VOL. 12 NO. 22 PAGES 92
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Market
‘Miljon plans to cover 10 lakh chemists over next five years’
Management
‘Pharmacy profession is in a revolutionary phase at present’ 16-30 SEPTEMBER 2017, ` 40
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by
CONTENTS MARKET
Vol.12 No.22 September 16-30, 2017 Chairman of the Board Viveck Goenka
John Kuriakose Director and Founder, Miljon Medi App
Sr Vice President-BPD Neil Viegas Editor Viveka Roychowdhury* Chief of Product Harit Mohanty
Akshay Jain Director, Miljon Medi App
BUREAUS Mumbai Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das, Mansha Gagneja, Swati Rana New Delhi Prathiba Raju DESIGN
National Design Editor Bivash Barua Asst. Art Director Pravin Temble Chief Designer Prasad Tate Senior Designer Rekha Bisht Graphics Designer Gauri Deorukhkar
APIs have given the Chinese dragon a stranglehold on Make in India’s lion. Can PSUs be the weapon to counter this threat? | P22 P35: REPORTS Evolving US generic market to plummet profitability levels of Indian pharma cos: Report
MANAGEMENT
39
Senior Artist Rakesh Sharma, Vivek Chitrakar
P40: INTERVIEW
Photo Editor Sandeep Patil
‘Pharmacy profession is in a revolutionary phase at present’
MARKETING Regional Heads Prabhas Jha - North Harit Mohanty - West Kailash Purohit – South Debnarayan Dutta - East Marketing Team Ajanta Sengupta Ambuj Kumar E Mujahid Nirav Mistry Rajesh Bhatkal Sunil Kumar
Abhay Kumar President, Indian Pharmacists Association (IPA)
P44: VENDOR NEWS Big data enabling new standard in SCHOTT’s pharma glass manufacturing
PRODUCTION General Manager BR Tipnis Manager Bhadresh Valia Scheduling & Coordination Ashish Anchan CIRCULATION Circulation Team Mohan Varadkar
INNOVATION WITHIN DYSLIPIDEMIA, HEART FAILURE AND THROMBOSIS SET TO REDUCE HIGH CVD MORTALITY RATE
RESEARCH
42
FDA APPROVES PFIZER’S LEUKAEMIA DRUG
43
NEW DATA BOOSTS CASE FOR EXTENDED USE OF ASTRAZENECA HEART DRUG
14
‘MILJON PLANS TO COVER 10 LAKH CHEMISTS OVER NEXT FIVE YEARS’
19
HEALTHCARE SENATE 2017 FOCUSSES ON FUTURE-READY HEALTHCARE
CORRIGENDUM In the September 1-15, 2017 issue, on page 42, the headline of ACE Technologies was wrongly mentioned.The correct headline is Fedegari’s integrated systems & solutions for pharmaceuticals
Express Pharma® Regd. With RNI No.MAHENG/2005/21398. Postal Regd.No.MCS/164/2016-18. Printed and Published by Vaidehi Thakar on behalf of The Indian Express (P) Limited and Printed at The Indian Express Press, Plot No.EL-208, TTC Industrial Area, Mahape, Navi Mumbai-400710 and Published at 2nd floor, Express Towers, Nariman Point, Mumbai 400021. Editor: Viveka Roychowdhury.* (Editorial & Administrative Offices: Express Towers, 1st floor, Nariman Point, Mumbai 400021) * Responsible for selection of news under the PRB Act. Copyright © 2017. The Indian Express (P) 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.
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EXPRESS PHARMA
11
September 16-30, 2017
EDITOR’S NOTE
A double whammy for the sector?
A
s expected, the August 30 meeting called by the Department of Pharmaceuticals (DoP) to discuss the Draft Pharmaceutical Policy 2017 saw a laundry list of recommendations from representatives of pharmaceutical companies and associations. While the Indian Drug Manufacturers’ Association (IDMA) gives the thumbs up to seven proposals, their written submission states that ‘the general impression from the Draft Policy is that the government wants to increase the span of price control through direct and indirect measures’. The letter calls for a 'liberalisation of pricing policy and procedures ’ and also quotes the Niti Aayog's Three Year Action Agenda, which recommends that the DPCO be delinked from the NLEM. IDMA's recommendations have some interesting points. For instance, one suggestion is that the production of key starting materials, critical intermediates and fermentation-based products can be taken up by pharma PSUs, maybe in partnership with private firms or joint ventures. Given the move to shut down pharma PSUs, this could be a good way to reduce the dependence on imports of APIs, especially from hostile countries like China, as well as ensure a steady supply of affordable quality APIs. The crucial role of pharma PSUs in the Make in India story, is highlighted in our cover story in the September 16-30 Express Pharma issue (See story: Make in India: The story so far). The story reviews the scheme two years after its launch but finds that the pharma sector has nothing much to show, inspite of being one of the focus areas. The cost of quality could also increase if the draft proposal to implement BA/BE studies for class II and IV drugs is passed. On the trade front,
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12 EXPRESS PHARMA September 16-30, 2017
This pressure could, in the medium term, lead to consolidation in the sector, benefiting the bigger players
IDMA also points out that restricting margins at the retail level will discourage chemists from stocking generics, especially in rural areas where the overheads are larger than the sales. Financial analysts at Motilal Oswal have predicted that the draft policy in its current form can lead to a 'double whammy'. A report dated September 7 analyses that that an enhanced focus on quality control, along with a shift toward trade generics, can lead to a significant contraction in the EBITDA margin (currently at 30-40 per cent) for domestic pharma companies. The domestic pharma business’ rich valuation of 25-30x one-year forward P/E due to strong profitability, stable revenue stream and high RoEs will also be eroded. If the cost of quality increases and revenue/margins contract due to a shift toward trade generics, then it will be a double-whammy (shrinking profitability and valuations) for the domestic business. With the US business of mainstream players already under pressure due to a challenging growth outlook, this draft policy (if implemented) can lead to further pressure on profitability and valuations. But the crunch on margins could lead to an interesting fallout. The Motilal Oswal analysts opine that this pressure could, in the medium term, lead to consolidation in the sector, benefiting the bigger players. The signs are clear that the pharma industry, both domestic and MNC companies, are united on their objections and will not accept the draft policy in its current form. But the Government too cannot back down entirely from its pro-people stance. Who will blink first? VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com
MARKET I N T E R V I E W
‘Miljon plans to cover 10 lakh chemists over next five years’ Recently, a mobile app called ‘Medi-App’ was launched for chemists, which is expected to help pharma companies, distributors, stockists and retailers to enhance the existing supply chain. John Kuriakose, Director and Founder and Akshay Jain, Director, Miljon Medi App, elaborate more the app, its benefits and their company’s growth strategies, in an interaction with Usha Sharma Tell us about Miljon MediApp and its functionality Medi-App is India’s first mobile application for retail chemists, launched by Miljon Medi-App, connecting pharma companies, distributors, stockists and retailers. The aim is to introduce digitisation in the order procurement process at the retail level, which is still in the archaic stage of salesmen booking orders from chemists directly. Medi-app will also be a direct medium of communication between the company and the retail trade. Medi-app is purely a B2B platform which offers companyspecific products to the retail chemists. The app is available free for chemists and stockists. Medi-App has the following information and functions: ◗ Product range with composition, pack shots ◗ Product MRP and PTR (Price to retailer). ◗ Scheme/bonus offer details ◗ Order placing by retail chemists which are conveyed to the stockist in real time. ◗ Company notifications for new products, schemes/gifts etc. can be sent direct to the chemists. ◗ Profile of chemists with all details of licenses, address, phone numbers and email ids. ◗ History of purchases made. Overall, how much investment did you make in developing the app? And from
14
EXPRESS PHARMA
September 16-30, 2017
company’s own resources. Miljon is co-certified under the Start-Up India scheme of Government of India. We can access funds from the special fund of `10,000 crores, set apart by the government for startups through venture funds. We also plan to go public in two years to fund our expansion.
John Kuriakose Director and Founder, Miljon Medi App
where did you arrange the funds? Do you have further investment plans? Medi-app is an original and pioneering idea developed by John Kuriakose. Medi-app and its back-end systems have been developed by DuBase, a Bengaluru-based software company, at the cutting edge of cloud computing technology. All funds required for developing the app and propagating it so far are internally funded. India has about 10 lakh retail chemists. It will require about `100 crores to cover all chemists. Initial investments for covering one lakh chemists requiring about `10 crores will be funded with
How are you creating app awareness among pharmacists? Till now, how many chemists have installed and how many are you targeting? Medi-app was test marketed in Mumbai and Jagraon (Punjab) before its formal launch in August 17. The test marketing was done with products of Makers Laboratories (An IPCA Group Co), from May to July 17. The results were very encouraging with 100 per cent success in downloads among the chemists targeted. 84 per cent used the app to place orders and 38 per cent placed repeat orders. Retail chemists are being approached directly using our stockist network and our field staff for downloading medi-app. Miljon plans to cover 10 lakh chemists over the next five years in a phased manner. In the first 12 months, one lakh chemists in Uttar Pradesh, Delhi, Haryana, Punjab, Gujarat, Maharashtra, Andhra
pharma companies. Knowledge and awareness about full product range of drug companies, especially trade generic companies, is spread by their field staff/stockists. The retailers also have no direct access to generics pricing offered by companies. They come to know of it through stockists which are often not accurate. Medi-app empowers chemists to get direct access to products of pharma companies with their prices and enables them to place orders direct to the stockists.
Akshay Jain Director, Miljon Medi App
Pradesh and Tamil Nadu are being targeted with the help of field staff and stockists. Around 300-500 stockists will be appointed to contact retailers and help them download mediapp. Akshay Jain, Director, Miljon, is in charge of managing this huge task of downloading operations. How MediApp will have an online touch with traditional flavour? Why do you think this can be a successful model? Medi-app plans to use and strengthen the existing distribution chain, infusing technology. Today, no retail chemist has direct access to the
Medi-app advantages to stockists ◗ Direct online link to chemists, ◗ Less dependency on field staff or salesmen for orders ◗ Real time receipt of orders enabling better servicing ◗ No disputes on rates or order quantity ◗ Full purchase history by chemists Medi-app advantages to pharma companies ◗ Direct online link to chemist, stockist and super stockist ◗ Reduces dependency on field staff to communicate with chemists ◗ Offers real time tracking of sales at chemist level ◗ Can tailor make marketing strategies in specific areas trough better and detailed analytics ◗ Direct and instant
communication with chemists through medi-app ◗ New product launches made easier and more efficient ◗ Better inventory management Medi-app plans to safeguard retail chemists from the onslaught of online pharmacies. In the near future, we will offer an extension of medi-app which will link every retail chemist with their regular customers. Customers can upload their prescriptions to the chemist through the app. Thus, every chemist will have a digital link with their customers and ensure that their customers continue to buy from them. So medi-app will be safeguarding the interests of brick and mortar chemists from online pharmacies. This will also
In the near future, we will offer an extension of medi-app which will link every retail chemist with their regular customers. Customers can upload their prescriptions to the chemist through the app enable pharma companies to be linked to the consumers for the first time. As we envisage covering the entire chain of pharma sales and strengthening each part of the chain, medi-app is being welcomed by the trade. Companies would rather welcome a ready-made platform like medi-app, rather than try to re-invent the wheel. Miljon plans to have a turnover of ` 1000 crore by 2020. This will ensure its success.
Tell us the company’s strategic partnership with Makers Laboratories? WIN division of Makers Laboratories, Ipca Group is the first company which has launched its entire product portfolio on Medi-App portal. Miljon Medi App has entered into a franchise agreement with Makers Labs to launch WIN division. These are trade generic products. Miljon will be responsible for all marketing and sales activities. About 40
products in various categories like antibiotics, analgesics, anti-inflammatory, antacid and nutraceuticals are being launched. These products will be exclusively available only on medi-app. Prashant Godha, Executive Director, Ipca Labs, said that he was confident of the potential of Medi-app and the advantages it offered in making WIN division a success. Which pharma products will be available on your app?
Miljon is in talks with other pharma companies for bringing them onboard medi-app, which is going to be the largest platform of retail chemists in India. Several companies have shown great interest. We will be adding companies in the next six months. We are confident that most major companies would come onboard in the coming years. Which drugs will be available on the app and will they be available at discounted rates? About 40 products in various categories like antibiotics, analgesics, anti-inflammatory, antacid and nutraceuticals will be available. All schemes and offers by the company are passed on to the chemists. u.sharma@expressindia.com
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EXPRESS PHARMA
15
September 16-30, 2017
MARKET GROWTH TRACKER
IPM clocks ` 115052 crs in July 2017 The industry witnessed a stress in their internal sales in the month of June due to GSTimplementation THE INDIAN Pharmaceutical Market (IPM) clocked ` 115052 crores of which the retail sector was valued at ` 96759 crores as of MAT July 2017 with a growth of 6 per cent over last year. However, on a monthly level we do see a steep decline in growths to a tune of -7.6 per cent. The share of top 10 companies continued to be 43 per cent in the IPM and these top companies have shown a de-growth of 7 per cent over SPLY. The top 150 companies continue to account for 97 per cent of IPM on MAT and month basis. Top 20 companies contribute to 64 per cent in both MAT and month level. Out of the Top 10 companies, only Lupin showed a remarkable growth on MAT basis but has de-grown on month basis. All the companies showed positive growth on MAT among the top 10 companies. Most of the companies in 11-20 bracket have shown de-growth for the month apart from Torrent, Sanofi and USV which reflected a positive growth. Glenmark and USV have grown in double digits while Pfizer and DRL reflected a negative growth for the MAT as well. While industry saw a stress in their internal sales in the month of June due to GST implementation we did see a greater impact at the stockists level in the first 10 days of July. Therefore, we do see a degrowth across the Top 20 companies with a few exceptions like Torrent, Sanofi and USV who have recorded a positive growth for the month. Basis the current trend, we should expect a pull in sales in the first half of next month. The impact can also be seen on the Top 10 brands of IPM as these brands which are valued at `320 crores for the month of July 2017 have shown a combined single digit growth at 3per cent over SPLY. However, this impact is mainly due to high degrowth of two brands belonging
16
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September 16-30, 2017
Table 1: Pharma market size in Million $ USD by country All values in Million USD
June Month
Month Growth per cent
MATJune
MAT growth per cent
Global pharma market
88,537
-6.5
1,081,176
4.1 2.5
US
43,734
2.5
450,969
China
6,547
2.576,648
0.4
Japan
6,366
-3.4
77,757
Germany
3,501
1.6
40,657
1.8
Brazil
2,113
12.1
24,167
27.3
0.4
Uk
2,009
-4.4
22,629
-12.5
France
1,803
-36.4
31,842
-2.9
Canada
1,681
2.5
19,662
3.1
India
1,306
4.7
15,924
7.8
Italy
1,205
-50.8
27,122
-4.6
Australia
1,029
-9.4
13,079
11.9
Russia
984
-7.9
14,034
21.4
Spain
943
-49.7
19,760
-6.1
Venezuela
358
-98
35,930
149.6
All values in Million USD
May Month
Global pharma market
88537
Sun Pharma
439
Lupin Laboratories
360
Dr Reddys Lab
Table 2: Indian companies’ market size in the global market Month growth per cent
MAT May
MAT growth per cent
-6.5
1081176
4.1
-10.1
5478993
6.1
-5.2
4174340
11.8
257
-3.5
3015223
-1.6 25.1
Cipla
194
24.3
2242963
Torrent
191
7.4
2173437
11.8
Aurobindo
184
-8.1
2206080
-5.5
Zydus Cadila
181
3.2
2147750
-0.7
Glenmark Pharm
155
-5.8
1841665
5
Intas
152
-10.3
2110887
15
Mankind Pharma
105
15
1180254
8.5
to anti-infective therapy which are Monocef (-33 per cent) and Augmentin (-13 per cent). Other top 10 brands like Lantus (34 per cent), Janumet (18 per cent) and Galvus Met (13 per cent) have shown a double digit growth while remaining have also grown positively. A major change in the list of top 10 brands is exit of Spasmo-Proxyvon +, Prevenar and Dexorange whose place is taken by Thyronorm, Betadine and Monocef. Also, Novomix rose to fifth position to enter among top five brands. The impact has been more on brands ranked 11-20 which were valued at ` 221 crore and showed a combined growth of (-3 per cent).
