Dr P V Appaji MPharm PhD Director General PHARMACEUTICALS EXPORT PROMOTION COUNCIL OF INDIA Hyderabad Email dgpharmexcilcom Presentation by CONTENTS Which are EU Countries ID: 568060
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Slide1
EU Directive 2001/83/EC
Dr. P. V. Appaji, M.Pharm, Ph.DDirector General,PHARMACEUTICALS EXPORT PROMOTION COUNCIL OF INDIAHyderabadEmail: dg@pharmexcil.com
Presentation bySlide2
CONTENTS
Which are EU Countries?Objectives of EU Directive 2001/83/ECDefinition of Falsified Medicinal ProductPotential targets of EU Directive 2001/83/ECCurrent Indian Pharmaceutical Industry StatusAdvantages with EU Directive to IndiaDisadvantages with EU Directive to IndiaPossible
NegotiationsSlide3
Which
Are EU Countries?Slide4
Objectives Of EU Directive
2001/83/ECIntroduction of a New Term Falsified Medicinal ProductAims to prevent suspected medicines reaching
patientsSafety features to be harmonised within the Union
Aims safety measures All through the supply chain (manufacturer to end user)
Contd
…Slide5
Prevent distortions in the internal
marketPrevent falsified medicinal products entering the legal supply chainAims at Ensuring Good Manufacturing Process of EU/EU Pharmacopoeia standardsAims at Pharmaceutical product quality for APIs, Generics formulations, Excipients
at the manufacturing level
Objectives Of EU Directive
2001/83/ECSlide6
EU Defines Falsified Medicine As
Any medicinal product with a false representation of:Its identity, inclusive of package and labeling, its name or its composition as regards to any of the ingredients inclusive of excipients and the strength of those ingredients
;Its
source, its manufacture, its country of manufacturing, its country of origin or its marketing authorisation holder
;
Its
history
:
The records and documents relating to the distribution channels
used
The
definition Excludes unintentional quality defects and
is without
prejudice to infringements of intellectual property rightsSlide7
Potential
Targets Of EU Directive 2001/83/ECConfirming GMP with audits (for APIs, formulations, Excipients)Confirming distribution with audits
Confirming GMP practices at least
equivalent to those laid down by the Union
Notification to the authority for any changes that may impact on the quality or safety of the active substances that are manufactured, imported or
distributed
Contd
…Slide8
Implementation of anti-tampering
devicesMaintaining records in the form of purchase/sales at various levels of supply chainPersons brokering medicinal products are also subject to inspection by competent authoritiesPersons brokering must have permanent address, contact details in the Union
Potential Targets Of EU Directive
2001/83/EC
Contd
…Slide9
Repeated inspections of Manufacturers (located in the Union or in third countries) and wholesale distributors of medicinal
productsInspections of the premises of marketing authorisation holders and of brokers of medicinal products are possibleData submitted to comply with monographs of European Pharmacopoeia
Potential Targets Of EU Directive 2001/83/ECSlide10
Current
Indian Pharmaceutical Industry StatusIndia is a leading exporter of quality pharmaceutical products globallyIndian exporters comply with ISO, GMP/WHO GMP, ICH guidelines etc.,
Indian Drugs & Cosmetic Act terminology - Spurious drugs - Not of standard quality or substandard drugs
- Adulterated drugs - Misbranded drugs
may fall under the purview with international actsSlide11
EU
rules for import of API’s. According to Articles 46b 2(b) i, ii & iiiWritten confirmation from the competent authority of the exporting third country of the following:
The standards of good manufacturing practice applicable to the plant manufacturing the exported active substance are at least equivalent to those laid down by the
Union.The manufacturing plant concerned is subject to regular, strict and transparent controls and to the effective enforcement of good manufacturing practice, including repeated and unannounced inspections, so as to ensure a protection of public health at least equivalent to that in the Union
;
In
the event of findings relating to non-compliance, information on such findings is supplied by the exporting third country to the Union without any delay.
Directive
2001/83/EC
as amended by
Directive 2011/62/EUSlide12
Implementation Of The New Directive
Concept paper submitted for public consultation.
