bi-monthly news letter of bulk drug manufacturers...

AUGUST ndashSEPTEMBER 2019

NEWS LETTER

BI-MONTHLY NEWS LETTER OF BULK DRUG MANUFACTURERS ASSCIATION INDIA

C-25 Industrial Estate Sanathnagar Hyderabad-500018

ANNUAL GENERL BODY MEETING OF BDMA(I)

Speech of Shri V V Krishna Reddy National President BDMA delivered on 28th September2019

President Emeritus Patrons Management Committee members on the dais respected invitees and members

It is gratifying to address this meeting as the National President of BDMA for the third consecutive year and thank you all for your continued support in discharging our duties Year 2019 has been very active with many ups and downs in the business of APIs

Pharma industryrsquos future is very promising and demand for pharma products is rising dramatically The policies of the present Government are aimed at making quality healthcare affordable to all and also increase access to healthcare in rural and urban areas Governmentrsquos New Pharma Policy is yet to take off but lacks the necessary punch to achieve the desired growth and objectives BDMA had made some recommended to the Govt in this regard

Realizing the fact that India now imports a lot of APIs from China the Indian government has initiated a lot of steps to reduce our dependence on imports and strengthening indigenous production This is now a right opportunity for India to increase domestic production of critical intermediates Government should do the following on priority without waste of time

Create Pharma industrial parks across the country with all environmental and support infrastructure

National laboratories to develop technologies which are technically and commercially viable and offer to industries on agreeable terms

Government to take the onus of environmental services and facilities in association with CPCB and NEERI or any expert body

The Department of Pharmaceuticals under the Ministry of Chemicals and Fertillizers have planned to promote dedicated Pharma Parks in few states to facilitate existing companies and new companies from within and outside India to invest and promote the manufacturing of APIs There is not much progress in this regard in the last four years and no new single industrial Pharma park has been commissioned Even the Hyderabad Pharma City is yet to take off

Government is looking at simplification of licensing and procedures which include GST amp Customs duties Foreign Trade Environmental issues Drug Control Authority Labour Department Department of Factories State Excise Service Tax and Electricity Boards

API industry requires highly skilled scientists and technicians In this regard BDMA is planning to set up a Training institute for Life Sciences Sector Skill Development at BDMA Jeedimetla building We had discussed with DoP for grants for which the response was positive However BDMA has to complete the building construction estimated to cost around Rs 4 crores and DoP will support in developing the support infrastructure like class rooms laboratories IT centre workshop etc Very soon we will approach the members for building fund donation and propose to suitably acknowledge by naming sections of the Training centre with the donor industry

API industry in Telangana

Telangana intends to maintain its pioneer status for bulk drugs production However the growth has been almost stagnant due to reasons listed below

Govt restrictions of expansion related to earlier ban notifications shifting of industries outside ORR NGT orders and its interpretation CEPI guidelines Moratorium on expansion based on CEPI score

No improvement of existing industrial parks and in particular the Jeedimetla and Kazipalli areas

Mucherla Pharma city had still not taken off in spite of initiating five years back by the Government

Lastly with all the new initiatives planned and support from the govt India will be a major force globally in the API sector I once again thank BDMA for giving me this opportunity and wish you all best of luck

