Express Pharma (Vol.10, No.6) January 16-31, 2015 Part - I

VOL. 10 NO. 6 PAGES 110

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CONTENTS MARKET Vol.10 No.6 JANUARY 16-31, 2015 Chairman of the Board Viveck Goenka Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das Bangalore Neelam M Kachhap Pune Shalini Gupta DESIGN National Art Director Bivash Barua Deputy Art Director Surajit Patro Chief Designer Pravin Temble

PETVS GLASS: Who will blink first?

The Health Ministry has predictably stirred a hornet's nest with its diktat to replace PETwith glass packaging.While it is still three months to the cut off date and a lot could happen before then, a review of the issues at stake tries to separate the truth from the hype | P32

Senior Graphic Designer Rushikesh Konka

P23: IPC SPECIAL

Senior Artist Rakesh Sharma

‘66th IPC will address issues in depth and try to evolve strategies’

Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Dr Raghu Pillai - South Sanghamitra Kumar - East Harit Mohanty - West Marketing Team Rajesh Bhatkal GM Khaja Ali Ambuj Kumar E Mujahid Yuvaraj Murali Ajanta Sengupta PRODUCTION General Manager B R Tipnis Manager Bhadresh Valia Scheduling & Coordination Rohan Thakkar CIRCULATION Circulation Team Mohan Varadkar

Ravi Udaybhaskar,, Chairman -Organising Committee and Secretary General, All India Drugs Control Officers

P38: PHARMA ALLY ‘Dow India has multiple assets with an unmatched product mix of excipients worldwide’

MANAGEMENT

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THE GOOD, THE BAD AND THE UGLY IN INDIAN PHARMA

12

PHARMEXCIL INAUGURATES THREE-DAY PHARMA BUSINESS MEET IN AHMEDABAD

13

TORRENT PHARMA IN AGREEMENT WITH RELIANCE LIFE SCIENCES

14

ASSOCHAM TO ORGANISE PHARMA SUMMIT

PHARMA LIFE

101

‘PHARMA TO CREATE APPROXIMATELY 45,000 JOBS IN 2015’ Kamal Karanth, MD, Kelly Services, India and Malaysia

PACKAGING SPECIAL

Savindu Kudrigikar,, GM- Pharma Marketing, India, Dow Pharma & Food Solutions

P40: PHARMA ALLY ‘We will continue working to promote science-based solutions around the world’ KV Surendranath,, Senior VP, International Site Operations; Senior VP, USP–India Ashok Dang,, Senior Director - Marketing & Technical Services, USP

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'OUR GOAL IS TO PROVIDE A TOTAL END-TO-END SOLUTION TO OUR CLIENTS' Dr Avi Chaudhuri, Chief Business Officer and Head of India Operations, Kezzler

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 & Administrative Offices: Express Towers, 1st Floor, Nariman Point, Mumbai - 400021) *Responsible for selection of news under the PRB Act. 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.

EDITOR’S NOTE

Could a surgeon become DCG(I)?

I

In his message for 2015, Dr G N Singh, Drug Controller General (India) (DCG(I)), pledges that this year would be for 'streamlining of regulatory procedures without compromising patient safety'. A laudable goal and it dovetails with CDSCO's statement on policy initiatives planned for 2015.

Many of these initiatives are in continuation from the past year, but the initiative sure to generate a lot of debate is the 'harmonisation of recruitment rules' for the post of DCG(I) and certain other posts in the CDSCO as well as in the Central Drug Testing Laboratories.

Sources reveal that an expert committee, chaired by Satyanand Mishra, former Secretary, Department of Personnel & Training (DoPT) and former Central Information Commissioner, has been appointed by the Ministry of Health & Family Welfare (MoH&FW) to examine/review the recruitment rules for these top drug regulatory posts.

Industry observers see an attempt to (once again) revise recruitment criteria, from the current mandatory pharmacy qualifications and experience to medical qualifications. Is this a turf war or something beyond?

Many in the pharma industry cannot see the logic in this move. The reasoning is, why fix it if it ain't broke? The Delhi Pharmaceutical Trust is one such group, consisting of professional pharmacy experts. In a letter to the MoH&FW dated November 20, 2014, the Trust has supported their argument by pointing out that the appointment of a surgeon as drug controller is fraught with as much risk as making a doctor the chief of army, under the belief that after all the army involves the health of serving and wounded soldiers.

An acknowledgement receipt dated December 22 was deliverd to the Trust on January 4, leading them to conclude that the matter is “under active consideration.� If this is true, then the debate on the recruitment rules for the most crucial posts in the country's pharma regulatory mechanism will be opened once again.

The Trust's main rationale is that drug regulation in India involves regulation of the manufacture of quality medicines and not managing healthcare programmes. The latter would call for the healthcare delivery skills of a medical practitioner as it requires in depth understanding of disease diagnosis and treatment. Thus India cannot be compared to other countries where it may be appropriate to have medically qualified personnel heading their drug regulatory systems.

The Trust is right when it points out that pharmaceutical sciences and medical practice have

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CDSCO's planned 'harmonisation of recruitment rules' is sure to resurrect this debate

evolved into completely different and mutually exclusive specialisations, even though they are both part of the overall healthcare system. The letter points out that each of the two streams have different subjects taught and rightly each have a separate regulatory mechanism. Industry sources mention that we do have one example of a medico who served as DCG(I): Dr P Dasgupta but maintain that medicos should not serve as drug regulators.

Is this development a sign that the Ministry believes that something in India's drug regulatory system is indeed 'broke' and needs fixing? How is it that in the past two years, many global regulators have imposed import alerts and product bans, a reflection of less than adequate manufacturing practices of pharma companies in India, while the same facilities clear the CDSCO's inspections? This reasoning may be flawed on many levels but maybe the Ministry is under pressure to be seen to be fixing it.

All change is painful and the industry would do well to adopt a collaborative rather than a confrontational stance. Some of CDSCO's planned policy initiatives like the 'introduction of provisions relating to phytopharmaceutical drugs under the system of modern medicine' are welcome because they seem to indicate that India is following in the footsteps of global regulators like the US FDA and Health Canada which already have separate norms for botanical-based medicinal products rather than clubbing them under the rules for chemical-based drugs.

The review of the Drugs and Magic Remedies (Objectional advertisement) Act, 1954 is also a welcome idea, given that much has changed since its inception six decades back. There is increasing evidence of violations of the fine line between information and advertisement, which directly impacts the end user/consumer/patient.

Other policy initiatives like the simplification and rationalisation of various applications and licenses as well as e-governance and digitisation will also get an enthusiastic thumbs up.

Publication of revised National List of Essential Medicines as NLEM, 2015. So will the finalisation of accreditation standards for clinical trials for ethics committees, investigator and clinical trials; the evolving of a Public Private Partnership model for engaging laboratories in private sector and the setting up of training institutes within the existing premises of the National Institute of Biologicals, Noida. This year is sure to bring many more surprises, not all of them good.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

Torrent Pharma in agreement with Reliance Life Sciences Reliance Life Sciences will manufacture these products at its facility in Navi Mumbai and supply to Torrent Pharma for a period of ten years AHMEDABAD-BASED Torrent Pharmaceuticals has entered into an exclusive licensing agreement with Reliance Life Sciences for marketing three biosimilars in India — Rituximab, Adalimumab and Cetuximab. As per the agreement, Reliance Life Sciences will develop and supply these products to Torrent Pharma after obtaining all necessary regulatory ap-

Consistent investments has ensured that our products are recognized worldwide for their quality and efficiency.

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PHARMACEUTICAL INDUSTRY provals. Torrent Pharma will be the only company to market these biosimilars in India other than Reliance Life Sciences. Reliance Life Sciences will manufacture these products at its facility in Navi Mumbai and supply to Torrent Pharma for a period of ten years.

Rituximab and Cetuximab cater to the oncology segment and are used in the treatment of various cancers like leukaemia, lymphoma, colorectal, head and neck cancers. Adalimumab is the most preferred therapy for the treatment of auto immune disorders like rheumatoid arthritis, psoriasis and IBD. Torrent Pharma has in the past launched the biosimilar Darbepoetin under the brand name of Darbatitor which is used during dialysis. Its acquisition of the domestic formulations business of Elder Pharma has already given it a strong foothold in the pain management segment.

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January 16-31, 2015

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MARKET PRE EVENT

ASSOCHAM to organise pharma summit Changing Dynamics the Road Ahead is the theme for the event, to be held in Delhi on February 18, 2015 Associated Chambers of Commerce and Industry of India (ASSOCHAM) is organising a pharma summit with the theme ‘Changing Dynamics the Road Ahead.’ It will be held on February 18, 2015, at Hotel Le Meridien, New Delhi, in association with Organization of Pharmaceutical Producers of India (OPPI), Indian Drug Manufacturers' Association (IDMA) and Confederation of Indian Pharmaceutical Industry (CIPI) and Indian Pharmaceu-

tical Association (IPA).

The objective of the summit is towards creating a platform for discussing the various issues and to streamline the regulatory framework and imparting more practicability in the Government policies.

The summit will be a common platform to converse about best practices that need to be implemented to provide a smooth environment for both, private and government officials. The event will encour-

age excellence and innovations in the industry. It would also seek to promote employment in the pharma industry.

Senior officials from the Union Ministry of Health and Family Welfare, Union Ministry of Chemical and Fertilizers will be at the event.

Senior officials and Directors from the Health Ministry of the various states, senior officials from the DCGI and the FDAs of the states, senior drug controller from the Centre and the states, senior officials from

the NPPA, CEOs, CMOs and regulatory affairs experts from the pharma industries, researchers and scientists from the pharma industries would also participate in the event. Heads of the Clinical Trials Division of the pharma industries, heads of the Government Affairs Division of the pharma industries, senior officials from the ICMR, CSIR and DBT and other stakeholders related to healthcare would also be present.

EP News Bureau-Mumbai

TO ADVERTISE IN EXPRESS PHARMA, CONTACT: 2nd Floor, Whites Road, Royapettah, Chennai- 600 014 Board Line: 044- 28543031/2/3 044- 42285522 Mobile: +91 9710022999 Fax: 044- 28543035 Email id: yuvaraj.murali@expressindia.com HEAD OFFICE MUMBAI Rajesh Bhatkal The Indian Express Ltd Business Publication Division 2nd Floor, Express Tower, Nariman Point, Mumbai- 400 021 Board line: 022- 67440000 Ext. 527 Mobile: +91 9821313017 Email Id: rajesh.bhatkal@expressindia.com

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CHENNAI Yuvaraj Murali The Indian Express Ltd Business Publication Division New No. 37/C (Old No. 16/C)

KOLKATTA Ajanta Sengupta The Indian Express Ltd Business Publication Division JL No. 29&30, NH-6, Mouza- Prasastha & Ankurhati,

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Vill & PO- Ankurhati P.S.- Domjur (Nr. Ankurhati Check Bus Stop) Dist. Howrah- 711 409 Mobile: +91 9831182580 Email id: ajanta.sengupta@expressindia.com KOCHI Yuvaraj Murali The Indian Express Ltd Ground Floor, Sankoorikal Building, Kaloor – Kadavanthra Road Kaloor, Kochi – 682 017 Mobile: +91 9710022999 Email id: yuvaraj.murali@expressindia.com COIMBATORE G.M. Khaja Ali The Indian Express Ltd No. 205-B, 2nd Floor, Vivekanand Road, Opp. Rajarathinam Hospital Ram Nagar Coimbatore- 641 009 Mobile: +91 9741100008 Email id: khaja.ali@expressindia.com

AHMEDABAD Rajesh Bhatkal The Indian Express Ltd 3rd Floor, Sambhav House, Near Judges Bunglows, Bodakdev, Ahmedabad - 380 015 Mobile: +91 9821313017 Email Id: rajesh.bhatkal@expressindia.com BHOPAL Ambuj Kumar The Indian Express Ltd F-102, Inner Court Apartment, 1st Floor, GTB Complex, Behind 45 Bungalows, Bhopal - 462 003 Mobile: +91 9999070900 Email id: ambuj.kumar@expressindia.com JAIPUR Ambuj Kumar The Indian Express Ltd S2, J-40, Shyam GHP Enclave, Krishna Marg, C-Scheme, Jaipur - 302 001 Mobile: +91 9999070900 Email id: ambuj.kumar@expressindia.com

IMPORTANT Whilst care is taken prior to acceptance of advertising copy, it is not possible to verify its contents. The Indian Express Limited. cannot be held responsible for such contents, nor for any loss or damages incurred as a result of transactions with companies, associations or individuals advertising in its newspapers or publications. We therefore recommend that readers make necessary inquiries before sending any monies or entering into any agreements with advertisers or otherwise acting on an advertisement in any manner whatsoever.

EVENT BRIEF FEBRUARY 2015 — MAY 2015 13

ASSOCHAM Pharma Summit

ASSOCHAM PHARMA SUMMIT Date:February 18, 2015 Venue: Hotel Le Meridien, New Delhi Summary: Associated Chambers of Commerce and Industry of India is organising the Pharma Summit with the theme ‘Changing Dynamics the Road Ahead,’ in association with Organization of Pharmaceutical Producers of India, Indian Drug Manufacturers’ Association and Confederation of Indian Pharmaceutical Industry and Indian Pharmaceutical Association.

The objective of this summit is towards creating a platform for discussing the various issues to streamline the regulatory framework and imparting more

practicability in the Government policies.

Ananth Kumar, Union Minister of Chemical and Fertilizer, Government of India has been invited as the 'Chief Guest' for the above summit and Dr VK Subburaj, Secretary, Department of Pharmaceuticals will be the 'Guest of Honour.'

Contact details: Bharat Kumar Jaiswal Assistant Director, The Associate Chambers of Commerce and Industry of India 5, Sardar Patel Marg, Chanakyapuri New Delhi – 110021 Tel: 46550514 (D), 46550555 (Hunting line) Fax: 46550550 Mobile: 9971047550 Email: bharat.jaiswal@ assocham.com

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PHARMA Pro & Pack Expo 2015

PHARMA PRO & PACK EXPO 2015 Date: May 13-15, 2015 Venue: Bombay Exhibition Centre, Mumbai Summary: PHARMA Pro & Pack Expo 2015 will be organised by IPMMA. 20,000 pharma trade professional/ decision makers and 250 industry majors will exhibit their technologies/ services.

Visitors’ profile include biotechnology specialists, plant management, CEOs, engineers, technocrats and scientists, policy makers, diplomats and foreign commercial corp, compliance, process engineering, corporate management, procurement department, custom manufacturing/ marketing

services, purchase officers, equipment suppliers and distributors, quality assurance/ quality control, maintenance engineering, R&D professionals.

Contact details: Indian Pharma Machinery Manufacturers’ Association 52, 1st floor, Suyog Industrial Estate LBS Marg, Vikhroli (West) Mumbai – 400 083 Tel: +91 22 6561 9272/ 2578 6007/ 2685 5108

IPHEX 2015 Date: May 13-15, 2015 Venue: Bombay Exhibition Centre, Mumbai Summary: Pharmexcil with Ministry of Commerce and Industry, Department of Commerce, Government of

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iPHEX 2015

India will organise iPHEX 2015. Over 400 overseas buyers from focus areas are being invited to participate in the exhibition.

Co-located with PHARMA Pro&Pack Expo 2015, a show for pharmaceutical machinery manufacturers, iPHEX 2015 will offer the industry majors from India and all across the world a great platform to connect and do business.

Contact details: Pharmaceuticals Export Promotion Council of India TV Industrial Estate, Unit No 211, 2nd Floor, 248-A, SK Ahire Marg, Worli, Mumbai – 400030 T: 91 22 24938750 F: 91 22 24938822

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cover )

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THE MAIN FOCUS

I think these courses are outdated. We need pharma courses that can infuse creativity in drug development, formulation science etc and lot of analytical sharpness for quality by design etc N Venkat,

Pharma companies starting their own pharma courses or training institutes to update the curriculum and improve pharma education in the country is increasingly finding favour among industry experts

Co-Founder and CEO, Vyome Biosciences

By Sachin Jagdale

Only changing the curriculum will not serve the purpose and there is a need for continuous training to the students Sudhir Deshpande, Legal Consultant, Pharmalex

To subscribe: bpd.subscription@expressindia.com

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cover )

O

f f- l a t e , sounds of dissent and dissatisfaction from the pharma industry have been heard over the kind of talent pool coming out of pharma colleges in India. With a few exceptions, pharma education system in the country has traditionally remained more theoretical than practical. Pharma companies do train new recruits, however, it is not just a time consuming process but also a financially eroding option. The growing discontent has led to a debate over pharma companies themselves venturing into the field of pharma education and take the baton in their own hands.

Time to take charge?

India is one of the largest pharma markets in the world.

Besides domestic pharma companies, many MNCs have also set up their operations in the country. These companies regularly introduce new operational methods/technologies at their manufacturing plants/laboratories. As a result, skilled workforce is a major requirement to handle these operations. However, according to industry experts, pharmacy colleges in India have not updated their curriculum with the changing times and have stuck to their outdated syllabus. This, in turn, have resulted in failure in terms of delivering employees who are capable of handling tasks from the day-one.