Only Duphaston (31 per cent) and Shelcal (19 per cent) grew in double digits while seven brands showed negative growth. Indian companies continued to dominate the IPM with a share of 79 per cent for the month of July 2017 and showed a de-growth of -8 per cent alike the IPM. MNCs maintained their 22 per cent share and for the first time in last one year showed a better situation than Indian companies in terms of growth as they had a combined growth of -4 per cent. Number one MNC Abbott (0 per cent) recorded a flat growth where as other top 10 MNCs like Sanofi (3 per cent), Novartis (1 per cent),
MSD (6 per cent), Janssen (7 per cent) and Eli Lily (8 per cent) all showed a positive and better than market growth for the month. Chronic therapy grew at 1 per cent and registered a better growth as compared to acute therapy (-12 per cent) which continues to dominate the IPM with 65 per cent share. Cardiac continues to be the largest therapy with a growth of 1 per cent while anti-infectives maintained its second position after displacing gastrointestinal therapy (third rank for July 2017) from the position last month. Anti-diabetic therapy continued to be the only therapy in IPM growing in dou-
ble digit with a growth of 12 per cent while Derma (4 per cent) was the second fastest growing therapy. DPP IV Inhibitors and combination was valued at ` 215 crores for the month and continued to be the number one therapeutic class 4 with a strong 21 per cent growth. However, Amoxy and Clavulanic Acid Solids (-24 per cent) and Cough Preparation Ethicals (-31 per cent) recorded a high negative growth for the month. Cardiac therapy has maintained its number one position in IPM. It has clocked a revenue of ` 1121 crores and a growth rate of 1 per cent as compared to SPLY. It is only one of the three thera-
MARKET pies from top 10 to show a positive growth. Rosuvastatin (` 61 crore), Atorvastatin (` 61 crore) and Telmisartan (` 50 crore) are the top three molecules in the therapy. Atorvastatin has continued to show high de-growth (-16 per cent) as compared to Rosuvastatin (3 per cent) and Telmisartan (9 per cent) both growing better than the therapy. Combination molecules contribute 40 per cent of sale in the cardiac therapy and have shown progressive growth at 4 per cent as compared to single molecules de-growing at (-6 per cent). In combination, strong growth was recorded by Telmisartan and Combination some of which are Telmisartan + HCT (6 per cent), Telmisartan + Amlodipine (8 per cent) and Telmisartan + Metoprolol (15 per cent). Among top five brands only Minipress-XL (-9 per cent) showed a negative growth whereas Rosuvas (8 per cent), Telma (23 per cent), EcosprinAV (11 per cent) and Telma-H (18 per cent) recorded strong growths. Anti-infective therapy which is valued at ` 1100 crores for the month of July has seen the highest de-growth of (-25 per cent) and it being the second largest therapy has pulled down the overall growth of IPM. However, value wise it has shown a better performance than May 2017 and June 2017. Its top 10 molecules have all shown a double digit negative growth with Ceftriaxone Injectables (-36 per cent) having the largest impact. Amoxy and Clavulanic Acid Solids valued at ` 99 crores and the biggest molecule in the therapy also showed a de-growth at -24 per cent. Even progressive molecules like Meropenam (-11 per cent) and Ceftriaxone + Salbactum (-16 per cent) performed poorly for the month. Gastro intestinal therapy continued to be the third largest therapy in IPM behind anti-infective and clocked a value of ` 1043 crores for the month with de-growth of -7 per cent. Pantoprazole + Domperid which is the largest molecule within the therapy at ` 65 crores for the month showed a de-growth of -2 per cent and only Pantoprazole Solids (2 per cent) showed a positive growth among top 10 molecules. However, Bacillus Clausii
EXPRESS PHARMA
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September 16-30, 2017
remained unaffected by the overall de-growth and continued to impress with a growth of 26 per cent for the month. Other top molecules which grew positively are Milk of Magnesia and Combination (14 per cent) and Lactulose (2 per cent). Even though the largest brand Spasmo-Proxyvon recorded a negative growth of (-16 per cent),
other top 10 brands like Pan (2 per cent), Pan-D (13 per cent), Pantocid (8 per cent), Pantop-D (7 per cent), Pantop (5 per cent) and Duphalac (19 per cent) recorded a progressive growth. Anti-diabetics continued to be the fastest growing therapy in IPM and for the month of July 2017 recorded a growth of 12 per cent over SPLY and a value of
` 918 crores. It maintained its fourth position in the IPM for the month and with this pace is soon set to enter the top three therapies. Top 5 brands of the therapy which are Mixtard (` 52 crores), Glycomet-GP (` 38 crores), Lantus (` 34 crores), Janumet (` 33 crores) and Novomix (` 29 crores) are also the top 5 brands of IPM for the month of July
2017 and all these brands grew robustly. In fact only one of the top 30 brands, Azulix-MF (-4 per cent), has shown negative growth. Among molecules DPP4 Inhibitors (215 crores) and Glimepiride + Metformin (171 crores) together contribute 42 per cent sales of the therapy and are the two largest molecules in IPM. SGLT-2 Inhibitors
MARKET maintained its progressive trend with growth for the month recorded at 104 per cent over SPLY. Only Metformin showed a negative growth (-6 per cent) among Top 10 molecules. Pain / analgesics marginally overtook Vitamins-MineralsNutrients (VMN) to take the position in IPM for the month of July 2017 and recorded a value of ` 739 crores at -10 per cent growth over SPLY. Calcitriol Combination was the largest molecule in therapy with a value of ` 55 crores but showed a negative growth of -9 per cent. Only three molecules among top 10, Paracetamol + Tramadol (12 per cent), Paracetamol Injections (10 per cent) and Diclofenac Injectables (2 per cent), recorded a positive growth. Trypsin-Chymotrypsin (14 per cent) was the highest growing molecule having value above ` 10 crores. Among top brands the number one brand Voveran (8 per cent) showed a stable growth whereas Ultracet (22 per cent) continued to grow robustly. Dermatology clocked ` 689 crores for the month of July 2017 and was only one of three therapies showing positive growth as well as the second fastest growing therapy in IPM with a growth of 4 per cent. Emollients remains the largest sub category within the therapy which grew at 2 per cent. Only two of top 10 molecules showed de-growth whereas the second largest molecule Itraconazole showed a tremendous growth of 83 per cent over SPLY. Luliconazole, which was launched just last year, has continued its impressive performance by clocking ` 20 crores for the month of July 2017. Betadine continues to be the top brand in Derma therapy which grew at (-1 per cent) while Panderm+ (53 per cent) and Candiforce (63 per cent) are among top brands which recorded a strong growth. Brands like IT-Mac (129 per cent) and Lulifin (135 per cent) continued their progressive performance in the month of July 2017.
SNAPSHOT – TOP 150 COMPANIES
Top 10 companies constitute 43% share of IPM on MAT and Month basis The top 150 companies continue to account for 97% of IPM on MAT and month basis ● For both MAT and month,Top 20 companies contribute to 64% ● GST implementation slowed down the growth of the top companies for month of July 2017. On a MAT basis, highest growth can been seen in the companies ranked between 101-150. Source: QuintilesIMS TSA & SSA, July 2017 ● ●
SNAPSHOT – TOP 40 BRANDS
Mixtard continues to be the top brand with a MS of 0.6% Lantus and Duphaston have shown phenomenal growth in July 2017 ● Other brands with remarkable growth are Utracet,Jalra-M, Udiliv,Telma and Istamet Source: QuintilesIMS TSA & SSA, July 2017 ● ●
Global (June 2017) The global pharma market is valued at $1081 billion growing at 4.1 per cent. The US continues to dominate the market with 41.7 per cent market share with
18
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September 16-30, 2017
growth of 2.5 per cent. Amongst the top market, India has notched up and is ranked 9th. Only market in the Top markets with more than 10 per cent
growth is Brazil. Except Germany, the remaining Top 5 EU markets are all de-growing as per June 2017 data. Indian companies hold 3.68
per cent share in the global market as per June 2017 data. For the month of June 2017, the IPM showed growth and among Top 10 companies, only Cipla and
Mankind showed more than 10 per cent growth. Top 10 companies contribute to 68 per cent market share among Indian companies in the global market.
MARKET POST EVENT
Healthcare Senate 2017 focusses on future-ready healthcare Experts come together to create a roadmap for the industry to transform into an entity which can effectively tackle unprecedented challenges and opportunities in future HEALTHCARE SENATE 2017, the national private healthcare business summit by Express Healthcare and The Indian Express Group, was recently held at Novotel Airport in Hyderabad. This year, the event's theme was ‘Building a future-ready healthcare sector in India’. Over three days, an impressive gathering healthcare leaders, game changers and innovators focussed on the roadmap to steer the industry towards transforming itself into an entity which is competent to handle both, opportunities and challenges of the future, which are likely to be unprecedented. Here are some of the sessions at Healthcare senate 2017. Thumbay Moideen, Founder & President, Thumbay Group spoke on the creation of an innovative, sustainable and self-financed private academic health system and elaborated on the efforts of the Thumbay Group in this direction. Dr Nupur Kohli, Healthcare Adviser, The Netherlands who is also a TedX speaker, drew comparisons between nations, majorly Netherlands. She highlighted the current
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MARKET challenges in India’s healthcare delivery system and shared learnings from global experiences which can be incorporated in the current healthcare system. It also saw panel discussions on very pertinent topics. ‘Fighting the antibiotic apocalypse’ saw experts come together to find effective ways to tackle growing resistance to drugs and the huge adverse implications on the country’s health. The panel comprised Dr Clive Fernandes, Group Clinical Director, Wockhardt Hospitals & JCI Consultant, Joint Commission International, Dr Selwyn Colaco, COO, Cytecare Cancer Hospitals, Dr Nandakumar Jairam, Chairman, CEO & GMD Columbia Asia hospitals, Dr Subramanian Swaminathan, Infection Control Expert, Global Hospitals and Sumit Marwah, CEO & Director, Dispoline India. 'Evolving role of hospital pharmacies' was another topic for discussion which had an eminent panel comprising Biplab Chatterjee, CEO, BPPI, Department of Pharmaceuticals, GoI; Dr Suresh Saravdekar, Chairman Hospital Division, IPA, Maharashtra; Prafulla Naigaonkar, Former Pharmacy in Charge,Tata Memorial Hospital; Dr Meena Shriniwas Shelgaonkar, Senior Research Consultant (Clinical Pharmacologist),CIIMS and Sojwal Vora, VP & Group Head–Supply Chain, Chief Procurement Officer, Manipal Hospitals. The panelists in this session showcased how hospital pharmacies can become revenue boosters if leveraged effectively. A panel discussion on ensuring cost efficiencies within capital intensive departments highlighted various ways to increase revenue through volumes to attain profitability without hampering quality. The panel comprised Dr Bhavin Jankharia, Partner and Consultant at PictureThis; Dr Vidur Mahajan, Executive Director, Mahajan Imaging; Dr Biren Chauhan, Group Centre Head, Sunshine Global Hospitals; and Dr Sandeep Chatrath, Regional
20 EXPRESS PHARMA September 16-30, 2017
Dr Alexander Thomas, Chairman, AHPI; Zoya Brar, CMD Founder, Core Diagnostics; Dr Abhijit Sinha Roy, Medical Director, Westminster Healthcare; Col Binu Sharma, VP, Nursing Columbia Asia Hospital & President, INS India; Soumya Kanti Purkayastha, Chief Executive, Berkeley HealthEDU
Thumbay Moideen, Founder & President, Thumbay Group
Dr Nupur Kohli, Healthcare Adviser, The Netherlands
A panel discussion titled ,‘People first’ delved on techniques that will lead organisations to empower their workforce and make them future ready Chief Executive Officer, Andhra Pradesh & Telengana, Apollo Hospitals. A panel discussion titled , ‘People first’ delved into understanding various strategies and deliberated on techniques that will lead organisations to empower their workforce and make them future ready. The panel included Dr Alexander Thomas, Chairman, AHPI; Zoya Brar, CMD Founder, Core Diagnostics; Dr Abhijit Sinha Roy, Medical Director, Westminster Healthcare; Col Binu Sharma, VP, Nursing Columbia Asia Hospital & President, INS India; Soumya Kanti Purkayastha, Chief Executive, Berkeley HealthEDU. Apart from insightful discussions, an Awards Nite was also part of the event. Best practices and innovation in healthcare delivery were recognised through Best Hospital Pharmacy Citations, presented by Glenmark. The game changers and visionaries of private healthcare in India were honoured with Express Healthcare Excellence Awards. After the awards, the delegates and winners continued the celebrations over the gala dinner. These are just a few of the interesting sessions at Healthcare Senate 2017. Catch the detailed and exclusive coverage about the event in the October 2017 issue of Express Healthcare. EP News Bureau
MARKET EVENT BRIEF 21
India Lab Expo 2017/ analytica Anacon India
7
Proactive & Sustainable Compliance Workshop
INDIA LAB EXPO 2017/ ANALYTICA ANACON INDIA Date: September 21-23, 2017 Venue: Hitex, Hyderabad Summary: India Lab expo, India’s largest exhibition on laboratory, scientific, analytical and biotechnology sector will see international as well as Indian manufacturers and distributors. Decision makers from sectors like hospitals, diagnostic labs, oil and petroleum, chemical, cosmetics and government departments will meet at the tradeshow. The event will be supported by Ministry of Science & Technology, Government of India. Contact details MMI India INIZIO 507 & 508, 5th Floor, Cardinal Gracias Road, Opp P&G building, Chakala, Andheri (E), Mumbai - 400099 Tel : +91 22 42554710 Mob: +91 9820668393 Fax: +91 22 42554719 Email: info@mmi-india.in
PROACTIVE & SUSTAINABLE COMPLIANCE WORKSHOP Date:December 7-8, 2017 Venue: Mumbai, India Summary: Markets and Markets, will organise a seminar on Proactive & Sustainable Compliance Workshop. The seminar will have a panel of international experts who will shed light on recent compliance challenges confronting the biopharma industry worldwide with a special focus on the Indian industry. Contact details Amit Shelke Email: amit.shelke@marketsandmar kets.com Phone no: +91 20 30108 270
To subscribe: bpd.subscription@expressindia.com
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22 EXPRESS PHARMA September 16-30, 2017
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THE LION AT CROSSROADS
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MAKE IN NORTH EAST INDIA
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MAKE IN INDIA ACHIEVEMENT REPORT
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THE LION AT CROSSROADS India's over dependence on China for supply of APIs and bulk drugs is a serious threat to ‘Make in India’. PSUs could be the key to break free of the dragon and expedite the lion's strides By Lakshmipriya Nair
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his September marks the third anniversary of the ‘Make in India’ initiative, launched by Prime Minister, Narendra Modi in 2014 to develop India into a global design and manufacturing hub. This nationbuilding endeavour seeks to raise the manufacturing sector’s contribution to 25 per cent of the GDP by 2020 and make India not only self-reliant but also a global leader.
A game changer….. In December 2014, an action plan for three years was charted to boost investments in 25 sectors, including pharma. Nirmala Sitharaman, then the
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Minister of State (Independent Charge) in the Ministry of Commerce & Industry, had informed that the government would emphasise on four areas: policy initiatives and new processes; robust infrastructure; focus sectors; and new mind-set/approach. Since then, the pharma sector has witnessed a slew of measures to aid the Make in India initiative. (See Box 1). Reportedly, these steps have resulted in the growth of the sector by 15.1 per cent from $27 billion in FY2014-15 to $31 billion in FY2015-16. Pharma exports increased by 9.7 per cent in FY 2015. (Source: http://www.makeinindia.com/article/-/v/sector-survey-
pharmaceuticals)
…..APIs could play
spoilsport PSUs can be Yet, this is only one half revived to of the story. The other half manufacture reveals a bleaker angle, that some selected and of India’s disproportionate dependency on Chinese APIs. very essential Last year, the National critical drugs such Security Advisor had raised a red flag on the over-dependas penicillin, or ence on China for the supply their large manu- of essential drugs and APIs. facturing plants Mansukh L Mandaviya, Minisleased to speed up ter of State for Chemicals and Fertilisers, had informed in production of a Rajya Sabha session that India’s API imports from China these APIs Daara Patel Secretary, IDMA
accounted to `13,853.20 crores in 2015-16, or 65.29 per cent of the total API imports of
`21,216.91 crores. Industry associations too have been raising this issue for quite some time now. Harish Jain, Secretary, Karnataka Drugs And Pharmaceuticals Manufacturers Association (KDPMA) informs, “Our dependency on APIs and intermediates from China is huge. KDPMA has been pushing for the growth of an indigenous API industry for more than a decade now and we have been flagging the issue at various forums.” China’s low price advantage has been the main reason for India’s dependence on the neighbouring country. However, strained political relations between the two nations, the
( Doklam standoff to cite the most recent example, have brought home the realisation that it is time to reduce this dependence as it could lead to a potentially volatile situation and grave risks as far as access to essential medicines are concerned. Moreover, this situation could also seriously derail ‘Make in India’ initiative’s progress and render a severe blow to its chances for success. An Associated Chambers of Commerce & Industry of India (ASSOCHAM )-Sathguru joint study, earlier this year had urged the need for “Make in India for India” in API manufacturing to benefit from lost market share, diminish India’s dependence on China and ensure self-reliance and sustainability.