“Implementing act on the requirements for the assessment of the regulatory framework applicable to the manufacturing of Active Substances of Medicinal products for Human Use”.
Consultation closed on March 23 , 2012
.
Implementation date : July 2013Slide13
Written
confirmation waived for countries to be listed as per Article 111b.Third country to request for “Equivalence assessment” Assessment to be done by the commissionIf assessment confirms equivalence , third country will be included in the list.Regular verification thereafter.
Written Confirmation & Equivalence Assessment
(111b
)Slide14
A review of relevant
documentationAn on-site review of the third country's regulatory system, unless a mutual recognition agreement ('MRA') is in place that covers the manufacturing of active substances; andIf necessary, an observed inspection of one or more of the third country's manufacturing
sites for active substances.
Equivalence Assessment Slide15
Third countries rules for
GMP implementationPending the adoption of a delegated act on the principles and guidelines of good manufacturing practice for Active SubstanceEU rules to be taken
into account are contained in Part II of the good manufacturing practice guideline of the EU (Eudralex Volume 4).
Country's Rules For
GMP
(
111b(1)(a
))Slide16
Article 111b(3
)The Commission shall verify regularly whether the conditions of the GMP equivalence are fulfilledThe first verification shall take place no later than three years after the country has been included
in the list.
Regular VerificationSlide17
The manufacture of active substances should be subject to good manufacturing practice regardless of whether those active substances are manufactured in the Union or imported.
With regard to the manufacture of active substances in third countries, it should be ensured that the legislative provisions applicable to the manufacturing of active substances intended for export to the Union, as well as inspections of facilities and enforcement of the applicable provisions, provide for a level of protection of public health equivalent to that provided for by Union law.
Minimum Expectations Of New DirectiveSlide18
A
written confirmation that the manufacturer of the medicinal product has verified, compliance of the manufacturer of the active substance with principles and guidelines of good manufacturing practice by conducting audits, in accordance with point (f) of Article 46. The written confirmation shall contain a reference to the date of the audit and a declaration that the outcome of the audit confirms that the manufacturing complies with the principles and guidelines of good manufacturing practice.
Responsibility of Formulators in the new
directiveSlide19
STATISTICSSlide20
Global Bulk Drugs Imports Region Wise
(Values In US$ Mn)
Sr.
no
Region
2008
2009
2010
YOY %
%share
1
EU
14794.04
15649.54
16673.38
6.54
50.58
2
North America
7379.52
4494.00
3866.23
-13.97
11.73
3
LAC
2180.33
3338.82
3611.87
8.18
10.96
4
Asia (Excluding Middle East)
2337.40
2445.33
2611.03
6.78
7.92
5
Other European Countries
1483.95
1045.19
1680.84
60.82
5.10
6
Asean
1211.84
1250.18
1255.68
0.44
3.81
7
South Asia
1069.94
1079.49
1082.13
0.24
3.28
8
Middle East
761.60
599.14995.2366.113.029Africa 420.60423.74450.696.361.3710Oceania 392.32368.32378.672.811.1511CIS 261.88385.31355.17-7.821.0812Other America 4.375.436.1914.100.02 World 32297.7931084.4932967.116.06
Source : UN COMTRADESlide21
21
Global Bulk Drugs Imports Qty : Region wise
(In
Kgs
)
