will communicate is what the consumer is really looking for. ‘Psoriasis 360’ was an excellent initiative by J&J that helped connect patients from across the world. They talked about how they felt, shared emotions, problems and crowd sourced solutions too.

Learning from each other’s June 1-15, 2013

M|A|N|A|G|E|M|E|N|T experience they adapted to life better. That was the power of this media in empowering patients.

Social media listening is the first essential step before one gets on to a Facebook page. Social media listening and web analytics will give you a clearer idea about what people are looking for, what are they talking about and what is the latent need. Social media listening also helps to understand the emotions around a certain issue and the intricacies surrounding it.

Based on your research, you can lay down your objective and plan out your strategy.

Apart from creating patient centric Facebook pages, a company can also connect with their customers and stake holders through FB. The few MNC pharma companies who have active Facebook page with large number of engaged users are listed adjacently* As the healthcare industry is undergoing a rapid change and patients are becoming more tech savvy, even doctors have begun to feel the

Company

Functionality

Likes

Pfizer

Global comms

62744

GSK

Global comms

74113

J&J

Global comms

42833

Sanofi US

US comms

2564

Roche

Careers

12549

Abbott

Careers

27312

Boehringer Ingelheim

Global comms

23366

AstraZeneca

US comms

12226

Merck

US comms

7220

*Source: Pharma gets social: World’s top Pharma on Facebook need to go digital. Doctors in western countries are already using Facebook to share knowledge, retain patients, create awareness, educate about medical inventions, research etc. Gradually this trend has caught up in India as well. A specialised doctor, like a cardiologist or oncologist can create his or her own page and share information about the disease or new treatments and connect with his patients. Especially with the rise in chronic lifestyle disorders, it is changing the way doctor-patient relation-

ship is developing. Even a simple update on waterborne disease trend observed on his FaceBook page by a family physician, helps hundreds of his patients realise the trends and helps in prevention. Community medicine is really turning into ‘community building’ online.

A lot of companies are also considering to build a social model similar to a FaceBook for doctor communities but with a closed platform. So sharing of information within a community of doctors becomes easy and

secured. With this there is a personalised engagement with doctors and individual needs could be met. Also it helps understand and profile a doctor based on his behaviour and attitude. With the healthcare industry moving on to the next level where patients have a higher say and control, this is a good time to think about getting a “face” for your brand or company. In this fastest growing network, there is huge opportunity for pharma and it can do lot a more in this growing space.

Industry insights Digital Darwinism - the threat is real The Digital Darwinism concept was first proposed in a seminal article by Christopher Vollmer in Booz&Co’s journal, Strategy+Business in late 2009. He rightly mentioned, “In the new marketing and media ecosystem, some will fail, some will thrive and all will have to evolve”. Yes, the digital ecosystem is the dynamic hub of interconnectivity with the customers as well as the stakeholders. Here, the survival of the fittest theory definitely applies to decide the successful, the also-ran and yes, the extinct.

So, what is at stake, the risk of not being there on the medium where all the relevant conversations are happening or, missing out on the opportunities which the medium presents in terms of efficient reach and experiential engagement with the consumer, who truly and definitely is the centre of the marketing universe.

Furthermore, the digital ecosystem, at an evolved level, offers an excellent platform to collaborate for co-creation of value.

A good number of companies, across industries, have adapted to this change and have adopted digital marketing practices in a big way, to great advantage. India has been at the forefront of this revolution thanks to the e-penetration rapidly augmented by a phenomenal m-penetration. What about pharma? We are perceived to be slow off the block and rightly so because of the sensitivities and the regulated environment.

Social media, being a two-way communication street and a multi-channel environment, obviously need advice and guidelines and it needs to

June 1-15, 2013

be understood. Of course, the ROI challenge is always there for a new initiative in today’s costsqueeze business environment.

But the question is, can social media forays be now avoided by pharma in India? Increasing number of patients use Internet for health and disease information. Online patient communities are discussing you and your products and lot of experience sharing is happening in real time. If the patients are here, physicians too are on the medium to understand what they want and also to harness the peer-to-peer interaction.

Physicians and patients need easy access to the information that they can understand and trust.

The onus is on the company to provide the same.

A better informed patient who is more likely to adhere to the advice and the therapy also means better health outcomes. This is facilitative of the pay-for-performance model where the payers look at pricing linked to economic benefits.

Thus, the social media roadmap goes way beyond product marketing. It facilitates reach, awareness, education, communication and image. This offers the opportunity to build and enhance relationships for the brands at the real and virtual marketplace by integrating the messaging across platforms for maximum impact.

While multi-channel marketing may be the starting point, the real gains are in closed-loop marketing where monitoring, tracking and evaluation of the results help in strategic planning addressing expressed needs and wants of stakeholders at each level.

For pharma, healthcare is first a responsibili-

www.expresspharmaonline.com

Amlesh Ranjan, Associate Director, Sanofi ty and then an opportunity. The strong emergence and rapid adoption of digital media offers an apt platform for making a difference to the healthcare as well as the brands. Marketing can give information or, source information in real time through the easiest available online webspace thus facilitating the healthcare journey to desired outcomes. Of course, this needs to be done within the prevailing regulations and guidelines. But as Darwin stated, "Survival is ultimately dependent on the ability to change and evolve." Adapting to the changed reality of the marketplace and adopting newer practices and tools will not only help survive but thrive…..and thrive, successfully.

Views expressed are personal

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W H AT ’ S INSIDE

RESEARCH EXPERTISE FOR DRUG DEVELOPMENT

Pfizer halts study of lymphoma drug unlikely to help survival PG 30 India develops $1 rotavirus vaccine PG 31

Personal genomics and its role in creating lifelong wellness Pankaj Mankad, Director – Physician, Xcode Life Sciences, Chennai, looks into the role and current limitations of personal genomics in health and disease t was just a decade ago that complete human genome sequence was established by a 13-year-long — Human Genome Project — an international collaborative research programme, at the cost of circa $2.7 billion.

Genomic science, since, has progressed in leaps and bounds with a potential to influence our daily life, health and wellness. Peri passu commercial translation of this modern research into personalised medicine is already here in India. It is not a question of if, but when and how these recent advances will be integrated into medicine and will have noticeable impact on our lives? At this early stage the question for consumers could be “Is this all Hype or is there Hope?” Here, we shall address this question objectively looking into the role and current limitations of personal genomics in health and disease.

Personal genomic information has the potential to influence our health through several domains. These include; Disgenomics plus oncogenomics – Science which assesses our genetic predisposition/risk of developing various chronic diseases and certain cancers; Pharmacogenomics – Study of how our genes regulate drug responses, and Nutrigenomics –Science related to interaction between nutritional components and our genes. Let us first examine the basics.

I

tions. The nucleotides are: A (Adenine), T(Thymine), C (Cytosine) and G (Guianine).

There are millions of these bases in a chromosome. They always have their fixed location. If a single base is replaced by another base, say A by C, it results in a variant gene and in medical term is called SNP (Single Nucleotide Polymorphism). Not all SNPs are harmful but all problems arise because of SNPs and other gene abnormalities.

Over the past two decades, candidate gene association studies and, more recently, Genome Wide Association Studies (GWAS) and International HapMap project have established tens of thousands of SNP associations with common chronic diseases, cancers and metabolic traits. These form the basis of personal genomics in maintaining health and well being.

A particular SNP may either increase or even reduce the risk of developing a disease. Once genome test is done, statistical association of every relevant SNP with many important common diseases is made to derive one’s relative risk of developing a disease. Although ethnic genetic data about Indian population are sparse, it is fair to begin this process using available information from Caucasian population and if possible, creating weighted database to suit our population. Failing this, we will never be able to catch up with the science let alone even begin the process.

The basics

PHARMA ALLY 32 PHARMA LIFE 62 28

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Genes, storing our unique personal information, are located in 23 pairs of chromosomes, present in every single cell in our body. One member of each chromosome pair is from mother; the other is from father. Genes consist of DNA; which has four nucleotide bases and they must remain in pairs to help form proteins for body func-

Chronic diseases, disgenomics and personalised medicine Today, chronic non-communicable diseases (NCDs) form nearly two thirds of total disease burden in our country. Deaths due to NCDs are more than double compared to communicable diseases (WHO data). Adverse financial impact of these in www.expresspharmaonline.com

the society is devastating.

The good news is that nearly three in every four chronic conditions are preventable.

Prevention becomes much more focused when one’s risks are known. Genetic assessment, however, is not alone in this game. Genetic predicted risk combined with information about a person’s lifestyle, diet, environment, and medical history will enable doctors to treat disease much more effectively and in many cases even prevent it.

This is personalised medicine. It is a broad and rapidly advancing field of healthcare that is informed by each person’s unique clinical, genetic, genomic and environmental information. Use of this information in an integrated and evidence-based manner to individualising personal care across the continuum from health to disease is the best way forward.

We know that heart disease risk can be reduced by lowering dietary intake of fat and salt, exercising more, and taking a cholesterol lowering medication. However, heart disease is not simply a condition caused by excess fat and cholesterol. There are many other modifiable risk factors, some genetically influenced, which can predispose a person to heart disease.