An urgent need to rev up API production…. Taking cognizance of this fact, the government is mulling over setting up specified pharma
Dependence on China for APIs could lead to a volatile situation in case of access to essential medicines zones to boost domestic manufacture of APIs, based on the recommendations of an interministerial committee, headed by Secretary, Department of Health Research to revitalise API production in India. The industry too has sent in their suggestions to revive API production in India. Daara Patel, Secretary, IDMA, informs, “Earlier, 2015 was earmarked as the ‘Year of APIs’, but there was no major improvement in the situation. In the past, there was no single agency which would be
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responsible to ensure that necessary steps were taken and proposals monitored to ensure that progress was made. In order to have meaningful progress towards self-reliance, we feel that an Inter-
Ministerial Committee may be formed headed by Department of Pharmaceuticals as the nodal agency to drive the mission forward. It would be much easier for industry bodies like IDMA to co-ordinate with one
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nodal government body in our endeavour towards achieving self-sufficiency.” He adds, “We had provided a list of APIs and key starting materials to the government that could be indigenously
revived. Various scientific institutions like DST, DBT, CSIR, ICMR etc., can be encouraged to work in synergy with industry on R&D relevant for best procedures of production. PSUs can be revived to
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KDPMA has been pushing for the growth of an indigenous API industry for more than a decade Harish Jain Secretary, KDPMA
APIs are capital intensive. Pharma parks with shared services can help to save on costs and be more competitive Sunil Attavar President, KDPMA
It’s totally illogical to close down these PSUs, instead of modifying the work culture and enforcing discipline Dr GS Grewal Member Core Committee, ADEH
26 EXPRESS PHARMA September 16-30, 2017
manufacture some selected and very essential critical drugs such as penicillin, or their large manufacturing plants leased to speed up production of these APIs. This would go a long way towards achieving self-reliance.” Recently, IDMA submitted an action plan for APIs to CDSCO. (Check: http://www.expressbpd.com/ph arma/latest-updates/idmapresents-action-plan-for-apisto-cdsco/388967/) Sunil Attavar, President, KDPMA, suggests, “Pharma parks will be favourable for the industry. APIs are a risky and very capital intensive industry with heavy investments required in setting up the units. If there can be shared services in a park like common effluent treatment plants, common testing centres, common energy generation etc., it will help the industry to save on costs and become more competitive. Also, having a park helps share best practices, it will also aid in ease of doing business as many agencies will come together at site.” He further recommends: ◗ There should be fast track approval and push to build capacity that is twice the country’s next five years requirements ◗ Use the land available with the PSUs to be earmarked for APIs with the help of private partnership ◗ State governments should be incentivised to set up mega parks with pre-approved environment clearances Madan Mohan Reddy, Chairman, Pharmexcil, at an industry event, said, “Pharmexcil is in talks with the government and the industry to manufacture some of the top 100 molecules that are currently being imported to help reduce the dependency on imports.”
….but, not without PSUs? Thus, several steps are underway to rejuvenate API
production in India but one oft-repeated suggestion from different quarters to become self-reliant in APIs involve reviving PSUs. For instance, Department Related Parliamentary Standing Committee on Commerce, in its report on 'FDI in Pharmaceutical Sector' said, “They (pharma PSUs) need to be revived, re-strengthened and made dynamic and healthy so that generic medicines and vaccines are produced in larger quantities and made available to the masses at reasonable prices.” Yet, in December 2016, a Union Cabinet meeting chaired by Prime Minister Narendra Modi, decided to close down two of the oldest pharma PSUs like the Indian Drugs and Pharmaceutical Limited (IDPL) and Rajasthan Drugs & Pharmaceuticals Limited (RDPL). The government also gave the go ahead for the strategic sale of Bengal Chemicals & Pharmaceuticals (BCPL) and Hindustan Antibiotics Limited (HAL) after selling their surplus land. This decision has evoked mixed reactions and many believe that at a time when the government is trying to make ramp up access to affordable medicines, closing down PSUs is an ill-advised move. Dr GS Grewal, Consultant Physician and Former President, Punjab Medical Council, Member Core Committee, Alliance of Doctors for Ethical Healthcare in India (ADEH), Ludhiana conveys his viewpoint with very strong words, “It’s totally illogical to close down these PSUs, instead of modifying the work culture and enforcing discipline. It’s like you have infection and instead of controlling it, you amputate a part of the body. On one side we are talking of Make in India, on the other we are handing over PSUs to private players”. He also highlights the vital role PSUs have played in the
past to tackle various public health emergencies, “The PSUs provided the opportunity for India to produce cheap bulk drugs which benefitted not only our country but also several other developing countries. Their participation in the national health programmes is remarkable. Even during the plague outbreak in Surat a few years back, the IDPL played a major role in supplying Tetracycline for bulk use. Even WHO has applauded the role of PSUs. They can directly control the pricing of drugs. However, the problem is that instead of controlling corruption, the government is targeting PSUs It gives an indication that individual companies/players are more competent to run the industry than our own trained bosses, which is a very serious concern.” Dr Arun Mitra, National Senior Vice President, Indian Doctors for Peace and Development (IDPD), and Member Core Committee, ADEH says, “We totally disagee with the decision to close the PSUs in the pharma sector. Without PSUs, cheap bulk drugs will remain only a dream.” Bejon Kumar Misra, Founder, Patient Safety and Access Initiative of India Foundation, however offers a different point of view. He says, “Loss-making PSUs needed to be closed much earlier than said as they are a burden on the citizens. These decisions should have been taken much earlier rather than waiting for years to hide the misuse and misappropriation of public funds. We, as citizens, pay taxes for social development and good governance. Investments made by government on PSUs like IDPL and HAL were relevant at one point of time and there is an urgent need to encourage growth but not at the cost of profit or efficiency.” However, he also believes that appropriate and timely steps could have helped make PSUs sustainable. He says,
PSUs are likely to play a potent role in manufacturing APIs and help reduce dependence on imports Nilaya Varma Partner and COO, IGH, KPMG in India
Pharma PSUs can play a mentoring role and adopt science and innovation to encourage R&D Bejon Kumar Misra Founder, Patient Safety and Access Initiative of India Foundation
Modernisation of PSU units as per present day technology is needed Dr Arun Mitra National Senior VP, IDPD, and Member Core Committee, ADEH
( “There are several audit paragraphs by CAG on PSUs in terms of mismanagement but our elected representatives never take cognizance of such reports and rather try to defend the officials responsible for such misuse of public funds. As a last resort, they try to close down the units at the cost of the tax payers, without any kind of deterrent action on the officials.”
Leveraging the true potential Nevertheless, like many other pharma and healthcare experts, Misra too is of the opinion that if leveraged effectively, PSUs can change the game and boost API production in India. He states, “PSUs in the
Many opine that closing down PSUs is an ill-advised move when we need access to affordable medicines pharma sector can play a mentoring role by creating state-of-the-art manufacturing processes and adopting science and innovation to encourage R&D. Moreover, they can play an important role in manufacturing of APIs or intermediaries required in the formulation business. This can make India self-reliant and competitive rather than depending on external sources, especially from overseas. API production dwindled only because of poor quality and a non-competitive environment. PSUs can also create centres of excellence for good manufacturing and distribution practices to trigger healthy competition based on global best standards.” Nilaya Varma, Partner and COO, Infrastructure, Government and Healthcare (IGH),
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KPMG in India, also points out, “PSUs play a significant role to direct the economy in a positive direction by achieving desired socio-economic objectives. With the advent of ‘Make in India’ initiative, the public
pharma sector can play a key role in manufacturing drugs and raw material indigenously. By the end of 2017, the government is planning to push the count of Aushadhi Kendras to 3,000, from the current 2,149,
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across India. With such significant investment in providing affordable medicine, PSUs are likely to play a potent role in manufacturing drugs and APIs, helping to reduce the dependency on imports.”
The formula for success? However, it is undeniable that PSUs have faced several problems in the past and continuing the same way is an unviable option. (See Box 2) This means that significant investment and
cover ) efforts are needed to make them self-sustainable and profitable. As Varma states, “PSUs have significant potential in India, however, some measures are needed to revive these companies, allowing them to become financially sustainable, and contributing to the ‘Make in India’ campaign.” He also lists down his action plan to revive PSUs: Assessment and judicious disinvestment: Many PSUs are under a lot of debt, and therefore, divestment of available lands can help with the repayment of debt for their smooth functioning, in future. The efficient working of these pharma PSUs can determine India’s self-sufficiency in drug production. In addition, this approach can lead to an increase in public–private partnerships. For example, the government is planning to set up steel plants on surplus land of PSUs by forming partnerships with private sector players to double the steel production capacity to 300 million tonnes by 2030. Strengthening HR policies: PSUs have been facing challenges in hiring best talent owing to their low remuneration compared to market standards. To hire best talent in public sector, PSUs can introduce incentive-based performance targets to increase motivation and efficiency amongst employees. In addition, revision of employees’ remuneration packages; introduction of trainings/skill building; and social security measures can determine attraction and retention of industry experts in the current competitive market scenario Listing of profitable PSUs: Another revival approach could be the start of PSU listing process. The companies having positive net-worth, no accumulated losses and earned profit in the three immediate preceding years can be considered eligible for listing. Through listing, these central PSUs can raise fresh equity
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MAKE IN INDIA IMPACT ◗ The Cluster Development Programme for Pharma Sector (CDP-PS), by the Department of Pharmaceuticals under the Ministry of Chemicals and Fertilizers launched in December 2015. ◗ Introduction of the Merchandise Exports from India Scheme (MEIS) since April 2015 by the Ministry of Commerce. The subvention of interest for export has helped pharma exporters. ◗ In May 2016, the Department of Industrial Policy and Promotion (DIPP) launched the National Intellectual Property Rights (IPR) Policy, to foster innovation in the sector and expedite IPR filings. ◗ The Union Budget 2017-18 also increased allocation to health by 23 per cent, which in turn
has supported pharma sector’s growth. ◗ 11 National Institutes of Pharmaceutical Education and Research (NIPER) to impart quality education in pharma sciences were approved till 2015. In 2016, three new NIPERs at Chhattisgarh, Maharashtra and Rajasthan were announced. ◗ 100 per cent FDI under automatic route in greenfield pharma and up to 74 per cent FDI under automatic route in brownfield pharma ◗ To augment the pharma sector up the value chain from generics to more value-added and innovative offerings, the government is offering special incentives to set up Special Economic Zones (SEZs) and National Investment Manufacturing Zones (NIMZ) in designated areas of Jammu & Kashmir, North East Region,
THE PROBLEMS WITH PSUs A few major factors that turned several state-owned PSUs into loss-making entities: ◗ Management and operational challenges PSUs have been facing operational and managerial inadequacies, leading to significant fund wastages and inefficiency in day-to-day activities. There is a need for a proficient management team that could tackle the current industry challenges. Furthermore, lack of a robust performance management system to encourage employees is impacting the overall work environment. ◗ Product quality challenges To maintain the quality of pharmaceutical products, pharma companies need to invest in R&D, technology upgrades, skill development and product quality testing. Due to lack of technology support and skilled manpower, several PSUs face challenges to achieve high-quality manufacturing. Another key reason for present performance of PSUs is the lack of ability to meet quality standards for products. ◗ Governance challenges There are several PSUs which lack adherence to guidelines related to board independence, appointment of audit and absence of women directors. Furthermore, some of the PSUs have faced challenges in complying with the corporate social responsibility norms owing to ineffective implementation of corporate governance guidelines. As per a report by the Comptroller and Auditor General of India (CAG), about 29 firms did
not have the required number of independent directors as part of their board, and they failed to pay dividends despite making enough profits in 2014–15. ◗ Human resource challenges Pharma PSUs are facing talent shortage, as private players provide better performance-based incentive plans, training opportunities, market standard compensation and several career progression policies, which has led to low retention rates of competent professionals in PSUs. There is a need for the PSUs to integrate ‘Cost to Company’ principle into their existing HR policies to improve employee remuneration and career progression. ◗ Technology and strategic challenges Technology-focussed enterprises are facing challenges to fill the technology gap that exist in their organisations and to diversify their business portfolios. This has led to a situation where profits are declining. With evidence of higher product quality and better service delivery in the private sector, people are increasingly relying on private entities over public entities for their product purchase decisions. The share of these public sector enterprises has been reducing over time, whereas that of the private sector enterprises has grown in market cap, assets and profitability.
Source: Nilaya Varma, Partner and COO, Infrastructure, Government and Healthcare (IGH), KPMG in India
Utilising surplus cash to revive low performing PSUs: Some of the low-performing PSUs that are incurring losses could be supported by the profit-making PSUs. Initiatives by the government to revitalise the loss-making and closed plants through joint ventures of profit making PSUs, would leverage the existing land and infrastructure of the PSUs rather than selling or divesting the existing set-ups. This would not only contribute towards increasing the indigenous production and support ‘Make in India’, but would also generate employment in the country. Participation in the government procurement tenders: PSUs can be allowed to participate in government procurement contracts. For example, involvement of pharma PSUs in procurement contracts, where tenders by the central and state governments are centrally procured. The participation of these PSUs in national drug tender would increase competition and improve the market dynamics. The initiative would also determine the procurement of drugs or other products at low prices and local production in the country. Efficient utilisation of R&D budget: One of the key measure for reviving PSUs would be efficient utilisation of R&D budgets, primarily to commercialise or improve the technology proposition. The union government is already taking initiatives and made R&D mandatory for all profit-making Central Public Sector Enterprises (CPSEs) in 2011. The government has also tightened up the standards for the review of PSUs, where they would not only be assessed on their R&D budget, but also on tangible outcomes — for example, improvement in process or technology. Such measures would increase the efficiency and enable smooth operation of PSUs, helping them lend their support to the ‘Make in India’ initiative. Misra also shares his recommendations and says,
( “There is an urgent need to revive all the PSUs in the pharma sector in collaboration with the private sector and research institutions. PSUs should facilitate in building the capacity of the small and medium scale pharma industries and look for fresh investors to join hands with the PSUs in a shared and equitable manner without any strife for control or dominance.” He adds, “Selection of the human resource is paramount and there should be least interference from political and bureaucratic executives. We should attach PSUs with scientists and successful managers along with adequate financial support but with strict monitoring of expenses by financial and management experts. The board members of PSUs have to be strong committed persons with social development as entrepreneurs. The road map is simple. Invite leaders of the industry to take up the challenge and allow creativity to prevail.” Mitra suggests, “Modernisation of PSU units as per present day technology is needed, which in turn requires government funding. There is a need to have accountability in all sectors, public or private.”
Time to act Thus, the industry offers several pertinent suggestions to bring PSUs back on track and leverage its potential to gain self-reliance in APIs and bulk drugs. A Parliamentary Standing Committee on Commerce’s recent report admitted, “the manufacturing sector has grown only by an average of 1.6 per cent in the last five years till 2015-16.” PSUs can also help the government in nullifying this accusation by ramping up the numbers in the manufacturing sector. Tackling unemployment is another major benefit of making PSUs work. In 2017, a report from UN’s International Labour Organisation (ILO) on global trends revealed, “Unem-
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ployment in India is projected to increase from 17.7 million last year to 17.8 million in 2017 and 18 million next year. In percentage terms, unemployment rate will remain at 3.4 per cent in
2017-18.” This situation too can be reversed to a certain extent by making PSUs profitable and viable, not just in pharma but across other sectors as well. It is time to create an effec-
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tive action plan with all stakeholders’ participation to break away from the Chinese dragon’s hold over India’s pharma industry and PSUs, if revived effectively, can be a ma-
jor weapon to win this battle. Only then would we be able to make the lion roar! lakshmipriya.nair@expressindia.com (With inputs from Usha Sharma)
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MAKE IN NORTH EASTINDIA The government is making all efforts to uphold GST and Make in India campaign as their progressive steps. This September, the Make in India campaign will be turning three and the government has given many lucrative schemes to encourage industries to work in line with the campaign. The government is trying to attract investors and encourage them to setup their manufacturing facilities in the North Eastern region and Himalayan states. Last year in May, PM Narendra Modi had said that he will consider the North Eastern Region as the Gateway to South-East Asia. And recently Arun Jaitley, Finance Minister announced that under the GST regime, the government has extended tax incentives to industries in the North Eastern and Himalayan states till March 2027 albeit as a refund. Under the new GST regime, there is no provision for exemption but there is one section under the Act which permits refunds. The industry experts are saying that the later move of the government is to implement indirect taxation structure and give exemption to business enterprises from paying sales tax.These businesses will be eligible to
claim the refund later. To bring a new tax regime based on exemption, the Department of Industrial Policy and Promotion (DIPP) is working on preparing a scheme which will replace the current system. However, the new GST regime is critical for several industries like automobile, pharma and consumer goods and companies must start units in backward areas, where the economic condition of the state is poor just by availing the advantage of area-basedprogramme. This is a major reason why the government is extending tax incentives since 2003 to these regions. On January 7, 2003, the new industrial policy and other concessions for these states were announced for 10 years. However, companies started looking to exit the state as the concession period ends. To retain companies, the government further extended the concession till March 2017. To those who set up their facilities before march 2017, now it has been further extended for 10 years which will help companies to contribute to PM Modi's vision of Make in India. By Usha Sharma
Apart from taxincentives,there is a need for dedicated pharma parks T
DR AJIT DANGI President & CEO, Danssen Consulting
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he most important priority for ‘Make in India’ campaign from the pharma industry perspective should be domestic manufacturing of APIs, as we are over dependent on China and other countries for supply of APIs as well as drug intermediates. Any disruption in supply chain due to any geopolitical reasons could drastically impact our formulation industry. The new draft pharma policy has taken cognizance of this problem and has proposed that for-
mulations manufactured using domestically produced APIs be exempted from price control for a period of five years as well as be given preference for government procurement. The finance minister’s announcement of tax incentives under GST for companies setting up manufacturing facilities in North Eastern and Himalayan states till March 2027 is a positive move and certainly encourage industry to set up their manufacturing plants in this region. Already more than a
dozen large pharma companies have made plans for the same. Apart from tax incentives, there is a need for dedicated pharma parks with subsidised water, electricity, common effluent plant etc. Assistance in land acquisition will help in attracting industry. A proactive drug control administration and skill training centre in the these zones and good logistic as well as digital infrastructure will provide necessary ecosystem for efficient running of such manufac-
turing plants. As regards to GST, while the government is periodically issuing clarifications on 'frequently asked questions', many SMEs will require guidance on interpretation on matters such as clearance of physicians samples not for sale, treatment of loan licence units, supplies made from erstwhile tax free zones etc. A GST Guidance Cell, in collaboration with industry associations, in these zones will help clear many such doubts.
