Mr Palu Dhanani UCL Kenya AGENDA Facility overview and history Manufacturing capabilities amp QMS Corporate Office Strides House Bilekahalli Bannerghatta Road Bangalore560 076 India ID: 919679
Download Presentation The PPT/PDF document "MMV’s Support: Local Production of An..." is the property of its rightful owner. Permission is granted to download and print the materials on this web site for personal, non-commercial use only, and to display it on your personal computer provided you do not modify the materials and that you retain all copyright notices contained in the materials. By downloading content from our website, you accept the terms of this agreement.
Slide1
MMV’s Support:
Local Production of Antimalarials
Mr Palu DhananiUCL, Kenya
Slide2AGENDA
Facility overview and history
Manufacturing capabilities & QMS
Corporate Office:
Strides House, Bilekahalli,
Bannerghatta Road,
Bangalore-560 076, India
Manufacturing Site:
Club Road, Past Kikuyu Post office
P.O. BOX 1748-00902,Kikuyu Town, Kikuyu, KenyaContact Details:Mr Perviz DhananiPhone: +254 733513075 Email: Palu@ucl.co.keWebsite: www.ucl.com
UCL initiatives & updates
MMV’s support: Local production
Empower AFRICA & key challenges
Slide3UCL, MMV & RENA collaboration
(antimalarials)
Project summary:
Sulfadoxine and pyrimethamine is a combination medication used to treat malaria
Sulfadoxine is a sulfonamide antibiotic and pyrimethamine is an antiprotozoal. The combination is considered to be more effective for intermittent preventive treatment of malaria in pregnancy (IPTp)
IPTp reduces maternal malaria episodes, maternal and foetal anaemia, placental parasitaemia, low birth weight and neonatal mortality
WHO recommends IPTp with sulfadoxine-pyrimethamine (IPTp-SP) in all areas with moderate-to-high malaria transmission
Sulfadoxine and pyrimethamine is on the World Health Organization's List of Essential Medicines
Sulfadoxine and pyrimethamine formulation is being jointly developed
by Rena Exports, India and Universal Corporation Limited, Nairobi, Kenya in collaboration with MMVProcess optimization and validation batches are already completed at UCL for WHO submissionS. No.Product NameLabel ClaimPrimary Packing SubmissionTarget for SubmissionCurrent Status
[Nov 2019] 01
Sulfadoxine and Pyrimethamine Dispersible Tablets
Each dispersible tablet contains,Sulfadoxine – 500 mgPyrimethamine – 25 mg
10’s & 100’s
WHODEC 2019
[Q3 FY 2019–20]Stability
studies and BE under progress
Each dispersible tablet contains,
Sulfadoxine – 250 mg
Pyrimethamine – 12.5 mg
Slide4S.
No.
Product Name
Label Claim
Target for Submission
01
Amodiaquine Hydrochloride Dispersible Tablets
Each dispersible tablet contains,
Amodiaquine Hydrochloride equivalent to Amodiaquine 150 mg
MAY 2020[Q1 FY 2020–21]Each dispersible tablet contains,Amodiaquine Hydrochloride equivalent to Amodiaquine 75 mgMAY 2020[Q1 FY 2020–21]02
Artemether and Lumefantrine Tablets
Each uncoated tablet contains,
Artemether – 20 mgLumefantrine – 120 mg
Submitted [SEP 2019]
03
Artemether and Lumefantrine DISPERSIBLE Tablets
Each DISPERSIBLE tablet contains,
Artemether – 20 mgLumefantrine – 120 mg
DEC 2019
[Q3 FY 2019–20]
04
Artemether and Lumefantrine Tablets
Each uncoated tablet contains,Artemether – 80 mgLumefantrine – 480 mgDEC 2019 [Q3 FY 2019–20]05Tenofovir + Lamivudine + Dolutegravir TabletsTenofovir Disoproxil – 245 mgLamivudine – 300 mgDolutegravir Sodium equivalent to Dolutegravir – 50 mgFEB 2020[Q4 FY 2019–20]06Albendazole Tablets 400 mgEach uncoated chewable tablet contains,Albendazole – 400 mgDEC 2020[Q4 FY 2020–21]07Sulfamethoxazole + Trimethoprim + Isoniazid + Pyridoxine Hydrochloride TabletsEach tablet contains,Sulfamethoxazole – 800 mg , Trimethoprim – 160 mgIsoniazid – 300 mg & Pyridoxine Hydrochloride – 25 mgOCT 2020[Q3 FY 2020–21]08Zinc Tablets [Dispersible]Each dispersible tablet contains,Zinc Sulphate Monohydrate equivalent toZinc – 20 mg DEC 2019[Q3 FY 2019–20]