For example, many people, as high as 40 per cent in some studies, have a genetic inability to properly metabolise folic acid in the body (MTHFR gene). This can lead to a build-up of

homocysteine in the bloodstream, causing increased risk of blood clots and atherosclerosis. For a person with this genetic variation, the only way to reduce risk is to take the active form of folic acid, which is not found in common vitamin supplements. Thus genomicsenabled medical technology can run various what-if scenarios and combine related genetic data to disease risk and show whether diet, exercise, medication, or some other factor or combination of factors has the greatest statistical likelihood of reducing that risk.

Epigenetics If I have a genetic susceptibility to develop heart disease, with a strong family history, is it not the final nail in the coffin (pun intended)?

No, not at all. Here comes the science of Epigenetics. In order for a disease to develop, the genes must be expressed in abnormal proteins. Gene expression is governed by the cellular material — the epigenome — that sits on top of the genome, just outside it (hence the prefix epi-above). It is these epigenetic 'marks' that tell the genes to switch on or off. A gene that is turned off can cause little harm. It is through these epigenetic marks that environmental factors like diet, stress, exercise, prenatal nutrition etc can make an imprint on genes and is even passed from one generation to the next. So our good habits now may also be beneficial to our children in future!

Pharamcogenomics and personalised medicine The greatest promise of personal genome information is its potential to offer individualised drug treatment.

Genetic variation has been shown to influence drug selection, dosing and adverse events. People metabolise drugs at different rates; however, doctors often prescribe drugs and select dosages based on a 'one-size fits all' paradigm.

Patients who June 1-15, 2013

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metabolise a particular drug more slowly than others might need a lower dose and thus could experience adverse side effects if prescribed the standard dosage.

Pharmacogenomics has already been successful in improving drug prescription and dosing. Most prescriptions are written with a ‘one dose fits all’ approach with adjustments based on gender, weight, liver and kidney functions or allergies. Some drugs have more laborious dosing calculations such as the anticoagulant warfarin.

Warfarin dosing is traditionally determined by a timeintensive ‘guess and test’ method, until the coagulation tests stabilise.

Pharmacogenomics identified several SNPs, such as CYP2C9 and VKORC1, affecting dosing of warfarin. One study found that a hypothetical pharmacogenetically driven clinical trial of the anticoagulant warfarin could save up to 60 per cent of the cost and reduce possible adverse events. Similar studies have been applied to thiopurines trastuzumab and imatinib for cancer, clopidogrel, tramadol, anti-psychotics, abacavir, carbamazepine, clozapine and June 1-15, 2013

many other drugs that all have significant genetic associations.

Caveats and challenges A few caveats about the genomics opportunity are in order here. First, the available databases of known disease-causing genetic mutations, although vast, are still evolving and subject to interpretative error. Prediction studies so far have been rather simplistic in the sense that most were based on a small number of variants that by themselves explain only a fraction of the genetic variability.

Interpretation of results should be also be done with caution, particularly by a lay person. It is important that a medical doctor and preferably a geneticist are involved in interpretation and discussion with a person. Negative risk should not provide false reassurance and be regarded as a licence to indulge!

Remember that most conditions are based on many factors; genetics is only one of them.

One of the unknowns is the extent to which genomic information can motivate people to change their www.expresspharmaonline.com

health-related behaviours.

Can the specificity and personalination of genomic information—i.e., being told that you have an X-fold increased risk of heart disease can motivate change?

Ignorance is bliss or Knowledge is power? Time will tell.

Use of the personal genome also raises ethical concerns. If someone has access to an individual’s genetic profile, it could affect decisions made regarding that person, such as denial of employment or life insurance. In the US, the Genetic Information Non-discrimination Act of 2008 protects against discrimination by health insurers and employers on the basis of DNA information.

Despite the need for caution, personal genomic testing provides an opportunity for us — all of us, both providers and patients — to learn about genomics and its role in predicting disease risk and adverse drug responses. It can also provide an opportunity to investigate your heritage and network with others who share similar genealogy and disease risk.

Need of the hour Critical to the widespread acceptance of the role of personal genomics in health and disease is the need to educate physicians and the public about the realistic benefits and risks of such an analysis to prevent over interpretation and misuse of this valuable information. It is important for everyone to educate themselves on these topics.

Two authoritative resources include the Personal Genome Project and the Personalized Medicine Coalition.

The cost to sequence a full human genome is falling like a rock. Estimates suggest that it could be less than $1,000 by the end of this year. What’s more, our ability to analyse the terabyte of data generated by sequencing one genome is also improving. This is a very rapidly evolving field of medicine not only for scientists, researchers, and clinicians but also for investors as dozens of big data start ups and a torrent of venture capital money is pouring into the hot new genome interpretation space. Let us not sit back but remain informed and take proactive steps to lifelong health and wellness.

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CLINICAL UPDATE Novartis drug significantly extends time without disease progression in women with HER2 positive advanced breast cancer Efficacy and safety data from the BOLERO-3 trial were assessed as part of a prospectively planned analysis esults of a pivotal phase III trial in women with HER2 positive (HER2+) advanced breast cancer showed that Afinitor (everolimus) tablets in combination with trastuzumab (Herceptin) and vinorelbine significantly extended progression-free survival (PFS) after prior therapy when compared to treatment with placebo plus trastuzumab and vinorelbine,meeting the study's primary endpoint.

Efficacy and safety data from the BOLERO-3 (Breast cancer trials of OraL EveROlimus-3) trial were assessed as part of a prospectively planned analysis.

These results will be presented on June 2 at the American Society of Clinical Oncology

R

(ASCO) Annual Meeting in Chicago, Illinois, as well as at future medical congresses, and shared with regulatory authorities worldwide.

"We are encouraged by the BOLERO-3 results and are committed to helping improve treatment options for the HER2 positive patient population where there remains an unmet need," said Alessandro Riva, Global Head, Oncology Development & Medical Affairs, Novartis Oncology.

"Everolimus works differently than any currently available treatment for HER2 positive breast cancer, and these results support its potential expanded role in advanced breast cancer."

Everolimus targets the PI3K/AKT/mTOR pathway, which is hyperactivated in many types of cancers. mTOR is a protein that acts as an important regulator of cell division, blood vessel growth

and cell metabolism. Data confirm that blocking mTOR is a proven approach to maximize the benefit of existing advanced breast cancer treatments.

Everolimus is approved as Afinitor in more than 65 countries including the US and the countries of the European Union to treat postmenopausal women with hormone receptor-positive, HER2 negative (HR+/HER2 negative) advanced breast cancer in combination with exemestane, after recurrence or progression following a non-steroidal aromatase inhibitor. The specific indications vary by country.

HR+/HER2 negative advanced breast cancer is the most common form of the disease. Approximately 70 per cent of all invasive breast cancers are positive for HR expression at the time of diagnosis.

BOLERO-3 is a phase III, randomised, double-blind

study of everolimus plus trastuzumab and vinorelbine conducted at 159 clinical trial sites globally. The trial included 569 women with HER2 positive locally advanced or metastatic breast cancer who were previously treated with a taxane and were resistant to trastuzumab. Participants were randomized 1:1 to receive either everolimus 5 mg/day orally or placebo, plus weekly vinorelbine 25 mg/m2 IV and weekly trastuzumab 2 mg/kg IV following loading dose of 4 mg/kg.

The primary endpoint of the trial is PFS. Secondary endpoints include overall survival, objective response rate, time to deterioration of performance status, changes in quality-of-life scores over time, clinical benefit rate, duration of response, time to response, safety and pharmacokinetics.

EP News Bureau-Mumbai

RESEARCH UPDATES Pfizer halts study of lymphoma drug unlikely to help survival Will continue to study the experimental drug, inotuzumab ozogamicin, in other hematologic cancers fizer which has been on a hot streak with three recent approvals of cancer drugs, has decided to halt a late-stage trial of a drug for aggressive non-Hodgkin lymphoma after independent monitors found it was not likely to improve survival.

Pfizer said it would continue to study the experimental drug, inotuzumab ozogam-

P

icin, in other hematologic cancers. â&#x20AC;&#x153;Hematologic cancers are a complex group of diseases, with more than 70 different types of lymphomas, leukemias or myelomas that require unique treatment options,â&#x20AC;? Mace Rothenberg, Senior Vice President, clinical development and medical affairs for its Oncology Business unit, Pfizer, said. No new or unexpected safety problems were identified by the independent monitors, Pfizer said.

Inotuzumab is not a particularly high-profile drug in Pfizer's developmental pipeline, but had reached the final stage of human trials before the company would have applied for FDA approval. Analysts at Cowen & Co had forecast sales of $100 million in 2016 for the drug.

The study tested inotuzumab in combination with Roche Holding's Rituxan in patients with relapsed or refractory aggressive nonHodgkin lymphoma who

were not candidates for intensive high-dose chemotherapy.

That combination was compared with patients who got either Rituxan and Teva's Treanda or Rituxan and the chemotherapy drug, gemcitabine.

During a planned interim analysis, an independent Data Monitoring Committee concluded that inotuzumab ozogamicin plus Rituxan would not improve overall survival compared with the other drug regimens.