THANK YOU

LIST OF BDMA COMMITTEE MEMBERS ELECTED FOR THE YEAR 2019-20 IN THE AGM HELD ON 28TH SEPTEMBER 2019

SlNo Name Company Name (Ms) DESIGNATION

1 SHRI VV KRISHNA REDDY

SRI KRISHNA PHARMACEUTICALS LTD NATIONAL PRESIDENT

2 SHRI M NARAYANA REDDY VIRCHOW LABORATORIES LTD PRESIDENT EMERITUS

3 SHRIBRSIKRI ABS MERCENTILE PVT LTD VICE PRESIDENT NORTH ZONE

4 SHRI NARESH K GUPTA LUPIN LIMITED VICE PRESIDENT WEST ZONE

5 SHRI RK AGRAWAL-MD NAKODA CHEMICALS LTD SRVICE PRESIDENT

6 SHRI R SRINIVASA RAJU STANDARD PRODUCTS MFGCO GENERAL SECRETARY

7 SHRI M VIJAY KIRAN COVALENT LABORATORIES PVT LTD SECRETARY

8 SHRI ANUP VEER VEERCHEMIE AND AROMATICS PVT LTD TREASURER

9 SHRI M NARAYANA REDDY

COVALENT LABORATORIES PVT LTD

PATRON amp PAST PRESIDENT

10 SHRI K NITYANANDA REDDY AUROBINDO PHARMA LTD


11 Dr VV SUBBA REDDY SRI KRISHNA PHARMACEUTICALS LTD


12 Dr B PARTHASARADHI REDDY HETERO DRUGS LTD


13 Dr NVENKATA REDDY VIRCHOW LABORATORIES LTD PATRON amp PAST PRESIDENT

14 SHRI VENKAT JASTI SUVEN LIFE SCIENCES LTD PATRON amp PAST PRESIDENT

15 SHRI PVRANVEER VEERCHEMIE AND AROMATICS PVT LTD

EXECUTICE COMMITTEE MEMBER

16 SHRI D RAJKUMAR REDDY COREY ORGANICS LTD


17 SHRI ANUP AGARWAL SREEPATHI LABS PVT LTD EXECUTICE COMMITTEE MEMBER

18 SHRI K SUBBARAO GLOCHEM INDUSTRIES LTD EXECUTICE COMMITTEE MEMBER

19 SHRI GMANIKYA REDDY SM LABS PVTLTD EXECUTICE COMMITTEE MEMBER

20 SHRIJSANJEEVA REDDY TEJASHRRI INTERMEDIATE PVT LTD


21 SHRIKRAJA RAO KEKULE PHARMA LTD EXECUTICE COMMITTEE MEMBER

22 SHRI P LAKSHMAN RAO RASULA PHARMACEUTICALS amp FINE CHEMICALS


23 Dr RAVI PENMETSA GLAND PHARMA PVTLTD EXECUTICE COMMITTEE MEMBER

24 SHRIMBALA SUBBA REDDY

VIRUPAKSHA LABORATORIES PVT LTD


25 SHRI VVASUDEV GOUD BALAJI FORMULATIONS PVTLTD EXECUTICE COMMITTEE MEMBER

26 DRCRNAIDU IPS (RETD) SRIAM LABS PVT LTD


27 SHRI SRINIVAS ISOLA SREEPATHI PHARMACEUTICAL LTD


28 SHRI NSRINIVASAN-DIRECTOR PORUS LABORATORIES PVT LTD


29 SHRI TBNV SUNDER RAO VISHNU CHEMICALS LTD EXECUTICE COMMITTEE MEMBER

30 SHRI RAVI SEELAM SHETTY KREATIVE ORGANICS PVT LTD


31 Dr GIRIDHAR THOTA SHODHANA LABORATORIES LTD EXECUTICE COMMITTEE MEMBER

32 SHRI CH A P RAMESHWAR RAO RAKSHIT DRUGS PVT LTD


33 SHRI MV RAMA RAJU VASUDHA PHARMA CHEM LTD EXECUTICE COMMITTEE MEMBER

34 SHRI P RAMESH KUMAR GLAND CHEMICALS PVT LTD EXECUTICE COMMITTEE MEMBER

35 DrPV APPAJI MEENAXY PHARMA PVT LTD EXECUTICE COMMITTEE MEMBER

36 SHRI M JAYANT TAGORE SYNTHOKEM LABS PVT LTD EXECUTICE COMMITTEE MEMBER

37 Dr SSURESH BABU ENAL DRUGS PVT LTD EXECUTICE COMMITTEE MEMBER

38 SHRI DINESH DUA NECTAR LIFE SCIENCES LTD EXECUTICE COMMITTEE MEMBER

39 SHRI RAVI YERRA RA CHEM PHARMA LTD EXECUTICE COMMITTEE MEMBER

40 SHRI K VAMSHIDHAR REDDY EMMENNAR PHARMA PVT LTD


41 SHRI MUDAY KUMAR REDDY MSN LABORATORIES PVT LTD


42 SHRI CS RATNA PRASAD VALENS MOLECULES PVT LTD


43 SHRI SVRAO STYRAX PHARMA PVT LTD EXECUTICE COMMITTEE MEMBER

44 SHRI VMADHUKAR REDDY SMLABS PVT LTD


45 SHRI PKIRAN KUMAR DrREDDYS LABS LTD EXECUTICE COMMITTEE MEMBER

46 SHRI PMADANMOHAN REDDY AUROBINDO PHARMA LTD


47 SHRI RAHUL THOTA SHODHANA LABORATORIES LTD EXECUTICE COMMITTEE MEMBER

48 SHRI LINGA REDDY SUNIL SARACA LABORATORIES LTD


49 SHRI NIKHIL THOTA SHODHANA LABORATORIES LTD EXECUTICE COMMITTEE MEMBER

50 SHRI KARTHIK CHANDRA ISOLA

SREEAPTHI PHARMACEUTICALS LTD


51 SHRI SSREENATH STYRAX PHARMA PVT LTD EXECUTICE COMMITTEE MEMBER

Hyderabad Chief scientist at the Centre for Cellular and Molecular Biology

(CCMB)