Hence, the pharma industry is mulling over starting their educational institutes which would train the students to cope with the growing demands and offer them handson experience into their fields.

N Venkat, Co-Founder and CEO, Vyome Biosciences, says, “I think these (currently

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existing) courses are outdated. We need pharma courses that can infuse creativity in drug development, formulation science etc and a lot of analytical sharpness for quality by design etc.”

Sudhir Deshpande, Legal Consultant, Pharmalex, joins the discussion, and supports the pharma industry’s claim.

“There is no doubt that the existing curriculum needs to be changed and industry-specific topics need to be included in the curriculum. However, only changing the curriculum will not serve the purpose and there is a need for continuous training to the students. The training institute, either from a pharma company or supported by pharma companies, will be definitely an answer to the problem,” opines Deshpande.

According to Dr Girish Walavalkar, CEO, Fermenta Biotech, there are educational institutes like the Institute of Chemical Technology (ICT) which have developed courses keeping the needs of pharma industry in mind.

However, he emphasises, “Every pharma company has its own specific requirements. So you can't prepare a course which will be useful to the industry in general. The main intention of the graduation course is to make the student acquainted with the overall industry. At the PhD level, you can have specific industry-oriented projects.”

There are industry experts who have spent a few decades working at senior positions in

Every pharma company has its own specific requirements. So you cant prepare the course which will be useful to the industry in general Dr Girish Walavalkar, CEO, Fermenta Biotech

As per my experience it is very difficult to have all types of trainers and subject matter expertise in each college or a single pharma company Rajashri Ojha, Founder and MD, Raaj GPRAC

reputed pharma companies and now are visiting lecturers to pharma colleges in India and abroad.

These experts can actually serve as great connecting links between the educational institutes and the industry. “Definitely industry-specific courses and educational training in India would help freshers to gain practical knowledge and skills required during the job,” asserts Rajashri Ojha, Founder and MD, Raaj GPRAC. Ojha has worked with many domestic and international pharma companies in India and abroad before starting training institutes for pharma students.

Revamping pharma education: A tough job?

The idea of starting pharma courses or training institutes looks promising but it might be easier said than done.

Walavalkar gives his own justification. “Starting their own course by the pharma industry is not practical. Pharma institutes are themselves a big business. We have very specific requirements and I don't think it is practical to start an institute. We may recruit student and train them,” opines Walavalkar. However, contrary to Walavalkar's opinion, N Venkat asserts that there are no hurdles if pharma firms want to start pharma courses or training institutes. “There should be willingness,” says N Venkat. According to him, the common problems that any company would face while recruit-

ing are quality and depth of students. They would need at least two years of mentoring before they can start thinking as required.

Deshpande echoes Walavalkar's views and says that training institutes by pharma companies may not be a viable option. However, he suggests, perhaps establishing an All India Training Academy supported by the pharma industry associations like Organisation of Pharmaceutical Producers of India (OPPI), Indian Pharmaceutical Alliance and Indian Drugs Manufacturers’ Association can serve the purpose.

“As per my experience it is very difficult to have all types of trainers and subject matter expertise in each college or a single pharma company. They will have to send their employees or students to other training institutes wherein they get maximum benefits and people get trained on specific subjects. Now is the time to start the ball rolling by setting up a totally harmonised system for pharmacy colleges to develop a syllabus that includes current industry needs such as inclusion of regulatory studies, quality compliance, validations, clinical and other aspects,” says Ojha.

Make it mandatory?

Industry experts strongly feel that representatives from the pharma companies should be included in the committee that is being formed to develop the curriculum. This will keep pharma institutes informed about the latest developments and the requirements of the industry, and help to modify or change pharma curriculum.

N Venkat says, “It will be of great help. And a major component should be the

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THE MAIN FOCUS

Industry experts strongly feel that representatives from the pharma companies should be included in the committee that is being formed to develop the curriculum.This will keep pharma institutes informed about the latest developments and the requirements of the industry, and help to modify or change pharma curriculum

visiting faculty concept with real problems being discussed and infusing creative thinking.”

“If industry representatives are included in the syllabus committee, it will certainly add value and will ensure that the syllabus is relevant to the pharma industry,” opines Deshpande.

But at the same time he also points out that mandatory inclusion of industry representatives in the curriculum developing body is a desirable option but not a necessity. He explains, “Even without making it mandatory, the syllabus committee can certainly co-opt for a industry representative in the committee.”

While supporting Deshpande's views, Walavalkar also points out that an industry representative's presence in the pharma curriculum developing committee is definitely going to be of great help.

Ojha describes the criteria for the selection of an industry representative. She suggests that a person with both academic and industrial experience will be the right fit for the job.

“Industrial expertise with more than 20 years of experience in a specific area is a must to have in a committee or board. The curriculum should be designed by senior people who have practical knowledge about the industry and academic problems. While designing the curriculum one should seek advice from industrial experts for subjects like pharmaceutics, drugs and cosmetics, biochemistry, pharma technology, food, medical devises, OTC, biosimilars, veterinary etc.”

Pharma institutes generally are comfortable with including industry

persons in their curriculum developing committee. However, they hold some apprehensions when it comes to demands of becoming more practical than staying theoretical.

A senior pharma educationist, on the condition of anonymity, accepts that pharma curriculum in India is indeed outdated and needs immediate revamp. However, at the same time, he also emphasises that they are educationists and quality teaching is their prime responsibility. Industry-friendly training to students is possible only to a certain extent at educational setups. Pharma students will always get better training on the job, once they join any company. “We are best at keeping the student acquainted with the overall industry,” he states.

Conclusion Pharma industry’s argument is based on a valid reason. However, pharma institutes have their own limitations as well. As most of these colleges are largely dependent on government funds, building the requisite infrastructure to make pharma courses more practical or industry friendly seems difficult. So, as suggested by Deshpande, pharma organisations can come together and start their own courses which will suit the industry needs. Or else, pharma companies can help pharma colleges to upgrade or set up training facilities for the students.

At the end of the day, what should matter the most is ensuring the best long-term interests of the students as well as the industry. sachin.jagdale@expressindia.com

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cover ) DR BHAGWAN DASS MIGLANI

A hospital pharmacist’s progress On the occasion of this year’s 66th Indian Pharmaceutical Congress, Dr Bhagwan Dass Miglani, Founder Secretary of the Indian Hospital Pharmacists’ Association recalls his evolution as a hospital pharmacist and the many changes in the profession today. Miglani recounts how the IPCs he attended and contributed to over the past decades allowed him to interact with outstanding personalities who helped him expand his horizons and become a leader in his own right

A

pioneer in hospital pharmacy, 85-year-old Dr Bhagwan Dass Miglani, a much sought after pharmaceutical consultant and educationist, has witnessed many reforms in pharma industry in India. Born in September1929 in Sahani village, Bhakkar tehsil, in erstwhile Pakistan, Miglani and his family migrated to India saw upheaval during partition. His family moved from his birthplace “due to ethnic trouble in

20 EXPRESS PHARMA January 16-31, 2015

the province of Sindh, and settled in towns along the banks of the Sindh river in Punjab. The family later moved to Rawalpindi, near Pakistan’s capital city of Islamabad in the province of Punjab.”

Recalling his choice of settling down in India, Miglani confirms, “My decision to migrate to India from Pakistan on partition made me what I am today.

Had I not migrated, I cannot even guess what I would have

been. The partition, if it can be taken as incident, thus, has had a striking impact on my life.” Post migration to India, like many families, his family also modified the spelling of their surname from ‘Minglani’ to the current ‘Miglani.’

First steps into pharmacy Parents are most often the best judge of their child's ability best and this was true of Miglani.

His father had toured Lahore

quite often and got to know of the pharmacy degree course run by Punjab University and decided that this would be a good career for his son. Miglani admits that he used to be fascinated about the profession of retail chemists right from his childhood, and thus gladly accepted his father's decision to take up pharmacy as his career.

Thanks to the economic security provided by his father, he could devote his time to

his career.

Besides his father, he also credits the influence of his mother and wife on his personality saying, “My mother, who was a pious religious lady, had a great influence on me and inculcated ethics as well as made me religious since she used to take me along to the gurdwara near their residence in Rawalpindi.

My wife Usha contributed in a great way in my career since she gave me all the time, which

( Having observed and followed closely so many leaders, Miglani was now ready to be one himself.

And the opportunity came when he laid the foundation of the Indian Hospital Pharmacists’ Association in 1963 at that year’s IPC largely belonged to her, for professional activities.”

Age no bar for role models Though it is conventional to choose role models who are far advanced in their careers, it is a fact that good examples of leaders can come in all shapes and sizes and indeed ages. In Miglani's case, it was a fellow student. As a student of the B.Pharm course in the Department of Pharmaceutics, Punjab University, located at Glancy Medical College and Khalsa College, Amritsar in 1948, he was so impressed with classmate Harkishan Singh, that he choose him as his role model. Singh was academically sound, religious, hard working, a disciplinarian, sincere, man of action, devoted and dedicated to his professional pursuits. Singh went on to become a prominent medicinal chemist and a science

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21

January 16-31, 2015

historian and worked in premier institutions in India and abroad.

Presently, he is Professor Emeritus at the Punjab University.

The two classmates have re-

mained friends since 1948, have worked together on many professional issues. Their differences on certain occasions never effected their friendship,

THE MAIN FOCUS

reveals Miglani.

From seeking out motivators at IPC …

There have been many thought

provoking leaders who encouraged and motivated Miglani to aim high. He freely acknowledges their contribution in his life and goes on to list their

cover ) names, “Prof KN Gaind, not only motivated me to continue post-graduate studies but made it possible for me to continue the same while in service under his guidance in the Department of Pharmacy, Punjab University, Chandigarh. I had been attending Indian Pharmaceutical Congress (IPC) sessions almost regularly after completion of my studies and came in contact with prominent personalities and pillars of the profession of pharmacy, like Prof ML Schroff (known as the 'Father of Pharmacy'), Prof GP Srivastava ( from Benaras Hindu University), Dr S Rohatagi (President, Pharmacy Council of India), Prof PC Dandiya (Professor Emeritus), Prof SN Sharma (Professor Emeritus) and others, like RB Patel (Drug Controller, Maharashtra and Gujarat), Dr Parminder Singh (founder of Ranbaxy Laboratories ), Dr Nitya Anand (Director, Central Drug Research Institute, Lucknow), had been motivational forces for me since they had been promoting the cause of the pharmacy profession.”

… to becoming a motivator Having observed and followed closely so many leaders, Miglani was now ready to be one himself. And the opportunity came when he laid the foundation of the Indian Hospital Pharmacists’ Association (IHPA) in 1963 at that year's IPC. Relating the sequence of events, Miglani recalls, “My mission has been to promote the profession of hospital pharmacy and for this hospital pharmacists, like, SH Merchant, NS Gayatonde, VK Oesterling, and others had not only been my motivational force but we also worked together to uplift the profession of hospital pharmacy.

I joined Irwin Hospital in 1951, as a hospital pharmacist and since then I wanted to organise an association of hospital pharmacists and to bring out a publication to be entitled, Indian

22 EXPRESS PHARMA January 16-31, 2015

AWARDS & RECOGNITIONS AWARDS

RECOGNITIONS

2014: Shri Bhojraj Panjamool Life Time Achievement Award, Association of Pharmaceutical Teachers of India (APTI) for Education and Research 2009: Lifetime Achievement Award, Indian Hospital Pharmacist’s Association (IGPA) in recognition of his contribution to the profession of pharmacy and development of hospital pharmacy 2007: Professor GP Srivastava Memorial Award, APTI, in recognition of excellence in pharma education 2002: Drug Inspectors Welfare Association (DIWA) Award, in recognition of his services to pharmacy profession especially in the area of hospital pharmacy 1985: Professor ML Schroff Memorial National Award, IGPA, in recognition of hi contribution to hospital pharma services, pharmacy education and journalism 1980: Acharya, Sir PC Ray Memorial Gold Medal, Indian Pharmaceutical Association (IPA) , in recognition of his hard and painstaking work for the profession of pharmacy in general, especially in the areas of hospitals and health clinics

◗ Convener, ER-2001 for Bachelor of Pharmacy (PCI), 1999 ◗ Member, Delhi State Essential Drugs Formulary Committee, 1996-97. ◗ Member, Sub-Committee of the Pharmacopoeia of India, Govt. of India, Ministry of Health (1982-83 and 1993-94); ◗ Member, Pharmacy Council of India, Ministry of Health and Family Welfare, Government of India, 1986. ◗ President, Delhi Pharmacy Council, 1983 ◗ Member National Formulary of India, Govt. of India, Ministry of Health (1979); ◗ Fellow, Indian College of Allergy & Applied Immunology, 1968 ◗ Founder Secretary, Indian College of Allegry & Immunology, 1967 ◗ Founder Editor - Indian Journal of Hospital Pharmacy, 1964-2007; Chief Editor, Graduatus Pharmaceutica, 1978-82; Member, Editorial Boards of The Pharma Times and Indian Hospital Administration, Indian Journal of Pharmacy Practice & Indian Journal of Pharmaceutical Education & Research.

Journal of Hospital Pharmacy, in the country. Margaret Benfield, Hospital Pharmacist, Holdsworth Memorial Hospital, Mysore, wrote to Dr Chakraborty, Secretary, IPC expressing the desirability of organising hospital pharmacists in India to improve the deplorable condition of hospital pharmacies.”

“That letter, referred to me, inspired me that when foreigners feel so concerned about our plight then why we ourselves are not sensitive to such issues.

Thus, I took the initiative to organise the IHPA in 1963 at the IPC Session at Pilani and instituted the publication of the Indian Journal of Hospital Pharmacy in 1964,” reveals Miglani.

Evolution of the pharma sector in India Comparing today's pharma industry to the situation when he

entered the profession, Miglani sees a sea change, mostly for the good. He recalls, “The pharma industry was almost non-existent when our country attained freedom. Today, we have more than 10000 pharma units. We have sufficient production of pharma formulations to meet the country's demand . We also manufacture a large number of bulk drugs. We have also been exporting drugs to many countries. Globally, we stand third in volume of production of drugs and 14th in value. Growth of industry as on average has been 14 per cent approximately. Further, India is becoming the favoured destination for pharma research and development of drug companies.”

But future progress is not without challenges. As he cautions, the major challenge to the pharma industry (in India) is to maintain quality of drugs as per

international standards. The challenge is to maintain excellent standard in pharma education. The regulatory authority, though it has evolved to a good extent, has to get rid of the menace of spurious and fake drugs available in the market. This challenge has to be met to ensure availability of standard drugs for effective medication to the ailing community. He feels, “The standard of pharma education has deteriorated and it needs lot of efforts to ensure that proper facilities in terms of equipment, space, teaching staff are maintained. The accreditation system has to be improved to upgrade the standards of pharma education in the country.”

Major changes still needed Listing the three major changes he would like to see, Miglani

points out that firstly, the world over, 'pharmacy' stands for pharmacy practice which implies practice in community and institutional (hospital) settings.

He would like to see that pharmacy is recognised as practice of pharmacy rather than as a part of the pharma industry.

Secondly, he advocates that there is a dire need to establish full-fledged departments of pharmacy in all major hospitals headed by a pharmacist possessing Pharm.D/Master in Pharmacy Practice as recommended in the Hathi Committee Report (1975) and National Human Rights Commission Report (1999). He feels that the importance of setting up such a department is justified since a major portion of a hospital's budget is spent on medicine, which he believes to be as much as 60-70 per cent. He also points out that as much as 80 per cent of patients attending hospitals require the services of a hospital pharmacy. At present, there is no such department and wherever they do exist, they are headless and is being managed multiple medical officer as additional duty.

And thirdly, he points out that at present there is dual control of pharmacy education under PCI and All India Council of Technical Education.

Miglani would like pharma education to be put under the charge of PCI with more power to ensure proper standard of education in teaching institutions.

While signing off Miglani sums up with some sage advice for young entrants to the pharma fraternity saying, “Present day pharmacy professionals have to be committed, dedicated and should work with a missionary spirit. The pharmacist’s sole objective should be to provide quality services for the welfare of the patient community by taking the challenging job of providing drugs of quality at reasonable cost and providing counselling to patients. We should get rid of the menace of greed and corruption.”

(

THE MAIN FOCUS

I N T E R V I E W

‘66th IPC will address issues in depth and try to evolve strategies’ Ravi Udaybhaskar, Chairman Organising Committee and Secretary General, All India Drugs Control Officers Confederation shares the glitches and opportunities behind organising the 66th IPC with Usha Sharma Why did the Local Organising Committee of IPC decided to organise the 66th IPC in January 2015 instead of December 2014?

The decision to organise 66th IPC in 2015 instead of 2014 is not taken by the Local Organising Committee and is taken by the Council of the Indian Pharmaceutical Congress Association. The decision is based on the feedback received from pharmaceutical industry, pharmacy teachers, potential speakers from abroad and regulators. Some of the difficulties expressed were semester examination in pharmacy colleges, winter session of the Parliament, CPhI India event in Mumbai and non-availability of foreign speakers due to Christmas holiday.

The 66th edition of IPC will have the theme ‘IndiaPharmacy of the World – Role

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January 16-31, 2015

cover ) of Indian Regulators and Pharma industry.’ Reveal more on the same.