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Continuityof taxincentives will not onlyboost the industrybut also human health
DR SANJIT SINGH LAMBA MD, Eisai Pharmaceuticals
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he pharma sector is the caretaker of national human resources of any country. Being a nation which has more concern and care for human beings and which has a huge population with hand to mouth means of earning, does necessarily require affordable pricing of medicines to all. In pursuit of that, providing tax incentives to pharma companies, irrespective of the zone or region is always a step in the right direction to provide affordable price of medicines to all. So, the continuity of tax incentives to pharma companies will not only boost the industry but also keep the well-being of human health. ‘Make in India’ is a major national initiative designed to facilitate investment, foster innovation and build best in class infrastructure that will further boost the economy and bring in more foreign investment in India. It should not be restricted as a concept and should be propagated to the world that Make in India as a philosophy is a reality and this can happen when the government is serious in giving incentives and tax breaks to companies. This will boost indigenous innovation and also compete with countries like China for API manufacturing.
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cover ) Under newtaxregime there is no place for complete exemption
SURESH PAREEK MD, Ideal Cures
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he Goods and Services Tax (GST) which stands today as India’s biggest tax reform took the country by storm when
it came into effect from July 1, 2017. The move to introduce this revolutionary bill has been appreciated as all indirect taxes are merged under one section. As Prime Minister Narendra Modi called it Goods and Simple Tax, good because it liberated us from layers of taxation, simple because it is uniformly implemented pan India. March 31, 2017, marked the expiration of area-based tax exemption in the North Eastern states of India. Nevertheless, manufacturing facilities set up before March 31, 2017 can avail 100 per cent excise duty exemption for a period of 10 years after com-
mencement of commercialisation, encouraging pharma and allied industries to set up facilities in these areas instead of neighbouring countries, in turn encouraging ‘Make in India’. However, under the new tax regime, there is no place for complete exemption. As per recent articles, the central government will forgo 58 per cent of its share of GST. Clarity on the remaining 42 per cent is expected in the coming six weeks. It is only then that we will truly understand the impact of GST and the extended tax incentive, on this area-based exemption. Manufacturing facilities are looking
for comprehensive clarity on the new policies as GST impacts their profitability, pricing and market share. New policies will pave the way for increase or decrease in the number of companies investing in these North Eastern states along with J&K, in turn impacting the Make in India campaign. If the remaining 42 per cent remains unrecoverable, it will majorly impact profitability and may discourage companies from setting up plants here. We however, are sure that the government will usher in policies that align this tax holiday under GST in a way that will facilitate future investment.
‘Make in India’will be defeated if existing and newSEZ/EOU are not well maintained
DR NAVIN SAXENA Chairman, Rusan Pharma
O
ne of the most desired result from tax incentives and boosting industrial growth, is to provide employment on a permanent basis and to generate the industry to come up in the region independently. An MNC or big corporate group with high turnover are impacted
32 EXPRESS PHARMA September 16-30, 2017
by GST and/or subsidy will make a temporary impact, as they tend to shift their base, once their tax subsidy and incentives are over, for example Baddi, Sikkim, etc. Thus, the importance of sustained tax benefit is very critical to ensure that the states are able to retain industrial growth and most importantly, not to lose employment. For example; it is very heartbreaking to see the state of affairs in the biggest and the oldest KASEZ (Kandla) of India, due to the sunset clause. Major manufacturing units have moved out. Factories/units have closed down and are in shambles. All the manpower have been totally removed from employment. This creates unemployment, which is a major set back and ancillary units become redundant.
Thus, another important factor to create impact to the ‘Make in India’ policy, is the sunset clause for income tax benefit for Export Oriented Unit (EOU)/ SEZ. If the government is planning for FDI under ‘Make in India’ concept, other than local manufacturing, supply to the export market should also be accessible to the investor. Hence, the suggestions are: Tax benefit: States and regions existing under SEZs and new regions need to be identified to be uplifted. They should be provided with a minimum period of 10 years and gradually reduced for the next 10 years. Creating EOU/SEZs in those regions wherein income tax benefits and subsidies under various headings are given as long as the units are in operation. This follows from the point that near by
countries the UAE, Dubai, Singapore etc., have zero income tax for an unlimited period. The question therefore arises, why should someone invest in India even for export markets. Hence the unit become unviable. Most favoured nation status (MFNS): India provides MFNS to various SAARC countries, Singapore. They are able to export goods to India with two per cent duty. If you are making an SEZ/EOU, manufacturing units in these regions should also have a three to four year minimum for supply to the domestic market without import duties. ‘Make in India’ will be defeated if SEZ/EOU are not well maintained and exempted from taxations. Most importantly. they should provide continuous and sustained employment to people.
This move will help further economic development of North East region
BHAVIK NARSANA Partner, Khaitan & Co
T
he GST tax incentive announced by Finance Minister is a welcome move and is in lieu of the excise exemption lost due to the onset of GST. This will not only help further economic development of the North East region but will also help in the overall ‘Make In India’ campaign. The excise duty exemption which was offered under the North East Industry and Investments Promotion Policies, 2007 was one of the main reasons why large pharma companies set up facilities in the North East, with many of these facilities having been set up in the last three years. Even though the GST incentive has been announced in the form of a refund, it is a welcome move as pharma companies would continue to avail indirect tax incentives. u.sharma@expressindia.com
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THE MAIN FOCUS
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MANAGEMENT REPORTS
Evolving US generic market to plummet profitability levels of Indian pharma cos: Report Indian pharma companies have to dexterously manoeuvre contingencies by expanding their existing pipeline and secure a dominant position in the US market says CARE Ratings in a report. Excerpts from the report THE US contributes about one third of the total Indian pharma exports. Furthermore, Indian pharma manufacturing companies accounted for 34 per cent of the total ANDA approvals by the US in 2016 as compared with 30 per cent in 2015. The total number of ANDA approvals has increased from 167 to 201 during the same period. India has the second highest number of USFDA-approved manufacturing plants outside the US with 2,633 FDA-approved drug products. Out of the total exports by Indian pharma companies, sales to the US were about one third in FY2016-17 (refers to the period April 1, 2016 to March 31, 2017). The US also provides significant opportunities for generic players across the globe. However, during last decade, the industry has undergone transition resulting in pressure on the profitability margins of the companies for whom exposure to US market is substantial.
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MANAGEMENT Primary contributors CARE Ratings has identified four primary contributors for the decline in margins, viz, (i) consolidation of pharmaceutical distributors in the USA, (ii) mergers among major drug players, (iii) significant increase in Abbreviated New Drug Application (ANDA) approvals and (iv) heightened scrutiny by US Food and Drug Administration (US FDA). Going forward, the Indian pharma companies have to dexterously manoeuver contingencies arising from above events by expanding their existing pipeline and secure a dominant position in the US market through increased penetration along with marking their place in new molecular entity segment. With increase in the number of ANDA approvals bagged by Indian pharma companies, its share in terms of volume also has increased in tandem. However, the share in terms of the value has shown the attenuated trend despite the introduction of complex and speciality drugs by the Indian pharma players, the reason behind this being upshot of pricing pressure at the back of increase in competition due to more number of ANDA approvals being granted for similar drugs.
Driving factors The prime intention and driving factor for consolidation of the pharma distributors is to draw the pricing efficiency from the generic players and extract benefits of economies of scale. The expected benefits derived due to consolidation of the distributors would lead to the savings of anywhere between $100 million and $1 billion. While the aforesaid synergies benefit US pharma industry, the actual adverse impact would be exerted on generic companies which in turn lead to pricing pressure and thus affecting the EBIDTA margins of Indian pharma companies. The bigger generic players are likely to sustain the impact to some extent due to larger scale of operations and diversification into other geogra-
36 EXPRESS PHARMA September 16-30, 2017
Source: 2017 Economic report on US pharmacies and pharmacy benefit managers
phies. However, its impact on the smaller generic players would be felt more acutely. CARE Ratings expects Indian pharma companies to witness decline in margins on account of this consolidation deals from FY18 onwards, although simmering of the same has begun since FY16. In order to report robust growth rates, the key strategies deployed by the pharma companies are penetrating marketing network, strong brand recall, wide therapeutic coverage and good number of new products in pipe line which require substantial investments in R&D. Consolidation of the global players has led to broadening the therapeutic segments which reduced the risk for these players as they would be capitalising on their existing strengths while netting off their mutual drawbacks. The need to strengthen the marketing and distribution network also played vital role in consolidation which has led to deeper penetration of the combined entity products thus improving the generated revenue. Consolidation promul-
MANAGEMENT gates larger revenue base which helps to support the large R&D budgets required to be spent on developing strong product pipeline. Furthermore, the combined entity will be deriving benefits from mutual skilled and experienced human resources along with optimum utilisation of the R&D infrastructure to explore on developing innovative drugs for various therapeutic segments. All the above factors culminate in improved economies of scale and efficient utilisation of resources while maintaining its operational profit margins amidst competition. Change in perceptible dynamics of approval process during last five years has boosted competition leading to pricing pressure in the US market in the medium term, especially on plain vanilla products. Now, the Indian pharma companies have to raise their R&D investment and direct them towards increasing the share of complex drugs, bio-similars, speciality drugs etc, thereby creating high-entry barriers, which results in lower competition and higher margins. Further with the change in operational dynamics especially of global pharma industry, the Indian pharma companies now have to shift on to developing new molecular entities (NME). In view of decreasing number of drugs going off-patent and increasing competition in the generic segment, it is imperative for the Indian pharma companies to focus on developing New Molecular Entities (NMEs) instead of merely re engineering the drugs developed by the counterparts from developed nations. With tightening US FDA timelines for ANDA approvals and affordable healthcare being a key focus area, the outlook for generics prices continues to remain subdued in the near future. In the wake of declining drug prices, generic players are likely to witness more mergers and acquisition. It is expected that the generic drug pricing will be moderate in the upcoming year, with speciality pharma and complex generics to be the next support
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Change in perceptible dynamics of approval process during last five years has boosted competition leading to pricing pressure in the US market in the medium term, especially on plain vanilla product
of growth for drug manufacturers as well as for distributors.
Impact of generic prices on top four Indian pharma companies Indian pharma companies have spent millions of dollars filing ANDAs with the US FDA to gain exclusive production rights for many drugs losing their
MANAGEMENT Heightened scrutiny by USFDA regulatory authority
patent protection in the US. Continued price competition in the US market will mean cheaper prices for generic drugs and greater choice for US consumers. While analysing and observing the EBIDTA margin trends in Indian pharma industry for last six years, CARE Ratings believes that the top players operating in this industry have been affected by the steep
38 EXPRESS PHARMA September 16-30, 2017
price erosion and witnessed decline in the margins. The issuance of the import alerts and warning letters for domestic manufacturing facilities have increased significantly over the past years following US FDA’s increasing focus on compliance of guidelines of cGMP. This restricts the manufacturing units to supply drugs to the US market from that fa-
cility resulting in the decline of revenue for the companies particularly to the US market and also from other markets subsequently if the issues are not closed out. In turn, the companies, in order to cover their fixed and operational expenses, sell their products in unregulated markets, rest of world markets and domestic markets to book revenue for the year
where the competition is fierce and profit margins are unattractive. In the current environment of pricing pressures faced by the companies on account of increasing competition, developments like these are likely to hamper the profitability margins of the pharma companies.
Way forward The steep price erosion and the increasing scrutiny by USFDA are of concern for the Indian pharmaceutical sector. To drive the growth and profitability
margins, the companies must increase its product launches in the US market. In order to tackle the impact of the declining generic drug prices, the Indian pharmaceutical companies must now venture into manufacturing more of specialty or complex medicine and expand their existing pipeline and secure a dominant position in the US market through increased penetration. Apart from that, they also need to venture to mark their place in the new chemical entity zone.
MANAGEMENT
Innovation within dyslipidemia,heart failure and thrombosis set to reduce high CVD mortality rate The GBI Research reflects efforts by the pharma industry to remedy the unmet need in treating this disease, which is associated with a five-year mortality rate of 50 per cent WITH OVER 1,400 products in active development, the innovation pipeline for cardiovascular disease (CVD) is extensive, with four key CVD indications – hypertension, heart failure, dyslipidemia and thrombosis – now accounting for around half of all pipeline innovation, according to GBI Research, a recognised leader in providing business information and analytics. The company’s latest report on cardiovascular disease looks at the current clinical and commercial landscape and highlights the particularly
high level of heart failure pipeline innovation. This reflects efforts by the pharma industry to remedy the unmet need in treating this disease, which is associated with a five-year mortality rate of 50 per cent. Currently, CVD therapeutics focus on managing risk factors such as high cholesterol and high blood pressure, and slowing disease progression. However, current treatments are ineffective at reversing damage, which typically relies upon surgical procedure. Anti-dyslipidemic
drugs are unable to reverse the build-up of atherosclerotic plaque, and anti-thrombotic drugs only focus on preventing new thrombus from forming rather than dissolving current clots. The current pipeline shows evidence of addressing this challenge with potentially more damage reversal treatments on the horizon. Heart failure and pulmonary hypertension remain poorly treated, and are associated with poor prognosis. The large pipeline for heart failure includes a high proportion (23 per cent) of first-in-class prod-
ucts relative to other CVD indications, and possesses the potential for breakthroughs in the treatment of this condition. The clinical and commercial landscape across the pharma industry is set for significant change over the coming decade and beyond, driven by a number of factors including low R&D productivity and stubbornly high clinical attrition rates. Jarratt continued, ‘The net effect is an increasingly challenging, complex and often unpredictable commercial environment which we explore in the report’.