Hyderabad Senior scientist from Hyderabad-based Centre for Cellular and Molecular Biology (CCMB) Dr Manjula Reddy has been chosen for the prestigious Infosys Prize 2019 in the Life Sciences category

The prize comprises of a pure gold medal citation and a purse of $ 100000 Infosys Science Foundation (ISF) said The prize to Dr Manjula comes for her ground breaking work concerning the structure of cell walls in bacteria

Dr Reddy and her colleagues have revealed critical steps of cell wall growth that are fundamental for understanding bacterial biology This work could potentially help in creating a new class of antibiotics to combat antibiotic resistant microbesrdquo the ISF said

A panel of jurors comprising renowned scholars and professors shortlisted the winners of Infosys Prize 2019 from 196 nominations

The other winners include Sunita Sarawagi Institute Chair Professor Computer Science and Engineering IIT Bombay in Engineering and Computer Science and Manu V Devadevan Assistant Professor School of Humanities and Social Sciences IIT Mandi in Humanities Siddhartha Mishra Professor Department of Mathematics ETH Zuumlrich was awarded in Mathematics while G Mugesh Professor Department of Inorganic and Physical Chemistry IISc in Physical Sciences and Anand Pandian Professor Department of Anthropology Krieger School of Arts and Sciences Johns Hopkins University in Social Sciences

ldquoThe Infosys Prize continues to recognize exemplary work in scientific research and enquiry Many Infosys Prize laureates have gone on to contribute significantly in key areas like healthcare genetics climate science astronomy and poverty alleviation amongst other things Their work has immediate implications for the human race and the planetrdquo S D Shibulal co-founder Infosys Limited and president of the Infosys Science Foundation said

Elaborating on the importance of Fundamental research N R Narayana Murthy Founder Infosys said ldquoWe should start helping our youngsters pursue fundamental research enthusiastically They should be encouraged and equipped to become contributors to solving huge problems that confront us every day I want India to be a place where discovery and invention happen every monthrdquo

All export incentives to be replaced with a duty refund scheme

The MEIS scheme was challenged by the United States at the World Trade Organization

Reimbursements will be done through a freely transferable scrip

Indias export incentive scheme called Merchandise Exports from India Scheme (MEIS) will be scrapped and replaced with a new duty refund scheme called Rebate of State and Central Taxes and Levies (RoSCTL)

The MEIS scheme is an export incentive scheme which was challenged by the United States at the World Trade Organisation (WTO) which is likely to take a call on the dispute in September this year Pre-empting an adverse report CNBC-TV18 learns that the Commerce Ministry has floated a Cabinet note for a WTO-compliant scheme to ensure that Indias exports remain competitive

Instead of giving export incentives the new scheme will seek to reimburse duties to exporters As per current estimates 11 State taxes and 6 Central taxes are not reimbursed to exporters

Exports should be zero rates from a tax point of view need to take measures to ensure that disabilities to export companies are minimised said Indias former ambassador to WTO Jayant Dasgupta

Reimbursements will be done through a freely transferable scrip which will be determined by the duty drawback committee under the Department of Revenue This committee will take into account the non-refunded duties that exporters have to bear and based on that it will derive a scrip rate for each export product Since this is a massive re-orientation exercise the new duty refund scheme will replace MEIS in phases

Ajay Sahai DG and CEO of Federation Indian Export Organisations (Fieo) said Embedded structure of tax being included in product costs needs to be looked at Ease of credit access with competitive interest rate will further help export companiesrdquo

As per current estimates of the Finance Ministry the duty foregone on account of MEIS has been estimated at Rs 44000 crore in FY19 and it is expected that the new scheme at the most will have the same level of duty foregone

It remains to be seen whether exporters suffer competitive disadvantage vis-a-vis other countries in the global market where exports are losing traction after the removal of MEIS and the implementation of the new scheme