Reuters

Lung drug shows promise in prolonged trial, says Bayer The drug was shown to help people suffering from pulmonary arterial hypertension ayer said extended use of its experimental riociguat pill to treat a lifethreatening form of high

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blood pressure in the lungs was shown to be safe and effective in a prolonged trial. In the extension of a late-stage trial, the drug was shown to help people suffering from pulmonary arterial hypertension (PAH), a progressively worsening condiwww.expresspharmaonline.com

tion that can overburden the heart, to better tolerate physical exercise.

It said that side effects, including headache, dizziness, indigestion and low blood pressure, were tolerable. Bayer has said it expects peak annual sales of more

than $646 million from the product. Preliminary results of the study were published in October, encouraging Bayer to earlier this year submit riociguat for regulatory approval in the US and Europe.

Reuters June 1-15, 2013

R|E|S|E|A|R|C|H

India develops $1 rotavirus vaccine The vaccine reduces the incidence of diarrhoea by more than half during the first year of the child's life and protects against all strains of rotavirus, continuing into the second year Shalini Gupta - New Delhi n a first of its kind public private partnership fostering medical innovation, ROTAVAC, a rotavirus vaccine developed jointly by the Department of Biotechnology (DBT) along with its various partners has demonstrated positive results from a phase III clinical trial.

The vaccine holds signifi-

I

THE MONOVALENT VACCINE ORIGINATED FROM AN ATTENUATED (WEAKENED) STRAIN OF ROTAVIRUS ISOLATED FROM AN INDIAN CHILD AT AIIMS 1985-86 cant importance for India in the light of data from ICMR which indicates that 40 per cent of all diarrhoeal admissions are caused by Rotavirus leading to the death of 10,000 children annually. Not only does the vaccine reduce the incidence of diarrhoea by more than half during the first year of the child's life, it demonstrates protection against all strains of rotavirus, continuing into the

second year.

The monovalent vaccine originated from an attenuated (weakened) strain of rotavirus isolated from an Indian child at AIIMS 198586. DBT, Bharat Biotech, the US National Institutes of Health (NIH), the US Centers for Disease Control and Prevention (CDC), Stanford University School of Medicine, and PATH have worked tirelessly since then towards its development.

Bharat Biotech which has invested ` 60 crores in the project would be applying for the license of the vaccine to DCGI by July informed Krishna Ella, Chairman and Managing Director, Bharat Biotech.

“There is a lot of weariness surrounding vaccines, however, nothing compares with them when it comes to deliverability. This effort is a testament to the fact that India can take a leadership role in producing low cost vaccines,” said Dr M K Bhan, Advisor to the Indian Academy of Pediatrics and former DBT Secretary.

Currently GSK and Merck are the only two companies selling the vaccine at around Rs 2500 per dose. The Indian vaccine is slated to come to the market somewhere in 2014 and would be priced at ` 50 for one dose.. shalini.g@expressindia.com

HyZone Class II Microbiological Safety Cabinets & HyZone Unidirectional Vertical Downflow Unit (Laminar Air Flow Unit) Manufactured As Per

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Plans regulatory filings with authorities to make this medicine available for patients

From Thermolab’s Testing Services To Assist You In Routine Maintenance & Revalidation.

rench drugmaker Sanofi said a late-stage phase III trial of a drug designed to treat myelofibrosis led to positive results. Myelofibrosis is a rare, life-threatening condition that involves abnormal blood cell production and scarring in the bone marrow.

"Patients with myelofibrosis in advanced stages are desperately ill and in need of treatments that will improve their outcomes," Debasish

F

June 1-15, 2013

Roychowdhury, head of Sanofi Oncology, said.

"Now we are planning regulatory filings with authorities to make this medicine available for patients."

Rare disease treatments are among Sanofi's key focuses following the acquisition of US biotech Genzyme as its sales are hit by generic competition and European austerity measures.

Reuters

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W H AT ’ S INSIDE

PHARMA ALLY

Sipra Labs records 30 per cent growth in 2012-13 PG 35 Waters releases new products in the analytical standards PG 36 Vacuum drying – Nothing works without drying PG 37 The future of inhalation therapy PG 39 Trends in tabletting and encapsulation technologies PG 41

Pharma Life 62 32

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June 1-15, 2013

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I

Indian government’s proindustry policies propelled the growth of different industries in a big way. However, growing industrialisation also inadvertently became the major cause of increased pollution of water, land and air. Industrial effluents, especially from industries that deal with chemicals, turned out to be the biggest culprit.

Pharma industry is one of the biggest consumers of chemicals and the effluents from this industry also came under the scanner of the environmentalists. However, on the positive side, over the years, pharma companies regularly kept updating technologies used for the treatment of effluents.

Evolution of effluents Pharma industry is a place where ‘discovery’ is always a buzz word. Last few decades saw many new types of drugs being introduced in the market. Different types of chemicals are regularly used to develop these drugs. Use of variety of chemicals also made effluents from the pharma industry more complex and difficult to treat.

Ashutosh Jain, Chief Operating Officer, Venus Pharma Gmbh and Chief Executive Officer, Unit I & II, Venus Remedies, looks after one of the most sensitive type of drugs i.e. injectables. He says that in the pharma sector high quantum of effluents

PHARMA INDUSTRY HAS SHOWED TREMENDOUS TECHNOLOGICAL GROWTH IN TERMS OF RESEARCH, MANUFACTURING PRACTICES ETC. ON THE OTHER HAND, AS FAR AS EFFLUENT TREATMENT IS CONCERNED IT LARGELY REMAINED CONVENTIONAL IN ITS APPROACH June 1-15, 2013

are generated in the bulk drug industry wherein chemicals in huge quantities are processed. He adds, “With passage of growth in the Indian pharma industry, new molecules and new chemicals are coming in use. We being a developing nation the ecological impact of these chemicals or drugs are generally not studied. For example, in developed nations before launching any new drug it is mandatory to have the impact on fungi and over all ecological system if the drug traces are drained in earth or waste water.”

In India, environmentrelated issues are perhaps not taken that seriously thoughpharma industry deals with life and death of the final consumer and is one of the fastest growing industries in the country. It is given that activities happening in this industry are going to impact people and the environment.

According to Jain, in India focus is restricted to the effects of drugs on human body and how it reacts to them, in short, pharmacokinetic and pharmacodynamic studies. Jain highlights, “In this process, the concern about environment takes a back seat. That is why not much importance has been given by the industry to the effluents. The only objective is to comply with the norms as prescribed by Pollution Control Board.”

Though with the growth of the pharma industry the menace of the pharma effluents has also increased, according to Dr BV Sivakumar, Chief Scientific Officer, Enaltec Labs, many countries had proper sewage systems in place for the effluents generated from industries, as early in the late 19th and the beginning of the 20th century. He informs, “The effluent treatment processes were basically by physical, chemical and thermal methods which were not costeffective, and were less efficient. Proper channelling and treatment processes are mandatory to get rid of the adverse effects of these effluents on the environment.”

Current technologies Pharma industry has showed tremendous technological growth in terms of research, manufacturing practices etc. On the other hand, as far as effluent treatment is concerned it largely remained conventional in its www.expresspharmaonline.com

ASHUTOSH JAIN,

DR BV SIVAKUMAR,

Chief Operating Officer, Venus Pharma Gmbh and Chief Executive Officer, Unit I & II, Venus Remedies

Chief Scientific Officer, Enaltec Labs

We being a developing nation the ecological impact of the chemicals or drugs are generally not studied

Proper channelling and treatment processes are mandatory to get rid of the adverse effects of effluents on the environment

approach. Moreover, to make things even more complicated, regulations in India to protect the environment from various effluent contaminants never proved adequate.

Sivakumar provides details about the technologies that are being commonly used in the treatment of pharma effluents. He says, “Conventionally, Effluent Treatment Process (ETP) includes a series of treatments, such as pretreatment, primary, secondary, and tertiary treatments. Pretreatment was previously a part of primary treatment process but later became a separate process where a bar screen, usually an automated mechanically raked one or a manually cleaned one is used to remove large objects. This is performed to prevent blockage of pipes or moving parts of the treatment plants.

During the primary treatment process, pretreated effluent is passed through primary sedimentation tanks where settling of sludge and skimming off of grease and oil occurs.

Effluents are neutralised and flash mixed to start coagulation and sedimentation which is later separated by settling tanks.”

Sivakumar adds, “Secondary treatments are employed to substantially degrade the biological content of the effluent.

Contamination from short chain organic molecules, sugars, fats are suitably removed during this process.

Secondary treatment involves majorly attached-growth and suspended-growth systems.

Attached-growth system has been further developed into moving bed bio-film reactors (MBBR). Suspended-growth

system provides higher removal rates as compared to the attached-growth system.”

Sivakumar says further, “In recent times, secondary treatments involve aerobicgranular sludge technique, soil bio-technologies, biological aerated filters and rotating biological contractors.

Final step of the secondary treatment stage involves settling of biological floc or filter material through a secondary clarifier to produce effluent containing low levels of organic material and suspended matter. Tertiary treatment is carried out to provide a final treatment stage to further improve the effluent quality before it is discharged to the receiving environment, such as sea, river, lake or ground.”