The president of IPC selects the theme for the congress. The theme is selected after taking into consideration factors such as host association which represents drug regulatory officers in the country and the current industry scenario.

Thanks to various government initiatives, robust regulatory mechanisms, focus on quality and innovation, India is poised to become pharmacy of the world. The Indian pharma market is expected to reach $25-30 billion by 2016 and Indian pharma industry has been able to penetrate the regulated markets such as the US and Europe. In this context, the theme of the 66th IPC is appropriate and in line to showcase India’s capabilities.

Many Indian pharma firms received warning letters and import alerts etc in 2014. Will the 66th edition look into these issues?

Yes, the 66th IPC will certainly address these issues in depth, have deliberations amongst stakeholders and try to evolve strategy to overcome these challenges. We have designed the programme in such a manner that these issues are addressed and the stakeholders are sensitised on relevant issues e.g. there will be an independent session on importance on documentation, data integrity etc. Focused discussions are also proposed to be held during President’s symposium, CEO’s conclave and the regulators meet organised in association with Pharmexcil. For this purpose, we have invited international regulators and we expect representation from 20 countries.

We have also invited Drugs Controller General (India), most of the state drugs controller and some senior officers in the state and Central Drugs Standard Control Organization. We have also invited CEOs of 60 to 70 pharma companies. We are

24 EXPRESS PHARMA January 16-31, 2015

sure the deliberations in such interactive meetings and sessions will yield fruitful results and will also help the regulators and the pharma industry to establish synergy enabling them to address the issues.

Globally, the image of the Indian pharma industry has been tarnished. What steps should be taken to re-build trust in the global market?

In our view, it is not correct to draw such generalised inference. It is true that there have been certain instances wherein few companies have been questioned on certain issues. However, these should be viewed as specific cases which have been dealt with by the concerned manufacturers by addressing issues raised.

Ever increasing export of medicines from India to both regulated and semi regulated market is a testimony to the fact that the international community has confidence in the quality of medicines manufactured in India. Certain specific issues like documentation, data integrity etc. need more focused attention and therefore an attempt will be made to sensitise the stakeholders on these issues and raise bar on quality management exercise.

A strong apprehension prevails in India about an other angle to these controversies and a strong feeling about deliberate attempts by certain interested parties outside India to tarnish the image of the Indian pharma industry. It should be noted that the competitive edge of the Indian pharma industry is to provide quality generic medicines at cheaper prices as compared to the foreign competitors, perceived as a big challenge by the foreign competitors. Due to this competitive edge, Indian pharma companies will play a crucial role by capturing significant global market share of generic medicines.

Controversies may be perhaps to create obstacles in pharma industry’s capacity to claim

The competitive edge of the Indian pharma industry is to provide quality generic medicines at cheaper prices as compared to the foreign competitors substantial market share of generic medicines in 2015 when many blockbuster drugs will be off patented. While specific incidences will have to be addressed specifically, we have to certainly project the positive features of the Indian pharma industry and capabilities of Indian regulators to ensure availability of safe, standard and efficacious medicines at affordable prices to needy patients in every country. We also have to showcase the capabilities of the Indian pharma industry and Indian regulators so that message is conveyed that both are at par with international standards.

What efforts need to be taken for uniforming the regulations in all states?

At the outset, it should be noted that regulations are

common for all states, lack of uniformity is in implementation due to differences in interpretation, lack of sufficient trained manpower etc. In fact, there is an inbuilt regulatory mechanism under the Drugs and Cosmetics Act, 1940 by way of two statutory bodies namely Drugs Consultative Committee and Drugs Technical Advisory Board. We will try and strengthen this mechanism. We will also explore the feasibility of having guidance manual for the regulatory officers in India both in central and state drugs control organisation. Ongoing continuous training programmes is another area where we need to give more attention. Systematic efforts in this direction and complete adherence to the directives issued on the basis of deliberations in drugs consultative committee and compliance of guidance manual will play an important role in ensuring uniformity in implementation.

Which topics will be discussed at the event?

The focus of the scientific programme will be on two components namely quality management mechanism and ensuring compliance through effective regulations and implementation. We have designed scientific contents in such a manner that it is specific to the theme and is relevant to the industry and regulators.

Experts from the pharma industry and regulatory agencies are invited to share their expertise on these issues with the delegates.

We have also invited social scientists to sensitise the pharma industry, regulators and the budding pharmacists about expectations of the consumers. There will be presentations from the stalwarts of pharma industry about expectations of the industry from academia.

Why do you think students and pharma companies should take part in the event?

This is a misconception.

The Indian Pharmaceutical Congress Association (IPCA) is organising IPC and IPCA is a federation of associations of pharmacy professionals from various facets of pharmacy profession such as industry, regulatory, hospital pharmacy, community pharmacy.

Therefore, the event is for all the pharmacists and not restricted to industry or any specific segment. For students, this is an opportunity to know about advances in technology, understand aspects of entrepreneurship and interact with the senior professionals of pharmacy professions.

Scientific paper presentations and poster presentations will give them an opportunity to showcase their abilities before seniors. Participation by the students in IPC is certainly value addition for them.

According to you which curriculum urgently requires upgradation and why?

There is a strong feeling that curriculum has been not kept pace with the current scenario, advances in technology and the requirement of pharma industry and other sectors.

Priority should be to change curriculum to give practical orientation. The methodology to make changes in the curriculum is also not dynamic.

In my view, the process should become more dynamic and should be such that inputs from industry, regulators and other sectors are considered while modifying the curriculum. The industry, academics, regulators and other stakeholders should sit together and modify curriculum to suit the requirements of the industry and other sectors such as research and development, clinical trials etc. It should also be such that students passing out of the colleges meet the expectations of the prospective employer thereby enhancing employment opportunities.

How is IPC 2015 different from previous years?

( I am sure 66th IPC will be different from any other congresses. This is the first time an international regulators’ meet will be organised in association with Pharmexcil. This is the first time that all state drug controllers and most of the senior officers of CDSCO are invited to participate in the international regulators’ meet.

Thus, we are providing a common platform for industry, Indian regulators, international regulators to interact with each other in order to understand and deliberate the relevant issues.

I am sure we will be successful in bringing back the industry to the pharma. We have already set a record of having the highest number of delegates registered from industry.

As a host, what are the problems you face?

IPC has become a mega event and organising of the congress is a herculean task. It demands a lot of financial resources, talented and dedicated human resources.

Fortunately, talented and dedicated manpower is available within the pharma fraternity. However, the cost of organising the Congress is increasing each year due to an increase in the cost of all inputs.

Raising of funds is becoming difficult day by day. The money spent on each delegate is almost double the registration fee. However, there are constraints in increasing the registration fee. We also need to consider student delegates and therefore this year we have reduced the registration fee for the students by 20 per cent. We have also invited international and Indian regulators for the interactive meetings. All this adds to the cost and become an additional burden for the organising committee. We will have to deliberate on these issues in IPCA and take a serious look at the current format and device methodology whereby IPC becomes self

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January 16-31, 2015

sufficient and more meaningful.

What message would you like to convey to the industry?

The Indian pharma industry and Indian regulators need to

ensure that robust quality management system is in place and there is a strict compliance of good manufacturing practices, zero tolerance to any deviation to ensure availability

THE MAIN FOCUS

of standard, safe and efficacious medicines at affordable prices to the needy patients. We also need to focus our efforts on promoting rational use of medicines.

Finally, we need to remember that we the pharmacists exist for safeguarding interest of the consumers and society. u.sharma@expressindia.com

MANAGEMENT REPORT

The good,the bad and the ugly in Indian pharma Chirag Talati, Analyst, Kotak Institutional Equities (KIE), gives an insight on the recent global currency movements and the risks they pose to Indian pharma. Excerpts from the report RECENT GLOBAL and currency movements have exposed the risks to Indian pharma’s ex-US growth profile and with a $2.2 billion revenue exposure to cross currencies, sharp movements as seen for rouble will hurt growth and margins. While Russia/CIS and Venezuela are set to have a material impact on a few companies, notably Dr Reddy’s Laboratories Ltd (DRRD), the Indian Rupee (INR) depreciation versus the United States dollar (USD) should help absorb some of this impact partially. Net impact is a -5 to +2 per cent change in EPS estimates with DRRD being the most impacted.

The good — rupee depreciation versus dollar to benefit the sector According to KIE economists, INR should see steady depreciation, albeit to a much lesser degree than other emerging markets. KIE economists forecast the USD/INR to average ~63 in FY2016 compared to 61 in FY2015 and 65 over the longer term. Ceteris paribus, increasing exposure to the US will provide a strong cushion to Indian pharma ($9 billion+ revenue exposure for the sector), with our analysis suggesting the highest sensitivity for Sun Pharmaceutical Industries Ltd (SUNP), which should see margin benefit of 50 bps and EPS upgrade of 160 bps for every one per cent rupee depreciation. This is followed by LPC (30 bps margin/120 bps EPS), DRRD (18 bps margin/90 bps EPS) and Cipla (5 bps margin/23 bps EPS).

The bad — negative impact from cross-currency moves for Japan, Brazil, SA The euro (EUR), South African rand (ZAR), Brazil real (BRL), Japanese yen

26 EXPRESS PHARMA January 16-31, 2015

EXPOSURE OF INDIAN PHARMA COMPANIES TO VARIOUS CURRENCIES INR

USD

EUR

ZAR

JPY

RUB

Others

Cipla

680

640

100

200

NM

NM

NM

Dr Reddy’s

325

1150

260

30

NM

270

150

Lupin

475

950

50

65

210

NM

100

Sun Pharma

632

1850

120

NM

NM

NM

75

Sun Pharma + Ranbaxy

1097

2645

265

50

NM

190

195%

Cipla

42.0

39.5

6.2

12.3

NM

NM

NM

Dr Reddy’s

14.9

52.6

11.9

1.4

NM

12.4

6.9

Lupin

25.7

51.4

2.7

3.51

1.4

NM

5.4

Sun Pharma

23.6

69.1

4.5

NM

NM

NM

2.8

Sun Pharma + Ranbaxy

24.7

59.5

6.0

1.1

NM

4.3

4.4

Sales (US$ mn)

% of sales

Source: Company, Kotak Institutional Equities estimates

(JPY) and Australian dollar (AUD) depreciated by five per cent, four per cent, 11 per cent, 10 per cent and seven per cent against the dollar compared to the September 2014 quarter with the cross-currency impact highest for ZAR, BRL and JPY. Indian pharma’s combined exposure to these currencies stands in excess of $1.5 billion in revenues with Cipla having the highest exposure (18.5 per cent of revenues), followed by DRRD (13 per cent), LPC (17.6 per cent) and SUNP (six per cent)

among our covered names. In case of further cross-currency moves, KIE expects DRRD to have a hit from euro depreciation (10 bps margin and 40 bps EPS for one per cent depreciation), while Cipla will see a negative hit from ZAR (13 bps margin and 58 bps EPS for one per cent depreciation) and LPC will be impacted by JPY (10 bps margin and 20 bps EPS for one per cent depreciation). SUNP is likely to have higher sensitivity to the euro though it could be negatively hit due to Ran-

baxy Laboratories Ltd’s (RBXY) exposure to euro and ZAR (11 per cent of RBXY and seven per cent of pro-forma).

The ugly – FYTD 40 per cent depreciation of ruble versus rupee to hurt DRRD The sector has a combined exposure in excess of $600 million to Russia/CIS, Venezuela, Bolivia and Nigeria. KIE believes this basket is also one of the most profitable given the pricing scenario in countries like Russia, low competitive

intensity in countries like Venezuela as well as lack of any major R&D spend for the region, which lifts the contribution margins. Since FY2012, Indian companies also benefitted from rupee depreciation versus Russian rouble (RUB) (+seven per cent and + five per cent for FY2013 and FY2014 respectively). Among our coverage universe, DRRD has the highest exposure with ~16 per cent of its revenues from Russia/CIS and Venezuela combined (-10 bps margin and -40 bps EPS for

one per cent depreciation). Despite having the cleanest country profile, SUNP will now start to see negative hits from RBXY, which has 13 per cent of its revenues and 20 per cent of its earnings before interest, taxes, depreciation, and amortisation (EBITDA) exposed to the basket.

DRRD to bear the highest impact, followed by LPC, Cipla and SUNP On a net basis, KIE estimates a positive impact for LPC and SUNP owing to the disproportionate reliance on the US market and raise KIE’s estimates by up to two per cent. KIE sees DRRD having a negative hit from the basket due to the sharp RUB depreciation and potential devaluation of Venezuelan bolivar and KIE cuts its own estimates by two to five per cent as the RUB exposure is partially offset by dollar. KIE also tweaks out target price for DRRD marginally to ` 3,175 (versus ` 3,130 earlier). KIE estimates for Cipla and Lupin change by +/-2 per cent while Biocon estimates are reduced by three to five per cent.

Five to 20 per cent of revenues in non-USD currencies for KIE’s coverage universe Indian pharma companies derive seven to 32 per cent of revenues from non-USD foreign currencies with SUNP having the lowest exposure and DRRD having the highest exposure at ~7.5 per cent and 32 per cent respectively. Among the major nonUSD foreign currencies, EUR, RUB, ZAR and JPY account for four to six per cent, three to five per cent, two to three per cent and two to three per cent respectively of total revenues for companies under coverage.

Headwinds from several cross currencies partially offset by USD tailwind For the past two years, Indian pharma companies benefitted materially from INR depreciation against USD, EUR and RUB. While the impact of USD/INR dynamic is understood by the market, even other currencies like ruble had been supporting growth. For example, for the past eight quarters, DRRD reported currency growth in Russia far outstripped the constant currencies growth. With USD strengthening against most currencies, the tailwind could potentially turn into a headwind for euro and rouble exposure, while yen, real and rand exposure will

For the past two years, Indian pharma companies benefitted materially from INR depreciation against USD, EUR and RUB continue to be a drag. KIE also notes that potential impact from devaluations in countries like Venezuela is not yet factored into estimates and could meaningfully hurt growth of companies like DRRD, which has been benefiting from stronger growth in the region for past two to four quarters.

Assessing margin and EPS sensitivity to various currencies

DI-CAFOS ® TRI-CAFOS ®

Accelerated disintegration time

Increased

KIE presents estimates of sensitivity of EBITDA margins and EPS estimates for one per cent depreciation of INR versus USD as well as one per cent appreciation of INR on crosscurrencies for other leading currencies. KIE believes DRRD has the worst currency exposure with impact from RUB, EUR and ZAR set to hit its profitability on a standalone basis, with its USD sensitivity too lower than peers due to large amount of outstanding hedges. While Cipla and Lupin are also likely to face headwinds due to ZAR and JPY/ZAR exposure respectively, given the low amount of cash flow hedges for both the companies (sub-$150 million versus USD), INR depreciation versus USD will help to absorb chunk of the negative impact. The impact on working capital is difficult to quantify though the possibility of write-offs in Russia/CIS and Venezuela cannot be ruled out for DRRD. Net impact is that KIE tweaks its estimates by -0.5 per cent to four per cent for the companies under our coverage with DRRD having the highest 5.3 per cent cut to FY2017 EPS. KIE also tweaks its target price marginally for DRRD upwards to ` 3,175 to account for roll-forward by three months on our DCF.

EXPRESS PHARMA

Superior excipients meeting your formulation challenges

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January 16-31, 2015

tensile strength

Improved tableting performance

Reduced tablet size

Protection of water-sensitive APIs

Enhanced powder flow

Chemische Fabrik Budenheim KG pharma@budenheim.com www.budenheim.com

Department of Pharmaceuticals Ministry of Chemicals and Fertilizers Government of India

Ministry of Health and Family Welfare Government of India

PHARMA SUMMIT

CHIEF GUEST

GUEST OF HONOR

Shri Ananth Kumar Hon’ble Minister Ministry of Chemical and Fertilizers Government of India

Dr. V. K. Subburaj Secretary Department of Pharmaceuticals Government of India

Changing Dynamics the Road Ahead 18th February, 2015 • Hotel Le-Meridien – New Delhi INTRODUCTION

T

he country's Pharmaceutical Industry accounts for about 2.4% of the global pharma industry by value and 10% by volume. Industry revenues are expected to expand at a CAGR of 12.1% during 2012-20 and reach USD 45 Billion. India's Generic drugs account for 20% of global exports in terms of volume, making the country the largest provider of generic medicines globally. The Generics market is expected to grow to USD 26.1 Billion by 2016 from USD 11.3 Billion in 2011. The th formulation industry-India is the largest exporter of formulation with 14% market share and ranks 12 in the world in terms of export value.

Market Trends and Opportunities: (According to DIPP) Between 2011 and 2016, patent drugs worth USD 255 Billion are estimated to go off patent leading to a huge surge in generic product and tremendous opportunities for companies. In 2011, India's OTC drug market stood at USD 3 billion and a rise to USD 6.6 Billion in forecast by 2016. With increasing penetration of chemist, especially in rural India, OTC drugs will be readily available.

Pharma companies have increased spending to trap rural markets and develop better infrastructure. The Market share of hospitals is expected to increase from 13.1% in 2009 to 26% in 2020.