Green ChemisTree Foundation in collaboration with the Science amp Engineering Research Board (SERB) Govt of India is pleased to invite nominations for the ldquoSERB-IGCW 2019 Green Chemistry Awardsrdquo to be felicitated during the 6th Industrial Green Chemistry World (IGCW) Convention and Ecosystem on 16th Oct 2019 at Victor Menezes Convention Centre (VMCC) IIT-Bombay India

The Science amp Engineering Research Board (SERB) Dept of Science and Technology Govt of India in collaboration with the Green ChemisTree Foundation co-felicitates Indiarsquos first and only Industrial Green Chemistry Awards under the prestigious title of SERB-IGCW 2019 Awards

middot The SERB-IGCW 2019 Awards will acknowledge outstanding case-studies incorporating the principles of Green Chemistry into chemistry routes chemical designs and manufacturing practices and any initiative taken towards pollution-prevention at the source of its generation

Nominations for SERB-IGCW 2019 are invited in the following categories

1 MNC Large and Medium Scale Companies 2 Small-Scale Industries 3 Green Chemistry Start-ups

Shortlisted applicants in this category will be provided with a complimentary booth at the IGCW-2019 EXPO (inclusive of travel and lodging)

4 Knowledge Community

Winners in this category (4B amp 4C) will be endowed with token reward of Rs 50000 and 100000 respectively

middot 4A -Technology Development firms Tools Software Process technology equipment Devices Diagnostics etc

middot 4B ndash Students

middot 4C - GuidesResearchers form Universities Research Institutes

The online submissions for the SERB- IGCW 2019 Awards are now open To submit your case studyies please click here httpindustrialgreenchemcomIGCW2019awardsnomination

ISHRAE is conducting RefCold 2019 an International Exhibition cum Conference on Refrigeration and Cold chain from 21st Nov to 23rd November 2019 at Hitex Hyderabad covering all sectors cold storages pharma cold chain logistics horticulture aquaculture dairy food processing and beyond

RefClod 2019 will have around 200 domestic exhibitors 50 international exhibitors covering 100000 sqft We are enclosing the RefCold 2019 brochure and presentation for your reference Request you to see promotional video at httpswwwyoutubecomwatchv=bW_lsXuJSuA

CSIR-IICT BDMAI Sample collection center_registration form and Analytical Charges Price list

This is in reference to BDMA collaboration agreement with IICT Hyderabad We had the first interaction meeting on 20th of May 2019 wherein many member industry representatives visited all their laboratories and analytical testing centers

In continuation we are now happy to inform you that a sample collection center has been inaugurated on 22nd of July 2019 by Dr S Chandrasekhar Director IICT Hyderabad at BDMA Office Sanathnagar

All the members can now deposit their samples at BDMA Office and the same will be collected and analysis done by IICT Hyderabad as per the industry requirements

The following are enclosed for your reference and use

1 Sample Registration Form

2 Testing Charges

3 Mode of Payment of Analytical Charges

Single point contact

a IICT- Sri G Veeraiah Ph09985769419 Email id gveeraiahiictresin

b BDMA- Mr Ch Sanyasi Rao Ph9959187512 Email id infobdmaiorg

We look forward to making this association with IICT a success

CSIR-Indian Institute of Chemical Technology

(Ministry of Science and Technology Govt of India) Tarnaka Hyderabad- 500 007

Analytical Charges

Part A Special discounted charges for the following routine tests applicable to MSMEs Startups (Up to 5 years) Academic institutions

All prices in INR (excluding 18 GST)

SlNo Analytical test Proposed Price

1 1H-NMR (CDCl3 300 MHz) 300-

2 1H-NMR (CDCl3 400 MHz) 600-

3 HPLC purity by general method without blank 500-

4 HPLC purity as per API (blank amp single injection) 750-

5 FTIR 200-

6 EI ESI APCI Mass Spec (direct low resolution) 500-

8 GCMS (low resolution one injection without blank) 1000-

9 LCMS (low resolution one injection without blank) 3000-

For other solvents additional

charges apply DMSO D2O

Acetone Benzene Rs 200- Methanol-D4 Rs 750-

HPLC grade Solvents to be submitted by the user or additional charges apply Rs 200- per sample

Part B Charges for the following routineadvanced tests for Industries (50 discount applicable to academic institutionsGovt laboratori s)