Source : UN COMTRADE
Sr. no
Regions
2008
2009
% Share
1
EU
245966892
211959660
34.38
2
North America
102548522
115833916
18.79
3
Asean
60793142
62754294
10.18
4
LAC
66273277
62238410
10.1
5
Africa
21592271
53634620
8.7
6
Asia (Excluding Middle East)
43341762
41036657
6.66
7
South Asia
27439759
32606046
5.29
8
Middle East
20308240
10668631
1.73
9
CIS
9776600
9706986
1.57
10
Other European Countries
9574246
8082215
1.31
11
Oceania 653181960445610.9812Other America 61153619133430.31 Grand Total 614758066616479339 Slide22
22
European Union`s Import of Bulk Drugs from
India
and China :
(Value in US$ MN
)
Source : UN COMTRADE
2008
2009
Sum of Trade Value
Sum of Trade Value
%share
China
1731.57
1607.08
10.27
India
198.46
195.94
1.25
Grand Total
14794.04
15649.54
Slide23
23
Bulk Drugs Import of EU From Other than the Union
(Country wise)(USD
mn
)
Source : UN COMTRADE
Rank
Country
2008
2009
2010
%share
YOY%
1
Switzerland
2970.63
3554.35
3630.52
39.43
2.14
2
USA
2126.95
1420.70
1984.07
21.55
39.65
3
China
1731.57
1607.08
1918.61
20.84
19.38
4
Singapore
467.08
501.82
764.56
8.30
52.36
5
Japan
383.30
327.01
297.18
3.23
-9.12
6
India
198.46
195.94
206.64
2.24
5.46
7
Argentina
46.27
55.47
66.80
0.73
20.41
8Rep. of Korea60.2162.1163.600.692.419Australia40.4944.3543.480.47-1.9710Mexico55.6955.3241.810.45-24.4311Croatia16.0913.0123.550.2680.9412Israel15.9420.1223.150.2515.0713Brazil25.7119.4221.880.2412.6714Oman20.5415.0613.840.15
-8.11
Total
8266.57
8011.07
9208.09
100
Slide24
Bulk Drugs
Import of EU From Other than the Union (Country wise)(In KGs)
Source : UN COMTRADE
Rank
Country
2008
2009
%share
1
China
84578208
67405329
69.92
2
Switzerland
10467365
12296464
12.76
3
India
5051482
3955366
4.1
4
USA
6116643
4559462
4.73
5
Singapore
1672838
2237104
2.32
6
Japan
2215849
1791154
1.86
7
Rep. of Korea
823479
750671
0.78
8
Israel
455673
96428
0.1
9
Mexico
389322
395720
0.41
10
Brazil
319181
222323
0.23
11
Croatia
74515
49950
0.0512Turkey1264712148490.2213Canada105296701830.0714Australia49519627740.0715Argentina151922852350.0916Colombia147207990710.1 EU Total11497560196399929100Slide25
Top Ten
HS codes Imported by EU Inclusive of EU members(Values in US$
mn)
Source : UN COMTRADE
Rank
Commodity Code
Commodity Description
2008
2009
% Share
1
H3-294190
Antibiotics & their derivatives (excl. of 2941.10-2941.50); salts thereof
3884.54
3982.35
25.45
2
H3-293719
Polypeptide hormones, protein hormones & glycoprotein hormones, their derivatives & structural analogues (excl. of 2937.11 & 2937.12)
1501.24
2597.71
16.60
3
H3-293722
Halogenated derivatives of corticosteroidal hormones
980.07
994.63
6.36
4
H3-293711
Somatotropin, its derivatives & structural analogues
338.39
734.40
4.69
5
H3-293628
Vitamin E & its derivatives
881.83
849.70
5.43
6
H3-293750
Prostaglandins, thromboxanes & leukotrienes, their derivatives & structural analogues
386.50
865.56
5.53
7
H3-294110
Penicillins & their derivatives with a penicillanic acid structure; salts thereof
779.53
774.88
4.95
8
H3-293729
Steroidal hormones, their derivatives & structural analogues (excl. of 2937.21-2937.23)
1082.59
649.06
4.15
9
H3-293790
Hormones, prostaglandins, thromboxanes & leukotrienes, natural/reproduced by synthesis(excl. of 2937.11-2937.50); derivatives & structural analogues thereof, including chain modified polypeptides, used primarily as hormones
1021.44
644.704.1210H3-293627Vitamin C & its derivatives656.69548.243.50 Total of Top Ten11512.8212641.2180.78Slide26
Top Ten
HS codes Imported by EU from China(Values in US$ mn)