The purported rise of lifestyle disease in India is expected to boost Industry sales figures. Over USD 200 Billion is to be spent on medical infrastructure in the next decade. Rising levels of Education are set to increase the acceptability of pharmaceuticals.

India's patient pool is expected to increase to over 20% in the next 10 years, mainly due to the rise in population. India is expected to rank amongst the top three pharmaceutical markets in terms of incremental growth by 2020. Cost of Production in India is significantly lower than that of the USA and almost half of that of Europe.

Weighted tax deduction of 200% under Section 35 (2AB) of the Income Tax Act for both capital and revenue expenditure incurred on scientific research and development. Expenditure on land and buildings are not eligible for deduction.

However, having such a huge market and investment capacity, Indian Pharmaceutical Industry is facing certain challenges of business viability and regulatory control over a couple of years and due to this the Growth of Industry may not reach up to the mark as anticipated.

Challenges currently being faced by the Industry

Objectives of the Summit

Clinical trials – amendment in compensation guidelines and approval process.

The objective of this summit is towards creating a platform for discussing the various issues and to streamline the Regulatory framework and imparting more practicability in the Government policies.

To converge all the senior officials from the Union Ministry, State Health Senior Officials, Health Policy makers, Pharmaceutical industry leaders, Clinical Experts, Researchers at a common platform to converse about the best practices which can be implemented to provide a smooth environment for both the private and government officials.

To encourage the excellence and innovations and to promote the employment in the pharmaceutical industry.

Drug Price control regulations by NPPA. The imbalance between control and decontrol basket will have far reaching implications on investment the in Pharma Sector.

Non Conducive environment for innovations and IPR because very low spending on Research and Development by Pharmaceutical Industries.

All of the above challenges are the main reasons for the unviable business environment and rising unemployment in the Indian pharmaceutical sector.

Participant Profile • Senior Officials from the Union Ministry of Health and Family Welfare • Senior Officials from the Union Ministry of Chemical and Fertilizers • Senior Officials and Directors from the Health Ministry of the various states • Senior officials from the DCGI. • Senior officials from the FDAs of the States.

• Senior Drug controller from the center and the States.

Participation Fee: Rs. 3,000/• Senior officials from the NPPA. • CEOs, CMOs and Regulatory affairs experts from the Pharmaceutical Industries.

• Researchers and Scientists from the Pharmaceutical Industries.

• Heads of the Clinical trials division of the Pharmaceutical Industries.

• Heads of the Government affairs division of the Pharmaceutical Industries.

• Senior officials from the ICMR, CSIR and DBT. • Other stakeholders related to Healthcare.

SUPPORTING PARTNERS

For further details, please contact: Bharat Kumar Jaiswal M: +91-9971047550 | E: bharat.jaiswal@assocham.com

The Associated Chambers of Commerce and Industry of India

Karanveer Singh

5, Sardar Patel Marg, Chanakyapuri, New Delhi-110 021 • Tel: 011-46550555 (Hunting Line) Fax: 011-23017008/9 • Email: assocham@nic.in • Website: www.assocham.org

M: +91-9560372937 | E: karanveer.singh@assocham.com

RESEARCH RESEARCH UPDATES

Hospira’s non-opioid painkiller gets FDAapproval US FOOD and Drug Administration has approved Hospira’s non-opioid injection that provides faster relief to patients suffering moderate to severe pain. The approval comes amid efforts to curb rising opioid-prescription drug abuse.

In the US alone, more than 16,500 deaths related to opioid-prescription drugs were reported in 2010. The drug, Dyloject, can be used alone, or in combination with non-opioid painkillers, the company said. Dyloject forms part of a

Dyloject forms part of a class of drugs called non-steroidal antiinflammatory drugs and can be used alone class of drugs called nonsteroidal anti-inflammatory drugs, which are commonly used as painkillers, but are also being studied for their anti-inflammatory effects.

The drug does not constitute a replacement for opioids, but can be administered within 15 seconds. Other injectable non-opioid painkillers depend upon dilution prior to administration, and typically require an infusion of 15 to 30 minutes for a full dose, Hospira said.

The FDA approved Hysingla ER, Purdue Pharma LP’s long-acting narcotic painkiller with abuse-resistant properties in November, in line with its efforts to combat escalating abuse.

Reuters

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January 16-31, 2015

AAS, ICP, ICPMS Sample Preparation for Pharmaceutical Industry

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RESEARCH

FDAapproves Novo Nordisk’s injection for obesity The drug has been approved for patients with a body mass index of 30 or above and at least one weight-related health condition such as diabetes THE US health regulator approved a formulation of Novo Nordisk’s diabetes drug, liraglutide, for treating patients of obesity, a disease that affects one in three Americans. The injectable drug, to be marketed as Saxenda, is the second obesity treatment to be approved this year after Orexigen Therapeutics' oral medication Contrave in September.

Saxenda enters a market that is yet to realise its potential due to limited ef-

the Obesity Society, said.

Saxenda's rivals include Vivus' Qsymia and Arena Pharmaceuticals' Belviq, which are taken orally. A study showed that half the patients given Saxenda lost at least five per cent body weight, the FDA said. Rival drugs show two to five per cent weight loss over and above diet and exercise.

Saxenda, which works by slowing the speed at which food leaves the stomach, has a better chance of being

fectiveness of existing drugs, reimbursement hurdles, bungled launches and the perception of obesity as a ‘lifestyle’ disease.

The drug has been approved for patients with a body mass index of 30 or above and at least one weight-related health condition such as diabetes, the US Food and Drug Administration said. A lower dose of liraglutide, marketed as Victoza, was approved for use in diabetes patients in 2010.

Novo believes Saxenda has a blockbuster potential, although doctors doubt it will be a game changer.

“None of the available drugs and none on the horizon are sufficiently powerful to eradicate obesity,” Lee Kaplan, chair of the clinical committee of

covered under Medicare and Medicaid than rival drugs due to Victoza’s established safety profile.

However, the drug is an injectable and that could hurt demand for it, physicians said. The FDA has pulled obesity drugs off the shelves in the past, after a series of lawsuits sought to link them with debilitating side effects. As a result, doctors are reluctant to prescribe drugs without an established record of their efficacy. Analysts expect the injection to be priced at about $40 per day compared with an average of $5-$6 for rival drugs. Doctors and analysts believe Saxenda could do well despite the hurdles.

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30 EXPRESS PHARMA January 16-31, 2015

Reuters

RESEARCH

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BioCryst’s Ebola drug shows promise in animal study The main goal of the study was to assess the effectiveness of two doses of BCX4430, against a placebo, on survival through 41 days in Ebola-infected monkeys BIOCRYST Pharmaceuticals said its experimental broad-spectrum antiviral drug showed promise against Ebola when tested in monkeys. The US National Institutes of Health is funding the development of the intramuscular formulation of the drug, BCX4430, which is also being tested in an early-stage trial in healthy volunteers. The main goal of the study was to assess the effectiveness of two doses of BCX4430, against a placebo, on survival through 41 days in Ebola-infected monkeys.

The monkeys were dosed with either 16 mg/kg or 25 mg/kg of BCX4430 or the placebo at the United States Army Medical Research Institute of Infectious Diseases. Ten out 12 monkeys treated with the drug survived, including all six given the higher dose. None of the animals given the placebo survived, the company

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said. A preliminary analysis also showed a reduction of the viral load in the blood of monkeys receiving the drug. A viral load is a measure of the severity of an active viral infection.

Reuters

FDA approves Cubists’drug for antibiotic-resistant bacteria

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Zerbaxa, treats infections caused by gramnegative bacteria, a type of antibioticresistant pathogens, often called superbugs CUBIST PHARMACEUTICAL’S drug to treat complicated urinary tract and intra-abdominal infections won US Approval, highlighting the regulator's interest in tackling the growing threat of the so-called superbugs.

The drug, Zerbaxa, treats infections caused by gram-negative bacteria, a type of antibiotic-resistant pathogens, often called superbugs.

Zerbaxa was a major driver behind Merck & Co’s offer to buy Cubist for $8.4 billion earlier this month.

The approval is significant for Cubist, whose main product, Cubicin, lost patent protection earlier than expected after a federal court invalidated four of its patents. Zerbaxa is the fourth new antibacterial drug approved by the FDA this year. The agency approved

Actavis Plc's Dalvance in May, Cubists' Sivextro in June and The Medicines Co's Orbactiv in August.

Cubist has earlier said it expects European approval for Zerbaxa during the second half of 2015.

Zerbaxa also faces competition from several other companies, including AstraZeneca and Actavis. The companies' rival drug is being reviewed by the FDA, which is expected to reach a decision in the first quarter of 2015. Tetraphase Pharmaceuticals Inc is also developing a drug for complicated intra-abdominal infections and complicated urinary tract infection, but with a lower dosage than that of Cubists'.

Reuters

EXPRESS PHARMA

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January 16-31, 2015

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PACKAGING SPECIAL

B

y April this year, manufacturers of pharmaceutical products in India will be banned from using polyethylene terephthalate (PET) as a primary packaging material for liquid oral drugs for products meant for paedriatic, geriatric, pregnant women, and women in the reproductive age group.

This is when the six months grace period given by the Ministry of Health and Family Welfare (MHFW), Government of India (GoI), expires and the industry has to fall in line with the Ministry's notification of October 19 last year, which followed a draft notification (GSR 701(e)) issued on September 29.

Considering that this notification could possibly be a prelude to the complete phasing out of PET as primary packaging in the pharma industry, it is understandable that associations of pharma companies are hoping that the Ministry will see their point of view. PET bottle manufacturers are also obviously hoping for a rethink on this decision.

Is this ban justified considering that materials like milk, water etc still use PET packaging?

To this, Arun Kumar Dukkipati, President, HSIL, the packaging products division of AGI Glaspac points out that packaging medicines in PET has a different connotation from milk packets etc., as medicines are intended to cure diseases and ailments. He sees the

32 EXPRESS PHARMA January 16-31, 2015

PETVS GLASS: Who will blink first?

The Health Ministry has predictably stirred a hornet's nest with its diktat to replace PET with glass packaging for certain formulations. While it is still three months to the cut off date and a lot could happen before then, a review of the issues at stake tries to separate the truth from the hype

By Viveka Roychowdhury Government’s decision as highly pro-active and laudable.

His company counts GSK, Pfizer, Ranbaxy, Dr Reddy’s Laboratories, Abbott, Aurobindo Pharma and Reckitt Benckiser as customers and also serves the food, chemical, spirits, and soft drink sectors.

The case against PET The move against PET has been gaining momemtum from 2013, when 5-6 NGOs filed PILs alleging that PET, when used as primary packaging material for liquid orals, suspensions and dry syrups, had severe adverse effects on human health due to the leaching of endocrine disruptors.

The September 29 notification, issued on the recommendations of the Drugs Technical Advisory Board (DTAB) after a meeting on November 25, 2013, triggered reactions across the spectrum of industry stakehold-

ers ranging from doctors and NGOs hailing the move and representatives of the pharma industry arguing the case for PET. The NGO which claims to have first raised the issue, HIM Jagriti, Uttaranchal Welfare Society, Dehradun felt vidicated by the October 19 notification. In its representation in 2013 before the Ministry and other officials, the NGO had requested a ban on PET bottles as primary packaging material in pharma liquid orals, suspensions and dry syrups as it claimed that leaching of various chemicals used in the PET/plastic bottles occurred under varying storage temperatures and also when the packaging becomes old, which can, in turn, lead to several diseases including cancer and physical infirmities.

Emboldened by the Ministry's decision, they launched a movement in December last year called ‘Act India’ aiming to

enable people demand responsible and safe packaging, and to promote the five ‘Rs’: reduce, reuse, recycle, rethink, restrain.

To raise further awareness about the issue and mobilise public opinion, they held a press conference in early December last year, to announce the launch of the Act India movement, where doctors and clinicians spoke about the harmful effects PET use.

Dr Hemant P Thacker, a physician and cardiometabolic specialist and consultant cardiologist at Fortis Hospital, who was one of the clinicians present at the event highlighted the possible long term health impact of such exposure saying, “Besides the fact that such bottles carry the hazard of toxic exposure, the passage of bisphenol A (BPA) and additives like di-ethylhexyl phthalate (DEHP) which gets leeched onto its contents, can lead to significant long term

medical consequences. Women (in the reproductive age group) and children consuming this potion out of such bottles could have impaired immune development, loss of pregnancy, preterm birth, low birth weight and congenital defects in the child which could manifest in later life.”

Dr Arbinder K Singal, a paediatric urologist buttressed this argument by quoting results from a study conducted in India, wherein the results reportedly showed that there was an approximately threefold increase in the incidence of genital abnormalities in Indian new born babies in the last 40 years.

According to him, many investigators linked this sudden increase to chemical exposures in the environment which interfere with sex hormones during development and sex differentiation which happens during 812 weeks of foetal development.

“Exposure to Endocrine Disruptor Chemicals (EDCs) during the first trimester significantly increases the chances.

These EDCs, such as phthalates and bisphenol-A are widely used in plastic bottles, vinyl floors, food wraps, medical products, and toys,” he said and recommended that studies in India should be started to collect more data. He also advocated that a possible step would be to institute a ban on production of chemicals which lead to such severe disorders.

The NGO's concerns, as well as members from the clinical/ medical community, seem to be that since India is a tropical country, storage temperatures

In case the government does not implement its decision of banning PET bottles for packing medicines, the health of a large section of population will be at stake Arun Kumar Dukkipati President, HSIL, Packaging Products Division, AGI Glaspac

are considerably higher than in colder regions across the world. According to Act India, while PET bottles have been tested for permissible levels of phthalates, antimony, acetaldehyde etc, for storage at temperatures of around 20oC, potential endocrine disruptor leaching increases to as high as four times the permissible limit, at higher temperatures, which is definitely of concern in our country where temperatures are considerably higher.

Another factor is that with logistics still a mostly unorganised activity in India, most consignments, even those in the pharma industry, could be left stranded in sub-optimal storage conditions and temperatures, sometimes for as long as 120 days according to Act India release, adding to the possibility and duration of leaching.

HIM Jagriti's initial submission to the Ministry quotes a study presented at the 24th Congress of the European Society for Paediatric Urology in Genoa, Italy, in April 2013 which showed a growing incidence of genital abnormality among boys possibly because of the increasing exposure to endocrine disruptor chemicals known as phthalates and bisphenol-A. The organisation then got the leaching testing done at Kolkata's National Test House, which confirmed their fears about the health impact of such leaching of heavy metals and phthalates. The American Society of Reproductive Medicine and International Federation of Fertility Societies have also reportedly requested the US Government for a similar action.

The other side If HIM Jagriti quoted international studies so is the opposing camp. The Indian Drug Manufacturers' Association (IDMA) had submitted a detailed representation to DTAB on December 20, 2013, requesting them to reconsider their recommendations, as it was 'neither based on scientific facts nor on established global practices'.

Their submission had refuted each point raised by the NGO, on endocrine disruption, phthalates, migration/leaching, antimony etc as 'incorrect and misinformed.'

IDMA's submission to the DTAB went on provide scientific documentary evidence to support their claim.

IDMA's submission claims that PET

does not appear in the list of 10,000 being studied by the United States Environment Protection Agency (USEPA) as part of an Endocrine Disruptors Screening and testing programme (EDSP).

IDMA's letter also refers to a report series titled 'Packaging Materials: PET of food Packaging Applications' by International Life Sciences Institute, Europe (ILSI) which is affliated to WHO and has a specialised consultative status with the US) which has mentioned that 'PET and its components have no links with any of the reported endocrine disruptors.'

IDMA has similarly disputed claims on phthalates (on grounds that they are not used in PET bottle manufacturing), migration/leaching (studies done at Industrial Toxicology Research Centre, Lucknow showed comparable migration with glass as well as PET and much below permissiable limits) and antimony (the IDMA letter quotes the Swiss Federal Office of Public Health, which mentions that risk to consumers from possible migration of antimony from PET bottles is negligible.)

As regards genotoxicity, the IDMA letter states that ILSI, Europe has concluded, after very comprehensive and detailed animal feeding studies, that there is no risk of genotoxicity arising out of use of antimony trioxide in PET. IDMA has now reinterated these issues through a letter to the MHFW dated November 3, 2014 and in fact, points out that an expert committee set up by the DTAB to study these allegations noted that ' information provided in the representation of the NGO and according ot the available literature, is not sufficient enough to establish a definite correlation of causality of plastic container for pharmacuetical products and adverse health effects.'

IDMAâ&#x20AC;&#x2122;s letter mentions that five such PILs filed by various NGOs were dimissed by the respective high courts (in Allahabad, Chandigarh, Jabalpur, Hyderbad and Bengaluru) citing the fact that PET bottles were already certified

by Bureau of Indian Standards (BIS) and were recyclable as well.

Better safe than sorry Inspite of the voluminous scientific data presented by IDMA, the absence of proof

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January 16-31, 2015

PACKAGING SPECIAL

of causality did not deter the DTAB from recommending the ban on PET. The fact that the impact of such exposure may not be evident now but could manifest in the future, probably weighed in on the DTAB to adopt a 'safe rather than sorry' stance.