I Routine

1 1H-NMR (CDCl3 300 MHz)sect 600-




5 FTIR 400-




II Advanced NMR 300 MHz (CDCl3 13C DEPT For one experiment)sect 900- NMR 400 MHz (CDCl3 13C DEPT For one experiment)sect 1200

-

1 NMR 500 MHz (CDCl3 1H 13C DEPT For one experiment) D2O exchange (extra)

1800- 400-


3600- 900-


6000- 1500-

4 HPLC assay (5 point calibration amp duplicate injection of API samples only )

6000-

5 HPLC Feasibility study (for Prep and Method development activities)

5000-

6 ICP-OES without sample prep Per element 500-

7 Sample prep for ICP-OES per sample 1000-

8 DSC 2000-

9 TGA 2500-

10 Size exclusion by GPC 5000-

11 EDAX 2000-

12 TEM Imaging 10000-

13 Scanning Electron Microscopy (2 images) (Extra image 500-)

2000-

14 Powder X-RAY 1200-

15 Single Crystal X-RAY (academic request quote) 40000-

16 XRF 3000-

14 Raman Spectroscopy 5000-

18 FESEM 5000

-

19 ESIAPCIEI ndashHRMS 4000-

20 GCMS (quantitative 5 point calibration LOD LOQ up to 5 samples)

50000-

21 GCMS (quantitative Method development and validation as per ICH Q2 R1 guideline up to 5 samples)

150000-

22 Headspace GCMS Residual solvents volatiles 4000-

23 LCHRMS LCMSMS (orbitrap QTOF) 8000-

24 LCMS (quantitative 5 point calibration LOD LOQ up to 5 samples)

150000-

25 LCMSMS (quantitative Method development and validation as per ICH Q2 R1 guideline up to 10 samples)

600000-

26 MALDI-TOF (MS or MSMS) 8000-

27 CHNS (Mol formula required) 3000-

28 CHNSO (Mol formula required) 4000-

29 Surface Area by BET 2500-

30 Particle size distribution (dry or water as solvent) 5000-

31 Particle size distribution (other than water solvent) 5000-

32 Zeta size analysis 5000-

33 Chemical Analysis (Silicate) 5000-

For other solvents additional charges apply

DMSO D2O Acetone Benzene Rs 200- Methanol-D4 Rs 750-

sect D2O exchange Rs 200-


Part C Charges for the tests under NABL scope (ISOIEC 17025) (For all industriesAcademic institutionsGovt laboratories)