GBI Research analysis also indicates that companies across the pharma spectrum pursue a first-in-class product development strategy, ranging from major pharma players to start-up biotech firms, despite the typically higher attrition risk of these products. The proportion of first-in-class products in the pipeline for the top 20 major pharma companies ranges from 20 per cent (for Novo Nordisk) to 60 per cent (for Amgen), indicating a significant focus on breakthrough innovation. EP News Bureau
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MANAGEMENT
APAC drug delivery devices market to reach $5.4 bn in 2023 Japan will emerge as the major country in APAC region contributing 64 per cent of the revenue in 2023 DRUG DELIVERY devices market in Asia Pacific (India, China, Japan, South Korea, Australia, New Zealand, and Taiwan) region is expected to grow at a CAGR 3.9 per cent, from $4.1 billion in 2016 to $5.4 billion in 2023, according GlobalData, a leader in providing business information and analytics. Asia Pacific (APAC) region contributed 21 per cent of global revenue in 2016 and the region is expected to witness higher growth compared to other regions. The report reveals that Japan will emerge as the major country in APAC region contributing 64 per cent of the revenue in 2023. Japan contributed 62 per cent of the revenue in the region in 2016 and during the forecast period, the market will grow at CAGR 4.2 per cent.The growth in the country is mainly attributed to higher usage of drug delivery systems in healthcare facilities, availability of reimbursement
for majority of the population, increasing prevalence of chronic diseases (diabetes and cancer), growing geriatric population, increased understanding of drug metabolism and increased preference for individual and customised therapy especially for cancer. Infusion systems and metered dose inhaler devices are the major revenue generators, while other segments in the market include central nervous catheters, needle free injections. Infusion systems and metered dose inhaler devices generate 55.1 per cent and 38.9 per cent of the revenue. Major companies having presence in the APAC drug delivery devices market include GlaxoSmithKline, Terumo Corp, AstraZeneca, Boehringer Ingelheim GmbH, Baxter International and Pfizer. These companies command 47 per cent share in the APAC drug delivery de-
vices market. Delivering the active pharmaceutical ingredient to the specific target site is extremely important to get desired therapeutic result, but it is a complicated process. In past few decades, the innovation in drug delivery devices has simplified the process, helping achieve better therapeutic effects. Once launched as drug carriers, these devices have now emerged as target-specific, doseoptimized systems with a higher level of safety and efficiency. According to GlobalData’s drug delivery devices analysis, 61 drug delivery devices are in pipeline out of which 51.5 per cent are in clinical stage and 36.8 per cent are undergoing the approval process. Most of the pipeline products are aimed at treating cancer and pain disorders while others are focussed on respiratory and neurological ailments. EP News Bureau
Global dermatology pipeline to see shift towards increased usage of biologics 42 per cent of the pipeline is in the preclinical stage, while 14 per cent is in the discovery stage and only three of drugs are in the pre-registration stage THE GLOBAL dermatology pipeline, which currently comprises 850 products with a disclosed stage of development, is primarily made up of drugs at an early stage of development, with the late stages of the pipeline dominated by generics and biosimilars, according to business intelligence provider GBI Research. The company’s latest re-
40 EXPRESS PHARMA September 16-30, 2017
port: ‘Global Dermatology Drugs Market to 2023’ states that some 42 per cent of the pipeline is in the preclinical stage, while 14 per cent is in the discovery stage and only three of drugs are in the pre-registration stage. Around a third of the pipeline is in clinical development, and fewer than half are novel. Overall, the dermatology
pipeline is highly innovative, owing to advancements in understanding the disease pathways of many skin disorders. The majority of dermatology pipeline assets are novel active pharmaceutical ingredients, with only a small proportion of products being either generics or repositioned from other indications. EP News Bureau
I N T E R V I E W
‘Pharmacy profession is in a revolutionary phase at present’ On the occasion of World Pharmacists Day, Abhay Kumar, President, Indian Pharmacists Association (IPA) speaks on various issues faced by pharmacists in India and elaborates on the role of the association in overcoming those challenges, in an interview with Swati Rana Brief us on the role of pharmacists in India. How is it different from the western countries? Pharmacists play a vital role in the healthcare system in India. Pharmacists in India are broadly divided into three different categories hospital pharmacists, pharmacists working in private sector as community pharmacist and pharmacists working in the pharmaceutical industry. Although pharmacists in India provide services at various levels in healthcare, they are less recognised and less paid. On the other hand, pharmacists in the western countries have better recognisation and status in the health sector than their Indian counterparts. What are the challenges faced by Indian pharmacists? How IPA helps pharmacists in overcoming these challenges? The major challenge faced by pharmacists in India is recognisation. The service
IPA is currently looking for the permanent recruitment of various posts of pharmacists lying vacant or are filled on contract basis
MANAGEMENT provided by pharmacists at various capacities goes unnoticed. There are many burning issues like cadre formation, promotional channel, grade pay and recruitment under government establishment, job security, pay and working environment in private establishment. IPA, ever since its inception has been trying to bring together all the pharmacists and pharmacy associations under its umbrella, as I believe that an unified voice is required to cater to all the major issues being faced by pharmacist fraternity today. The association is working on the grade pay, cadre formation and promotional avenues. There has been very little scope for pharmacy graduates. We have been representing the government at various levels to
accommodate this vast pool of professionals for their ambitious projects like rural health /community health programmes. Taking serious note on our demands, the government in its national health policy has incorporated pharmacists as one of the professionals to be trained for handling patients at the primary levels. Tell us about the current issues on which IPA is working. What are the steps taken to help pharmacists in remote area? IPA is currently looking for the permanent recruitment of various posts of pharmacists lying vacant or are filled on contract basis. There is discrimination in pay scale of pharmacists in different states and even in organisations like railways, paramilitary forces and other agencies. Establishment of
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Drugs Control Department in every state is high on our agenda. The implementation of Pharmacy Practice Regulation – PPR, which came into existence in 2015, is also in the pipeline. Tell us about the government's contribution in uplifting pharmacists within the country? Government can still do a lot for the betterment of pharmacy profession at large. Creation and filling up of vacant posts, strengthening of central and state drug control department, making it mandatory for every medicine shop to have full time pharmacists are few basic expectations from the government. Creation of pharmacy cell in Ministry of Health & Family Welfare, involving pharmacist in national health programme and cadre formation with
promotional avenues are few of the points on which IPA is awaiting response from the government. In 2015, IPA had two new branches in Bihar and Andaman and Nicobar. Tell us about your further expansion plans. We have expanded in Rajasthan, Bihar, Delhi Maharashtra, Chattisgarh, as our own branches or associated with existing local association. At present, IPA is the largest association of pharmacists in India. Soon, we will have our presence across the country. The theme of World Pharmacists Day 2017 is 'From research to health care: Your pharmacist is at your service.' Your comments. Precisely this year's theme 'From research to health care: Your pharmacist is at
your service' could be called as the entire process involved where pharmacists' talent and calibre is deliberated. Right from the molecular level where the drugs are designed and developed in laboratory until it is dispensed to the patient, the essentiality of the pharmacist is acknowledged. What is your message to the pharmacists? The pharmacy profession is at a revolutionary phase at present. We need to stand together for the betterment of pharmacist fraternity. I wish best of luck to the aspiring pharmacists who are studying and are unemployed. I wish to extend my warm greetings to all my colleagues with the request to give their best in terms of professional skills and knowledge they have to the patients. swati.rana@expressindia.com
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RESEARCH UPDATES
FDAapproves Pfizer’s leukaemia drug The FDA said the drug has a boxed warning as it may cause severe or fatal liver damage, including blockage of veins in the liver
T
he US Food and Drug Administration (FDA) has approved Pfizer'sdrug, Mylotarg, for certain patients with acute myeloid leukaemia (AML), re-clearing a drug that had been pulled off the market in 2010. The drug was cleared to treat adults with newly diagnosed AML and tumours expressing the CD33 antigen, as well as patients aged two years and older with CD33-positive AML who have relapsed, or did not respond to initial treatment. The FDA said the drug has a boxed warning as it may
cause severe or fatal liver damage, including blockage of veins in the liver. Mylotarg got accelerated approval in 2000 as a standalone treatment for adult patients with CD33-positive AML who had experienced a relapse, but was voluntarily withdrawn as subsequent confirmatory studies failed to show clinical benefit and had safety concerns, including a high number of deaths. The approval includes a lower recommended dose, a different dosing schedule and a new patient population, the FDA said. A cycle of Mylotarg is
expected to cost $24,600, Pfizer said. Mylotarg is thought to work by taking the anti-tumour agent to the AML cells that express the CD33 antigen, blocking the growth of cancerous cells and causing cell death. AML is a cancer that originates in the bone marrow and progresses rapidly, resulting in an abnormal increase in white blood cells. About 21,380 people will be diagnosed with AML this year and of those, 10,590 patients will succumb to the disease, according to estimates from the National Cancer Institute. Reuters
Novartis gene therapy approval signals new cancer treatment era The treatment, called Kymriah, was approved for patients up to 25 years of age NOVARTIS WON highly anticipated US approval for the first of a new type of potent genemodifying immunotherapy for leukemia, a $475,000 treatment that marks the start of a potential new treatment paradigm for some cancers. The approval was widely expected after an FDA advisory panel last month unanimously recommended the action. Novartis also announced an agreement with the US Centers for Medicare and Medicaid Services under which payment for the therapy will be based on clinical outcomes achieved. The treatment, called Kymriah, was approved for patients up to 25 years of age who have relapsed or not helped by prior treatment for B-cell acute
42 EXPRESS PHARMA September 16-30, 2017
lymphoblastic leukemia (ALL). Dr Kevin Curran, a paediatric oncologist at Memorial Sloan Kettering Cancer Center in New York, noted the treatment’s high cost. “Of course, we have to talk about pricing from a national standpoint,” he said. “But if I have a parent and a (sick) child in front of me, and I have an opportunity to save them, we’re going to take that.” Kymriah belongs to a new class of treatments called CART therapies. It involves removing disease-fighting T cells from a patient, genetically modifying them to better recognise and attack cancer, and then replacing them, where they can circulate for years seeking out the disease. Novartis estimates some 600
Novartis also announced an agreement with the US Centers for Medicare and Medicaid Services under which payment for the therapy will be based on clinical outcomes achieved ALL patients a year would be eligible for Kymriah. It expects to open five treatment centres within days and 35 by year-end. “We’re entering a new frontier in medical innovation with the ability to reprogram a patient’s own cells to attack a deadly cancer,” Food and Drug
Administration Commissioner Scott Gottlieb said in a statement. The FDA said it has granted 76 applications for trials involving experimental CAR-T therapies. “Two years ago many people would have told you these types of treatments were science
fiction,” said Brad Loncar, CEO, Loncar Investments, which runs the Loncar Cancer Immunotherapy ETF In clinical trials, CAR-T therapies have shown remarkable efficacy against blood cancers. In the pivotal Novartis trial, 83 per cent of patients achieved remission with a disease that has historically poor outcomes. However, this type of therapy carries risk of severe side effects. Kymriah will have a boxed warning for cytokine release syndrome, a potentially lethal systemic response to the activation and proliferation of CAR-T cells, causing high fever and potential for neurological problems. Reuters
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New data boosts case for extended use of AstraZeneca heart drug The trial studied subjects who had a heart attack within the past one to three years ASTRAZENECA’S bloodthinner Brilinta cuts the risk of cardiovascular death by 29 per cent in patients with a history of past heart attacks who keep taking it beyond the standard 12-month initial period, according to new clinical trial data. The findings were presented at European Society of Cardiology congress, are from a sub-analysis of the Pegasus clinical trial, which first reported positive results in 2015. The trial studied subjects who had a heart attack within the past one to three years and was designed to prove the value of extended use of Brilinta, which is a key product for AstraZeneca. The sub-analysis also showed a risk reduction of 20 per cent in all causes of
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death, while bleeding rates were consistent with the drug’s safety profile, AstraZeneca said. Reuters
Bristol-Myers, Daiichi Sankyo to test Opdivo combo for cancers
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Opdivo belongs to a new class of medicines called PD-1 checkpoint inhibitors, which work by taking the brakes off the immune system BRISTOL-MYERS Squibb Co and Daiichi Sankyo said they were evaluating a combination of Bristol-Myers’ immunooncology drug, Opdivo, with the Japanese company’s experimental drug in patients with breast and bladder cancers. Opdivo belongs to a new class of medicines called PD-1 checkpoint inhibitors, which work by taking the brakes off the immune system. The combination therapy involves Daiichi Sankyo’s DS-8201, which delivers chemotherapy directly to target
cancer cells. The drug is in early stage clinical development to treat different breast and solid cancers. The companies said the clinical study in patients with HER2-expressing advanced breast and bladder cancer is expected to begin enrollment in the first quarter of 2018. Bristol-Myer’s blockbuster Opdivo is already approved to treat advanced melanoma and lung cancer, and competes with Merck & Co’s Keytruda. Reuters
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Big data enabling new standard in SCHOTT’s pharma glass manufacturing SCHOTT Glass India will be able to measure 100 per cent of every single glass tube in production SCHOTT HAS recently integrated a specially developed big data solution into its pharmaceutical tubing production in India, replacing statistical sample-based quality assurance with 100 per cent on-line measurement. With the new IT-based process called perfeXion, process- and product-quality data of each individual glass tube is collected online and in real-time — an innovation that sets new standards in the pharma glass industry. During the multi-layered process of pharma tubing production, statistical quality control is not 100 per cent thorough. However, thanks to a unique big data approach, SCHOTT Glass India is now able to measure 100 per cent of every single glass tube in production. Instead of selecting a few glass tubes from each batch for statistical quality control, the new perfeXion system measures the entire glass tube many times over as it is drawn from the melt. Lasers
recognise deviations in diameter and wall thickness, for example, and camera and IR inspection systems can even detect the smallest inclusions in the glass. Around 100,000 data tags are generated every minute. An integrated IT system, evaluating the continuous glass tube with real-time data measurements, calculates incidents of imperfection with such precision that it can later differentiate corresponding individual tubes which can then be sorted out. Each tube is checked again at its completion. “This data enables for post-
processing steps to be efficiently aligned with the tubing quality. With big data, the international technology group is creating a new industry standard and raising the quality of pharma glass production to a new level,” said Sundeep Prabhu, VP Sales and Marketing, SCHOTT Glass India. The system’s development took several years. Analysing a curved tube surface zooming down a production line was a particularly difficult challenge. The effort, however, has paid off, not least because the data analysis is a source of insight into how production can be
further optimised. Every year, SCHOTT produces about 150,000 tonne of glass tubing worldwide, most of which is destined for pharma packaging. Thanks to the new perfeXion approach, quality data can be traced back more detailed along the value chain. “There comes a particular responsibility being a pharmaceutical industry supplier, and traceability is a major issue in the industry,” says Dr Patrick Markschläger, Executive VP, SCHOTT Tubing. “By gathering information on each individual glass tube, we’ve already made an
important contribution to quality assurance for downstream post-processing steps at the very beginning of the value chain.” “Companies that want to systematically control their production to make it more efficient in the long run can’t afford to miss a strategic use of production data,” adds Dr Frank Heinricht, Chairman of the Board of Management, SCHOTT. “Making intelligently linked data available to others not only optimises processes – it creates new creative potentials for product and process development.” The system is tailored for production of glass tubing, but other areas of the company can certainly benefit from the findings in the medium-term. SCHOTT’s perfeXion has been installed at all its tubing lines globally, including its India plant in Jambusar, Gujarat, where the system has been implemented from July 1 onwards. EP News Bureau
Dr Christian Fischer named CEO of Gerresheimer Dr Fischer has been a member of the Management Board of Gerresheimer since August 2017 DR CHRISTIAN Fischer is to assume responsibility as CEO of Gerresheimer. He succeeds Uwe Röhrhoff. Fischer joined the Management Board as a regular member on August 1, 2017, having previously been President Performance Chemicals at BASF in Ludwigshafen, where he spent 24 years. Dr Christian Fischer has been a member of the Manage-
44 EXPRESS PHARMA September 16-30, 2017
ment Board of Gerresheimer since August 2017. He joined BASF in 1993. Having started his career as a laboratory team leader, he went on to be Deputy Division Manager, Global Marketing Director, and Sales Director in different plastic divisions. As Group VP, Fine Chemicals Asia Pacific based in Hong Kong from 2004 to 2008, he was responsible for the production and
marketing of products for the pharma, cosmetics, aroma, animal, and human nutrition industries. Between 2008 and 2014, he was as President responsible for BASF SE’s global materials and systems research. As President Performance Chemicals from 2015 to March 2017, he held overall responsibility for plastic additives, fuel and lubricant additives as well as chemicals for
the mining, oilfield, water, paper, and leather industry. Christian Fischer holds a diploma degree in Chemistry (University of Regensburg) and a PhD in the same subject. He also has a degree in Business Administration (VWA Mannheim). He was appointed honorary professor at the Technical University of Munich (TUM) in 2014. EP News Bureau
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BOGE shapes the future of Industry 4.0 The goal is to ensure that the system adapts itself to the requirements and operates with maximum energy efficiency BOGE COMPRESSORS has made it a development task to pave the way for the fourth industrial revolution in compressed air technology. In the smart factory of the future, compressed air technologies automatically communicate with connected peripheral equipment. The foundation for this is laid down in the self-describing communication protocol OPC Unified Architectures. In cooperation with users, the Bielefeld family company is developing standards for intelligent component networking. The goal is to ensure that the system adapts itself to the requirements and operates with maximum energy efficiency. New components should also simply be able to integrate into the system by “Plug-and-Pressure”. “The intelligent networking of compressed air generators and consumers of compressed air opens up a wide range of op-
portunities to monitor, control and optimize the entire system topology,” says Peter Boldt, Head of Development, BOGE. As one of the first manufacturers of compressed air solutions, BOGE is working on an inte-
grated networking approach which takes the process technologies connected to compressed air into consideration. “The communication protocol from OPC Unified Architectures (OPC UA) is, as an open
standard interface for Industry 4.0 applications, one of the most promising solutions in Europe,” says Peter Boldt. In contrast to the usual market and manufacturer-specific bus protocols, OPC UA offers the
possibility of establishing a vendor-neutral standard. The plant technology automatically undertakes the technical configuration to adjust the defined parameters to the demand-oriented design for the production of compressed air. An easy commissioning of complex compressed air systems and flexible reconfiguration are benefits of the Smart Factory. This is opening up new potential for users and plant designers to save energy. BOGE has laid the technological foundation for intelligent system networking with the top cluster ‘it's OWL’ of the German Federal Ministry of Education and Research (BMBF). Since 2016, BOGE developers, together with manufacturers and users of consumables, have been working on the development of a future-oriented networking standard. EP News Bureau
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IMPORTANT Whilst care is taken prior to acceptance of advertising copy, it is not possible to verify its contents. The Indian Express (P) Ltd. 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.
46 EXPRESS PHARMA September 16-30, 2017
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KNAUER with AZURABio LC offer platform for bio-chromatography THE PURIFICATION and separation of biomolecules is a challenging task and basically must be tailored to each sample. KNAUER offers with AZURA Bio LC a mature, highly adaptable platform for biochromatography. The systems are designed to accelerate or simplify all popular FPLC techniques such as size exclusion, ion exchange or affinity chromatography. The company can offer systems from simple to highly-automated, or for maximum throughput. Furthermore, any system can be put together. Depending on how biochromatography applications evolve, the system can grow and be supplemented by other components at any time.