This stance is justified when you consider the regulatory infrastructure in our country. An industry source associated with pharma packaging industry points out that BIS certification cannot be proof that all PET bottles used as primary packaging in the pharma sector are safe as the country does not have sufficient checks and controls and re-cycled polymers could be used. This logic applies to not just PET but other materials used in pharma primary packaging, for example, say in strip packs, or in heat sealed lacquer packs. Pharma companies are thus totally dependent on certifications provided by vendors and its anyone's guess if these certificates will stand up to scrutiny.

Implementation hurdles There are clearly economic and practical reasons why pharma manufacturers are opposing this notification. IDMA's letter points out that while the total pharma market of PET is one lakh metric ton (MT) per year, it will require nine lakh MT of glass annually to replace this, due to the higher weight of glass.

Do the country's glass packaging players have the capacity to meet this increased demand? The same industry source points out that most major glass packaging companies in this category have prefered to focus on beverages and personal care products, both in domestic and global markets.

Arun Kumar however is quite confident that the glass packaging industry is completely geared up to meet the demand of the pharma industry both in terms of quality and quantity. His point is that glass packaging has always been widely used as primary packaging in the pharma industry and though current use might be slightly less, there was no need for concern on using glass bottles for filling in technical terms.

From the logistics point of view, the IDMA letter quotes from a study, which says that 1.20 lakh PET bottles can be transported in a container versus only 90,000 100 ml glass bottles as the weight of a case of PET bottles is approximately 10 times lower that a case of glass bottles.

It follows that heavier cartons, with less units per conrton, will result in increased transporation and freight costs, increased packaging costs (as mono cartons will be required for each glass bottle).

34 EXPRESS PHARMA January 16-31, 2015

Manufacturers will also have to factor in a minimum of two to three per cent loss due to breakage of glass bottles in transit.

IDMA has estimated that there will be a 25-30 per cent cost increase per bottle, which in turn will increase the cost of medicines supplied in glass bottles.

As demand of glass bottles increases, their prices will shoot up, as demand will be more than supply, which will furhter lead to severe shortages as SME pharma companies may not be able to afford purchase of glass bottles at these elevated prices. The IDMA letter has therefore has warned of shortages of liquid medicines due to this notification.

But Arun Kumar estimates that while the cost of medicines will increase by about a per cent or two if this decision is implemented, he opines that this increase is insignificant when compared to the cost the whole healthcare system would have to bear in future due to the ill effects of plastic leaching into the contents in the container.

The packaging industry source goes a step further, calling the high price claim a storm in the teacup, as pharma companies already operate with 35-40 per cent raw material cost (RMC) of which packaging materials account for approximately 20 per cent. Cost increases due to freight and breakages might turn out to have a larger impact rather than material costs.

One of the most compelling reasons to use glass is, of course, the fact that it can be recycled. At the consumer end, IDMA points out that there could be instances of injury due to breakage of the glass bottles during dispensation of medicines. This could be cause for concern, especially since this notification includes formulations for geriatric and paedriatric use.

Most industry spokespersons preferred to comment off the record for this story citing the 'sensitive nature of the issue'. The Health Ministry is faced with powerful lobby groups on all sides: NGOs, the medical fraternity, and glass packagers on one side, and pharma manufacturers and PET packagers on the other side who seem admanant not to accept the decision as fait accompli.

It is still three months to the cut off date and a lot could happen before then.

Whatever the result, it is the patient/consumer who will be impacted the most in the long run. As Arun Kumar points out, in case the government does not implement its decision of banning PET bottles for packing medicines, the health of a large section of the population could be compromised. viveka.r@expressindia.com

PACKAGING SPECIAL

I N T E R V I E W

'Our goal is to provide a total end-to-end solution to our clients' Kezzler has created a unique programme which helps in eliminating counterfeit drugs.

Dr Avi Chaudhuri, Chief Business Officer and Head of India Operations, Kezzler talks about the programme, its USPs and more, in an interaction with Usha Sharma Counterfeit drugs are a big challenge in the pharma sector. What are your solutions to counter this problem?

Kezzler has a diverse set of solutions to meet virtually every brand protection required for the pharma sector. Broadly speaking, our solutions can be divided into two areas.

The first solution is consumer empowerment. Kezzler was the first company in India to set up a robust point-of-sale (POS) verification system to empower consumers to authenticate their medicine right after purchase.

Each saleable unit protected by Kezzler contains an encrypted alphanumeric code generated by our patented cryptographic algorithm. The consumer can text the code to a dedicated number or scan the 2D barcode on the medicine packs. Either way, a verification message arrives on the handset immediately, providing both assurance as well as any other pertinent information that the brand owner wishes to transmit.

The second solution that Kezzler offers is aimed at the brand owner. The idea is to empower them via their own personnel to survey the market place in order to find and document instances of counterfeit medicines.

Over the years, we have developed a large set of tools and technologies to assist our customers and to ensure that their brands are fully protected. It is our view that the fight against counterfeits must be a shared cause. On the one hand, consumers need to be encouraged to verify their purchases, but at the same time, the brand owner must undertake robust initiatives on their own to combat this menace and protect

the equity of their brands. We provide a highly customised set of solutions that are tailored to each individual client in order to meet their risk mitigation objectives.

How effective is Kezzler's technology 'PASS' SMS? How is it designed to suit the pharma sector?

The Kezzler PASS programme with Pfizer is a great success story that is now being expanded to more products and territories. We currently protect some of the biggest and most important drugs for Pfizer, including Viagra, Lipitor and Norvasc. In order to protect its consumers and the brand, Pfizer had experimented with different solutions over the years, all well documented in the public domain. Pfizer then relied on Kezzler's global experience of more than a decade in combating the counterfeit menace to put together an exceptional solution, with fantastic results. The Kezzler programme was launched a couple of years back based on a unique tamper-evident label with our encrypted security code and various

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January 16-31, 2015

PACKAGING SPECIAL other protective features.

The combination of technologies that we brought to bear on this programme representing both consumer empowerment through POS verification as well as trading partners throughout their supply chain, has resulted in substantial escalation of genuine sales, providing an excellent return on investment (ROI). Most importantly, customers are no longer being duped into buying fake medicines.

What is the USP of your products? Are they cost effective solutions as well?

There are two broad areas that encompass our unique selling point — technology and service. In terms of technology, one of our USPs concern code security. The unique identifier (alphanumeric security code) that we apply on each product is created by our patented cryptographic algorithm. The most important aspect of this platform is that none of the codes generated by our algorithm are actually stored in a database for future look up.

Instead, when we receive a code for validation from a consumer, agent or inspector we simply run the algorithm to determine if the code was generated by us.

If so, the validation test passes and the code (along with the product) is determined to be genuine. The absence of a database means there is nothing to hack and no data to steal. Imagine a situation where a database gets hacked and the data is stolen. It would represent a public relations nightmare for the owner, something that actually happens quite frequently. This is a critical reason why seven of the top 10 global pharma companies rely on Kezzler to protect their brands and consumers. The absence of a database in the Kezzler environment also means that the number of products we protect can be infinitely expanded. Hence, programme scalability represents a second core USP of the Kezzler platform. Even a mid-sized Indian pharma company creates many millions of consumer units each year.

36 EXPRESS PHARMA January 16-31, 2015

Given the fact that all this data needs to be maintained for several years, it can easily be seen that expansion limits will quickly creep in with standard database formats offered by all other companies.

The Kezzler platform can even accommodate security coding down to the individual tablet level so that expansion to trillions of unit codes is fully possible. Our clients will never be constrained by code delivery capacity or validation limits.

A third technology-related USP concerns system performance. By not having to rely on a database to look up a particular security code at the time of validation, we are able to bypass the prolonged search times that occur with large database systems. We just run our algorithm to decrypt a code when it hits our servers and therefore the response time is in the order of milliseconds, whether we have generated five thousand or five billion codes for a client. The last thing a brand owner will want is to test their customers' patience by having them wait intolerably to discover whether they have a genuine product in their hands.

The second broad area of our USP is with regard to service. As an engineering company, what we love to do most — and what we are best at — is customising our offerings for the specific needs of our clients. It would be accurate to say that all our clients in India rave about the 'Kezzler service'.

But it all starts long before the programme rolls out. There are no two clients that have exactly the same requirements — their products are different, their brand protection strategies are individualised, and each has a different long-term vision. We work with each company to tailor a custom-designed solution that fits their risk mitigation objectives and requirements. We are often told that we are the only company in this space that has the global knowledge of best practices combined with the technological capacity to deliver winning solutions. And that to me is our core USP because after all, our customers must be satisfied with the outcome.

Over the years, Kezzler has developed a large set of tools and technologies to assist its customers and to ensure that their brands are fully protected And yes, Kezzler does all of the above in a most costeffective manner. We are a benefit-driven company that operates on a competitive cost scale to create an outstanding value proposition. The resulting ROI is perhaps our most endearing USP. What is your experience regarding the deployment of serialisation in India's pharma industry?

We see two types of pharma companies in India. One that is value-driven and another that is purely cost-driven. The companies in the second category want the cheapest solution, period. On the one hand, I can understand the necessity to be economically sound and not pay more than you need to, especially in a competitive climate. However, an outlook that is purely costcentric in my opinion creates a myopic vision of running a business because the long-term economic benefit of having a 'good' solution rather than the 'cheapest' solution is then thrown out the window. Many pharma companies are discovering the folly of this approach because the regulatory requirements are becoming ever more demanding. Furthermore, their competitors in the pharma space who decided to proceed with a value-driven approach are able to take advantage of innovations and best practices in our field that low cost

solution providers simply cannot deliver.

The gain perceived by companies taking the costdriven approach is short-lived and quickly leads to major problems. There are many examples, but I will give just one here as an illustration. The Directorate General of Foreign Trade (DGFT) programme initially required a mere unique serial number on a package for it to leave India. That is simple enough and therefore many Indian pharma companies chose to adopt very low-cost solutions without thinking of the expanding requirements ahead. Well, now that time has come. The DGFT recently introduced a significant new requirement — the so-called monocarton rule — along with additional procedural mandates that are to be introduced in early 2015.

Furthermore, the growing list of countries with stringent new regulatory demands for pharma exports will impose a whole new set of challenges.

The low-end vendors are simply not capable of meeting all these new regulatory demands, leaving their clients struggling to find alternative solution providers that have the technology, experience, and expertise to help them.

So, an interesting dynamic is emerging in India. Costdriven companies are now discovering that they need to join their peers in the valuedriven group. And that is good for us, because that is exactly the space Kezzler is in, and where we firmly want to be.

Do you think there will be rapid growth in the serialisation process in Indian pharma ? How well prepared is your company to tap this opportunity?

There will be an immense growth in Indian pharma serialisation starting in 2015, due to both export regulations and domestic business practices. The DGFT monocarton rule will create a many-fold expansion of the items that need to be serialised before leaving India. Latin American countries (Brazil and Argentina) have serialisation due dates starting as early as

2015. The 28 countries comprising the EU will require pack-level serialisation by 2017.

And you can throw into the mix various other countries (Korea, Saudi Arabia, etc.) with fastapproaching deadlines, as well as various new countries we are aware of that will make announcements very soon.

Consequently, Indian exporters need to get their serialisation programmes fully into gear right away so that they are not frozen out of these plum markets.

On the domestic front, we are seeing very good movement among our own clients and many new ones as they seek to protect their customers and preserve their brand equity.

But it's a lot more than just risk mitigation. Unique product coding provides an excellent way for a brand owner to connect with its customer on a one-to-one basis directly through the mobile handset. We offer a large set of very exciting programmes that capitalise on this connection, which are all custom-made for the unique requirements of each client.

I believe that Kezzler is exceptionally well prepared to tap into all of these opportunities. We have been in India since 2006 and in fact introduced the very concept of serialisation to the Indian pharma industry. In the early days, people would often wonder why is this fellow telling me to put a number on my product. Serialisation has become a mainstream concept since then and with its universal acceptance now as the best way to protect people and products, many Indian companies are turning to us.

Most of our new customers come to us by way of referrals from many of our happy clients.

And quite often, someone will move from one company to another and discover the serialisation problems unfolding there, and then point out that the Kezzler solution at their previous company runs like a Swiss watch.

India's DGFT has postponed the implementation of barcodes on primary packages a couple of times.

How will this move affect

PACKAGING SPECIAL the industry?

A major initiative such as the DGFT programme will necessarily require postponements. In the past, I believe the postponements were helpful for the concept to settle in and for companies to think through how best to move forward. But we are now at a tipping point. Even if there is a postponement on the monocarton rule, which I predict will not happen, the industry simply cannot wait because of the regulatory demands outside of India and the mere fact that so many companies are moving rapidly forward. If you are not doing it yourself then your competitor is, and therefore you are already behind in terms of protecting your products in the wider global market.

As for the primary products, such as blisters, strips, etc., I am of the opinion that unless these represent the saleable consumer unit in the export market, then they should not be serialised at all.

In nearly all cases, exported blisters and strips are placed in a monocarton (or polypack) because unlike the situation in Indian pharmacies, the vast majority of medicines in overseas markets are contained in a monocarton. Therefore monocartons absolutely need to be protected; otherwise, the DGFT programme itself would have a huge design flaw. The bottom line is that blister and strip serialisation (primary level) should be scrapped because it is not needed and would actually be very difficult and costly to implement for the Indian pharma industry, especially the SMEs. I therefore hope the delay for security coding of primary-level products is permanent. The only exception is bottles that are sold as such.

This is classified as a 'primary' and yet if not placed in a monocarton, then it represents the saleable unit. From a consumer interaction point of view, this is no different than a monocarton and therefore should be protected.

How many pharma companies have adopted this technology?

Serialisation as a technology strategy is now widely adopted among exporters, due almost entirely to current and emerging regulatory demands. On the domestic front, the main driver has been risk mitigation, although we are seeing more and more excitement over our consumer engagement and data analytics offerings. From a risk mitigation point of view, our programmes have been immensely successful.

For example, the Swiss drug giant Roche made a painful discovery about 10 years back that counterfeit variants of their oncology drugs were surfacing in

India. They engaged Kezzler as early as 2007 and we put together a terrific programme for them that empowered both consumers and clinicians. The programme was so successful that no further instances of fake Roche products were seen in India. And if you think about it, there was a very committed counterfeiter out there who had gone to great pains to create an artificial product with absolutely no therapeutic value, and which was being sold for thousands of rupees. However, these criminals did not even dare take the chance of replicating our technology for the simple reason that they knew we would have caught them. So the result was that counterfeit oncology drugs moved out of India and started surfacing in other markets, all the while Indian cancer patients were fully protected.

The case with Viagra represents another such success story, though obviously with a very different drug. The growing presence of fake Viagra represented a worrisome problem for Pfizer, both from a healthcare perspective as well as its business operations. Kezzler created a unique programme as discussed earlier, which again resulted in the elimination of counterfeits from those markets where our technology was applied. Consumers are now protected and the brand owner is deriving significant ROI from revenue growth through sales of the genuine product.

How can this technology help brand image and scale up profitability?

We believe information exchange has great value for brand owners and consumers, allowing for a real time dialogue and the beginning of a deeper relationship.

We are seeing a lot of creative brand managers who are able to harness both the power of serialisation and the exponential growth in mobile communications. As an innovationdriven company, Kezzler is constantly coming up with creative new ideas on how to capitalise on this technology to bring greater opportunities to brand owners and most importantly, to the vast numbers of people out there who crave information and value. Simply put, those brand managers that can take rapid advantage of the powerful new opportunities in mobile communication, consumer engagement, and informaticsdriven product branding will increase their brand value and profitability. And Kezzler helps them create outstanding new programmes to drive their business. u.sharma@expressindia.com

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PHARMA ALLY I N T E R V I E W

‘Dow India has multiple assets with an unmatched product mix of excipients worldwide’ Dow Pharma and Food Solutions has recently launched an excipient, Methocel DC2, which reduces manufacturing costs and development time by 60 per cent.

Savindu Kudrigikar, GM- Pharma Marketing, India, Dow Pharma & Food Solutions, discusses the outlook, defining trends, growth opportunities and new launches in an interview with Sachin Jagdale What is the scope of growth for the pharma excipient sector over the next five years? What is going to be the role of Dow India in the same?

Over the last few years India has been an important hub for pharma developments. By virtue of this, the industry here has been a seat for excipient usage and development as well.

Various innovative delivery systems are being explored by pharma companies and the need for innovative and performance excipients is on the rise. India is known for its quick adaptability to new excipients and associated technologies.

Pharma excipients, which serve various therapeuticenhancing purposes such as facilitating drug absorption or solubility, are being highly valued by the pharma industry and by the world’s regulatory bodies, including the FDA and the European Medicines Agency.

Dow India has multiple assets with an unmatched product mix of excipients worldwide and can effectively service and growth with the Indian market.

Dow Pharma and Food Solutions (DP&FS) business, growing at a CAGR of 19 per cent, has doubled its presence in the Indian market over the last four years. Dow India, participates in the oral drugdelivery system – immediate release and controlled release formulations market. Globally, the company holds five of the top 10 excipient chemistries applied to a total functional

38 EXPRESS PHARMA January 16-31, 2015

excipients market which are valued at $4.4 billion.