SlNo Analytical test Proposed price

1 NMR (1H 13C 15N 31P 19F ndash 1D 400 MHz) (CDCl3 DMSO D2O Acetone Benzene)

2200-


3200-

3 EI-MS (DIP) 2000-

Direct ESIAPCI-MS (low resolution) 6000-

EIESI HRMS 8000-

4 GCMS 6000-

5 GCMS (Headspace) 8000-

6 LCMS or LCMSMS (High resolution QTOFOrbitrap) 16000-

7 CHNSO analysis 5000-

8 Trace elements analysis (as per USP232 amp 233) per element Sample Prep 2000- extra

1000-

9 Color test for Drinking water 1000-

10 Odor test for Drinking water 1000-

11 Taste test for Drinking water 1000-

12 Turbidity test for Drinking water 1000-

13 Total dissolved solids(TDS) test for Drinking water 1000-

14 pH test for Drinking water 1000-

15 Fluoride test for Drinking water 1000-

16 Estimation of tocols 8000-

17 Acid value 1000-

18 Iodine value 1000-

19 Saponification value 1000-

20 Unsaponifiable matter 1500-

21 Free fatty acid 1000-

22 Moisture (by Karlfischer) 1500-

23 Moisture amp Volatile impurities 1000-

24 Cloud point 1000-

25 Hexane content 3500-

26 Phosphorous estimation 2500-

27 Test for presence of Mineral oil 1000-

28 Test for presence of Argemone oil 1000-

29 Test for presence of Castor oil 1000-

30 Test for presence of Sesame oil 1000-

31 Test for presence of Cottonseed oil 1000-

32 -Oryzanol content 3000-

35 Fatty acid composition (saturated fatty acids MUFA PUFA

3000-

36 Trans Fat content 3500-

37 Refractive Index 1000-

38 Slip Melting point 1000-

Indian Pharma Market registers 94 per cent growth in August 2019

The Indian Pharmaceutical Market (IPM) has registered a growth of 94 per cent for the month of August 2019 as against July growth of 132 per cent According to AIOCD AWACS report the IPM has recorded sales of Rs135210 crore and a growth of 93 per cent for Moving Annual Total (MAT) basis during August 2019 Among the top 50 corporates 46 exhibited positive growth for the month of August 2019 Among the top 10 companies Alkem and Glaxo exhibited high growth momentum in August while Sun Pharmaceutical Industries Ltd and Ranbaxy have gained growth momentum in August and Cipla Lupin Torrent appear to have slowed down Mankind growth momentum is positive while Intas Zydus Cadila growths remained steady Aristo Pharma and Dr Reddys Laboratories growth have picked up in recent months Amongst the 11-20 ranked corporates Aristo exhibited highest growth (269 per cent) followed by Dr Reddys at 147 per cent Sanofi India at 144 per cent and Emcure + Zuventus at 115 per cent Amongst the 21-30 ranked Corporates FDC exhibits highest growth (174 per cent) followed by Himalaya (16 per cent) Indoco remedies at 151 per cent and Novartis + Alcon at 12 per cent

Amongst the 31-40 ranked corporates JB Chemicals exhibits highest growth at 213 per cent followed by Franco at 159 per cent Hetero at 145 per cent Blue Cross at 132 per cent and Meyer Organics at 106 per cent Amongst the 41-50 ranked corporates Boehringer Ingelheim exhibits the highest growth (315 per cent) followed by Corona (224 per cent) Hegde amp Hegde (138 per cent) and win Medicare (101 per cent) Amongst the 51-60 ranked corporates pharmed exhibits the highest growth at 209 per cent followed by Fourrts at 207 per cent Fresenius Kabi at 179 per cent and Troikaa at 118 per cent Amongst the 61-70 ranked Corporates Danone exhibits the highest growth (204 per cent) followed by Tablets India (171 per cent) and Maneesh (124 per cent) Amongst the 71-80 ranked corporates Leeford exhibits the highest growth (464 per cent) followed by Eli Lilly (304 per cent) Shreya (173 per cent) and Oaknet HC (154 per cent) Amongst the 81-90 ranked corporates Roche exhibits the highest growth at 213 per cent followed by Samarth at 117 per cent Amongst the 91 -100 ranked corporates Torque exhibits the highest growth (244 per cent) followed by Alniche LS (149 per cent) and Unison (113 per cent)Amongst the 101-200 few of the Corporates exhibiting high growths are Celon Labs Linux Labs KLM Labs Reckitt Benckiser Galpha Menarini India Entod Deys Medicals Dabur Juggat Johnoson amp Johnson Stadmed Finecure Pharma Icon Gland MSN ICpa Health Anglo French Bestochem etc A total 8 companies launched in the past 36 month and only 2 companies have crossed the Rs10 crore mark in annual sales FDC related market showed negative growth of -679 per cent while the Approved FDC market showed a growth of 10 per cent while the single molecules grew at 98 per cent for the month August-19 Price component of GD for the FDCs for August-19 is 08 per cent other GDs in terms of volumes are at -706 per cent while new introductions exhibited a growth of 19 per cent The Approved FDC component Growth drivers see Volumes GD at 04 per cent prices at 62 per cent while new introduction exhibits a high growth of 34 per cent The single molecules growth drivers are volumes at 26 per cent Price growth of 5 per cent and New Introductions contribute to 22 per cent For the month of August MNC were exhibiting a growth of 104 per cent whereas Indian companies were exhibiting a relatively slower growth of 91 per cent Amongst the top MNCrsquos Boehringer Ingelheim at 266 per cent exhibits the highest growth followed by Danone at 20 per

cent Glaxo at 147 per cent Sanofi India at 123 per cent Anti-infectives exhibiting a double digit growth of 153 per cent for August-19 Respiratory segment exhibiting a growth of 13 per cent Dermatology growing at 95 per cent Gastrointestinal exhibiting growth of 8 per cent with vitamins and minerals at 71 per cent All the chronic care segments except Anti-diabetic which exhibits a double digit growth of 112 per cent Cardiac segment is exhibiting a single digit growth of at 79 per cent and CNS registering a growth of 71 per cent for the month of August 2019