Source : UN COMTRADE
Rank
Commodity Code
Commodity Description
2008
2009
% share
1
H3-294190
Antibiotics & their derivatives (excl. of 2941.10-2941.50); salts thereof
346.29
381.43
23.73
2
H3-293628
Vitamin E & its derivatives
271.30
245.69
15.29
3
H3-293627
Vitamin C & its derivatives
395.00
327.26
20.36
4
H3-294130
Tetracyclines & their derivatives; salts thereof
96.13
115.76
7.20
5
H3-293629
Vitamins & their derivatives, unmixed (excl. of 2936.10-2936.28)
124.20
79.35
4.94
6
H3-294110
Penicillins & their derivatives with a penicillanic acid structure; salts thereof
59.99
68.63
4.27
7
H3-294140
Chloramphenicol & its derivatives; salts thereof
43.44
47.97
2.98
8
H3-293729
Steroidal hormones, their derivatives & structural analogues (excl. of 2937.21-2937.23)
25.26
31.04
1.93
9
H3-293721
Cortisone, hydrocortisone, prednisone (dehydrocortisone) & prednisolone (dehydrohydrocortisone)
26.04
27.21
1.6910H3-293621Vitamins A & their derivatives39.6631.831.98 Total China1731.571607.08100.00Slide27
EU's Top HS codes imported from
India(Values in US$ mn)
Source : UN COMTRADE
Rank
Commodity Code
Commodity Description
2008
2009
% share
1
H3-294190
Antibiotics & their derivatives (excl. of 2941.10-2941.50); salts thereof
64.96
70.61
36.04
2
H3-294150
Erythromycin & its derivatives; salts thereof
29.38
32.78
16.73
3
H3-293629
Vitamins & their derivatives, unmixed (excl. of 2936.10-2936.28)
19.82
16.64
8.49
4
H3-293890
Glycosides, other than rutoside (rutin) & its derivatives, natural/reproduced by synthesis, & their salts, ethers, esters & other derivatives
10.34
12.02
6.13
5
H3-293999
Vegetable alkaloids, natural/reproduced by synthesis, & their salts, ethers, esters & other derivatives (excl. of 2939.11-2939.91)
9.61
11.97
6.11
6
H3-293930
Caffeine & its salts
10.21
8.69
4.43
7
H3-293729
Steroidal hormones, their derivatives & structural analogues (excl. of 2937.21-2937.23)
8.30
8.01
4.09
8
H3-293722
Halogenated derivatives of corticosteroidal hormones
5.59
6.01
3.07
9
H3-293959
Theophylline & aminophylline (theophylline-ethylenedia-mine) & their derivatives (excl. of 2939.51); salts thereof , n.e.s.
6.12
5.64
2.8810H3-294110Penicillins & their derivatives with a penicillanic acid structure; salts thereof7.043.361.71 India`s Total198.46195.94100.00Top ten constitute 90 % Antibiotics & their derivatives constitute 37% Vitamins & their derivatives 8.49 % Erythromycin & its derivatives constitute(inclusive of penicillin) 18.4 % Slide28
India's exports to EU Country wise
accounting for 90%(Values in US$ mn)
Source :
DGCIS
Rank
Country
2008-09
2009-10
2010-11
% share
Cum share
YoY%
1
Germany
234.47
201.87
198.37
20.36
20.36
-1.73
2
Italy
126.45
110.86
113.27
11.63
31.99
2.17
3
Spain
116.21
97.52
108.63
11.15
43.14
11.39
4
UK
71.85
76.17
101.00
10.37
53.51
32.60
5
Netherlands
66.02
60.29
55.05
5.65
59.16
-8.69
6
France
33.35
33.47
50.39
5.17
64.33
50.55
7
Hungary
50.3744.1745.104.6368.962.118Malta22.1636.6844.094.5373.4920.209Ireland73.1832.0441.274.2477.7328.8110Poland35.3726.6032.563.3481.0722.4111Slovenia41.7538.8132.293.3184.38-16.8012Belgium49.1331.6026.272.7087.08-16.8713
Austria
23.41
38.62
24.00
2.46
89.54
-37.86
14
Czech Republic
8.44
6.93
18.01
1.85
91.39
159.88
Total of 14
952.16
835.63
890.30
1.85
91.39
6.54
EU Total
1018.02
902.18
974.16
Slide29
India's exports to EU country wise
accounting to 90%(in Kilos)
Source : DGCIS
Rank
Country
2008-09
2009-10
2010-11
% share
Cum share
YoY%
1
Germany
7616870
11720506
9770630
30.12