Dow innovates along the value chain to advance human progress. Our portfolio includes, solutions to improve the synthesis and purity of active ingredients, active pharmaceutical ingredient (APIs) to help pharma manufacturers provide safe and trusted treatment alternatives and solutions and formulation expertise to help customers tackle global industry challenges, finding the right solutions to enable the formulation and release of drugs in safe, more effective and user-friendly ways.

Over the years, we have provided solutions for sustained release, polymorphism, taste masking of APIs which were being actively sought by the pharma industry. We are also focused on some of the emerging needs of pharma industry like API solubilisation and are confident of leveraging our global expertise to offer suitable solutions.

Dow India is constantly looking at mirroring its global capabilities of innovation and customer-centric application research for the Indian market.

This includes building a knowledge base with the customer, bridging demand and supply gaps based on an understanding customer needs and providing with relevant solutions. We have always been at the fore-front of collaboration with customers for delivering innovative solutions that make a difference

to healthcare industry.

What is Dow India's arrangement with Colorcon and the control release alliance?

Since July 2007, Colorcon and Dow Pharma & Food Solutions formed a global Controlled Release Alliance bringing joint resource to accelerate pharma product development efforts and reach market throughout the world.

Colorcon has exclusive, global sales and distribution rights for the following Dow Pharma & Food Solutions' products used in controlled release applications: METHOCEL Premium hydroxypropyl methylcellulose (HPMC), ETHOCEL Premium Ethylcellulose Polymers and POLYOX Water Soluble Resins.

Dow India is constantly looking at mirroring its global capabilities of innovation and customercentric application research for the Indian market

How is the alliance likely to benefit the Indian pharma market in the coming years?

The Dow-Colorcon CR alliance offers high quality products and continuously investigates new applications to help pharma and nutritional supplement companies develop robust solid dose formulations.

We are connected to our customers through an extensive network of technical service managers, the DowColorcon Control release alliance listens closely to customer needs and develops creative solutions to formulation problems.

Through the use of our fullyformulated products, DowColorcon CR alliance offers pharma companies cost-

effective, high quality products with advanced performance and appearance. With our comprehensive range of formulation and process expertise, we are able to assist customers anywhere in the world to help them meet their solid oral dosage manufacturing goal. Knowing how time-to-market influences success, we help our customers complete their projects from product concept through formulation development to final production in reduced time frames. To enhance the use of alliance products, our services are available on site at customers' facilities or in one of our conveniently located laboratories around the world like: ◗ Formulation development ◗ Concept/Feasibility testing ◗ Process optimisation ◗ Tablet Design - Brand Enhancement ETHOCEL, METHOCEL and POLYOX polymers offer an outstanding range of controlled release properties for a variety of dosage forms and processing methods. Variations in molecular weights and chemical substitutions provide multiple ways to optimise formulation performance. Each range has fundamentally different hydrophilicity, swelling and erosion characteristics, to provide flexibility in control of the main mechanisms of release.

Dow & Colorcon's regulatory affairs and quality departments work closely together to stay up-to-date on all regulatory changes that

affect the components used in formulating our products. Our global regulatory affairs group can also guide clients in selecting the right product to meet their application and target market.

The Dow & Colorcon pharma training programmes deliver the latest on coating technology and formulation.

Focusing on theory and practical application, the Control Release Allianceâ&#x20AC;&#x2122;s educational programmes provide pharma scientists with knowledge on film coating, core formulation and controlled release.

Dow & Colorcon are actively involved in independent research at leading universities around the world. These studies can provide new

The Dow & Colorcon pharma training programmes deliver the latest on coating technology and formulation directions in product technology for the pharma industry. In addition, we sponsor and participate in education courses, seminars, and symposia throughout the industry.

What is Methocel DC2 and how will it revolutionise the pharma market?

There is an industry-wide shift from batch based to continuous processing such as roller compaction a continuous dry granulation technique. Dry granulation involves less production steps than wet granulation, thus improving efficiency and reducing

EXPRESS PHARMA

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production costs. Avoiding degradation of moisture-labile or heat-sensitive APIs may be another reason for the paradigm shift. Direct compression is the ideal continuous processing option because all granulation steps would be eliminated, further simplifying the manufacturing process.

Through significant improved flow, METHOCEL DC2 product family, enabled by Dowâ&#x20AC;&#x2122;s patented Designed Particles Morphology (DPM) Technology helps customers enjoy the benefits of dry powder processing techniques while improving tablet quality and delivering the controlled release performance expected

from the proven family of METHOCEL excipients.

Direct compression reduces waste and shortens the development time and manufacturing costs by 60 per cent. This polymer is particularly helpful in manufacturing of heat sensitive and moisture sensitive drugs as the wetting and drying steps

are eliminated. It also restricts the additional dosage that is added to cope with the loss of viable drug due to the wetting/drying process.

Tablets made with METHOCEL DC2 assayed at 96 per cent of the expected API content. The polymer also Continued on Page 47

PHARMA ALLY I N T E R V I E W

‘We will continue working to promote science-based solutions around the world’ It has been 10 years since USP set up its office in India and has been working towards integrating global pharma standards into the industry in India. Shalini Gupta finds out more in an interview with KV Surendranath, Senior VP, International Site Operations; Senior VP, USP–India and Ashok Dang, Senior Director - Marketing & Technical Services, USP

What have been the highlights at USP India in the past year? Elaborate.

The focus of work at USPIndia has been on the development and creation of new monographs, along with the modernisation of existing standards, including those addressing impurities, which are an important factor in assuring the quality of medicines. Additionally, we continue to build on our strong working relationship with the Indian Pharmacopeial Commission, supporting joint education programmes and workshops as part of our ongoing outreach to the Indian pharma industry.

China and India are important pharma markets of the world. What do you see as the challenges when it comes to quality of products and standardisation in both these countries?

A substantial portion of the world’s pharma ingredients and products come from China and India, which has a significant impact on the global pharma marketplace. In those countries, and around the world, USP continues to encourage cooperation and harmonisation as a mechanism to advance standards that help ensure the quality, safety and benefits of medicines.

USP has facilities and laboratories in both China and

40 EXPRESS PHARMA January 16-31, 2015

KV Surendranath Senior VP, International Site Operations; Senior VP, USP–India

Ashok Dang Senior Director - Marketing & Technical Services, USP-India

India, and we have good working relationships with both the Chinese Pharmacopoeia Commission and Indian Pharmacopeial Commission (including Memorandums of Understanding with both, supporting collaborative work on education programs and the development of standards).

USP also provides education programmes to promote quality medicines to manufacturers in both India and China. We believe that the quality of medicines is a shared concern and we will continue working to promote sciencebased solutions around the world.

started office and how does this compare to USP’s operations in other offices in APAC regions?

The India facility is the first office opened by USP outside the US, with a modest start in 2005, including a small laboratory and only 20 employees. Over the past ten years, USP-India has grown substantially and now includes more than 100,000 sq ft of lab space and 150 scientists working on the development and modernisation of standards for chemical and biological medicines, along with dietary medicines. It is USP’s largest facility outside the US.

How far has USP India come in the last 10 years since it

Herbal medicines form an integral part of Indian

pharma. How do you at USP ensure that companies manufacturing herbal drugs go through proper quality standards? Are any such awareness drives or workshops conducted in India for Indian companies engaged in manufacturing of herbal products?

Herbal medicines have been an active area for USP with public standards available in several publications, including USP-NF, the Dietary Supplements Compendium (DSC) and Herbal Medicines Compendium (HMC). USP is continuously evaluating newer products to be included in these compendiums.

Additionally USP offers verification programmes for dietary ingredients and supplements manufacturers.

These programmes are aimed at adherence to good manufacturing practices, proper documentation and ultimately good quality products.

PharmaChk has been a revolutionary device to detect counterfeit drugs.

What other initiatives are underway at USP to counter the menace of fake drugs?

Especially in India? Will PharmaChk be available in India anytime soon?

PharmaChk is one of several new technologies that USP is helping to develop and

evaluate, using our Center for Pharmaceutical Advancement and Training (CePAT) facility in Ghana, Africa. In the trials conducted so far, PharmaChk has shown promise in helping to detect poor quality medicines, but there is much development work that remains. In August, PharmaChk received a substantial grant in order to help bring the device closer to commercial production and availability, and we are hopeful for the future.

In addition to working with PharmaChk, USP is also involved in field testing another device, called CD-3+, which was launched in 2013 by the US Food and Drug Administration – intended to help rapidly screen for counterfeit or poor quality medicines. Also, one of this year’s USP Fellowship Award recipients is working on research into a simple paperbased technology as a test for counterfeit medicines in regions where more sophisticated equipment is not available. It is important to note that different devices will have various strengths, and no single device will be a universal solution, but we are encouraged by this work.

Additionally, USP’s Promoting the Quality of Medicines (PQM) programme works with pharma manufacturers around the

PHARMA ALLY world, including businesses in India, to provide technical assistance at no cost to the manufacturers to help prequalify various medicines that are used to treat multidrug resistant tuberculosis.

The prequalification programme is managed by the World Health Organization for the United Nations – to help assure the quality of essential medicines.

What activities have been underway at USP India this year? Workshops, meetings etc.? How are you working along with the Indian Pharmacopeia?

USP has strong working relations with Indian Pharmacopeial Commission (IPC) via a Memorandum of Understanding (MoU) established in 2008. This MoU allows us to work on joint education programmes, conducting workshops on topics of interest to Indian pharma industry. We are also exploring the possibility of a pilot programme on development of standards.

USP India will be focussed on the development of standards for chemical and biological medicines and will continue to reach out to industry and other concerned parties with regular educational efforts USP India will be focussed on the development of standards for chemical and biological medicines and will continue to reach out to industry and other concerned parties with regular educational efforts.

including more than 170 monographs for compounding preparations and 40 supporting general chapters, which would be a useful resource for any pharmacist or health care facility involved in this activity.

Is the recently released compounding compendium to be available in India too?

What benefits will it offer?

The new USP Compounding Compendium is available worldwide – purchased online and delivered electronically to subscribers.

The publication brings together all of USP’s quality related standards for compounded medicines,

What are your goals and plans for the next few years?

This is an exciting time for USP because a very special event that is on the horizon – the 2015 US Pharmacopeial Convention meeting. This gathering, which occurs once every five years, will provide guidance on issues relating to USP’s future. The meeting, which will be held in April 2015

in Washington, DC, includes: Election of USP’s Council of Experts – the body that oversees USP’s scientific and standard-setting decisions.

Election of USP's Officers and Trustees – the leaders who make decisions that guide USP's policies and strategic direction.

Adoption of resolutions that advance the mission and vision of USP. As part of this process, USP is in the midst of a worldwide search for expert volunteers – pharmaceutical scientists, academicians, regulatory professionals, healthcare practitioners, and others who work with medicines and foods – to apply to serve as scientific

decision makers on the USP Council of Experts and Expert Committees for the period from 2015 to 2020.

Currently, there are 880 volunteer experts on USP’s many Expert Committees, Expert Panels and Advisory Groups. 272 of those experts come from outside the US, including 48 different countries. India has the largest international delegation of volunteer experts at USP (42 experts).

For more information, see the Call for Candidates section of the USP website for information about applying to serve as an expert volunteer (https://callforcandidates.usp. org/) What plans do you have for the USP India office in the next few years? Do you plan to add more labs and recruit more people?

Future plans for USP-India and USP as a whole are directly connected to the upcoming USP 2015 Convention. shalini.g@expressindia.com

PHARMA ALLY POST EVENT

SELECTBIO INDIAorganises conferences on mass spectrometry More than 100 participants, both from academia and industry, attended the meetings SELECTBIO INDIA recently organised two international conferences on ‘Applications of Mass Spectrometry’ and ‘Advances in Forced Degradation Studies of Pharmaceuticals’ at CSIR-IICT, Hyderabad.

More than 100 participants, both from academia and industry, attended the meetings.

Among the keynote speakers were Dr Juergen Gross, Head Mass Spectrometry Lab, Heidelberg University, Germany and Dr Saranjit Singh, Professor/Head, Pharmaceutical Sciences, NIPER Mohali, India.

The workshop on mass spectrometry was conducted at NCMS Lab, at the end of applications of mass spectrometry conference. The workshop included live demonstrations on ‘LC-MS-MS, GC-MS, LC-MS, HRMS, MALDITOF/TOF’ with interpretation of various mass spectra.

The conferences were inaugurated by Dr Juergen Gross, Dr Saranjit Singh, Dr M Vairamani, Dean, School of Bioengeneering, SRM University, Chennai.

Dr Sanjay Bajaj, Managing Director, SELECTBIO INDIA, welcomed the speakers and delegates and introduced to them the organisation and its activities. He informed the audience that SELECTBIO is now doing over 100 events annually across the globe and over 25 events annually only in India. He also introduced their new events and the new activities like ‘MedhaKnowledge Contest’ which is open to all scientists, ‘Feeling & Thoughts’ and ‘Know Your Speaker.’ He also informed the audience about a new division, TechNet India. This was followed by felicitating the sponsors namely, ACD Labs, Lhasa.

The opening talk at the

42 EXPRESS PHARMA January 16-31, 2015

Participants at the conferences

Scientific Session 1 in Applications of Mass Spectrometry conference was delivered by Dr M Vairamani, Dean, School of Bio-Engineering, SRM University. He explained various mass spectrometry approaches like Electron Ionization, REIMS, Surgical Mass Spectrometry, MALDIDESI, DESI-MS Imaging, Paper Spray Ionisation, Molecular Ionisation from Carbon Nanotube Paper and Megavolt Electrostatic Ionisation.

Gross, speaking in his keynote talk, explained several principles related to mass instruments and outlined the properties of various mass analysers like time-offlight, magnetic sector, linear quadrupole, linear quadrupole ion trap, fourier transform-ion cyclotron resonance, and orbitrap.

Dr R Srinivas, Head, NCMS, CSIR-IICT, Hyderabad elucidated some basic

aspects of mass spectral interpretation.

The last talk in this session was a technology spotlight i.e. company presentation which was presented by KK Bhagchandani, Director, Advanced Chemistry Development.

The last session of this conference was on the advanced applications of mass spectrometry. The first talk in this session was delivered by Gross. He overviewed various Ambient MS techniques like ASAP, DAPCI, DAPPI, DART, DESI, DeSSI. He explained the DART Ionisation as the aspect of mass calibration in both positive ion and negative ion modes. He discussed that due to both positive ion and negative ion modes DART-MS has shown broad applications for rapid analysis of complex molecules. In his presentation he also explained various applications of DART-MS. Dr Utpal Tatu, Professor,

Department of Biochemistry, Indian Institute of Science, in his presentation, described the mass spectrometric analysis of the clinical proteomes of Plasmodium falciparum and Trypanosoma evansi, identification of diagnostic antigens for diagnosis of animal Trypanosomosis as well as mass spectrometric identification of a novel trans-splicing-based expression of Hsp90 in Giardia lamblia.

The scientific sessions on Advances in Forced Degradation Studies of Pharmaceuticals was initiated by Singh, who compared stress testing studies given in various Pharmacopoeias and in regulatory guidelines with day-to-day experiments. Alok Chaudhary, Senior Research Scientist, Ranbaxy discussed various forced degradation studies and protocols from the perspective of the pharma industry.

The session also included

a technology spotlight i.e. company presentation by KK Bhagchandani, Director Advanced Chemistry Development. In his presentation he discussed that R&Ds can save time in identifying, characterising and evaluating impurities and degradants.

Singh elaborated the relevance and importance of degradation products in pharma substances and products. He highlighted a strategy for the characterisation of degradation products involving use of hyphenated LC-MS, LCNMR and LC-IR techniques.

The same was duly explained through multiple case studies.

Srinivas explained the identification and structural characterisation of drug degradation products and metabolites by liquid chromatography, electrospray ionisation tandem mass spectrometry (LC MS/MS, MSn) combined with H/D exchange.

Dr R Nageswara Rao, Chief Scientist/Head, Analytical Chemistry, CSIR-IICT, Hyderabad explained the major mechanisms of chemical decomposition of pharmaceuticals including hydrolysis/dehydration, oxidation, isomerisation/ epimerisation, decarboxylation, rearrangements, dimerisation/ polymerisation and photolysis and transformation products involving reactions with excipient/salt forms.

The event concluded with presentation of posters award.

The poster by Manisha Puranik was adjudged the best amongst the rest and was awarded the 'Best Poster Award.' Dr Sanjay Bajaj, Managing Director, SELECTBIO INDIA closed the conference with his closing remarks and also presented the vote of thanks.