WHO-PQ submission projects at UCL
Slide5Slide6Deaths due to malaria caused by
falciparum stands at ~
90% in AfricaA lot of effort is required to considerably reduce this numberThe developed countries have always played a major role in this battle, but a larger contribution is required to win the warMost manufacturers of pre-qualified antimalarials are located in
India, followed by China, and some in the western countriesIn Africa, there are only 2–3 manufacturers that are able to continuously supply pre-qualified antimalarials
The gap in ability of local manufacturers must be addressed to make the distance between manufacturer and procurer/consumer shorter, enhancing access in this region
Empower:
Local manufacturing
Slide7EXPECTATION
CHALLENGES
IMPACT
PROPOSED ACTION PLAN
SKILLLED & EXPERIENCED RESOURCES
Cultural
and behavioural
Attrition of skilled resources
Outsourcing
of resources with higher costInconsistencies in product deliveriesRepeated deficiencies/non-compliancePoor-quality investigations/CAPA, and inadequate problem-solving skills and decision-making capabilitySignificant reduction in tender allocations from institutionsStringent monitoring & heightened supervision Continuous training/evaluation and development [technical and behavioural]REGULATORY COMPLIANCE Too many inspections by regulatory authorities and institutions Continuous improvement as witnessed by inspectorsKnowledge enhancement & exposure to regulatory requirements Mutual recognition by regulators & institutions will help AFRICA to grow skill & experience
SUPPORT AFRICA
In spite of WHO-prequalified facilities available in AFRICA [e.g. UCL], key product tenders [e.g. ORS/Co Trimoxazole, etc.] were allotted to other facilities outside Africa that were not even WHO prequalified
More than 70% of the medicines consumed in Africa are imported
Level playing field Help develop capacity/capability in Africa
Key challenges as an African manufacturer
Slide8UCL, MMV & RENA collaboration (antimalarials)
Description
Local Manufacturers
Funded Program Export
Summary
RDL
1.5%
Exempt
Local manufacturer can not attempt to bid for any export order or a donor-funded tender (PEPFAR (USAID)/Global Fund) since there is a significant disadvantage because of the payment of RDL and GOK [Almost 3.75%]
GOK2.25%ExemptExcise DutyN/AN/A
Duty
Exempt0%
VAT
Exempt
0%
THE CURRENT SITUATION:
2. INCENTIVES BY FOREIGN GOVERNMENT TO THEIR MANUFACTURERS:
In Kenya there is no subsidy to the local manufacturerIn India and China there are export subsidies accorded to their manufacturers e.g. in India the manufacturer receives a subsidy of almost 3.5%–4.6% on their export price
Using the price examples, local Kenyan manufacturer is clearly disadvantaged by 7–7.5% over the imported product
3.
STATUS UPDATE ON FUNDED PROGRAMMES & EXPORTS:
In Kenya there is no subsidy to the local manufacturer
Local manufacturer in Kenya has lost out to Indian & Chinese counterparts due to price difference of 1–5%
Slide9Our views
If we had enjoyed similar conditions, if we had been given the preference, the local manufacturer would have been more competitive than the Indian and Chinese counterparts
The result of local manufacturing means:
Ancillary dependent industry would grow. More locally manufactured goods like jars, shippers, etc.