Source Pharmabizcom

Mission Pharma needs Central push Chinese inspiration

Rutam Vora | Updated on August 31 2019 Published on August 31 2019

Domestic drugmakers chart a growth path with one foot in generics and the

other in emerging technologies ldquoCan we live in this world without genericsrdquo asks a combative Pankaj Patel Chairman of the Zydus Cadila Group insisting that the generics story is anything but over But that said he adds the Indian drug industry is also looking at emerging sectors and that is where it could do with some help from the Government A model that has played out rather well in China

ldquoThe future is going to be bio-similars and biological drugs driven by innovationsrdquo says Patel optimistic that the industry has its foot in the generics and emerging segments In fact driven by this outlook companies have even ramped up their research spends says Patel But for a collective sustainable growth of the industry the responsibility lies largely with the government say veteran pharma voices echoing similar thinking

The Indian government and its regulatory bodies have a bigger-than-ever role to play in driving the next wave of growth for the pharmaceutical industry says Sudarshan Jain Secretary General with the Indian Pharmaceutical Alliance a platform of large domestic drugmakers ldquoEnabling policies and a supportive ecosystem will help the industry achieve Vision 2030rdquo he adds

For instance ldquowe have been demanding a dedicated separate Ministry for Pharmaceuticals in the Central government that will give undivided absolute attention on the growth of the sector in the countryrdquo he says calling for a stable policy with an outlook of at least five years and a push for infrastructure

Pointing out that it is the governmentrsquos role to create a conducive environment to attract investments in the pharma space Jain says India has failed to capitalise on its past strength in making Active Pharmaceutical Ingredients (API) to reduce the reliance on imports

But itrsquos the China experience that industry thinks India can emulate The IPA points to the Chinese governmentrsquos interventions at the infrastructural and policy levels that helped the API industry grow at 147 per cent to about $70 billion in 2016 compared to the 5-7 per cent growth of the global API market

Cues from China Some of the interventions by the Chinese government included larger Special Economic Zones ldquoabout 10-15 times the size we see in Indiardquo transport infrastructure for lower logistics cost subsidised land common waste processing and utilities lower electricity and labour costs and flexible labour laws besides the lower borrowing costs at 5-7 per cent as against 11-14 per cent in India The Chinese Government also kick-started a new wave of regulatory and policy-level interventions to foster innovation locally These included changes in approval process rationalising clinical trial data and creating guidelines for digital healthcare among others

Government spending Reiterating a long-standing plea Jain urges the Government to increase government spends on healthcare from about 12 percent now to 25 per cent of GDP in the next five years and about 5 per cent by 2030 in line with the developed European and North American economies In fact there should be greater harmony between the policy on affordability and accessibility of drugs and the one on viable and sustainable pricing structure for the pharma players they point out

Vision 2030 Despite the regulatory censure that many large companies face from the US regulator pricing pressures and escalating manufacturing costs the $ 38-billion pharmaceutical industry has held its ground Jain says

It is the fourth largest forex earner for the country with nearly 60 per cent of the worldrsquos vaccines being made in India and almost 40 per cent of US oral solids going from India And this success was built on distinctive capabilities in different areas of the value chain such as manufacturing product development and process innovation

But destination 2030 is to double the Indian pharma industryrsquos global market share (by value) from the current about 36 per cent to about 7 per cent And that can be achieved by companies tapping uncharted territories like China and Japan developing technology platforms and next-gen APIs It will also require homeground support from the Government say seasoned industry hands

Source Business Line Published on August 31 2019

National laboratories to develop technologies which are technically and commercially viable and offer to industries on agreeable terms

Government to take the onus of environmental services and facilities in association with CPCB and NEERI or any expert body

The Department of Pharmaceuticals under the Ministry of Chemicals and Fertillizers have planned to promote dedicated Pharma Parks in few states to facilitate existing companies and new companies from within and outside India to invest and promote the manufacturing of APIs There is not much progress in this regard in the last four years and no new single industrial Pharma park has been commissioned Even the Hyderabad Pharma City is yet to take off

Government is looking at simplification of licensing and procedures which include GST amp Customs duties Foreign Trade Environmental issues Drug Control Authority Labour Department Department of Factories State Excise Service Tax and Electricity Boards

API industry requires highly skilled scientists and technicians In this regard BDMA is planning to set up a Training institute for Life Sciences Sector Skill Development at BDMA Jeedimetla building We had discussed with DoP for grants for which the response was positive However BDMA has to complete the building construction estimated to cost around Rs 4 crores and DoP will support in developing the support infrastructure like class rooms laboratories IT centre workshop etc Very soon we will approach the members for building fund donation and propose to suitably acknowledge by naming sections of the Training centre with the donor industry

API industry in Telangana

Telangana intends to maintain its pioneer status for bulk drugs production However the growth has been almost stagnant due to reasons listed below