Versatile and scalable One can easily upscale product purification process because the selectable AZURA Bio LC pumps cover a flow rate range from 0.02 to 1000 ml/min. The target molecule is difficult to determine by UV? No problem, with AZURA Bio LC one can also incorporate a refractive index detector or a fluorescence detector. The AZURA Bio LC systems can be combined with all common LC columns on the market. The easy-to-use software PurityChrom Bio also reflects openness by allowing easily create methods and adapt to different purification requirements. One can have the choice to work based on column volume, flow volume or time and can even make improvements during the run. Learn more about AZURA Bio LC ‌ www.knauer.net/azurabio/ Contact details Vijay B More CEO Cell:+919967597352 Chromline Equipment Company Unit 17 & 17A Ground Floor,Udyog Bhavan, Sonawala Road,Gorgaon (East), Mumbai 400063 Tel. :+912226860816,+912261887317 Fax: +912226860306 Mail:vijay.more@chromline.in Website: www.chromline.in
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Gandhi Automations’dock levellers facilitate fast,smooth and safe transition GANDHI AUTOMATIONS is India's number one entrance automation and loading bay equipment company. This widely recognised position has been achieved over years of hard work, innovation, commitment to quality and reliable customer service. The company is also proud to be certified to ISO 9001: 2008. Since its inception in 1996, the company has been manufacturing, importing, distributing and installing products that are problem free and easy to operate. The company offers complete logistics solutions by providing dock levellers, dock shelters, sectional overhead doors and dock houses. Electro-hydraulic, mechanical and air-powered dock levellers offered by Gandhi Automations are not only 'a bridge for connecting a vehicle,' but also facilitate fast, smooth and safe transition by compensating the difference in heights between the loading bay and the vehicle. This contributes to minimising energy used and savings on heating and chilling costs result-
ing in maintaining the quality of the transported goods. Dock levellers offered by Gandhi Automations are designed as per EN 1398 standard for the most demanding loading and unloading operations.
Efficient loading and unloading of goods The importance of efficient loading the goods has always been evident, and it has increased over the years, essentially for two reasons: the lesser availability and the higher cost of manpower. Consequently lesser qualified manpower is being utilised which leads to damage in the
goods. The cost of loading and unloading the goods can be calculated precisely and is exactlxy definable, which allows for a scientific approach to find out the investment that goes into the process. Gandhi Automations has always designed solutions based on such scientific approach and feedback from clients. The dock levellers offered by the company ensure loading and unloading with lesser effort and minimal cost. It is possible to load and unload your products in a safe way and in the process obtain remarkable energy savings. The
loading bay remains with the dock leveller in rest position and the sectional overhead door closed, until the vehicle is positioned. The driver drives back centring to the dock shelter and stops the vehicle the moment it gets in contact with the bumpers. The sectional overhead door is then opened only when the vehicle is positioned, brakes applied and engines shut off .This eliminates the exit of hot air, intake of cold air (or the opposite in hot and inside conditioned places) and intake of exhausting gases in the warehouse. After the sectional overhead door opens, the lip of the dock leveller connects to the truck bed for loading / unloading to take place. At the end of the loading/unloading the dock leveller is put in rest position and the sectional overhead door is closed, without moving the vehicle. The vehicle then departs at the end of the process. Following are the two types of dock levellers:
Radius lip dock levellers Radius lip dock levellers allow
the dock to connect with the truck bed, thus making it possible to drive directly on and off with forklift trucks etc. The selfcleaning lip hinging system does not retain rubbish with automatic end-of-run, so as to keep the 25 mm security distance between the folded lip and structure as per EN 1398 & EN 349.
Telescopic lip dock levellers Telescopic lip dock levellers are ideal for connecting vehicles unable to drive near dock i.e. sea containers, side loading railway wagons etc. These types can be supplied with a lip extending up to 1 m. Gandhi Automation’s dock levellers are equipped with the most secure safety devices and accessories. Contact details Gandhi Automations Chawda Commercial Centre Link Road, Malad (W) Mumbai – 400064, India Off: +91 22 66720200 / 66720300 Fax: +91 22 66720201 Email: sales@geapl.co.in Website: www.geapl.co.in
Ami Ploymer launches Imaprene and Sifter sieves Imaprene - Thermoplastic Elastomer Tube (TPE) Imaprene pharmaceutical grade thermoplastic elastomer tubing is designed for peristaltic pump transfer. Imaprene is opaque tubing especially known for its excellent flexibility and flex crack resistance. Imaprene is manufactured by using world class thermoplastic elastomer. It is manufactured and packaged in dust free environment of ISO 9001 QMS, ISO 14001 & OHSAS 18001 certified facility. It has excellent chemical and solvent resistance. It is superior flex crack resistance and
48 EXPRESS PHARMA September 16-30, 2017
durable for peristaltic pump application. It has smooth bore to ensure least contamination. It is non-toxic and nonhaemolytic.
size distribution of powders and granules. Sifting is mainly achieved by used of vibratory, rotary and centrifugal screeners.
Sifter sieves
Characteristics
A sieve or sifter, is a device for separating wanted elements from unwanted material or for characterising the particle size distribution of a sample, typically using a woven screen such as a mesh. Sifting is mainly used in two areas, Check screening of raw material to remove extraneous material and sizing to sort, segregate or control the particle
◗ Sieves have to be specially designed to resist the high tensile stress generated. Since particle size distributions plays a vital part in drug dissolutions, maintaining the accuracy of the sieves apertures in an essential part of sieves manufacturing. ◗ Proper thickness of wire, accurate nominal apertures sizes, high tensile strength and taut-
ness of the sieves are essential part of sieve for high sifting performance. ◗ Material of construction Stainless Steel – 316 and 316L. ◗ Aperture sizes – 4075 to 70 microns or mesh sizes 4# to 200# with ASTM standard being certified 90X microscope. ◗ Sieves are available in various sizes from 4” to 30” diameter. The most common size used 20” (550mm) & 30” (750mm) diameter. ◗ The silicone is food grade material, transparent in appearance. ◗ Nontoxic and molded on the stainless steel ring.
Applications ◗ Pharmaceutical industries ◗ Food industries ◗ Used in vibro-shifter machine ◗ Chemical industries Contact details Ami Polymer 319, Mahesh Industrial Estate, Opp.Silver Park, Mira-Bhayander Road, Mira Road (E), Thane - 401104, Maharashtra Tel: +91 22 28555 107 / 631 / 914 Cell: +91 86910 13935 Email: mktg@amipolymer.com Web: www.amipolymer.com
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ClearView by Electrolab: Acosteffective solution Aditya Marfatia, Director, Electrolab and Neelam Sayed, Application Scientist Electrolab, give an insight on ClearView by Electrolab, which utilises the innovative and proven UV technology to reduce frequent water bath cleaning by maintaining a clean dissolution water bath for extended period of time
Aditya Marfatia, Director, Electrolab
Neelam Sayed, Application Scientist, Electrolab
DISSOLUTION TESTS are commonly conducted on a dosage form to evaluate the time taken for its active ingredient to release into the body and help predict how the drug performs inside the body. The dissolution test is an important quality control tool and also enables to establish bioavailability and bioequivalence. As the dissolution procedure is an important test to evaluate safety, predict efficacy and stability with respect to manufacturing and storage conditions, regulatory bodies are more stringent about GMP compliance with reference to the dissolution test. Over the past few years, many pharmaceuticals companies have faced drug recalls and have also been issued with form 483, warning letters etc. from regulatory bodies due to problems associated with dissolution
testing. Several observations recorded have either due to failed dissolution specifications, improperly calibrated or poorly maintained dissolution equipment. An observation in form 483 issued to a pharma company in April 2017, has cited the improper maintenance of the dissolution water bath, along with other dissolution related issues. The observation states â€œâ€Ś.. Your analyst recorded the water in water bath for dissolution tester as clear. I observed the water in the water bath was not clear as required in your written procedure for operation and calibration of the dissolution tester. I also observed unidentified whitish **** floating in the water bath. Your QC supervisor reviewed the instrument set-up and approved the analyst to proceed
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PHARMA ALLY with the testing without documenting the unclear water in the water bath.” The temperature of water inside the dissolution water bath acts as a perfect incubator for promoting growth of single celled organisms like algae, fungi, bacteria etc. The constantly stirring water introduces a good supply of oxygen that further promotes the propagation of these organisms. This propagation later gets deposited in the water bath tubing and pump and significantly affects the circulating system by reducing the flow rate and thus causes a great impact on temperature regulation. The heating efficiency of the system may also be hampered, as the response from the temperature sensor is delayed due to the formation of biofilm over the temperature sensor. The microbial growth deposited on water bath wall, tubing, pump and other contact parts may lead to breakdown resulting in lower throughput. In order to extend the life of the dissolution tester and enable continuous use for many years, it is essential that the water bath is cleaned thoroughly at regular intervals. Cleaning of water bath is a tedious aspect of using dissolution technology and usually lab performs this maintenance every week. In addition to these general practices depicted above, chemical agents such as algaecides, Bronopol, Deconex, Cetyl Pyridinium Bromide etc. are sometimes added to water bath to eradicate microorganisms and to maintain clean water bath for longer period of time. But such chemical agents offer limited effectiveness as they may be organism specific and may not be able to inhibit the propagation of other organisms commonly found in untreated water. Going beyond the conventional bath dissolution tester, bathless dissolution testers are also available; where vessels are heated by a heating jacket instead of a water bath. These systems eliminate frequent water bath cleaning and all other associated maintenance. In order to prevail over the above concerns, Electrolab has introduced ClearView, a costeffective solution that can be
50 EXPRESS PHARMA September 16-30, 2017
Schematic representation of general practices of cleaning of water bath with their probable drawbacks
Data on file
easily retrofitted to most brands of conventional 8 and 14 station dissolution testers (USP Dissolution Apparatus 1-7) and disintegration testers. ClearView utilises the innovative and proven Ultraviolet (UV) technology that significantly reduces frequent water bath cleaning by maintaining a clean dissolution water bath for extended period of time. ClearView is a non-chemical, rugged water sterilisation system with a smaller footprint
that incorporates an UV steriliser into the water bath’s circulating system. The steriliser contains an UV lamp that safely emits germicidal rays that disrupts or alters the DNA or RNA of single celled organisms that are commonly found in untreated water. Although, the UV light alters the DNA or RNA of these microorganisms but; it does not otherwise alter the water being treated or cause any damage to the water bath, tubing, pump etc. Being
fully enclosed, ClearView does not cause any harm to human beings nor does it have any impact on the dosage form being tested. Although, the efficiency of ClearView depends on the source water biodurden, but deconex 12 BASIC in combination with ClearView can be used to enhance the efficiency of the system. Integration of ClearView not only enhances the visual observation of the dissolution process but also significantly reduces
breakdown, cost of consumables like high purity water, water bath, tubing, pump etc. and also reduces the labour time involved in water bath cleaning and maintenance. Contact details Electrolab Email: sales@electrolabgroup.com Website: www.electrolabgroup.com Tel: +91–22 – 4041 3131/ +91–22–41613122
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Fedegari’s integrated systems & solutions for pharmaceuticals ACE TECHNOLOGIES brings to you world renowned autoclaves and sterilisers from FEDEGARI, the trendsetters in the manufacture of sterilisers and plants for processes using densephase fluids. Each one of FEDEGARI’s products is the result of research, design and manufacturing work since the last 50 years. When all the technologies and knowledge we now take for granted and access so easily were unavailable, expertise, tradition and perseverance of both the craftsman and the entrepreneur ensured achievement of ambitious results, well beyond the reach of others. The difference between two similar products became immediately evident on just touching and recognising the handcraft finish. Nowadays, these distinguishing features are much harder to recognise in an industrial product. Culture today, lacking the practical approach of the past, leads to diminished appreciation of tangible values and takes the ability of machine tools to produce the same finish for granted. But while this is true for products manufactured in runs of thousands of units, it cannot apply to one-of-a-kind products, such as custommade machines. It’s a bit like saying that all sterilisers sterilise by virtue of their name. Yet this is not so: the end result is the consequence of machine features and user know-how. With a Fedegari steriliser, a user, having the required know-how, is aware of obtaining a performance unattainable with other machines. This is why our best clients are also the most demanding. The overall performance of a machine or of a system is not the logical consequence of a set of components itemised according to relevant standard features, but rather the result of the people whose minds and hands designed and built them. The skilful alchemy created by many human talents, co-ordinated and guided towards an apparently simple goal: Manufacturing the best sterilisers in the world. Each Fedegari product is the result of extensive research, design and manufacture, our way of doing things here for the past 50 years, with professionalism
and dedication. Being considered one of today’s leading steriliser manufacturers worldwide stems from the distinguishing features imposed by the founders from the company’s very start, in the early 1950s. Over half a century later, we have retained the ‘craftsman’s spirit’ of our early days, the care for detail in giving shape to matter, without neglecting the rigour of those days, combining these factors with the requirements of industrial production. Fedegari was the first to introduce an absolutely innovative strategy in the field of sterilisation: to exclusively design machines according to specific user operating requirements. Our sterilisers are highly customised industrial products, designed to satisfy the needs of our customers. They are based on specifically engineered functional modules minimising risks connected to production of everdiffering machines, while guaranteeing top performances. Precisely thanks to constant collaboration with our customers, we have been able to develop and increase our company’s know-how, something without which we would never have achieved today’s results. ACE technologies is an official representative of Fedegari in India. Contact: acetechnologies@vsnl.net for more information.
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TLC to Instrumental TLC and finally,HP-TLC Dilip Charegaonkar, MD,Anchrom Enterprises, gives an insight about HP-TLC, which will soon be a routine technique in every lab due to very recent development viz. acceptance in pharmacopeias IT IS now high time for professional analysts and regulatory labs in India to realise that High Performance Thin Layer Chromatography (HP-TLC) will soon be a routine technique in every lab due to very recent development viz. acceptance in pharmacopeias. Historically, Thin Layer Chromatography (TLC) has been used to analyse just about every non-volatile organic sample. Literature of 1960s has reports of volatiles being derivatised to become non-volatile and therefore, suitable for TLC analysis! The apparatus as well as methodology used for TLC had too many variables and nobody ever agreed on a set of rules. Some used pre-coated plates, others lab made ones. Gypsum was used as a so-called binder, while some used starch. Since Stahl used 0.25 mm thick layers, it has become the norm. Glass plates sizes used were 40x20, 20x20, 20x10 cm. Samples were applied with the help of various types of capillaries as well as pipettes and syringes. Most of them damaged the layer. The damaged part of the layer contains the highest concentration of sample. For the same weight of sample yet it is still a usable and powerful technique, bigger the diameter of spot, lesser the visibility of impurities etc. etc. Even official pharmacopeial text is ambiguous. Yet, it is still a usable and powered technique. After a couple of decades, as the instrumentation for chemical analysis was developed in the late last century, TLC was also instrumentalised. HP-TLC precoated layers with 5μm particles with a narrow cut were introduced. This came to be known as High Performance Thin Layer Chromatography (HP-TLC) but was actually Instrumental TLC because all the parameters that affect chromatography were not considered while developing methods. Only the manual operations were replaced by instruments,
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Dilip Charegaonkar, MD, Anchrom Enterprises
which however, brought in changes in the technique and additional capabilities. All this changed forever with the introduction of HPTLC as an official method in the US Pharmacopoeia in August 2015 in the form of chapters 202, 203 (and 1064) USP Chapter 2251, for the first time, deals with adulteration of materials of botanical origin with synthetic drugs. As of now, the evaluation is based on ‘HP-TLC fingerprint’ i.e. a qualitative test. However, in future, even when quantitative analysis is introduced, the
HP-TLC is only recently properly defined by a universally accepted SOP. Those who have instrumental TLC set-up in their lab, only need to adopt the USP chromatography methodology using the software that controls the HP-TLC system, for universally acceptable cGMP compliant results chromatography part i.e. sample preparation – application – development – derivatisation (if any) will not change. The separation part is independent of detection part ! Only the mode of evaluation will be changed or added. Therefore, it has become imperative for all analytical
chemists to understand and implement the USP SOP asap. This SOP describes (as does any regulatory methodology) very clearly, how to prepare samples, type of layer, sample application technique-size and position, chromatogram development- humidity, saturation, chamber type and size, elec-
tronic auditable documentation etc. Moreover, HP-TLC meets all the regulatory requirements of today, if this SOP is followed. It may be realised that HPTLC has been made official for analysis of “materials of botanical origin” which has a far wide scope. Materials of botanical origin have a complex matrix, variability due to natural and or man-made causes. Adulteration is another major issue. To sum up, HP-TLC is only recently properly defined by a universally accepted SOP. Those who have instrumental TLC set-up in their lab, only need to adopt the USP chromatography methodology using the software that controls the HP-TLC system, for universally acceptable cGMP compliant results. The following table gives a comparison of parameters to be controlled, as stated in most pharmacopoeias.
MAIN PARAMETERS OF TLC AND HP-TLC IN USP/ PHEUR USP Chapter 621
USP Chapter 203 cGLP REQUIREMENTS
IQ-OQ
NO
YES
PQ
NO
YES
System Suitability Test
NO
YES
Instruments
Simple apparatus
Suitable devices for each step
Documentation
Visual evaluation
Electronic,Auditable STATIONERY PHASE (Plate)
TLC or HP-TLC layer 10-15 μm particles
HP-TLC layer, 5 μm, 60°A, 0.2mm thick, 20 ×10 cm, polymeric binder, F254 indicator, pre-coated only (glass support preferred) SAMPLE APPLICATION
Spot (2-5 mm) or band (5-10 mm) Appropriate positioning; 10mm centre to centre.