“Besides ETP plant, Sewage Treatment Plant (STP) plant, Reverse Osmosis (RO), Ultra Filtration (UF), ozonisations are technologies that are more commonly used for effluent treatment/management in the pharma industry,” says Mahaveer Bafna, Chairman and Managing Director, Bafna Pharmaceuticals.

Technologically backward?

As already discussed, in India pharma effluents are generally being treated using conventional methods. There are varied opinions among industry veterans about domestic pharma players' capability of using advanced technologies in the treatment of effluents. Many pharma players say that technologies for the treatment of pharma effluents are available in India. However, some of the industry players counter argue that during some speEXPRESS PHARMA

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cific events we are indeed dependent on foreign players for the technology.

“Yes, Indian pharma industry is well equipped with technologies to process effluents,” says Jain confidently.

While pointing out the specific case of bulk pharma, however, Bafna says, “Our own technologies are suitable but in critical sectors like bulk pharma we are still dependent on foreign support for the technology.”

Challenges Pharma manufacturing units or research labs are not the only sources of effluents in the pharma industry.

There are many other activities as well that generate effluents in the pharma unit.

Sivakumar says, “As industries scale up, their production strength and the types of drugs being dealt, with increase. Effluents generated from manufacturing operations, quality control, canteen, warehouse, engineering, and miscellaneous such as floor washes, equipment cleanings, utilities; pose a challenge for the treatment processes to be adopted due to the broad categories of various effluents generated.

In recent times, the effluent treatment processes have evolved many fold to tackle the adverse effect on the environment caused due to effluents.”

Besides bulk drugs the major concern of pharma industry is effluents generated from hormones, anticancer drugs and antibiotic products.

Sundeep V Bambolkar, Joint Managing Director, Indoco Remedies says, “In the case of bulk drug manufacturing process the efflu-

SHASHANK SANDU,

MAHAVEER BAFNA,

Managing Director, Sandu Pharma

Chairman and Managing Director, Bafna Pharmaceuticals

Ayurvedic industry did not have any problems with respect to effluents as we use plantbased organic material. The only effluent generated is due to the use of boilers and generators

Our own technologies are suitable for the effluent treatment but in critical sectors like bulk pharma we are still dependent on foreign support for the technology

In the case of hormones, anti-cancer drugs and antibiotics, it is necessary that the active chemicals should be deactivated before it is brought to the effluent treatment plant

ents consist of more of solvent which are high in Biochemical Oxygen Demand (BOD) and Chemical Oxygen Demand (COD) and very difficult to treat. Secondly, due to demand in new products the effluents, properties change sometimes and then it becomes difficult to treat.”

He adds that high volume of batch failure in bulk drug manufacturing process is also a factor.

He adds, “In the case of hormones, anticancer drugs and antibiotics, it is necessary that the active chemicals should be deactivated before being brought to the effluent treatment plant. If this is not done it will create problems to the surroundings. So it is important that we deactivate the same and also have a mechanism to check whether its been done.”

Ayurveda industry is an inseparable part of the Indian healthcare system.

Though ayurvedic medicine manufacturers are not the direct users of chemicals, medicine manufacturing process does produce effluents in this industry as well.

However, if industry experts are to be believed, the effluents generated from ayurvedic medicine industry are not as harmful to the level of the effluents from the modern medicine industry.

Shashank Sandu, Managing Director, Sandu Pharma informs, “Ayurvedic industry did not have any problems with respect to effluents as we use plantbased organic material. The only effluent generated is due to the use of boilers and generators. The ayurvedic industry uses processes which are developed indigenously and they are good enough to take care of the matter.”

Ayurvedic industry is using its waste to generate by-products like organic manure and vermiculture, which is perhaps not possible with the effluents from the pharma industry. However, to convert effluents from the ayurvedic industry into usable form, it is essential to have government support, which according to Sandu is lacking. With the government's help modern technologies can be used in the treatment of effluents from the ayurvedic industry.

treatment is the protection of the environment in a manner commensurate with public health and socio-economic concerns. He says, “Against the high cost conventional effluent treatment systems, there is an increasing need for low cost methods of treating effluents. So as to counteract this shortcoming and to preserve the high quality of the environment, a new concept known as cleaner production for effluent pollutant minimisation is being practised. Low cost methodologies which are very efficient to remove pollutants from the effluents are the need of the hour, which in turn shall ensure the safety, efficacy and quality of the treated effluents.”

Jain stresses on natural processes for the treatment of effluents whereas, Bambolkar feels that the next step in the evolution would be minimal use of water in the manufacturing process.

He says, “The treated water should be recycled to the maximum so that there is minimum load on the fresh water resources.”

Pharma industry works to keep human beings healthy. So obviously, they would not want people to fall sick due to effluents from their manufacturing units. It will not come as a surprise if in the future we get to see pharma companies investing more money in effluent management besides focusing on their core job of manufacturing life saving medicines.

Ayurveda perspective

In the years to come According to Sivakumar, the ultimate goal of effluent

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www.expresspharmaonline.com

SUNDEEP BAMBOLKAR, Joint Managing Director, Indoco Remedies

sachin.jagdale@expressindia.com June 1-15, 2013

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VENDOR NEWS Sipra Labs records 30 per cent growth in 2012-13 Eyes a target of Rs 100 crores in next five years ipra Labs has announced a 30 per cent growth in 2012-13, and has now set sights on achieving a target of Rs 100 crores in the next 4-5 years.

The last financial year turnover was Rs 33 crores.

“If we follow the same growth path we will achieve it without much difficulty,” says K Sreedhar, Director

S

(Analytical).

Sipra specialises in crystallography studies, metabolic studies, genotoxity, and impurity profile. “We have now attained the reputation of being a one-stop research and solution provider to the industry. We not only help organisations by testing their product samples but also help them in filing for clearances from USFDA and other regulatory organisations by providing

detailed analysis. Sipra has complete expertise in testing for genetoxic impurities,’’ Sreedhar says.

Sipra is also reportedly working on providing webenabled, post-analytical services. “Customers will want to access research and analytical records from time to time and we want to put it up online for them. For this we are creating a database here and records of all our customers will be avail-

able to them at the click of the mouse. It is a very quick response mechanism, especially very helpful during audits etc,” informed Sreedhar .

Talking about the industry’s growth, he said that it is an emerging sector and testing requirements will only go up due to tighter regulations and thus the industry has a good future.

EP News Bureau - Mumbai

ClinTec International to open an Istanbul office Sponsors partnerships in Clinical Trials in Russia-CIS and MENA-Turkey conference to be held in Istanbul linTec International will formally open an office in Istanbul, Turkey. The office will provide ClinTec’s global team with access to a new patient population, and further consolidate the British CRO’s presence in the Middle

C

East and North Africa (MENA) region.

Dr Rabinder Buttar, Founder and Chief Executive Officer, ClinTec International said, “The launch of this new office in Turkey reflects the growing significance of Turkey- and the wider MENA region- to the global clinical research market. We are

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2231 8879 / 80 Fax: +91-33-22138582 Cell: 09830130965 / 09831182580 Email: prasenjit.basu@expressindia.com ajanta.sengupta@expressindia.com KOCHI Dr Raghu Pillai Business Publications Division, The Indian Express Limited, Sankoorikal Building, 36/2248, Kaloor,Kadavanthara Road, Opp. Kaloor Private Bus Stand, Kaloor - 682 017 Tel: (0484) 2343152, 2343328 Fax: 2343153 E-mail: Kochi.bpd@expressindia.com raghu.pillai@expressindia.com COIMBATORE The Indian Express Limited, Business Publications Division, 1st Floor, 731, Avinashi Road, Opp. PRS Grounds, Coimbatore-641 018 Tel: 2212157/2216718/2216732 E-mail: bpdcbe@vsnl.in

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June 1-15, 2013

delighted to be at the forefront of developing expertise in Turkey and the MENA region as a whole.”

The company is also sponsoring partnerships in Clinical Trials at Russia-CIS and MENA-Turkey conference to be held in Istanbul on May 22 - 23, 2013. The conference aims to explore the chal-

www.expresspharmaonline.com

lenges and opportunities facing companies when conducting clinical trials in the MENA region.

Bindhya Cariappa, Executive VicePresident- Global Clinical Development ClinTec’s will be delivering a speech on Rare Disease Trials in the MENA region.

EP News Bureau - Mumbai

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EXPRESS PHARMA

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PRODUCTS Industrial Equipwash launches spray balls T he spray ball is a simple yet highly effective device for internal washing of process and storage tanks. A spray ball, powered by the cleaning fluid, generates a dense spray to clean every part of the vessel. There is only one moving part and maintenance is zero. No lubrication is necessary and this prevents any risk of oil or grease contamination of product, thereby making the spray ball ideally suited for hygiene sensitive applications. Spray balls are widely accepted for

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Waters releases new products in the analytical standards and reagents portfolio aters Corporation introduced Quality Control Reference Materials (QCRMs) and certified containers to the analytical standards and reagents product group.

Specifically designed for Waters instruments, QCRMs are the simplest and fastest means to understand a chromatography or MS systemâ&#x20AC;&#x2122;s health while ensuring repeatable performances. Waters certified containers for solvents and mobile phases are uniquely processed and treated to prevent extraneous peaks and baseline noise.