Growth of local clearing and forwarding companies
Corporate tax, PAYE and other social benefits making more of technical and skilled resources
Generate foreign exchange retained in the country
More employment
Making certain SDGs a reality
When the donor funds eventually dry up, there will be no capacity built for self-sustainability and the country/region will experience challenges in the supply of quality medicines Current situation is:Kenya or the local manufacturer:Does not earn any revenue as items are currently procured from either India or ChinaLoss of the opportunity to create employment (export of jobs to other countries) Loss of opportunity to develop the country.Loss of foreign exchangeNo capacity-development of local industry
Slide10Our initiatives
STRATEGY
EDUCATION
SUCCESS
Slide11Future Leadership
Programme
(FLP)
Total of 17 staff selected, comprising Production/Warehouse/QA/QC/Eng/Planning /Finance
Inauguration of the programme on
05/04/2018
FLP programme of UCL comprises 6 modules
Know your business [business and product strategy]
Finance and non-finance
Ownership and accountability Understanding human dynamics and leadership stylesHigh-impact presentations
Target date to complete the modules
March 2019
Slide12Training
programme: concept
Identification
Selection
Training
Empowering
Skills development
Skilled and empowered resource
Slide13Advantages for trainees:
A good level of support, when starting career
Training and development opportunities within UCL
A mentor to talk through any problems
The chance to understand different departments of UCL and gain experience of different functions
“TRAINEE PROGRAMME” is UCL’s unique initiative and its efforts create employment for local population [Kenyans], started in 2017. This is in line with the Sustainable Development Goals
“TRAINEE” is an individual who undergoes training for managerial or supervisory positions
The trainee
programme
eases candidates into the world of work and gives them the skills necessary to become part of the larger teamThe trainee programme is the best way to prepare UCL employees to become managers in the future. It equips them with the required skills, judgment and know-how of being an effective and responsible manager
Objectives
Slide14Team – Product Development
Team – Quality Control
Security & Administration
Procurement
Procurement
Quality Assurance
A few UCL trainees
Slide15Department-wise summary
2017
2018
Total
Recruited
Attrition
Current status
[TOTAL – OCT 2019]
PRODUCTION
19NA19811ENGINEERING1NA11NA
QUALITY CONTROL
714
214
17QUALITY ASSURANCE
93
125
7PRODUCT DEVELOPMENT
NA
5
5
NA
5
FINANCE 12312SUPPLY CHAIN MANAGEMENT 14523HR, SECURITY & ADMINISTRATION13413INFORMATION TECHNOLOGY1NA11NASALES & MARKETING34743TOTAL4335782751Status update on trainee recruitment
Slide16The way forward:
Trainee
programme
UCL plans to recruit about 30 to 50 trainees in 2020 in various functions of UCL,
while sustaining the current numbers
This depends on UCL business forecast and sustenance
Finding new ways to motivate to trainees and develop skill sets
Healthy & empowered AFRICA
Slide17Facility overview and history
Slide18O
verview and history
Located at Kikuyu, KENYA, 21 km from Nairobi & 37 km from Jomo Kenyatta International Airport
1996 I
ncorporation of Universal Pharmacy Ltd
2004
Manufacturing starts at the facility
2005 & 2008
Finn fund invested in UCL
2011 WHO-PQ approval of lamivudine 150 mg and zidovudine 300 mg tablets2013 Certified in Environmental, Health and Safety management system ISO 14001 and OHSAS 18001 (by bureau VERITAS KENYA)2016 Merger of Strides Pharma Care Limited, Cyprus and UCL (JUNE 2016)2018 WHO acceptance for variation submitted [site transfer] for Efavirenz tablets 600 mg [HA390] & lamivudine, nevirapine and zidovudine tablets 150/200/300 mg [HA 524]
Capabilities
Tablets
Hard gelatin capsules
Liquid orals
Dry syrups
Topical
Slide19UCL
Slide20Regulatory approvals
August
2004
August
2007
February
2009
August
2010
September
2013
October
2017
April
2007
March
2014
July
2016
November
2010
IVORY COAST
August2012June2011April2012September2014June2016August2018ETHIOPIAMay2007April2008LESOTHODecember2008October2017MALAWIJuly2006August2006October2009October
2012
NAMIBIA
December
2008
May
2011
SIERRA LEONE
December
2008
Slide21Key customers
Slide22Manufacturing capabilities
and QMS
Slide23Key statistics
Site Specifications
Employee Strength
Department
Strength
Production and Packaging
101
Quality Control
36
Quality Assurance43
Storage and Distribution
25
Facilities & Engineering
23
Support Service 100
Total
328
Blocks
Built-up area
(sq. meter approx.)
Warehouse [RM/PM]
4001
TabletsORSLiquidsOintment & Creams3299Packaging [Including Jar Packing & Coding]1631Finished Goods warehouse 2770QA and QC 831Facilities and engineering 550Change rooms and laundry 566CapacitiesDosagePer Annum[Single shift operation]
Tablets
2,500,000,000
Satchets
160,000,000
Liquids
20,000,000
Ointments and creams
12,000,000
Dry powders
5,000,000
Capsules
160,000,000
Slide24QMS and IT enablers
Material Management
Production & Planning
Quality Management
Plant Maintenance
Sales & Distribution
Finance & Controlling
Change Management
Deviation/OOS/OOT/Complaints
CAPA/FAR/Recall Internal & Vendor Audit Chromatography Management System
Sample mgt. / Specification / STP
Analytical Worksheet
Stability Management
Standard / Column Management
Master Document Control
BMR / BPR Issuance & Control
Training Management
Training Assessment
Training Content
Access Control
Attendance software
Time sheet management
Leave ManagementPayrollTravel Management
Slide25QMS and IT enablers
T
E
A
M
Together
Everyone
Achieves
More
Thank you