Band 8mm × 1mm, 8mm from bottom, 20mm from side, 11.4mm centre to centre 15 sample per plate
CHROMATOGRAM DEVELOPMENT Development distance- ¾ of plate length Chamber saturated Flat or Twin trough. Development distance- 70mm Pre-condition plate over 33% RH MgCl2 sat. sol. for 10 minute before development. Chamber saturation 20 min Twin trough Dry plate vertically in cold air. Evaluation & Accepted Criteria By human eye Rf & intensity
Imaging Software Auditable System Suitability Test Compliance Zone position Rf, zone separation, colour and relative intensity Summary HP-TLC has to be cGMP compliant like GC or LC
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Domino Printech India to launch Ax-Series
DOMINO PRINTECH India will launch the Ax-Series, a new range of continuous ink jet (CIJ) printers optimised for the demanding industrial packaging environments and more suitably designed for Indian market conditions. In developing the new series, Domino has rewritten the rules of coding and marking by revisiting the underlying science behind CIJ and introducing innovations in three key areas. This has resulted in a comprehensive re-engineering of the technology that will reset customer expectations of productivity, quality and cost of ownership. Domino’s three ‘pillars’ of innovation across the Ax-Series are the new i-Pulse print head and inks, the i-Techx electronics and software platform, and Domino Design, a fresh approach to the total product design to maximise productivity and ease of operation. Contact details Rohanjoy Purkayastha Manager Marketing Handheld: +91-9818600319 Phone : 0124-4886100
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Cole-Parmer launches ThinTouchPROtect nitrile gloves COLE-PARMER, a leading global source of laboratory and industrial products, equipment and supplies since 1955, recently launched ThinTouchPROtect Nitrile Gloves – a line extension of company’s ThinTouch range of gloves. Specially formulated, designed and tested to stringent standards, the gloves provide user with maximum assurance, superior comfort and enhanced tactility. These gloves offer highest protection against many risks than any other glove in the category. They are tested against 29 chemotherapeutic drugs as per ASTM D 6978-05. They have exceptional breakthrough time even for Carmustine (3.3 mg/ml) – 127.5 mins and ThioTepa (10.0 mg/ml) – 240 mins where other gloves have failed. Manufactured using a unique formulation - they undergo series of exhaustive tests to ensure these are the best in the category. The gloves are highly chemical resistant and are qualified for oncology production and research applications. The anti-static property with resistivity of 1X107 Ohms
The glove has a great tactile feel for wearer comfort over extended period of use at humidity 51 per cent - makes these gloves an ideal choice in processes demanding low electrostatic discharge.
The glove has a great tactile feel for wearer comfort over extended period of use. Its unique colour provides visual
differentiation from other natural rubber latex and synthetic gloves. ThinTouchPRotect Nitrile Gloves are available in 9.5” and 12” length and S to XL sizes. These are ambidextrous with beaded cuffs ensuring ease of donning and have textured fingertips for enhanced wet or dry grip. The gloves have low-particulates to prevent glove-related work contamination.
Contact details Vinita Singh Marketing Manager Cole-Parmer India403, A-Wing, Delphi Hiranandani Business Park, Powai, Mumbai 400 076, India Tel: +91-22-61394410 (Direct) +91-22-61394444 (Board) +91-8828126093 (Mobile)Fax: +91-22-61394422 vinita.singh@coleparmer.in www.coleparmer.in
APPLintroduces silicone extruded gaskets AMI POLYMER Pvt Ltd (APPL) offers a wide range of silicone extruded gaskets in more than 1000 different shapes and designs (In round and square types). APPL’s extruded gaskets (Autoclave) are made from Food-Pharma Grade pure silicone rubber which can easily withstands a temperature range of -80°C to +250°C. Extruded gaskets are available in square cross sections like 6mm x 6 mm, 8mm x 8mm, 10mm x 10mm, 20mm x 20mm, 25mm x 25mm etc. with OR without hollow. These extruded gaskets are available in red, white, orange or any colour as per customer's requirement. These extruded gaskets are manufactured from fully automatic mi-
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crowave continuous curing system which ensures accurate dimensional properties, glossy surface finishes and aesthetically beautiful colours. Extruded gaskets can be used in clean room doors, telecom shelters, air tight door seal application, bakery ovens, freeze doors, pharmaceuticals processing machine’s doors, autoclaves, isolators, dry heat sterilizers, etc. Contact details 319, Mahesh Industrial Estate, Opp. Silver Park, Mira-Bhayander Road, Mira Road (E), Thane – 401104, Maharashtra Board: 91-22-28555107 / 631 / 914
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MASCO Group: Complete solution provider for clean utilities Alberto Borella, CEO, MASCO Group, gives an insight on wide range of services related to the validation, of both equipment and process, in the pharma and cosmetic factories MASCO GROUP is a group of companies with a long experience in generation, storage and distribution of Clean Media (purified water, water for injection, clean steam), as well as in supplying complete ‘turn-key’ solutions for pharmaceutical and biotech plants, including product preparation areas. Moreover, the group offers a wide range of services related to the validation, of both equipment and process, in the pharmaceutical and cosmetic factories.
Company overview and strategic potential The Masco Group has its headquarters in Italy, but several different subsidiaries around the world: in US, China, Russia and France. The group positions itself as the leader in providing engineering and industrial solutions to its clients in the pharma and cosmetic industry. Masco’s reputation for reliability and excellence has allowed to establish strong relationships (+10.000 installed units) with leading pharma and cosmetic companies. The group revenues despite market conditions, grew by 10 per cent CAGR in last 10 years. Growth was mainly internal (thanks to development of new markets and new offices opening) and strongly driven by Stilmas (i.e., contribution of ~ 80 per cent to total revenues).
Masco Group strength relies strongly on four pillars: research for continuous improvement and best talents in the market; willingness to maintain value, performance and leadership; research for edging technologies and engineering solutions; determination to meet high moral and ethical standards in performing work. The company has continuous ambition towards higher standards and quality, constantly monitored and certified by third party bodies.
Production process, main products and brands The Group consists of three companies: Stilmas, Olsa and DOC.
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PHARMA ALLY Stilmas is an industrial and engineering company engaged in research, design, development and construction of high technology clean utilities systems for pharmaceutical and biotechnological industries. The scope of the business encompasses design, production, assembly and installations of equipment and instruments up to successful qualification. The range and variety of production includes generation equipment, as well as complete storage and distribution systems for purified water, water for injection and pure steam obtained by multiple technologies: chemical, thermal and mechanical. A dedicated R&D department and its active participation in international committees, allows Stilmas to be up to date with the latest developments regarding the international regulations and standards in the pharmaceutical, biotechnological and cosmetic industry. Olsa is a manufacturing company specialising in engineering, development and construction of high technology, durable equipment, including complete production systems for pharmaceutical, biotechnology, cosmetic and fine chemicals industries. Olsa’s range of products covers different production ‘states’ starting with liquid forms (including aseptic processing), semi-solids and solid components (API and fine chemicals). The equipment and turn-key systems are constantly evolving with the latest developments regarding international regulations and the standards in the pharma, biotechnology and cosmetic industries. Modern and extensive range of products, process competence, dynamic organisation, global presence and available financing makes Olsa the ideal partner for advanced process solutions in the biopharmaceutical and cosmetic industries all over the world. DOC is a consulting company with international experience in cGMP compliance and validation for the pharma industry. It plays the role of 'System Integrator' acting as 'Communication Platform & Facilitator' between the cGMP Compliance Requirements and final users. Its services are widely used by
56 EXPRESS PHARMA September 16-30, 2017
and the wide range of services offered by DOC have their roots in the strong expertise and skills of the staff. Professional and qualified support is provided every day to the clients following these simple principles that represents company’s values: people first; flexibility; internationalism; know how in motion. These elements make DOC a recognised and qualified provider of validation services for pharma market on a global scale. In 2016, Stilmas delivered several new products, in particular a distiller MS 5010 HPS producing 15.000 l/h of water for injection in less than 15 minutes granting the highest quality standards and the lowest consumption. In 2017 a unique in the world distiller will be delivered: an MS 9010 HPS producing 20.000 l/h of water for injection. The unit is under assembly at Stilmas factory in Settala.
Main features of Stilmas pharma manufacturers, engineering and contracting companies worldwide. DOC is considered as an active contributor and reliable partner to main regulatory bodies worldwide, by providing: unbiased point of view on market development (with the angle of pharma companies as well as of manufacturers); consultancies on existing/ potential new regulatory rules.
Mission and values The mission of Stilmas is to design and manufacture pharmaceutical grade systems able to produce purified water, water for injection and pure steam at their highest quality standards. The ambition of the company is to maintain its positioning as an essential reference on the assigned market, a leading provider of fully integrated solutions and services, based on: a unique combination of close partnerships with customers and suppliers; an exceptionally comprehensive range of equipment and systems and in depth expertise in its customers’ applications. Stilmas has more than 100 years of experience, over 10.000 installed units and 1000 complete turn-key pharma water
systems supplied and validated worldwide. These factors make Stilmas a leader in the realisation of clean utilities systems. The mission of Olsa is to design, manufacture and serve biopharmaceutical and cosmetic systems capable of being the most reliable production processes with highest quality standards. In a changing world in which we can see a large, ongoing effort of government and international organisations to supply medicines globally, Olsa strives to play a key role in the supply efforts of delivering safe, reliable, durable and technologically advanced.
Equipment and complete production Systems to the bio pharma and cosmetic industries. Olsa has the following identity values: Customer first; deep knowledge of the production processes; development of internal competences; team spirit; a long-term experience joined with courage for innovation; a wide range of equipment and systems; a continuous exchange of knowledge with customers about production processes. The DOC’s global mission is a provision of a functional system totally validated. Activities
◗ Rapid start up: The distillate is produced after only few minutes from the switch on ◗ Energy saving: The best performances in terms of energy saving, thanks to an extremely accurate design of the condenser/evaporators and heat recovery system ◗ High flexibility: The production capacity can be varied by up to 80 per cent without any plant modification ◗ Unique purification system: Gravitational purification principle for a better guarantee of distillate purity ◗ Simple and clean mechanical construction: baffle – free decontamination chamber – no welding; granting the best inspectability and minimised corrosion risk, for the longest expected life of equipment ◗ Extremely limited maintenance: no moving parts, expansion joints or mechanical seals; compact construction and low weight: little extra head room needed for dismounting and inspection up to ten effects, for a maximum energetical efficiency. When it comes to the latest investments, Olsa built a new facility for offices, workshop and laboratory in Italy. The factory was officially inaugurated in 2016.
Achievements and rewards In 2017, Stilmas will celebrate its 105 years of existence, Olsa 70 years and DOC 20 years. In the recent Stilmas history, there were several important events to celebrate, in particular: a new production site establishment in China (2005); the extension of the facilities in Settala, Italy with extra 4.000 square metres (2008); opening of a representative office in Moscow, Russia (2010); inauguration of a new production facility and offices in Settala (2014). For Olsa such a turning point would be year 2006, when Olsa. Established Olsa USA, as well as 2010, when new offices were established in Milan or 2016, when Olsa built a new facility for offices, workshop and laboratory in Settala. Also DOC arrived to its 20year-anniversary by achieving a lot. In 2011 DOC received ISO 9001:2008 certification for cGMP compliance and validation consultancy services. In 2015, DOC established a new division: Process and Product Validation Business Unit, providing so far a full range of validation services from consulting and training, to the validation of an entire pharma facility. All three companies had a re-branding in 2015. Stilmas, Olsa and DOC new brand strategies were designed to reflect the leading position of the companies in their areas of expertise, emphasising the belonging to the Masco Group. When it comes to the prizes, for the second time in the past few years, Stilmas was awarded with the Italian Industrial Excellence award. In 2016 Stilmas won the Italian Industrial excellence nomination. The award was given by the OSSERVATORIO PMI after the evaluation of the performances and the growth rates of the Italian companies. The recognition is based on the fundamental parameters such as: better results within the defined sector, profitability, financial solvency and the company management. Another great result achieved along the Stilmas hundred years of history. ACE technologies is an official representative of STILMAS Masco group in India. Contact acetechnologies@vsnl.net
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TECHNIC PHARMA EQUIPMENTS Mfg. of: Pharmaceuticals, Food, Cosmetic & Chemicals Machinery
Liquid - Syrup Manufacturing Plant
Rapid Mixer Granulator
Zero Hold Up Filter Press
Fluid Bed Dryers
Double Cone Blender
Automatic Ointment Manufacturing Plant
Mass Mixer
Coating Pan
Starch Paste Kettle
Tray Dryer Octagonal Blender
CONTACT : Fact.: Gala No. 16, Building, No. B-11, Sagar Industrial Estate, Dhumal Nagar, Waliv, Vasai (E), Dist. Palghar-401208. Raj Yadav : 07798007538, 08888911581 Mohan Sahani : 09730252310, 08080802767 Email: rajtpe1979@gmail.com, mohan.tpe@gmail.com Visit us: www.technicpharmaequipments.com
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With high performance comes design freedom. A choice of 9 RAL colors to go with your brand image.
You demand. We fulfill. Bangalore I Delhi I Guwahati I Hyderabad I Jammu I Kolkata I Mumbai I Vadodara I Sales@labguard.biz I www.labguard.biz Call National Hotline - 022 65650606
9 RAL colors available
The Reagent Racks featuring in this image is not a standard LabGuard product.
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FC
O M M IT M E N T
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O RT
25 Y E
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Anniversary www.chromline.in
Knauer Germany- HPLC, UHPLC & Semi Prep Columns Azura Analytical HPLC, UHPLC, Compact HPLC Systems
PSS GmbH, Germany GPC-SEC Calibration Standards, GPC Columns & 21 CFR Compliant GPC UniChrom software
Knauer,Germany Azura Bio HPLC
Biostep GmbH, Germany - HPTLC Densitometer CD 60
Biostep GmbH, Germany Chromajet DS 20
Biostep GmbH, Germany - HPTLC Applicator AS 30
Microwave Digestion system
Knauer Germany Freeing Point Osmometer
For further details contact Exclusive Distributor:
CHROMLINE EQUIPMENT COMPANY Unit No. 17, Udyog Bhavan, Sonawala Road, Goregaon (East), Mumbai 400 063, India. Tel.: 022 2686 0816 / 61887317 Website: www.chromline.in E-mail: mail@chromline.in
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2
Designers, Engineers & Manufacturers of Machinery & Filteration Equipments for:
es Decad ies. ustr Over d In to ice of serv ing Stronger Grow t & Integrity us with Tr
Pharmaceuticals, Packaging, Chemicals, Food, Beverages, Distilleries, Breweries, Paints, Food, Oils & Consumers
MAJOR PRODUCTS MANUFACTURED AT UNIPACK Linear Vial/Bottle Washing Machines Sizes: vials 2ml to 100 ml & Bottles 15 ml to 500 ml Scramblers/Unscramblers Sizes:24” dia, 36” dia. 48” dia 60” dia Hydraulic Loading Platforms Inspection Tables Loading and unloading Conveyors Liquid Filling, Rubber Stoppering & aluminium Cap sealing Machines for Vials Powder Filling, Rubber Stoppering & aluminium Cap sealing Machines for Vials
Sterlity Testing Units in S.S. Sizes: Single Place, Three Place & Six Place Plate and Frame Type Filter press in SS Size: 20 cm X 20 cm, 40 cm X 40 cm, 60 cm X 60 cm, 100 cm X 100 cm Zero hold up/Sparkler Filter press Size : 600 LPH to 15500 LPH Sterile Pressure and Storage Vessels Size : 10 ltrs to 500 ltrs Membrabe Filter Holders (Size: 293 mm, 142mm, 90mm) Inline Filter Holders (Size:47mm, 25mm, 13mm) Basket/Bag/Catridges Filters
We Supply different sizes of Filter Sheets and Filter Modules of Major International Brands
Our Achievements: Over 2500 installations of our major products manufactured in-house are supplied to all Leading Companies in India & Multinationals abroad
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introduce
An Enterprise Providing Professional Value of Optimized Technology Name Source : Advantage + Technology + Praxis + Practice
From Technique for Humanity
From Zero Base to Innovation
Breakthrough the existing frame, users-centered and innovative new product
Optimized Technology
1st Indian Company to launch “CE” approaved equipment. 1st Indian Company to launch “PLC Based” Control System. Capsule Filling 21CFR Part 11 Compliant Software
Tablet Press
F Series
P Series
GSM Technology: SMS Mobile Alert. “Best Service in its Class”. Acclaimed by our Proud Customers.
Our World Class & World Renowned Equipment n
Walk-In Humidity Chambers.
n
BOD Incubators.
n
Humidity Chambers.
n
Bacteriological Incubators.
n
Walk-In Cold Chambers
n
Photostability Chambers.
n
Cold Chambers.
n
Deep Freezers.
n
Walk-In Incubators.
n
Ovens.
Mack Pharmatech Pvt Ltd. B-48, Malegaon MIDC, Sinnar, Dist. Nashik, Pin - 422 113, Maharashtra, India
+91 2551230877
+91 2551230877
sales@mackpharmatech.com
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www.mackpharmatech.com
service@mackpharmatech.com
Sejong Coater
Sejong FBD
C Series
D Series
Source Genuine Sejong Spares from Allpharm Alone Save your high tech machines from Non OEM, Spurious parts
A 404, Rajeshri Accord, Teli Galli Cross Lane, Andheri (East), Mumbai - 400 069 Tel: +91 97691 99633 Email: mail@allpharm.in Web: www.allpharm.in
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VISIT US @ Multiple Products Under One Roof HALL #5, STALL #N‐36 28TH ‐ 30TH NOV, 2017
TH
07 ‐ 12 FEB, 2018
BOMBAY EXHIBITION CENTER, MUMBAI, INDIA.