The Waters QCRM portfolio is a unique collection of standards and mixtures specially formulated and based on the expertise of Waters scientists. QCRMs enable one to

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The new certified containers help ensure that the customers can produce dependable, consistent and high quality results as easily as possible. Certified containers can be used on any LC sys-

tem, including UPLC, LC/UV, and LC/MS. Manufactured to stringent standards, these unique containers prevent extraneous peaks and baseline noise stemming from high TOC, glass chemistry interference, and glass degradation due to glass matrix hydrolytic attack.

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DataMan 50L by Cognex T

he high performance, compact DataMan 50L by Cognex brings in premium reading technology to single-line laser scanner arena. The key features are: unmatched read rate performance; high read rate performance; fast, accurate reading of 1-D oriented barcodes (either ladder or picket fence); best-in-class reading of 1D omnidirectional barcodes; IDQuick for fast, accurate reading of 2-D codes (S models); delivers high read rates than singleline or raster laser scanners; high read rates of 1-D liner barcodes, including those that are damaged, distorted, blurred, scratched, low height or low contrast; no moving parts; its solid state cannot easily wear; do not require any replacement; no

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read analysis. The ability to analyse 'no reads' by letting the user see what the reader sees, either live on a monitor or through image archiving.

DataMan 50L holds a premium barcode reading technology in a compact barcode reader. Its high read rates can read damaged, distorted, blurred, scratched, low height or low contrast.

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June 1-15, 2013

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VALUE ADD Vacuum drying – Nothing works without drying The collective vision at Promas Engineers is to transform and lead the process and pharmaceutical equipment industry. The R&D and Technical Team at Promas Engineers give an outlook about vacuum drying and its processes rying is a mass transfer process consisting of the removal of water or another solvent by evaporation from a solid, semisolid or liquid. Vacuum is a region with a gaseous pressure much less than atmospheric pressure.

The earth’s atmosphere exerts a pressure upon us (known as the atmospheric pressure), which can be measured in a number of ways. At sea level the standard pressure is described in different units as: 101,300 Pascals; 1,103 millibar; 760 Torr; 760 mm of Hg; 29.92” of Hg;14.7 psia.

In the approximate vacuum range from about one Torr to near atmosphere, typical applications are mechanical handling, vacuum packing and forming, gas sampling, filtration, degassing of oils, concentration of aqueous solutions, impregnation of electrical components, distillation, and steel stream degassing.

D

Vacuum-based industrial applications Industrial vacuum applications range from mechanical handling (such as the manipulation of heavy and light items by suction pads)

to the deposition of integrated electronic circuits on silicon chips.

At lower pressures down to about 10-4 torr, many metallurgical processes such as melting, casting, sintering, heat treatment, and brazing can derive benefit. Chemical processes such as vacuum distillation and freeze-drying also need this range of vacuum. Freeze-drying is used extensively in the pharma industry to prepare vaccines and antibiotics and to store skin and blood plasma. The food industry freeze-dries coffee mainly, although most foods can be stored without refrigeration after freeze-drying, and this technique is receiving widespread acceptance.

The pressure range down to about 10-6 Torr is used for cryogenic (low-temperature) and electrical insulation. It is used in the production of lamps; television picture tubes, X-ray tubes; decorative, optical, and electrical thin-film coatings; and mass spectrometer leak detectors.

In thin-film coating, a metal or compound is evaporated under high vacuum from a source onto a base material or substrate. The base material is generally plastic for decorative coatings; glass for optical coatings; and glass ceramic, or silica for electrical coatings.

To achieve vacuum high enough for thin-film coating and for other industrial uses requiring pressures down to

Salient features

June 1-15, 2013

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10-6 torr, a pumping system consisting of an oil-sealed rotary pump and a diffusion pump is used. The oil-sealed rotary pump (sometimes referred to as forepump) 'roughs' the chamber down to a pressure of about 0.1 Torr, after which the roughing valve is closed. The fore valve and high-vacuum baffle valve are then opened so that the chamber is evacuated by the diffusion pump and rotary pump in series.

Why vacuum drying?

Vacuum drying is recommended for materials that could get damaged or have its properties changed when exposed to high temperatures. The vacuum removes the moisture while preventing the oxidation or explosions that can occur when certain materials combine with air. Vacuum drying is also ideal in situations where a solvent must be recovered or where materials must be dried to very low levels of moisture.

Why use vacuum dryers?

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Vacuum drying process requires less energy and so it reduces the environmental impact and economic cost for drying the products It works faster than any other drying methods and thus saves considerable amount of time Vacuum drying tends to retain the integrity of the original products without

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damaging it with heat. For foods, this can be valuable as other drying processes can degrade quality of the food and thereby reduce its appeal Using vacuum drying equipment also prevents workers’ exposure to health risks like fumes and explosions

What are vacuum tray dryers?

It involves heating the shelves inside the vacuum chamber. This technique can apply heat indirectly to the product by forcing physical contact with the shelf. A hot medium flows through the shelves, thus enabling it to conduct heat to the tray placed on the shelves.

Why vacuum tray dyers?

(Also called cabinet dryers) ❍ ❍

❍ ❍ ❍

Conduction-based drying Intelligent design of heating shelf for maximum conduction of medium Drying without contamination Faster and energy efficient method of drying Reduces batch time and saves cost

Vacuum tray dryer Promas vacuum tray dryers are most commonly used as batch dryers. Vacuum tray dryers are of two types-cylindrical and rectangular cross section. The boxes are loaded and unloaded via a door.

Inside them are several heating plates mounted one above the other with fixed gap between them on which the product is placed in trays.

The top of the bottom heating plates and trays should be as smooth as possible to permit optimal heat transfer between the plates and products. The heating medium flowing through the heating plates should be water or thermal oil. The distance between the heating plates is determined primarily by the surface loading and the foaming of the products in the case of food products.

The preheating phase is very important in order that the drying curve and the foaming of the product are identical throughout the cabinet. The dimensioning of the vacuum systems is an important facEXPRESS PHARMA

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tor in the design of drying cabinet systems.

Salient features Our unique feature is the inclusion of an online cartridge filter post cyclone separator for product recovery and for ensuring a better life of oil sealed vacuum pump thus cutting costs of the user considerably.

Shown in image below

Water heating system : The vacuum system accessories used for the drying system

KF flanges and fittings A vacuum flange is a flange at the end of a tube used to connect vacuum chambers, tubing and vacuum pumps to each other. Vacuum flanges are used for scientific and industrial applications to allow various pieces of equipment to indirect via physical connections and for vacuum maintenance, monitoring and manipulation from outside a vacuum’s chamber. Several flange standards exist Klein Flange (KF) Quick Flange (QF) or NW, sometimes also as DN.

(KF) types. Use ISO KF for tube sizes DN16 to DN50. Our standard range of KF flanges and fittings are manufactured from 304 (1.4301) stainless steel. ISO KF constitutes an economical system of reusable interfacing stainless steel vacuum fittings and components for 19.1, 25.4, 38.1and 50.8mm OD tubing.

Assemblies are usable to 108mbar. Maximum temperature for sustained use is 150°C. They are ideal for vacuum systems requiring regular assembling and disassembling. Each vacuum seal is made by compression of an Oring on a centering ring between mating flanges. The seal is made in seconds by finger-closure of a wing nut on the all-metal hinged SS 304 clamp. The ISO KF family of modular building block components includes all commonly used standard fittings, feedthroughs and accessories.

Reducing flanges are available to connect different size components. Mating flanges are offered to interface with pipe and other flange systems including LF and CF.

ISO KF Flanges and fittings Introduction KF vacuum systems employ components with metric interface dimensions which have been defined by the International Standards Organisation (ISO). This ensures a high degree of compatibility between components obtained from different sources. Vacuum ISO KF are compatible with Klein Flange

Features ❍ Quick connection and disconnection ❍ 316L (1.4301) stainless steel fittings ❍ All SS 304/ 316 clamps ❍ Viton O-ring bakeable to 150°C ❍ Single wing nut closure ❍ ISO compatible

Specifications

Water heating system

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Material fittings 304/316 stainless steel, TIG welded Clamps- Aluminium Standard O-rings Du Pont Viton fluoroelastomer Vacuum O-ring compression by uniform pressure application around the 15° outer flange surfaces Flanges ISO standard dimensions 360° rotatable Four standard flange sizes for use with four tube sizes Tube bore sizes 12.7, 15.8, 22.1, 38.1 and 50mm Maximum temperature 150°C Components seusable and interchangeable with other ISO Dimension components of the same size

Clamps Hinged clamp assemblies are the most commonly used method for making ISO KF vacuum seal connections.

Prior to clamping, flanges can be rotated 360° and accept self-centering ring seals. Pressure is applied uniformly around the 15°outer surface of both flanges by finger-tightening.

The single wing nut until the first metal-to-metal contact is made between the spacing lips of the centering ring and the inner surface of the mating flanges. This compresses the O-ring between the flanges and makes the vacuum seal.