30.12
-16.64
2
Netherlands
3641275
3910589
3957463
12.20
42.33
1.20
3
Spain
3366070
3432590
3912810
12.06
54.39
13.99
4
UK
41432169
3482514
3694881
11.39
65.78
6.10
5
Italy
2492780
2614643
2869720
8.85
74.63
9.76
6
Ireland
2925405
3197986
2133818
6.58
81.21
-33.28
7
Belgium
2838243
220502614568484.4985.70-33.938France1405119135738512912013.9889.68-4.889Poland4757314884056477472.0091.6832.6210Austria3302315439284236051.3192.99-22.1211Denmark3258452320763779801.1794.1562.87
Total of 11
66849738
33185648
30536703
1.17
94.15
-7.98
Grand Total
68541825
34836142
32433801
100.00
100.00
-6.90Slide30
India's top ten Products by HS codes exported to EU
(Values in US$ mn)
Source : DGCIS
Rank
Commodity Code
Commodity Name
2008-09
2009-10
2010-11
%share
Cum share
yoy%
1
29420090
Other diloxanide furoate, cimetidine, famotidine nes
715.14
559.18
560.69
57.56
57.56
0.27
2
29419090
Other antibiotics
38.17
62.49
74.42
7.64
65.20
19.09
3
29335990
Other cmpnds cntng a pyrimidine ring (w/n hydrgntd) or piperazine ring in structure
14.33
21.06
24.03
2.47
67.66
14.10
4
29332990
Other compnds cntng an unfused imidazole ring (w/n hydrgntd ) in structure
6.04
17.12
17.30
1.78
69.44
1.05
5
28276010
Potassium iodide
6.36
6.46
16.86
1.73
71.17
160.99
6
29415000
Erthromycin & its drvtvs slts thereof
7.47
15.42
16.361.6872.856.10729362920Nctnc acid & nctnmd(niacinamide/niacine 17.3415.4315.001.5474.39-2.79829222933Para acetyl aminophenol(paracetamol)16.6718.3913.781.4175.80-25.07929371900Other polypeptide hormones thr dtvtvs & strctl anlges 1.051.5713.261.3677.16744.591029163190Other salts and esters of benzoic acid9.4010.8612.111.2478.4111.51
India's Total Exports to EU
1018.02
902.18
974.16
100.00
7.98Slide31
PIC/S
Pharmaceutical Inspection Convention (PIC)&Pharmaceutical Inspection Co-operation Scheme (PICS)Slide32
PICS Established in 1995.
Current members – 40 Participating Authorities Partners
a) EDQM European Directorate for Quality of Medicines and Health Care, France
b)
EMA- European Medicines Agency
c) UNICEF
d) WHO
Requirements :
Law on medicinal products.
A GMP guide equivalent to PIC/S or EU GMP Guide.
A GMP inspectorate fulfils PIC/S quality
system requirements
.
Experienced GMP
inspectors
Brief note on PIC/SSlide33
Objective of PIC/S
An active and constructive co-operation in the field of GMP.
To facilitate networking
between participating authorities and to increase mutual trust, to exchange
information
and
experience,
in the field of GMP and related areas, and
mutual
training
of GMP inspectors.
Attain confidence of drug regulatory authority.
Avoid duplication
relating to
→
Inspections
→
Licensing
procedures
→
Expenditure
→
One
time
procedureSlide34
Mutual recognition of Inspections.
Harmonisation of GMP requirements. Uniform inspection systems.Training of inspectors.
Exchange of information.
Mutual confidence.
Goals
of PIC/SSlide35
PIC/S Constituted fee 8,100 CHF
PIC/S Committee meetings – 2 per annumSeminars - 1 per year.Expert Circle meetings 3- per annum
Events duration are 1 to 3 days in other PIC/S countries.
Registration fee 8100 CHF & In assessment process, annual fee is 50% of Reg. fee for expert
.
Financial CostsSlide36
PIC/S is not a trade agreement.
Membership in PIC/S may facilitate the export of pharmaceuticals.Non-PIC/S Countries (e.g. Colombia) may accept accreditation of PIC/S participating Authorities. Consequently, the Pharmaceutical industry located in these countries indirectly benefits PIC/S membership.
BenefitsSlide37
Thank You