Imavac™ - Silicone Hose reinforced with SS 316 helical wire
for Food & Bio-Pharma Industries
TH
®
We are specialized in manufacturing Platinum Cured Silicone Tubes, Braided Hoses, Inflatable Seals / Gaskets and customized polymer solution for food, medical and pharmaceutical industries application.
GANDHINAGAR, AHMEDABAD, GUJARAT. INDIA
Imawrap - Silicone Hose reinforced with Polyester Fabric & SS 316 helical wire
®
Imaprene™ - Thermoplastic Elastomer Tube (TPE)
Imavacfit - Silicone hose reinforced with Polyester Braiding and SS 316 helical wire
Silicone Inflatable Seals & Gaskets
TM
Ami Polymer Pvt. Ltd.
www.amipolymer.com
“Sealing Expert in Silicone” An ISO 9001:2008/14001:2004/18001:2007 & Clean Room Certified Co. DMF #26201 accredited by USFDA
mktg@amipolymer.com
Top Features Carts for Sterile & OSD Application
§ Maximum cleaning exibility. § Customized trays & racks.
GMP WASHER
§ Precise & automatic dozing of
cleaning agents. § Steam heating arrangement for
effective cleaning. § Rotary spray arm at the top and
bottom for external cleaning. § Internal cleaning via nozzles on
Carts. § Effective HEPA ltered drying. § 21 CFR Part 11 compliant control system. § Batch printing for process documentation and validation.
Steam Sterilizers Closure Processing Systems Hot Water Spray Sterilizers Steam Air Sterilizers Dry Heat Sterilizers WFI Stills Pure Steam Generators Ethylene Oxide Sterilizers
Machinfabrik Industries Pvt. Ltd.
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MACHINFABRIK INDUSTRIES PVT. LTD. R - 89 / 90, Rabale, MIDC., Thane Belapur Road, Navi Mumbai - 400701, India www.machinfabrik.com | sales@machinfabrik.com | 91-22-6736 8200
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RM 200 – The Classic Mill for Grinding, Mixing and Trituration The RM 200 is the latest generation of the classic “RETSCH Mill” which replaced manual mortars and pestles more than 90 years ago. Mortar grinders are widely used for reproducible sample preparation in R&D, materials testing and especially in pharmaceutics and homeopathy.
PRE M I UM QUA LI TY M A DE IN GE RM AN Y
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marketing@verder-scientific.co.in www.verder-scientific.co.in
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EXPRESS PHARMA Filtration Made Easy
www.kesarcontrol.com
www.kesarcontrol.com
www.kesarcontrol.com
Versatile Vacuum Filtration with Magnetic Filter Funnel
MF series Magnetic Filter Holder Humidity Chamber
Cold Chamber
Multi-branch Manifold
Service Network all over INDIA Mfg. Unit : B/8, Karma Industrial Estate, Nr. Trikampura Patiya, Vatva, Ahmedabad - 382445. Gujarat, INDIA. Tele : 079 - 25890727
Contact Details: Wadala Shree Ram Indl. Estate, Unit No. C-32, 3rd Floor, G. D. Ambekar Marg, Wadala, Mumbai - 400 031, Maharashtra India. Phone: +91 22 4356 0400 Fax: +91 22 4356 0425 Email: pharma@shahbros.com
Mobile : 09427613646 Email : service@kesarcontrol.com
www.shahbros.com
ATCC Culture
l l l l l l
AtccÂŽ Derivatives Lyophilized Cultures Available in 1st, 2nd & 4th Passage, Kwik Stik / Kwik Stik Plus & CRM Quantitative & Qualitative with Certification Easty to Usage and Handling Biochemical Test Report is Provided Along with Every COA of Culture
June Enterprises Pvt. Ltd. l +91 9323021231 info@june4gmp.com l www.june4gmp.com
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LABORATORY EQUIPMENTS Laboratory Centrifuges
Laboratory Stirrers
Bench Top Orbital Shaking Incubator
Magnetic Coupling
Humidity Chamber with TFT Display
Ultra Low Frezeer Gerber Centrifuge
Neya Centrifuges
UTC Freezer
Medico Plus
Multi Vortexer
Walk in Chamber
REMI SALES & ENGINEERING LTD.
Remi House, 3rd Floor, 11, Cama Industrial Estate, Walbhat Road, Goregaon (East), Mumbai-400 063. India Tel: +91 22 4058 9888 / 2685 1998 l Fax: +91 22 4058 9890 l E-mail: sales@remilabworld.com l Website: www.remilabworld.com
COMPARISON CHART OF WSDS & OTHER SDS SIEVES
WESTERN STATIC DISSIPATIVE SILICONE SIEVES (WSDS)
Food Safety EC No 1935: 2001
Description
Other SDS Sieves
WSDS Sieves
Comments
MOC (Material of construction)
Chlarinated /Nitrile Rubber
Silicone Rubber
Silicone is preffered & suggested material far pharmaceutical application
Area of application
Petroleum & Other Industries
Food, Beverage, Medical, Pharmaceuticals
WSDS is first choice in Pharmaceuticals & Medical industries
High Temperature Resistance
No
Yes
WSDS always used for high temperature application
Autoclavable property
No
Yes
WSDS is repeatedly autoclavable
Bacterial & Mildew resistance
No
Yes
WSDS is Fungus resistant
Stable Static dissipative behaviour independent from humidity
No
Yes
WSDS supports stable static dissipative behaviour which is independent from humidity
Negative effect on metal corrosin and metal bonding
Yes
No
WSDS is suitable for Non-Corrosive material
Risk of hazardous residual monomers in rubber
Yes
No
WSDS is Non hazardous
Requirement of stabilizers
Yes
No
WSDS requires no stabilizers
Migration of anti-static agent to environment & contact material
Yes
No
There is no migration of anti-static agent to environment & contact material in WSDS material
WESTERN POLYRUB INDIA PVT LTD Certified Co.DMF#29096 accredited by USFDA
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C 12/13, Singh Industrial Estate No. 1, Ram Mandir Road, Goregaon (West), Mumbai - 400 104, India. Tel.: 91-22-26764144 / 26760203 / 66944301 / 66949199 l Mobile : 91-9833590390 / 91-9833508079 Website: www.westpolyrub.com l Email: info@westpolyrub.com
September 16-30, 2017
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ISO 9001 - 2015 Certified
Photon Cleantech Inc.
Manufacturer and Supplier of Cleanroom Turnkey Projects & Cleanroom Equipments
CERTIFIED
ISO 9001:2015
Ceiling Suspended LAF Lupin
Modular Operation Theatre
Dispensing Booth
Air Shower
Bio Safty Cabinet
Cleanroom Panel
Doors
DY PB Lupin
Garment Cabinet
Fore more info contact:
Photon Cleantech Inc. Survey No. 106 A/3, Office No. A-6, Surya Lok Nagari, Pune - 411028, India. l l / Website: www.photoncleantech.com Mobile: +91 8805060111 / Email: photoncleantech@gmail.com
Experiment With The Truth Certified ISO 9001: 2008
A BENCHMARK FOR
QUALITY SOLUTIONS
STABILITY CHAMBER
WALK-IN STABILITY CHAMBER
AUTOCLAVE-WINGNUT
PRODUCT RANGE l l l l l l
Autoclave BOD Incubator Bacteriological Incubator Cooling Incubator Deep Freezer Hot Air Oven
l l l l l l
Muffle Furnace Photo Stability Chamber Pharma Refrigerator Stability Chamber Vacuum Oven Walk-in Stability Chamber
Osworld Scientific Equipments Pvt. Ltd.
B-44, New Empire Industrial Premises, Kondivita, J. B. Nagar, Andheri (East), Mumbai - 400 059. India Tel.: +91-22-28320880 / 28390487 E-mail: info@osworldindia.com
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B.O.D INCUBATOR
www. a. ldindi oswor com
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OSMOMETER 3250
Milk Cryoscopes Available
127, Bussa Udyog Bhavan, Tokershi Jivraj Road,Sewri, Mumbai - 400015. India
Tel: +91-22-24166630 Fax: +91-22-2662776 E-mail: support@rosalina.in Web: www.rosalina.in
Wiper Type Sight Glass
DIN 100 Light Glass LED
Swastik Associates Shed No. 1, 2 & 3, Sr. No. 30/7, Behind Dran Company, Dhayari-Pune 411041 Phone : 020 24690268 / 24690041, 9923124949 / 9028716622, 9028716222 Email : sale1swastik@gmail.com swastikpune1@gmail.com
Our other product details u
SS Fittings
u
SS Valves Manual & Pneumatic
u
SS Filters
u
SS Pumps: Centrifugal, Self Priming & Shear Pump
u
SS Powder Blender
u
SS Steam & Water Mixing Station
u
Drain Trap
Manhole Round Dia 450
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Sight Glass Flange with LED
LED Bush
4W / 15W / 20W / 24W
Manhole Pressure Type
Manhole Elliptical
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To Advertise in
Business Avenues Please Contact: ■ Mumbai: Rajesh Bhatkal 09821313017 ■ Ahmedabad: Nirav Mistry 09586424033 ■ Delhi: Ambuj Kumar 09999070900 ■ Chennai ■ Bangalore: Kailash Purohit +91 9552537922 ■ Hyderabad: Mujahid 09849039936 ■ Kolkata: Ajanta 09831182580
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PHARMA LIFE AWARDS
Healthcare Senate 2017 celebrates excellence and leadership in healthcare Honours visionaries, game changers and champions with Best Hospital Pharmacy Citations and Express Healthcare Excellence Awards By Lakshmipriya Nair
T
he Awards Nite was one of the major highlights at Healthcare Senate 2017 – the national private healthcare business summit. Held on the second day of the event, the awards were an endeavour to recognise best practices and innovation in healthcare delivery through Best Hospital Pharmacy Citations and Express Healthcare Excellence Awards. The Welcome Address by Viveka Roychowdhury, Editor, Express Healthcare set the stage for the evening. She spoke on the vision of the awards and explained the methodology adopted to select the winners. She also thanked the jury members and the partners for their contributions in helping choose the most deserving winners. The Guest of Honour, Rajendra Pratap Gupta, Advisor, MoH&FW, took the stage to deliver his address wherein he urged the private healthcare sector to devise ways and control costs without compromising quality. He opined that functional, asset-light and no frills hospitals are the need of the hour in Indian healthcare. Alok Kumar, Advisor, NITI Aayog, in his Special Address, spoke on the government’s endeavours to make healthcare more accessible and affordable to the masses. He also shared his views on the way forward for the healthcare system in India and listed down investment in healthcare, building public health cadre, need for data-driven and decentralised
approach, stewardship by government as priorities for the sector. The audience was very appreciating of these insightful sessions and were happy to see the government’s interest in plugging gaps in the country’s healthcare system. Next, Best Hospital Pharmacy Citations were given away to pharmacies of seven hospitals. The recognitions acknowledged the role and significance of hospital pharmacies within the healthcare system. They also provided encouragement to hospital pharmacies to take their right-
ful place in the health ecosystem by implementing best practices and through constant innovation. Glenmark was the presenting partner for Best Hospital Pharmacy Citations. Subsequently, Dr Krishna Komanduri, Adjunct Professor of Medical Physics, University of Pittsburgh & Director, CTSI addressed the audience and shared his experience of adopting a cloud-based solution for oncology. An eminent healthcare expert, he is a strong proponent of technology adoption to improve healthcare delivery. Express Healthcare Excellence Awards ceremony fol-
BEST HOSPITAL PHARMACY CITATIONS ◗ HCG Ltd (Single Specialty Hospitals) ◗ Hiranandani Hospital, Mumbai (Standalone Multispecialty Hospitals) ◗ Holy Spirit Hospital, Mumbai (Standalone Multispecialty Hospitals) ◗ Jupiter Hospital, Mumbai (Standalone Multispecialty Hospitals) ◗ Apollo Hospitals Ltd (Corporate Chain Multispecialty Hospitals) ◗ Global Hospitals, Mumbai (Corporate Chain Multispecialty Hospitals) ◗ Sagar Hospitals (Corporate Chain Multispecialty Hospitals)
To subscribe: bpd.subscription@expressindia.com
lowed his session. Bejon Misra, Chairman of the Jury took the stage to explain and inform the audience about the need for such endeavours to recognise the game changers and innovators in the healthcare. He also advised that the healthcare industry should have patients’
wellbeing at the core of all their initiatives and activities. Eight awards were given away to healthcare organisations who were doing a fabulous job across five key areas and were paving the way for a progressive transformation in the sector. lakshmipriya.nair@expressindia.com
EXPRESS HEALTHCARE EXCELLENCE AWARDS ◗ Category: Innovative Marketing Practices (Multispecialty Hospital) Winner: Aster Medcity ◗ Category: Innovative Marketing Practices (Single Specialty Hospital) Winner: Healthcare Global Enterprises Ltd ◗ Category: Inspirational Workplace (Multispecialty) Winner: Apollo Health Enterprises Ltd ◗ Category: Corporate Social Responsibility (Multispecialty) Winner: Mission of Mercy Hospital & Research Centre ◗ Category: Patient Care (Multispecialty) Winner: Apollo Health Enterprises Ltd – Project WOW ◗ Category: Health Tourism (Multispecialty) Winner: Narayana Health ◗ Category: Special Jury Award for Corporate Social Responsibility Winner: Kasturba Hospital ◗ Category: Special Jury Award for Inspirational Workplace (Multispecialty) Winner: Six Sigma Star Healthcare (P) Ltd
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PHARMA LIFE APPOINTMENT
Novartis appoints Vasant Narasimhan as CEO Joseph Jimenez, CEO, Novartis, will step down as CEO in 2018, after eight years in position THE BOARD of Directors of Novartis has appointed Vasant (Vas) Narasimhan, MD, Global Head of Drug Development and CMO, as CEO, Novartis, effective February 1, 2018. Dr Narasimhan is a member of the Executive Committee and joined Novartis in 2005. Joseph Jimenez, CEO, Novartis, will step down as CEO in 2018, after eight years in position. Dr Narasimhan has held numerous leadership positions across Novartis in commercial, drug development and strategy roles. Prior to his current role, he served as Head of Development for Novartis Pharmaceuticals. Before joining Novartis in 2005, he worked at McKinsey
& Company. He received his medical degree from Harvard Medical School in the US and obtained a master’s degree in public policy from Harvard’s John F Kennedy School of Government. In addition, he holds a bachelor’s degree in biological sciences from the University of Chicago, also in the US. During and after his medical studies, he worked extensively on a range of health issues in developing countries. Dr Narasimhan is an elected member of the US National Academy of Medicine. He is a US citizen born in 1976, and lives in Basel, Switzerland. Dr Narasimhan said, “I would like to congratulate Joe
and express my gratitude to Joe, Joerg, and the Board of Directors. I feel honoured and humbled to be asked to lead Novartis. We will continue our legacy of bringing leading inno-
vation to patients around the world. With our recent launches, our strong pipeline, broad capabilities, world-class leadership team, and committed people, I am very confident about our future.” Jimenez, who has been CEO since 2010, joined the company in 2007. He first led the Consumer Health Division, and then held the position of Division Head, Novartis Pharmaceuticals. Jimenez will step down as CEO, effective January 31, 2018, and will be available for advice and support at the request of the Chairman of the Board of Directors or the CEO until he retires from Novartis on August 31, 2018.
Joerg Reinhardt, Chairman of the Novartis Board of Directors, commented, “I would like to express my sincere appreciation for Joe’s achievements as CEO. During his tenure, Joe focussed Novartis on leading global businesses, while divesting non-core divisions. Under his leadership the innovation pipeline was rejuvenated, and we successfully navigated the patent expirations of our two largest products. We anticipate a smooth transition as Joe built a strong leadership team and mentored his successor. Novartis will be well positioned to continue its momentum.” EP News Bureau
INITIATIVE
Cadila Pharmaceuticals concludes ‘Swachhta Pakhwada’initiative The major highlight was the cleaning of Malav Talav, a heritage monument located in Dholka, near Ahmedabad CADILA Pharmaceuticals commemorated the national Swachhta Pakhwada by successfully concluding a ‘Safai Sankalp’ campaign under its CSR umbrella. The major highlight of the cleanliness drive was the cleaning of Malav Talav, a heritage monument of national interest located in Dholka, near Ahmedabad. Apart from company employees, senior representatives from Archaeological Survey of India (ASI) and Dholka Nagarpalika also joined the drive to create awareness among the public about preserving our national heritage.
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Under this initiative, many cleanliness drives and community awareness programmes were organised in the company’s business location across the country. Employees of Cadila
Pharmaceuticals along with Panchayat members, village people and school children cleaned the public places, school premises in the villages and also spread the message of impor-
tance of cleanliness in keeping diseases away. As part of the Swachhta Pakhwada celebration announced by the Ministry of Chemicals and Fertilisers, team
Cadila Pharmaceuticals took a pledge for maintaining cleanliness at their respective locations and actively participated in the series of awareness programmes including cleanliness drives and awareness rallies and Nukkad Nataks. Cadila Pharmaceuticals’ Safai Sankalp campaign touched the lives of around 50,000 people in Gujarat and Jammu. People covered in the campaign are now expected to carry forward the message of cleanliness within their homes and at the community for a disease free healthy society. EP News Bureau
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