EP News Bureau-Mumbai

PHARMA ALLY INSIGHT

Importance of scanning electron microscopy in pharma products Dr V Satyanarayana, Managing Director, Sipra Labs and Dr Ashok Sadhukhan,Vice President, Sipra Labs give an insight about quality control mechanisms adopted by Sipra Labs for examining the size and quantity of sub-visible particulates in final products NOW-A-DAYS, all pharmaceutical and biopharma companies follow testing requirements for inspection of visible particulates, and also for examining the size and quantity of sub-visible particulates in final products. These quality control mechanisms are typically employed at the end of the production cycle and are typically done via optical inspection. However, pharma manufacturers and CROs are finding that they need high resolution

Understanding pharma products with SEM-EDS Understanding the physical properties of pharma products is a key to success in process development. Physical characterisation services can assist formulation or process development, quality control and GMP lot release testing. Applications include solid dosage forms, suspensions, parenteral, gels and liquid emulsions. Particulate matter can range in size from sub-microns to several hun-

Dr V Satyanarayana, Managing Director (sitting) and Dr Ashok Sadhukhan, Vice President with Hitachi SU1510 SEM- EDS along with an analyst

(~ 400,000X) provided by a scanning electron microscope (SEM) to characterise, control and elementally quantify the size and shape of these particles. SEM combined with Energy Dispersive Spectrometry (EDS) is a powerful combination of analytical techniques for the evaluation of APIs, finished products and particulate contaminants.

dreds of microns. In most cases, particle size distribution and total count are required. Foreign particles or particulate matter in drug powder products is an area of extreme concern. Unwanted particles should be controlled and their sources need to be identified. Contamination due to an excessive amount of particulate matters in pharma products might lead to quality and safety

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PHARMA ALLY

Figure 1a

Figure 1b

Figure 2

Figure 3a

Figure 4a

Figure 4b

problems. Particle contamination in manufacturing sites might even result in the suspension of production line by regulatory authorities.

Scanning electron microscopy provides visual information about the organic and inorganic submicron particles (size, shape, and morphology), and also chemical identification based on the X-ray energy lines. Depending on the nature of the sample (organic, inorganic, or metallic), and the type of information desired, the imaging and chemical characterisation capabilities of SEMEDS lead many pharma laboratories to use this technology to evaluate morphology, size, shape and elemental composition of metallic and organic sub-visible particles.

Even the cleanest rooms can produce particulate matter shed by gowns, gloves, skin, sample preparation equipment, glassware and others. Containers and closures, specifically rubber closures contribute particulate matter due to leaching, chemical reactions and friction, lead to changes in physical properties. Some of the most common materials identified in pharma environ-

44 EXPRESS PHARMA January 16-31, 2015

ments are stainless steel, silica, aluminum, salts, minerals, organic fluorinated compounds, and carbonaceous materials in varying sizes and shapes. SEM Images and EDS spectra of some pharma products carried out in Sipra Labs are shown in Figure 1 (smooth vs irregular) and Figure 2 (cross section of a tablet).

During formulation, it is useful to have a means to investigate the distribution of excipients and API within the tablet itself. Besides quantifying the API within the tablet, another check can be obtained by measuring thickness of the tabletâ&#x20AC;&#x2122;s coating by using a Back Scattered Electron (BSE) Image.

Tablet coatings have numerous functions including strengthening, controlled release, ease of handling and packaging, protection of the tablet from moisture, improved taste, facilitate swallowing, and to provide tablet identity.

Metal particles are common contaminants in the drug manufacturing process, a problem that should be addressed before the product goes to market. Though small in size, repeated ingestion of metal-contaminated pharma-

ceuticals can lead to metal poisoning â&#x20AC;&#x201D; lead and chromium particles being the most dangerous. Particles were studied in Sipra Labs by SEM with EDS. Sipra Labs get two kinds of information: a high-quality morphological image showing the features of a contaminant such as metals (Figure 3a), glass fragments and minerals, and a spectrum of the elemental constituents present in a sample. Our laboratory could use EDS to analyse inorganic materials and identified contaminants. This technology platform is also used to characterise certain organic materials, particularly if they contain elements other than carbon and oxygen (as do silicone rubber stopper fragments).

Another important use of SEM is to demonstrate delamination of glass bottles, ampoules, prefilled syringes, rubber stoppers and others. Figure 4a as control and Figure 4b shows glass delamination which was found in injection bottle. This report could enable the client selecting vials to suit the products.

During bio-pharma manufacturing, Proteins can aggregate at any point of time. Regulatory

agencies pay special attention to these aggregates that can enhance immune responses and cause adverse clinical effects, and those that can compromise the safety and efficacy of a protein product. Rod-like microparticles were observed in the formulated monoclonal antibody (mAb) solution. The particles had a thin and elongated morphology. Based on the Raman spectral comparison and SEM/ EDS analysis, the observed particles were confirmed as the same protein drug substance in the form of rod-like crystals. Based on this identity confirmation, formulation modifications may be carried out either to prevent or to promote the formation of protein crystals to facilitate the final delivery form of the drug product.

In an effort to meet FDA recommendations, pharma manufacturers and contract research facilities are adopting the Quality by Design (QbD) approach to assess the quality and safety of solid and parenteral drug products with respect to foreign particles. The use of automated SEMEDS is illustrated as part of the QbD approach to monitor the particle content in the pharma and bio-pharma products.

About our analytical testing laboratory The analytical testing laboratory of Sipra Labs in Hyderabad, India was established in 1994 as a provider of R&D, QA and QC services to pharma and bio-pharma companies.

With the significant increase in the numbers of pharma and bio-pharma industries requesting SEM services for particulate analysis, a high resolution Hitachi SU1510 SEM with EDS facility had been added in 2012 in Sipra Lab's state-of-the-art facility at Sanathnagar, Hyderabad. It serves as a resource of unbiased, independent analytical data and counsel. The SEM laboratory is equipped with all the capabilities along with polarising light and stereo phase contrast microscopes. The outstanding technical support enables easy visualisation of agglomerates, broken particles and foreign particles, therefore providing effective services in the rapid analysis and characterisation of pharma particles.

We continuously develop new services to help clients improve their return on expenditure, time and reliability to data, and stay ourselves competitive.

PHARMA ALLY VENDOR NEWS

COMSOL Server launched Applications can now be distributed throughout an organisation, providing design teams, production departments, and others with access to simulation tools built by experts COMSOL HAS launched COMSOL Server, a new product developed specifically for running applications built with the application builder. The application builder allows COMSOL multiphysics software users to build an intuitive interface around their COMSOL model that can be run by anyone, even those without prior simulation experience. COMSOL Server enables the distribution of applications, allowing design teams, production departments and others to share applications throughout an organisation using a Windows-native client or web browser.

COMSOL Server is the engine for running COMSOL apps

Simulation apps can be distributed to colleagues and customers throughout an organisation using COMSOL Server

and the hub for controlling their deployment, distribution, and use. After creating an app with the application builder, the server provides engineers and

researchers with a cost-effective solution for managing how the app is used, either within their organisation or externally to a worldwide audience.

Svante Littmarck, President and Chief Executive Officer, COMSOL Group said, “COMSOL Server provides an environment for running applica-

PRODUCT

Phenomenex develops versatile new Kinetex F5 columns PHENOMENEX, a global leader in the research and manufacture of advanced technologies for the separation sciences, has launched Kinetex F5, a robust pentafluorophenyl propyl (PFP) core-shell phase that overcomes reproducibility and performance limitations of existing PFP and F5 products on the market. After extensive internal and external testing found that existing PFP and F5 fully porous and core-shell products produced sporadic basic compound adsorption and analyte retention time shifting, Phenomenex, in partnership with customers, redefined the industry standard

46 EXPRESS PHARMA January 16-31, 2015

and developed this new coreshell pentafluorophenyl.

The new Kinetex F5 phase delivers improved reproducibility compared to other PFP or F5 columns on the market and can significantly reduce method development time with its dynamic and responsive chemical functionality. It is an ideal solution for HPLC/UHPLC development work with its combination of polar and nonpolar interactions including hydrogen bonding, electrostatic, hydrophobic, aromatic and steric/planar mechanisms. Additional versatility of this phase gives scientists the ability to use reversed phase, 2D-LC,

HILIC, SFC or even 100 per cent aqueous separation modes. With its fluorinated groups and carbon ring structure, the Kinetex F5 is an excellent choice for both polar and non-polar compound separations as well as challenging methods that include halogenated, conjugated or isomeric compounds.

Kinetex F5 is available in 2.6 and 1.7 μm particle sizes and delivers all the advantages of Phenomenex’ Core-Shell Technology including better resolution, higher efficiency, easy method transferability and cost savings from reduced solvent consumption. The Kinetex 2.6

μm F5 provides performance comparable to sub-2 μm particles on both standard HPLC and UHPLC systems. The 1.7 μm column delivers 20 percent greater efficiencies than fully porous sub-2 μm products.

Contact details Phenomenex India Laxmi Cyber City, Ground Floor B Block, Survey no: 10 Kondapur, Hyderabad 500 084 India Tel: 040-3012 2400 Fax: 040-3012 2411 Website: http://www.phenomenex.com

tions created in the application builder that is easy to access and use. Using the Application Builder and COMSOL Server together, an R&D engineer, for example, has the tools to create applications that will serve their specific industry in a format which is easy to use and quick to implement.”

With COMSOL Server, applications can be run in a COMSOL Client for Windows or in Google Chrome, Firefox, Internet Explorer, Safari, and other major web browsers.

COMSOL Server can be hosted in a corporate network or in the cloud.

EP News Bureau-Mumbai

PHARMA ALLY Continued from Page 39

‘Dow India has multiple... increases the productivity (reducing steps and raw materials) and decreases the energy utilised in carrying out the operation of manufacturing a tablet.

Across the industry, tablets are manufactured in batches – a process that the industry is trying to do away with for a while to get a streamlined and continuous operation. The addition of METHOCEL DC2 also helps in reduction of bottlenecks.

A polymer from the same family METHOCEL VLV has been instrumental in reducing the cycle time of the coating operation of the tablets by about 30 per cent.

Tell us about the cost

Indian generic pharma companies have strong product development skills and have set up worldclass active pharma ingredients (API) and formulation manufacturing facilities effectiveness of METHOCEL DC2.

Designed to help the pharma industry shorten development time and lower manufacturing costs, METHOCEL DC2 supports pharma manufactures looking to switch to roller compaction and direct compression for matrix tablet applications.

METHOCEL DC2 will help manufacturers replace wet

To subscribe: bpd.subscription@expressindia.com

granulation in matrix tablet production, lowering manufacturing costs by as much as 60 per cent, reducing waste, and shortening development time.

Furthermore, direct compression methods offer better formulation options for heat- and moisture-sensitive APIs. Indian generic pharma companies have strong product

development skills and have set up world-class active pharma ingredients (API) and formulation manufacturing facilities to cater to the pricesensitive India market and global generics market. Many of these dominate India’s domestic market through a large sales team, strong relations with physicians and medical institutions.

METHOCEL DC2 is designed

to help support their competitiveness.

Indian pharma companies are now seeking to move up the value chain to drug discovery and development by leveraging the country’s scientific talent.

Given the strengths of Indian and global pharma companies, it makes sense for them to come together to develop India’s domestic market, source products for global market and to discover and develop new drugs and therapies.

Who are your pharma clients in India for Methocel DC2?

We work with the all the leading pharma companies in India. sachin.jagdale@expressindia.com

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WEST BENGAL PHARMA REVIEW INSIGHT

Pharma industries in West Bengal Dr Chintamoni Ghosh, Director of Drugs Control, Government of West Bengal, elaborates on how the pharma sector is one of India’s most important sectors in terms of projected revenue growth from exports and for meeting the needs of Indian population THE ALOPATHIC system of medicine was introduced in India first time by the British ruler. Before the advent of British rule, the indigenous system of medicine, i.e ayurvedic, and unani, called Indian System of Medicine (ISM) were used in India. Mainly bulk drugs were manufactured by foreign companies in India and exported for converting into finished formulation to bring it back again to India. After the World War II, import of finished formulation were decreased significantly and indigenous companies tried to set up their own manufacturing facilities. The Calcutta Chemicals, Standard Chemicals and East India Chemicals were the pioneers to set up manufacturing facilities in West Bengal.

The Indian pharmaceutical industry can be said to have begun with the setting up of ‘Bengal Chemical and Pharmaceutical Works’ in Kolkata.

Subsequently, institutes like Kings Institute of Preventive Medicine in Chennai, Pasteur Institute in Coonoor, the Central Drug Research Institute in Kasauli and others were set up.

Post-independence, many other public sector companies such as Hindustan Antibiotics in 1954 and Indian Drugs and Pharmaceuticals in 1961 were set up to reduce the imports of important antibiotics and also to meet the county’s demand from indigenous production.

Today the pharma industry is in the front rank of India’s science-based industries with wide ranging capabilities in the complex field of drug manufacturing and technology. It ranks very high in the third world, in terms of technology, quality and range of medicines manu-

48 EXPRESS PHARMA January 16-31, 2015

factured.

From simple headache pills to sophisticated antibiotics and complex cardiac compounds, almost every type of medicine is now made indigenously.

The Indian pharma sector has 300 large units that control about 70 per cent of the market with market leader holding nearly seven per cent of the market share and about 8000 small scale units together which form the core of the pharma industry in India. These units produce the complete range of pharma formulations, i.e., medicines ready for consumption by patients and more than 400 bulk drugs, used for production of pharma formulations. Consequently, larger companies are cutting back on outsourcing and shifted to companies with facilities in the five tax-free states — Himachal Pradesh, Jammu & Kashmir, Uttaranchal, Sikkim and Jharkhand.

SMEs have been finding it difficult to find the funds to upgrade their manufacturing plants, resulting in the closure of many facilities.

In 2005, India introduced product patent recognition to all new chemical entities (NCEs) i.e., bulk drugs developed then onwards. This introduction of product patent regime from January 2005 is leading into long-term growth for the future which mandated patent protection on both products and processes for a period of 20 years. Under this new law, India will be forced to recognise not only new patents but also any patents filed after January 1, 1995. The Indian pharma industry is mounting up the value chain. From being a pure reverse engineering industry focused on the domes-

tic market, the industry is moving towards basic research driven, export-oriented global presence, providing a wide range of value added quality products and services, innovation, product life cycle management and enlarging their market reach. The old and mature categories like anti-infectives, vitamins, analgesics are de-growing while, new lifestyle categories like cardiovascular, Central Nervous System (CNS), anti diabetic and anti-cancer drugs are expanding at double-digit growth rates.

Domestic market The industry has enormous growth potential. The factors are listed below: ◗ The large population of over of a billion ◗ Increasing income capacity ◗ Demand for quality healthcare ◗ Change in disease patterns ◗ Increased demand for new medicines to combat lifestyle related diseases More than 85 per cent of the formulations produced in the country are sold in the domestic market. India is largely selfsufficient in case of formulations. Some life saving, new generation under-patent formulations continue to be imported, especially by MNCs, which then market them in India. Overall, the size of the domestic formulations market is around `160 billion and it is growing at 10 per cent per annum.

Export potential The pharma sector is one of India’s most important sectors in terms of projected revenue growth from exports and for meeting the needs of Indian

DR CHINTAMONI GHOSH Director of Drugs Control, Government of West Bengal

population. There are a larger number of markets to which Indian pharma companies can now export as a result of global trade liberalisation and capacity building by Indian companies over the last decade.

◗ Country's main Patent office in Kolkata.

The State Government is adopting a number of policy measures to accelerate the industry’s growth and to make it internationally competitive.

Pharma sector in Bengal

Thrust areas of policy

Agriculture is the backbone of the West Bengal’s economy. Industrial and services sector also contribute to the development of the state economy.

Pharma industries, especially formulation units, require less land compared to other heavy Industries; Return on Investment (RoI) is fast and very good. In modern pharma industry one requires less but highly qualified and skilled manpower, which is available in the state as it is evident from the fact that many personnel from the state of West Bengal are holding high position in the pharma industry in other parts of the country.

◗ Industrial licensing for all bulk drugs cleared by Drug Controller General (India), all their intermediaries and formulations will be abolished, subject to stipulations laid down from time to time. ◗ Create an incentive framework for the pharma industry, which promotes new investments and encourages the introduction of new technologies as well as new drugs. ◗ Permit Foreign Investment up to 100 per cent excepting in a few areas. The Government is also making arrangements for the automatic approval for Foreign Technology Agreements for all bulk drugs cleared by Drug Controller General (India), all their intermediaries and formulations excepting some designated items.

The Directorate of Drugs Control of the State has extended a helping hand to the pharma producers in meeting global standards in stages.

Since all surviving industries in West Bengal are GMP compliant, requirements of advanced tools and technology, validated and aseptic processing will no more be a problem. The West Bengal Government is planning to announce a comprehensive drug policy for the state. A strong motivation within the pharma industry is now required to regain its lost pride and position. The effect was negated in government taxation and pricing policies.

Advantages of pharma industry in West Bengal ◗ Potential market with a target large population in the eastern and north eastern states. ◗ Successful implementation of land reforms, the rural economy has developed resulting increase of purchasing power. ◗ Prime medical facility in Kolkata, Durgapur and Siliguri for patient from neighbouring countries, especially Bangladesh, Nepal and Bhutan ◗ NIPER campus has established in the state. ◗ A proposed pharma manufacturing zone and chemical hub ◗ Special Export Processing Zone (SEPZ) at Falta ◗ NPPA-CIFG in Kolkata for redresse the grievances of consumer ◗ Biotech Policy is declared

Albert David to tap new markets In the last fiscal (2013-14), the company, touched a turnover of ` 292 crores and is expecting to touch ` 330 crores by March 2015 KOLKATA-BASED pharmaceutical company Albert David, a unit of the Kothari group, has recently undertaken a range of initiatives for the development of new products for increasing its market share in formulation segment to achieve sustained growth in the current fiscal year.