Govt restrictions of expansion related to earlier ban notifications shifting of industries outside ORR NGT orders and its interpretation CEPI guidelines Moratorium on expansion based on CEPI score

No improvement of existing industrial parks and in particular the Jeedimetla and Kazipalli areas

Mucherla Pharma city had still not taken off in spite of initiating five years back by the Government

Lastly with all the new initiatives planned and support from the govt India will be a major force globally in the API sector I once again thank BDMA for giving me this opportunity and wish you all best of luck

THANK YOU
















































































(CCMB)







































2 Testing Charges








Analytical Charges




1 1H-NMR (CDCl3 300 MHz) 300-

2 1H-NMR (CDCl3 400 MHz) 600-



5 FTIR 200-











I Routine





5 FTIR 400-





-


1800- 400-


3600- 900-


6000- 1500-


6000-


5000-



8 DSC 2000-

9 TGA 2500-


11 EDAX 2000-



2000-



16 XRF 3000-


18 FESEM 5000

-



50000-


150000-




150000-


600000-

















2200-


3200-

3 EI-MS (DIP) 2000-


EIESI HRMS 8000-

4 GCMS 6000-





1000-









17 Acid value 1000-

















3000-








Source Pharmabizcom































































































(CCMB)







































2 Testing Charges








Analytical Charges




1 1H-NMR (CDCl3 300 MHz) 300-

2 1H-NMR (CDCl3 400 MHz) 600-



5 FTIR 200-











I Routine





5 FTIR 400-





-


1800- 400-


3600- 900-


6000- 1500-


6000-


5000-



8 DSC 2000-

9 TGA 2500-


11 EDAX 2000-



2000-



16 XRF 3000-


18 FESEM 5000

-



50000-


150000-




150000-


600000-

















2200-


3200-

3 EI-MS (DIP) 2000-


EIESI HRMS 8000-

4 GCMS 6000-





1000-









17 Acid value 1000-

















3000-








Source Pharmabizcom















































2 Testing Charges








Analytical Charges




1 1H-NMR (CDCl3 300 MHz) 300-

2 1H-NMR (CDCl3 400 MHz) 600-



5 FTIR 200-











I Routine





5 FTIR 400-





-


1800- 400-


3600- 900-


6000- 1500-


6000-


5000-



8 DSC 2000-

9 TGA 2500-


11 EDAX 2000-



2000-



16 XRF 3000-


18 FESEM 5000

-



50000-


150000-




150000-


600000-

















2200-


3200-

3 EI-MS (DIP) 2000-


EIESI HRMS 8000-

4 GCMS 6000-





1000-









17 Acid value 1000-

















3000-








Source Pharmabizcom


















1 1H-NMR (CDCl3 300 MHz) 300-

2 1H-NMR (CDCl3 400 MHz) 600-



5 FTIR 200-











I Routine





5 FTIR 400-





-


1800- 400-


3600- 900-


6000- 1500-


6000-


5000-



8 DSC 2000-

9 TGA 2500-


11 EDAX 2000-



2000-



16 XRF 3000-


18 FESEM 5000

-



50000-


150000-




150000-


600000-

















2200-


3200-

3 EI-MS (DIP) 2000-


EIESI HRMS 8000-

4 GCMS 6000-





1000-









17 Acid value 1000-

















3000-








Source Pharmabizcom



















I Routine





5 FTIR 400-





-


1800- 400-


3600- 900-


6000- 1500-


6000-


5000-



8 DSC 2000-

9 TGA 2500-


11 EDAX 2000-



2000-



16 XRF 3000-


18 FESEM 5000

-



50000-


150000-




150000-


600000-

















2200-


3200-

3 EI-MS (DIP) 2000-


EIESI HRMS 8000-

4 GCMS 6000-





1000-









17 Acid value 1000-

















3000-








Source Pharmabizcom
















-



50000-


150000-




150000-


600000-

















2200-


3200-

3 EI-MS (DIP) 2000-


EIESI HRMS 8000-

4 GCMS 6000-





1000-









17 Acid value 1000-

















3000-








Source Pharmabizcom




















2200-


3200-

3 EI-MS (DIP) 2000-


EIESI HRMS 8000-

4 GCMS 6000-





1000-









17 Acid value 1000-

















3000-








Source Pharmabizcom

























3000-








Source Pharmabizcom


















Source Pharmabizcom
















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