Clamps

Centering rings Centering ring assemblies are placed between two ISO flanges with matching outer diameters. The widest portion of the centering ring rests inside a capture groove on the flange and the O-ring rests on the flat polished surface outside the capture groove. On a blank flange, the groove seen on the face of a flange is the capture groove, with the O-ring making contact with this flange face just outside the groove.

Features ■ ■ ■ ■ ■

Fastens ISO KF of comparable size Quick make and break Stainless steel wing nut and bolt SS304 construction Requires centering ring with elastomer gasket.

Way forward in drying Usage for drying operations will rise as the demand for energy efficient, faster, environmentally friendly and cost effective drying technologies continue to increase worldwide.

Centering rings

KF flanges and fittings

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VALUE ADD The future of inhalation therapy Dr Gerallt Williams, Director, Scientific Affairs, Aptar Pharma, talks about the pivotal role of the pressurised metered-dose inhaler ressurised metered-dose inhalers (pMDIs) are devices that deliver a specific amount of medication to the lungs by releasing an aerosol which is inhaled by the patient. Today, pMDIs are the most widely used drug delivery devices used to treat asthma and chronic obstructive pulmonary disease (COPD) with an estimated 600 million units sold every year. Their story began more than fifty years ago, at the time when asthma medication was administered using a glass squeeze bulb nebulizer, which was fragile and unreliable. By March 1956, the first pMDI products were launched: the Medihaler-Iso and the Medihaler-Epi. These devices contained the drugs isoprotenerol and epinephrine respectively and were formulated with alcohol, ascorbic acid and the chlorofluoro carbon (CFC) propellants Freon 12 and Freon 114. Asthma treatment was revolutionised as a result.

P

Excellence in engineering The basic design of the pMDI system has changed very little in fifty years. It consists of a container, which holds the active drug formula; the metering valve, which helps to deliver the correct aerosolised dose of drug; the

actuator, usually a single entity that includes the mouthpiece, the body of the device and nozzle [See Figure 1]. The entire formulation is made up of the drug, the propellants and often contains surfactant and other excipients. The interaction of the formulation with the other pMDI components defines the final dosage form and characteristics 1.

Although parts of the pMDI system have been significantly improved over the past five decades, a user of pMDIs in 1956 would probably know how to use a modern pMDI. This familiarity is also one possible reason why the average time required for regulatory approvals is less than for dry powder inhalers (DPIs). The operation mode of the pMDI is also wellunderstood by regulators.

One of the main benefits of using pMDIs, as recognised by patients and healthcare providers, are their convenience and ease of use. A pMDI typically contains 120 to 200 doses (but there are products with between 60 and 300 doses marketed) in a small, pocket-sized portable device, unlike nebulizers and DPIs. The large number of doses available from a device means that pMDIs are a costefficient option which can reduce healthcare costs.

The phase-out of CFC propellants Despite the basic components of the pMDI remaining

unchanged, there has been a great deal of innovation in pMDI technology. In the 1970s, it was recognised that traditional CFC propellants were responsible for the depletion of the stratospheric ozone2. As a result, hydrofluoroalkane (HFA) propellants were developed to replace CFC gases. The phase-out of CFC-based pMDIs has occurred at different times for various countries. In the US, most of the CFC products have been transitioned, although a couple of products will remain in the market until end of 2013. In certain developing countries, CFC-based pMDIs continue to be sold to provide low-cost inhalers according to article 5 of the Montreal Protocol, an international agreement that controls the production and consumption of substances causing ozone depletion. The development of HFA pMDIs in the late 1980s, and changing regulatory requirements in the 1990s, led to a significant increase in the number of patents being filed in the pulmonary delivery technology area. Between 1991 and 2000 over 1300 patents were filed, in comparison with 240 from 1981-19903. The market dynamics for pMDIs began to shift, as several leading manufacturers began developing DPIs; the majority, however, continued to research new technologies to improve existing pMDI designs4. The surge in innovation opened up the pul-

Figure 1: Schematic of typical pressurised metered-dose inhaler

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monary drug delivery market and resulted in a range of new therapies, some for treating systemic diseases, as well as diseases of the lung.

Industry challenges, technical hurdles The pressure to find solutions to the technical hurdles encountered by pMDI manufacturers during the switch from CFC to HFA propellants drove innovations in pMDI design with a focus on drug formulation and metering valve designs.

Surfactants, used to prevent particle aggregation and lubricate the valve mechanism, as well as other excipients, have different solubilities in HFAs. One option was to find a low-volatility co-solvent, such as ethanol.

Traditionally, a two-stage filling process was used to fill pMDIs, whereby the active ingredient, low-boiling liquids and other excipients are filled into the empty canister, valve sealing or crimping takes place and then the high boiling propellant is pressure filled through the metering valve. This filling process works well for CFCs as some have a boiling point lower than room temperature, thus facilitating the first stage of the formulation and filling process at room temperature while other CFCs had higher boiling points and were used for the second stage of the manufacturing process. However, since HFAs do not have such a low boiling point, it was necessary to redesign the filling process. A single stage filling process was therefore developed, where the concentrate is pre-mixed with the HFA under pressure and the whole formulation is then pressure filled through the metering valve, into the canister, following valve sealing or crimping.

The sealing components (elastomers/gaskets) of the metering valve used within the CFC pMDIs were not compatible with the new HFA propellants: different swell characteristics led to propellant leakage and the introduction of moisture into the device, impacting on product performance. Increased valve EXPRESS PHARMA

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friction was also caused by the absence of the traditional surfactants which were present within the original CFC products. Following the phase out of CFC propellants, novel metering valve designs were developed, which minimised these effects.

Key innovations To improve compatibility of the formulation with the valve components, a new generation of elastomer sealing gaskets have been developed. Increased regulatory standards with a strong focus on ‘extractables and leachables’ forced technical improvements to elastomers/ gaskets, in order to reduce the levels of extractables and leachables that could potentially enter into the drug formulations5. New generations of sealing gaskets have been developed to replace the traditional black sealing gaskets, which contained carbon black fillers and therefore potentially high levels of polynuclear aromatics (PNAs). Most of these black gaskets (e.g. Nitrile) have now been replaced with cleaner white gaskets which incorporate alternative fillers.

The development of one particular new generation of gaskets i.e. ethylene propylene diene monomer (EPDM), has greatly reduced the extractables and leachables burden [See Figure 2].

Generics and changing market dynamics Until recently, the pulmonary drug delivery market has not been subject to a significant amount of generic

product substitution, contrary to other therapeutic areas and dosage forms. This is largely a result of the complex technical, regulatory, and commercial processes required to develop and commercialise a pharma product for inhalation6.

The intellectual property rights on intricate formulation and delivery device design, plus pioneering manufacturing processes, have helped to protect products.

However, opportunities do exist for generic players to enter the market as the regulatory standards evolve. For example, in the field of establishing bioequivalence for certain types of drugs, the introduction of the FDA’s Federal Food, Drug, and Cosmetic Act section 505 (b) (2) (which describes the new drug application route for development of inhaled clinically equivalent products) may help to overcome some of the technical and regulatory hurdles involved in establishing therapeutic equivalence for generic drugs7. Within Europe, new guidelines and research on bioavailability and bioequivalence studies for orally inhaled drugs are also in place8. Opportunities to introduce lower cost inhaled medicines to the market will continue to arise as pressure grows to reduce healthcare costs across the US and Europe.

Improving patient compliance The industry also faces a drive towards improving patient drug adherence,

which has driven innovations in the design of pMDIs and new developments appearing on the marketplace. Improving the ease of use and effectiveness of pMDIs has been paramount: coordination of the inhalation and dose actuation can be challenging, particularly for elderly or very young patients. The development of Breath Actuated Inhalers (BAI) devices, have improved inhaler usability and compliance, however the cost and added complexity implications associated with such devices has led to minimal take-up within the market place. The use of ‘Spacer devices’, attachments to pMDI actuators, which can increase the amount of drug reaching the lungs and also eliminate the need for a coordinated actuation and inhalation of the device are also useful to the patient.

Nevertheless, the drawbacks are that spacers make pMDI’s larger and less convenient to use. In addition to these mechanical improvements, novel formulations have been developed, which enable a more consistent dose delivery for low-dose suspensions or for the delivery of multiple drugs (e.g. reliever and prophylactic drug combined in one single pMDI).

‘Smart’ devices Technical progress has resulted in integral dose counters and external ‘add on’ devices that are able to provide patients with dosage information and feedback, such as drug quantities remaining in a device

Figure 2: The reduction in extractables levels as new elastomer varieties are developed

and timing of next dose.

The development of ‘smart’ devices with integrated electronic systems (‘e-devices’) that can feed information back to healthcare providers about patient use of inhalers may help unravel the question of how patient adherence could be improved and lead to improved health outcomes. A good example of this ‘telemonitoring’ approach to drug taking is the Nexus6 ‘Smartinhaler’, a device credited with helping patients to self monitor and adhere to their asthma or COPD medication.

Improving pMDI design: The role of Aptar Pharma The metering valve is a critical component of the pMDI system. It should accurately and reproducibly deliver a measured volume of propellant based formulation containing the dispersed drug, and also form a propellant-tight seal under high pressure with the canister.