“In the current fiscal, we have introduced new products and would be soon adding more brands to expand our product basket,” said Kamal Prasad Mundhra, Executive Director, Albert David.

Albert David, which makes pharma formulations, bulk drugs and injections, has three

manufacturing plants — in Kolkata (for tablets and powder, small volume parenterals, oral liquids, bulk drugs), Ghaziabad (for IV fluids in glass and polythene containers using the latest Form-Fill-Seal (FFS) technology and small volume parenterals) and Mandideep (disposable syringes and needles).

In the last fiscal (2013-14), the company, touched a turnover of ` 292 crores and is expecting to touch ` 330 crores

by March 2015.

The company has successfully launched Rabeprazole and its combination (Anti-peptic ulcerant range) and Montelukast and its combination (anti-asth-

matic range).

New formulations have been launched in the therapeutic segments like anti-asthmatics (for the treatment of seasonal allergic rhinitis), anti-ulcerants another proton pump inhibitor and nutritional supplements in the treatment of patients with malnutrition, stress and convalescence, debility, etc.

During the current financial year, the company plans to further strengthen Alamin range of products by launching alamin liquid, alamin drops and other variants of L Arginine sachets.

He said, “We also have plans to venture into pre-probiotic, infertility and nutraceuticals

market.”

Mundhra said, “The company has given much thrust on its research and development initiatives. The company has made significant investments in fully renovating and expanding its R&D facility at Kolkata. The facility had been further equipped with more analytical and functional instruments as well as manpower to enhance its R&D capability to deliver more advanced and efficacious dosage forms in oral solids, oral liquid and some APIs. A number of R&D projects in product and process development have been taken up, which is at different stages of development.”

KAMAL PRASAD MUNDHRA Executive Director, Albert David

To expand the geographical reach of the company’s products in export market, a number of dossiers have been submitted in different countries.

Approval of some dossiers has been received during this financial year.

Commenting on the Indian pharma industry, he said it is an extremely fragmented market with severe price competition and government price control.

But inspite of these, Albert David will continue to grow with the current strategies in place and is equipped to meet any future challenges, he added.

EP New Bureau-Kolkata

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WEST BENGAL PHARMA REVIEW

STADMED to focus more on the domestic market

ASHEESH ROY

Director, Stadmed

The company has launched 20 new brands including brand’s extensions KOLKATA-BASED pharmaceutical company STADMED has achieved remarkable growth in the last three years.

Stadmed is focusing more on the domestic market to catch up with the growth driven by the small and mid sized Indian pharma companies.

In recent past, the company has launched 20 new brands including brand’s extensions, out of which 12 brands are successfully growing and competing strongly with the leaders to enhance

50 EXPRESS PHARMA January 16-31, 2015

the market share. It has created more rural headquarters to increase its reach to various types of medical practitioners.

The company is aiming to increase its prescriber base and area of operation in domestic retail pharma market.

Stadmed is growing rapidly in Andhra Pradesh and Telengana and has objectives to operate in these states in full capacity by the year end.

Research and development and formulations are the

other areas the company has focused upon. Stadmed successfully developed innovative release method in specific drug category viz. pain, nutrition supplement, sedative hypnotics etc. The company is dedicated to provide quality medicines since seven decades. Growing demand and growth in business has been a challenge for the company to meet.

With a field force of 400, the company is able to retain its talents. Formation of dif-

ferent strategic business unit (SBU) and segment-wise promotion is the motto of the company. At present, the company has two SBUs and has plans to increase it by four in the next couple of years. The represented product market is immensely potential and addition of brands in urology, paediatrics and in chronic care segments have strengthened the product portfolio.

Asheesh Roy, Director Sales and Marketing, Stadmed says, ‘We are opti-

mistic to reach newer heights within the next few years. The rich experience and market image of the company will drive us faster to achieve the ` 200-crore. mark sooner. The unique drug delivery system in recently launched ‘UrifurSR’ (Nitrofurantoin sustained release tablet) has given us success for better patient compliance at most affordable price. We are aiming to create more SBUs for more focused promotion.’”

EP News Bureau-Kolkata

WEST BENGAL PHARMA REVIEW

Bengal Chemicals on the path of revival The company has two factories in Kolkata (Maniktala and Panihati) and one each in Mumbai and Kanpur THE CENTURY-OLD Bengal Chemicals & Pharmaceuticals Ltd. (BCPL) is on the path of revival after EA Subramanian, has taken over as the Managing Director in February last year.

Subramanian is a Chemical Engineer and brings with him years of experience in running such organisations. He had earlier worked M/s HLL Lifecare, a CPSU under the Ministry of Health & Family Welfare and with DS Group in the private sector.

BCPL, a Government of India Enterprise under the Ministry of Chemicals & Fertilizers,

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Department of Pharmaceuticals, founded by the great scientist Acharya Prafulla Chandra Roy, is a 114-year-old company having a strong presence in pharma and home products.

The company has two factories in Kolkata (Maniktala and Panihati) and one each in Mumbai and Kanpur.

In generic pharma division, BCPL produces tablets/capsules of both Betalactum and Cephalosporin range. BCPL is the only pharma CPSU having a strong manufacturing base in ointments like Chlotrimazole, Povidine Iodine etc.

With the extension of Pharmaceuticals Purchase Policy (PPP), of Government of India, for Pharma PSEs for a period of five years from November 2013, the company has enough market prospects for its pharma products. In addition to the generic pharma, the company is also having popular brands like Eutheria (Pain balm), Aqua Ptychotis (Digestive stimulant), Kalmegh (liver tonic) etc. which are having a good market presence.

In home products segment, the company manufactures popular products like Pheneol,

White Tiger (floor cleaner), naphthalene balls, bleaching powder, Kiln Toilet etc. The company manufactures alum for water purification in its chemical division. Other major products include â&#x20AC;&#x2DC;Cantharidine hair oilâ&#x20AC;&#x2122;, a 75-year-old hair oil brand and is well known for its properties to arrest hair fall.

Speaking to Express Pharma, Subramanian stated that the company is growing at a rapid pace after years of stagnation.

From a meagre production turnover of ` 19.70 crores in FY 2013-14, the company already achieved a production of ` 38.62

EA SUBRAMANIAN MD, Bengal Chemicals & Pharmaceuticals Ltd

crores in the seven months of FY 2014-15 with a growth of 236 per cent. The company is planning to achieve a turnover of ` 60 crore by the end of the current financial year.

The company was a pioneer in Anti Snake Venom Serum (ASVS) manufacturing in India and is planning to restart the project for manufacturing the same as per current WHO-GMP norms. BCPL have 11 depots and 11 C&F agencies to reach the length and breadth of the country. The company is in the process of strengthening its distribution network all over India.

We value human life Albert David Limited has been in continuous pursuit of providing quality healthcare solutions. Applying its world class expertise to make high quality and affordable medicines.

Our eternal passion is to work towards bettering human life.

Montelukast 5mg/10 mg + Levocetrizine 2.5/5 mg

B R E AT H E

Tablets

Ursodiol 300mg & Silymarin 140 mg tablets

EASY

Isoxsuprine hydrochloride 10mg Tablets, 40mg SR Tablets, 5mg/ml IM / IV

15, Chittaranjan Avenue, Kolkata - 700 072, Phone: 2212-9700/9637/9592, Fax: 033-2225-8714/2212-9629, E-Mail: adidavid@cal.vsnl.net.in, E-Mail: adldavid@dataone.in, Website: www.albertdavidindia.com

I N T E R V I E W

‘In India, we are considered to be one of the best and trusted brands in the industry’ Debasish Roy, MD and Subhasish Roy, CEO, The United Engineering Company (UEC) spoke to Express Pharma about the current state of pharma packaging industry in the country

Today, after five decades in pharma-machinery manufacturing industry, how has UEC positioned itself?

In the last five decades, UEC has developed more than 30 kinds of indigenous pharmaceutical machinery and we are continuously upgrading ourselves. From the early 60’s of the last century, UEC has become a major house of the import substitute in pharma machinery though we are much aware of high-speed machine from the first world country and also stiff competition from low valued machines from our neighbouring countries, UEC machines still hold their own position. In India, we are considered to be one of the best and trusted brands in the industry. ‘UNITED’ machines also cut a niche for itself in the international markets. We are growing as a brand day-by-day.

In the Indian pharma industry, automatic ampoule filling and sealing machine means UEC. Which machines are in your product basket for small volume and large volume parenteral manufacturers?

UNITED Automatic Ampoule Filling & Sealing (AFS) machines are widely accepted in the market, not only in India but also overseas. They are the most reliable and efficient machines available in the market, adhering to all the current manufacturing practices, technologies and automation. We have various models of our AFS machine

54 EXPRESS PHARMA January 16-31, 2015

round and flat bottles. These machines are manufactured as per the latest manufacturing techniques and automation.

Debasish Roy

Subhasish Roy

having various outputs and dosing system to cater to the customer’s need.

Apart from our AFS machines, our product list offers ampoule and vial washing, automatic liquid filling, automatic rubber dispensing and pressing, and, automatic sealing machines for vials, both in automatic and semi-automatic models.

We also manufacture automatic labelling machines for ampoules and vials both for paper and sticker labels.

Our latest inclusion being the external cleaning and drying machine for ampoules and vials, has made our brand a one stop solution for our clients. These machines are available in models with different outputs.

All the UNITED machines are manufactured with equal expertise and are accepted and appreciated in India as well as in abroad for their quality, efficiency, performance and the fact for these being ‘value for money’ products. Our customer support team also plays an important role in making our brand trustworthy.

line of machines?

Apart from our pilot scale and automatic linear line of machines for bottles, we have introduced a total range of rotary machines for bottles, which includes UNITED ARBW —Automatic Rinsing Machine which can handle 30 ml to 450 ml in the same machine and can clean the container with both water and air. The ‘ARBW’ has five different models depending on the speed.

UNITED 'RBFS' Automatic monoblock bottle filling and capping machine which has three different models with a newly developed special UNIZIGMA head for pet bottles.

For non-metallic caps we have introduced a special 'Pick and Place unit' and 'Magnetic Screw Capping Head', to maintain a certain torque as required by the customer.

Inline with the above high speed labelling machines, we manufacture high speed labelling machines for sticker and paper labels suitable for

What are the latest developments for your bottling

The company had introduced ‘UNICOATA’, automatic coating machine lately. Tell us more about the machine. Where is ‘UNICOATA’ used?

‘UNICOATA’ was introduced by UEC quite a few years back and has had a remarkable response. It is a complete range of solutions for automatic tablet coating.

It provides the user with best and uniform coating results with simple operation, yet equipped with the latest technology.

'UNICOATA' maintains an international standard and is a 'No-Frill', easy to use machine and excellent results. Around 60 machines have already been installed including 'Multiple installations' in Iran, the US and Bangladesh.

Maintaining strict ‘quality control’ parameters, is an important element in today’s pharma production business. How is UEC conforming to the quality guidelines?

UEC has a QC Team, who are responsible of all the raw materials. Apart from DQ, IQ and OQ, UEC's QC team are responsible for physical and chemical testing of raw material from reputed testing houses. Most of the machine

parts of UEC are made from CNC or VMC and are hardened depending on the quality of the material, procurement of appropriate raw materials from the right place.

Which pharma companies use UEC machines?

It is very hard to name a few of the companies in India as we are catering to the needs of most of the pharma companies. Besides, we are providing our machines to leading names in Bangladesh like Opsonin Pharma, Renata (previously Pfizer Bangladesh), Drug International, Hamdard – Bangladesh, Pharmadesh Lab, Kemiko Pharma, Incepta Pharma, Essential Drugs and several others.

Do you export these machines and to which countries?

We have a strong foothold in the overseas market and have exported to countries like Bangladesh, Iran, Nairobi, Nigeria, Bolivia, Sri Lanka, Sudan, South Korea, Indonesia, Malaysia, Mauritius, Chile, the US, Canada, the UAE, Nepal.

Presently, we are looking to extend our horizons to the European and other markets.

What are your future plans?

Being into business for more than five decades, we have a lot of things to do, a lot of targets to achieve and explore different avenues.

Turning every unturned stones and being better than the best is the motto for the future.

The UEC: Leaders in pharma packaging machinerymanufacturing since 1963 THE UNITED Engineering Company (UEC) with the brand name 'UNITED' is known for being the pioneer and commander in packaging machinery manufacturing in India.

UEC, which was started in 1963 by GD Roy, from the beginning, attained a high reputation in providing machines and services of highest standards with utmost care. With the founder's innovative ideas and unmatched leadership qualities, UEC crossed various boundaries in different fields of work.

Initiating the business with solutions for parenterals (ampoules and vials), UEC has di-

UEC puts in a lot of effort for their R&D and strives to provide the best and optimised solution to its customers versified its business into the bottle packaging sector and has also mastered in providing machines for automatic tablet coating. UEC also provides customised solutions for its customers.

With a vision to provide the best pharmaceutical manufacturing technology, UEC has also ventured into different industries such as distilleries, cosmetics, foods and beverage, paints, chemicals, home care, office and student stationery and others.

The company has also expanded its footprints abroad in a large way. Today, 'UNITED' machines are exported to

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more than 21 countries across the globe namely the US, Canada, Bolivia, Nigeria, Kenya, United Arab Emirates, Iran, Sri Lanka, Bangladesh, Malaysia, Indonesia, Vietnam, Korea and others.

UEC puts in a lot of effort for their research and development and strives to provide the best and optimised solution to its customers. By virtue of dedication and continuous hard work of their R&D team, 'UNITED' machines provide technically advanced solution for its customers.

Presently, UEC is having its head office at Kolkata. It has three manufacturing units in West Bengal, covering an area of over 10000 sq ft. UEC is having another office at Mumbai along with a service station.

The United Engineering Company has been honoured by the prestigious ‘Innovator’s

56 EXPRESS PHARMA January 16-31, 2015

Founder: GD Roy (R)

Award’ from the Indian Pharmaceutical Congress for their innovation and development.

Today, at UEC, machines are equipped with the latest technology. For its customers, UNITED machines are cost effective but are guaranteed with the highest quality, optimum production and ensured unconditional service.

UEC is equally focused on being a corporate citizen. It has never shirked the responsibility of the society and has always been an active participant in numerous social events which help in uplifting the quality of living of the deprived.

With almost every pharma formulation manufacturer being an 'UNITED' machine user coupled with over 50 years experience, UEC commits in becoming better than the best in the near future.

PROFILE

Neomachine Mfg Co: Aleader in automatic coating technology KOLKATA-BASED Neomachine Mfg Co was started in 1973 with an objective of manufacturing all types of pharmaceutical machinery.

For a decade, the company catered to the requirements of the Indian pharma companies in injectable, liquid, tablet, capsule and ointment sections machinery.

‘While catering to this market segment, Neoma-

chine happened to come across a Kolkata-based pharma producer, who were envisaging problems in film coating of tablets. Until then, the tablets were being coated in conventional pans, which were not only causing health hazards to the coating personnel, but was also a timeconsuming process. Inspired by this opportunity, Neomachine started the process of

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developing an automatic coating machine in the right earnest. After, two years of research and development, the first ‘Neocota, Automatic Coating System’ was manufactured in 1984.

During the last three decades, Neomachine manufactured and marketed more than 550 machines, out of which 100 machines were exported to the different coun-

tries like the US, Australia, China, Jordan, Yemen, the UAE, Uganda, Kenya, Sudan, Cyprus, Saudi Arabia, Austria, Brazil, Bangladesh, etc.

Neomachine, a professionally managed organisation now has two manufacturing units in Kolkata, which are equipped with state-of-theart equipment like fabrication, machining, assembling, finishing and other related

ANUP MAITRA Managing Director, NEOMACHINE

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jobs. The company has been strictly following all the quality control guidelines during manufacturing. The boughtout items are inspected at the manufacturers’ works period-

ically. The company has a dedicated team of engineers for providing erection and commissioning and prompt aftersales service to the clients.

The in-house R&D facility

is abreast of the latest technology upgradation and the latest developments in ‘coating technology.’ This helps in continuous improvement of the product.

Neomachine also provides DQ/IQ/OQ/PQ Qualifications for automatic coating system and are in the process of getting CE Certification.

Over the years, the com-

pany has gained vast experiences in manufacturing ‘Automatic Coating System’ by interacting with various Indian and multinational pharma and confectionery units based in India.

The in-house R&D facility is abreast of the latest technology upgradation and the latest developments in ‘coating technology.’

This helps in continuous improvement of the product Products like Cadbury India’s fast-moving product ‘Gems’ and Parke Davis’ ‘Chicklets’ are coated in the systems manufactured by Neomachine. The company also impart aqueous and nonaqueous film coating and sugar coating technology to clients, who need the same expertise.

Neomachine also supplies Hepa Filter for filtration of incoming drying air and Mobile Bed Wet Scrubber for purification of exhaust air for the companies that need these items.

Neomachine, being a single-product company, manufactures various models of Neocota. The automatic Coating Machine, gained vast experience in coating technology since the last two decades. Neocota is designed to comply with current US FDA and other international legislation as well as anticipated trends. The improved and flexible design enables Neocota to perform in national and overseas environment without any system modification.

58 EXPRESS PHARMA January 16-31, 2015