Aptar Pharma, a leader in innovative and proven inhalation drug delivery devices for asthma and COPD, has developed metering valves that have been selected by major branded pharma companies and generic producers across the globe. Each year, several hundred million metering valves are produced in Aptar Pharma GMP ISO7 clean rooms. Aptar Pharma is the only metering valve manufacturer that designs, develops and manufactures its own elastomer formulations and rubber gaskets - a key component of the valve within its unique in-house and dedicated Elastomer Center.

Aptar Pharma’s DF30 metering valve technology platform has been the industry gold standard for more than 20 years. The new optimised DF30Plus model offers several key benefits, including better compatibility across a wider range of drug formulations, including ethanol-containing formulations. The cost-effective solution has an ultra-low extractible level and its robust design enables accurate and consistent performance with an excellent pressure filling capability.

Future directions for pMDIs If the past success of pMDIs is anything to go on, the future for this mode of drug delivery looks very

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bright indeed. It is predicted that innovative solutions will continue to be found which will reduce dosing variability and increase dosing and aerosol efficiency.

Figure 3: The DF30Plus: the new optimised metering valve from Aptar Pharma

Improvements in formulation, such as the development of new surfactants to improve drug solubility; and technical improvements to device design, to improve ease of use and ensure consistent and reliable drug delivery, will drive innovation in the application of new therapies other than asthma and COPD. An example of pMDIs being used in other therapeutic areas is the recent renewed interest and market launch of several pMDI products to deliver medication via the nasal route in order to treat ailments such as allergic rhinitis, congestion etc.

Recent research and development has also focused on improving patient compliance, once specific area of activity has been the development of mechanical dose counting devices which are now an integral part of the pMDI system. Although such devices are only mandatory for new products destined for sale in the US, the inclusion of dose counting devices can now be found within pMDI products in Europe, Latin America and India.

Aptar Pharma is striving to ensure that pMDI technology reaches its full potential. So, in addition to its

work on metered valves, the company has collaborated with key partners in inhalation therapy to produce innovative solutions for pulmonary drug delivery. Local state-of-the-art manufacturing facilities have also been introduced in order to streamline logistics and costs towards local market needs, e.g. manufacturing sites in China & India.

References: 1. Oliveira, R.F., Teixeira, S., Silva, L.F., Teixeira, J.C. and Antunes, H. Study of a Pressurized Metered-dose Inhaler Spray Parameters in Fluent™. Proceedings of the World Congress on Engineering 2010 Vol II. 2. Molina, M.J. and Rowland, F.S. (1974) Stratospheric sink for chlorofluoromethane: chlorine atom catalysed destruction of ozone. Nature: 5460; 810812.

3. Clark, A.R. (2005) Pulmonary Delivery Technology: Recent Advances and Potential for the new Millennium. In Hickey, A.J. (ed.) Pharmaceutical Inhalation Aerosol Technology. Marcel Dekker, New York, USA: pg 514.

4. Fradley, G. 2006 Fifty Years of the Pressured

Metered Dose Inhaler – Building on a Golden Heritage. Future Drug Delivery. Available online at http://www.touchbriefings.c om/pdf/1859/3M_tech_proof .pdf 5. Guidance for Industry Bioequivalence Recommendations for Specific Products U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) June 2010.

6. Oliver, MJ (2012) Developing Inhaled Branded Generic Products: A Review of Successful Past Practices.

Respiratory Drug Delivery 1: 299-304.

7. US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) (1999) Guidance for Industry Applications Covered by Section 505(b)(2) Draft Guidance. Center for Drug Evaluation and Research (CDER), Rockville, MD, USA. 8. Dissanayake, S. (2010) Application of the EU Guidelines for Pharmacokinetic Studies of Locally Acting Orally Inhaled Drug Products.

Respiratory Drug Delivery 1: 293-304.

VALUE ADD Trends in tabletting and encapsulation technologies An article outlining some of the latest trends to watch out for in tabletting and encapsulation technologies and ACG’s advanced technological contributions ral administration of drugs is considered to be the most important method for maximum effectiveness. In fact, pharmaceutical companies first check the probability of a particular drug in an oral dosage form.

This is particularly so since oral dosage is seen as a dosage form that improves patient adherence. Tablets and capsules are the most common forms of solid oral dosage, and are widely used because of several advantages. Firstly, there is exact dose precision unlike syrups or suspensions. Secondly, tablets and capsules are capable of effectively masking the taste of drugs, which is not the case with liquid

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dosages. Lastly, liquids are less portable, require more space on the shelf, pallet and shippers, and turn out to be a high-cost affair in comparison to tablets or capsules that are packed in attractive blisters.

ACG Worldwide, an integrated manufacturing, packaging and R&D solution provider for the global pharma industry, is predominantly a leader in technologies associated with solid oral dosages. For over five decades now, the company has been persistently raising the bar for technological advancements to help the pharma industry develop efficacious solid dosage.

dose precision and least content variability. In addition, tablets are not only the easiest and cheapest of all oral dosage forms to package and ship, but also the most costeffective to produce.

By nature, pharma companies always press ahead for increasingly cost-efficient tabletting technologies.

However, they don’t lose focus from the most critical factors like productivity, reliability, flexibility, safety and yield. In addition, the solution provider’s capability to offer on-time service support proves to be an important deciding factor.

Tablets Tablets offer the greatest capabilities of all oral dosage forms alongwith the highest

Although the operating principle and fundamental design of a rotary tablet press has remained unchanged for

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Current tabletting trends and ACG’s innovations

the last few decades, pharma machinery manufacturers like ACG have made multiple machine design improvements to cater to challenging requirements of the future.

Features like an interchangeable turret system, virtually tool-less design and automatic dual micro-dosing lubrication system were introduced by the company as special features a few years ago, now they are standard requirements for today’s tabletting machines.

Destiny 8100 (output: 1 million tablets per hour) has the capability to produce bilayer tablets with the help of a retrofittable kit. Pharma companies across the world are treating different ailments in a patient at the same time or administering multi-drug therapies for a single illness through bilayer

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P|H|A|R|M|A| A|L|L|Y tablets. They are also being considered for controlling release profiles of separate incompatible APIs or administering fixed dose combinations of different APIs. In addition, ACG highspeed high-volume tabletting machines Legacy 6100 (output: 400,000 tablets per hour) has been at the forefront in adding Multi-Unit Particulate System (MUPS) capabilities. A recent and challenging technology, MUPS or the compaction of multiparticulates combines the advantages of both tablets and pellet-filled capsules in one dosage form.

Few of the advantages of MUPS are: ● Uniform drug absorption and greater bioavailability ● Increased patient compliance ● Enjoys cost advantage of a tablet over capsules, with benefits of both ● Ideal for pharma companies looking at extending patent life or developing a product’s line extension

Pharma companies across the world are treating different ailments in a patient at the same time or administering multi-drug therapies for a single illness through bilayer tablets. They are also being considered for controlling release profiles of separate incompatible APIs or administering fixed dose combinations of different APIs.

Capsules Capsules, the other dominant form of oral solid dosage, are elegant, portable, and easy to use as well as easy to administer. In addition, capsules are particularly beneficial for drugs with an unpleasant taste or odour.

Although considered to be slightly expensive compared to tablets, capsules are economical if produced in large quantities.

Tabletting process, which requires pressure to compact powder into tablet, results in high loss of costly APIs, whereas there is no such wastage in a capsule-filling process.

With branding printed on them, capsules serve as an additional layer of anti-counterfeiting while helping endconsumers in brand identification and quick recall. Besides pharma products, the nutraceutical industry is another consumer of capsules, especially those made with hydroxypropyl methylcellulose (HPMC), or simply known as vegetarian capsules.

Current encapsulating trends and ACG’s innovations About 50 per cent of new chemical entities in the pipeline are highly potent, with sales for high-potency pharma ingredients expected to take off majorly. Most of the oncology drugs, opioids, hormonal agents and prostaglandins fall under this category. This calls for development of containment capsule-filling technologies, which not only protects the environment but also the personnel handling these potent drugs. ACG’s highcontainment special purpose automatic capsule-filler, SECUREFILL 12T, was built for this cause.

In addition, customised attachments for combination filling on encapsulation allows for gentle dosing of granules, pellets, powder, mini and micro tablets, capsules, and softgel, all in one capsule combination.

ACG offers a wide range of combination filling attach-

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ments, such as: ● Magazine type tablet filling attachment for standard round/capsule/oval shape tablet with fibre optic sensor based non fill detection ● Magazine type minitablet filling attachment with ACG vision system colour camera based non fill detection ● Disc type micro-tablet filling attachment with ACG vision system colour camera based non fill detection ● High-speed disc type micro-tablet filling attachment with ACG vision system with two-high resolution colour camera based NFD ● Capsule-in-capsule filling attachment with fibre optic sensor based NFD ● Softgel in hard gelatin capsule filling attachment with fibre optic sensor based NFD The global pharma industry is poised for slow growth in the next few years, boosted only a little by emerging markets. Some of the major factors behind this outlook are spiralling R&D costs and longer payback period.

Against such a backdrop, pharma companies look towards experienced partners like ACG Worldwide to offer best-in-class solutions as well as cost-effective methods of producing effective and affordable healthcare.

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Drugs Control Administration (A.P).

Department of Biotechnology approved Institutional Bio-Safety Committee (IBSC).

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ONE STOP SOLUTION FOR PHARMACEUTICAL RESEARCH

SIPRA LABS LIMITED Industrial Estate, Sanathnagar, Hyderabad – 500 018.

Tel: 040-23802000, Fax: 040-23802005 Email:sipra@sipralabs.com web: www.sipralabs.com

June 1-15, 2013

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JOB TRENDS Low hiring sentiments in pharma sector However, the hiring activity in the sector is 24 per cent higher than what it was an year ago lthough the pharma sector index has seen a consistent growth in the last five months, it has dipped by six per cent in the month of April 13â&#x20AC;&#x2122; indicating a sentiment of caution among the employers of this sector.

However, the hiring activity in the sector is 24 per cent higher than what it was an year ago.

According to the Naukri Job Speak, the index value of the sector has dropped after five consecutive months of an upward trend where the index grew by 44 per cent, from 1150 to 1657 between November 2012 to March 2013.

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The Naukri job speak index for the pharma sector is a monthly report that indicates hiring trends across industry sectors, geographies and functional areas

About Naukri.com Naukri.com, Indiaâ&#x20AC;&#x2122;s No. 1 job site and the flagship brand of Info Edge revolutionised the concept of recruitment in India. Since its inception in 1997, Naukri.com has seen contin-

ued growth whil e outperforming its competitors in every sphere. Info Edge was the first Internet Company to list in India. The site enjoys a traffic share of around 61 per cent as per the Sept Comscore

data. Naukri.com is a recruitment platform that provides hiring-related services to corporates/recruiters, placement agencies and to job seekers in India and overseas. It offers multiple products like

Resume Database Access, and Response Management tools and its services include job postings, and recruiter branding solutions on the site. The site has a database of over 29 million resumes

and has serviced over 46000 clients in FY-2012. The company has over 2000 people operating through 48 offices in 31 cities in India and overseas offices in Dubai, Abu Dhabi, Riyadh & Bahrain.

Jobs from Naukri.com Manager Legal Company: Exp: Location: Job Id:

Nagarjuna Agrichem Limited 10-15 Hyderabad / Secunderabad 080113000229

Company: Exp: Location: Job Id:

Famy Care Ltd 5-8 Navi Mumbai 170413001759

BDM - International Marketing Regionals Sales Manager Company: Exp: Location: Job Id:

Alchem International Limited 8-13 Delhi/NCR 060513000207

Company: Exp: Location: Job Id:

Naprod Life Science Pvt. Ltd. 3-8 Mumbai Suburbs 160413001561

Company: Exp: Location: Job Id:

Dr Reddys Laboratories Ltd 8-11 Hyderabad / Secunderabad 300413000773

Sr. Executive - Drug Regulatory Affairs

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Mumbai 190313003737

Business Managers Company: Exp: Location: Job Id:

Lutim Pharma Pvt Ltd 5-8 Punjab 030513900757

Production Manager Executive Assistant - MD

Senior Manager - Business Process Management

Location: Job Id:

Company: Exp: Location: Job Id:

Cadila Pharmaceuticals Limited 2-6 Ahmedabad 160413002557

Company: Exp: Location: Job Id:

Capricorn Pharma India Private Limited 8-13 Bengaluru/Bangalore 040513001742

Project Manager Manager -purchase Company: Exp:

Titan Laboratories Pvt. Ltd 5-8

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Company: Exp: Location: Job Id:

Brooks Laboratories Ltd 10-12 Vadodara/Baroda 040513900065

June 1-15, 2013

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AWARDS Dr Vijay Viswanathan to receive First Vivian Fonseca Scholar Award Award ceremony to be held from June 21-25, 2013 in Chicago, Illinois merican Diabetes Association will award Dr Vijay Viswanathan, Head and Chief Diabetologist, MV Hospital for Diabetes (WHO Collaborating Centre for Research, Education and Training in Diabetes), Chennai, with the Vivian Fonseca Scholar Award, instituted for the first time this year for diabetes research in special populations, for his work on diabetes and TB. The award will be given at the 73rd Scientific Sessions from June 21-25, 2013 in Chicago,

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June 1-15, 2013

Illinois.

The award was established by the association to recognise diabetes research focused on the South Asian, Asian American, Native Hawaiian and Pacific Islander popula-

tions and/or research by a scientist from these areas of the world. The award is given in honour of P N a g e n d r a n .

It recognises the contributions of Dr Vivian Fonseca, the Association’s 2012

THE AWARD WAS ESTABLISHED BY THE ASSOCIATION TO RECOGNISE DIABETES RESEARCH FOCUSED ON THE SOUTH ASIAN, ASIAN AMERICAN, NATIVE HAWAIIAN AND PACIFIC ISLANDER POPULATIONS AND/OR RESEARCH BY A SCIENTIST FROM THESE AREAS OF THE WORLD

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President, Medicine and Science, who in his years of volunteer service to the organisation, has been a mentor and role model to many researchers and clinicians.

The connection between diabetes and TB is gaining much public heath importance world over. In the abstract, “Effect of Diabetes on the Treatment Outcome of Smear Positive Pulmonary Tuberculosis- A Report from South India,” Vijay had reported that TB patients who have diabetes do badly compared to those without diabetes which has significant public health implications.

EP News Bureau-Mumbai

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APPOINTMENT Wockhardt appoints V Suresh as President, Finance Brings with him more than three decades of qualitative and multi business experience

est level in the field of finance, accounting, strategy, projects, secretarial business development, investment banking and consultancy. He has also handled comprehensive financial restructuring, as well as internal financial management issues.

With this appointment, Wockhardt has further strengthened its top manage-

ockhardt has appointed V Suresh as the President Finance.

A chartered accountant and a company secretary, he brings with him more than three decades of qualitative and multi business experience at the high-

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ment team, adding depth to its finance department.

V Suresh will take charge from Giri Giridhar who will be leaving the organisation on completion of all regulatory and mandatory audit of accounts for the FY 2012F13 to ensure a smooth handover of operations.

EP News Bureau-Mumbai

CAMPUS BEAT Novartis Biotechnology Leadership Camp to be held in Hyderabad Three winning students from India to participate in the International Novartis Biotechnology Leadership Camp at Basel, Switzerland he next edition of the Novartis Biotechnology Leadership Camp (BioCamp) will be held in Hyderabad from July 8 - 10, 2013. BioCamp is a pioneering seminar organised by Novartis that brings talented students from diverse faculties and different universities closer to the pharmaceutical industry. â&#x20AC;&#x153;BioCamp is a great platform for intelligent, young minds to interact with leaders

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SELECTED STUDENTS WILL HAVE THE OPPORTUNITY TO LEARN FROM AND NETWORK WITH LEADERS IN THE PHARMA AND BUSINESS SECTOR AND HONE THEIR TEAM BUILDING SKILLS

in the pharma industry. The three-day seminar will provide students with the opportunity to look closer at the pharma industry and help them make career choices.

Healthcare is a challenging area in our country and BioCamp reflects the Novartis commitment to furthering the cause of healthcare,â&#x20AC;? said Ranjit Shahani, Vice Chairman and Managing Director, Novartis India.

BioCamp is open to postgraduate students and young researchers in natural sciences, medicine, biotechnology, bio-informatics, pharmacy, business administration

or law (specialisation in Intellectual Property Rights) interested in pursuing a career in the pharmaceutical/biotechnology industry.

Selected students will have the opportunity to learn from and network with leaders in the pharma and business sector, as well as hone their team building skills.

The top three students from the India BioCamp will represent India at the International BioCamp being held at Novartis global headquarters in Basel, Switzerland from August 25-29, 2013.

EP News Bureau-Mumbai

NEW COURSE InClinition to start PG Diploma in Advanced Pharmacy The one-year weekend course would be based on ten different modules nclinition, a pharmaceutical and clinical consulting firm, will start its first classroom training weekend course post graduate diploma in advanced pharmacy (PGDAP) since this academic year from July 2013. This course aims to bridge gaps between industry and academia. The objective of this course is to prepare students of lifescience, pharmacy, biotechnology and other allied stream for various job descriptions across the indus-

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try. This one-year weekend course will be conducted in Dombivli near Mumbai through classroom coaching by eminent people from the pharma industry. The course is based on ten different modules including regulatory, QA, QC, project management, and many more.

There will be no end of course examination, as evaluation will be done by assignments of different modules.

The module assignments will be formative and based on case studies in real life pharma scenario. At the end of course, students will do projwww.expresspharmaonline.com

COURSE CONTENTS WILL BE DECIDED THROUGH DISCUSSIONS BY DIFFERENT INDUSTRY EXPERTS IN THESE SEGMENTS OF THE INDUSTRY. EACH BATCH WOULD COMPRISE ONLY 16 STUDENTS

ect work. Course contents will be decided through discussions by different industry experts in these segments of the industry. Each batch would comprise only 16 students. Apart from these, students will get e-newsletter fortnightly, experts group discussion forum membership, updates of scientific meeting and conferences including coverage on regulatory amendments.

Admissions have started since the month of May 2013.

EP News Bureau-Mumbai

June 1-15, 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.