Regulating the Pharmaceutical Sector Current Scenario and Main Challenges
Dr. B R JAGASHETTY
B.Sc; M.Pharm; LLB; Ph.D
Drugs Controller, Karnataka State
04.10.2013
1
Ironies of life
 The lawyer hopes you get into trouble.
 The Doctor hopes you fall ill.
 The Police hopes you become a criminal.
 The teacher hopes you are born stupid.
 The coffin maker wants you dead.
 Only
A
THIEF
wishes
you
prosper
in
life
2
Current Scenario of Pharmaceutical sectors
India's pharmaceutical market grew at 15.7 per cent
during December 2011. Globally, India ranks third in
terms of manufacturing pharma products by volume.
According to McKinsey, the Pharmaceutical Market is
ranked 14th in the world.
By 2015 it is expected to reach top 10 in the world beating
Brazil, Mexico, South Korea and Turkey. More
importantly, the incremental market growth of US$
14billion over the next decade is likely to be the third
largest among all markets.
The US and China are expected to add US$ 200bn and
US$ 23bn respectively.
3
C D S C O – Functions
 It is headed by Drugs Controller General of India
 Is
responsible for Standards of
Authorization, clinical trials, cGmp
drugs,
Market
 Approval of new drugs and clinical trials
 Import Registration and Licensing
 Licensing of Blood Banks, LVPs, Vaccines,
products & some Medical Devices
r-DNA
 Laying down regulatory measures & amendments to D
&C Act and Rules
4
C D S C O – Functions
 Banning of drugs and cosmetics
 Grant of Test License, Personal License
 Testing of Drugs by Central Drug laboratories
 Laying down standards of drugs, cosmetics, diagnostics and
devices.
 Publication of Indian Pharmacopoeia
 Coordinating the activities of the State Drugs Control
Organizations to achieve uniform administration of the Act
and policy guidance.
 Guidance on technical matters.
 Monitoring adverse drug reactions (ADR).
5
C D S C O – Functions
 Conducting training programmes for regulatory
officials & Govt. Analysts.
 Screening of drug formulations available in
Indian market.
 Evaluation / Screening of applications for
granting No Objection Certificates for export of
unapproved / banned drugs.
6
State Drugs Control – Functions
 It is headed by Drugs Controller
 Licensing of drug manufacturing and sales establishments.
 Licensing of drug testing laboratories
 Approval of drug formulations for manufacture
 Monitoring of quality of Drugs & Cosmetics, manufactured
by respective state units and those marketed in the state.
Investigation and prosecution in respect of contravention of
legal provisions.
 Administrative actions.
 Pre- and post- licensing inspection.
 Recall of sub-standard drugs.
7
Approval of Clinical Trials, Import, &
Manufacture of New Drugs
 Requirements and Guidelines - Schedule Y
 Permission to import new drug – Rule 122 A
 Permission to manufacture new drug – Rule 122 B
 Definition of Clinical trials – 122 DA
 Definition of New Drugs – 122 E – New substance
having therapeutic indication
 Modified or new claims, new route of administration for
already approved drug
 Fixed Dose Combination
8
HATHI COMMITTEE REPORT 1975
 Build up Testing facilities for combined food and drugs




and center should assist finance
Legal-cum-intelligence cell – Spurious drugs Maharastra, Karnataka, Gujarath & West Bengal
States should have adequate no of Inspectors with
proper salary, sufficient to attract good talents and
they should have proper knowledge of preperations of
injectables, antibiotics, vaccines, sera etc.
The officer overall in-charge of Drugs Control in a state
constitutes kingpin of organisation. Hence he should
have adequate knowledge
Drug Advisory Board shall be constituted comprising
representative from medical profession, police dept,
social workers, industry and trade
9
MASHELKAR REPORT 2003
 A new structure for the Drug Regulatory System in the country
including the setting up of a National Drug Authority
 Measures to strengthen the drug regulatory infrastructure in
Centre and States
 Health Food/Dietary Supplements/Therapeutic Foods
 Over The Counter Drugs (OTC) - Schedule K should be reviewed
comprehensively. Products, which by virtue of their long usage
and /or nature of their application (e.g substances used for
household cleaning and disinfectants generally used in a diluted
form and not meant for direct application on human skin) could
be considered for inclusion in the exempted category under
schedule K to further facilitate their easier access to the public at
large.
 Medical Devices and Diagnostics
 Drug Development including Clinical Research
10
MASHELKAR REPORT 2003
 Storage and Distribution - State Licensing Authorities
should devise suitable standard operating procedures
to restrict excessive concentration of retail/wholesale
outlets.
 The drug manufacturers should follow good storage
practices for their products during transport as well as
their depots.
 The drug manufacturers should have limited number
of main stockists. Only these main stockists should
sell to the retailers or hospitals.
 The manufacturers should ensure that retail and
wholesale chemists are aware of proper storage
conditions of their products.
11
MASHELKAR REPORT 2003
 PROBLEM OF SPURIOUS AND SUBSTANDARD DRUGS
- Evaluate the Extent of Spurious and Sub-Standard
Drugs and Recommend Measures Required to Deal with
the Problem – Whistle-blower scheme to be extended to
state officers
 Recommended Action by the Consumer and other
Professional Associations - There is an urgent need for
an awareness campaign to educate the consumers and
the medical and paramedical professionals. The
Committee, in particular, recommends that the
Consumers and health professional / associates should
play an active and visible role to create awareness
about the hazards of spurious drugs. They should
undertake campaigns at the national level to educate
the public on the ways and means of detecting spurious
drugs and the advantages of purchasing from licensed
sources with valid cash memos.
12
MASHELKAR REPORT 2003
 The Committee observed that in India, because of
numerous licensing authorities (State/UT’s), the
implementation of drugs laws has been weak and nonuniform even after 56 years of enforcement. It is well
established that the regulatory infrastructure in many
States is below par, while it is functioning better in
some. This has resulted in lack of adequate confidence
among the consumers and level playing field for
industry. The Committee observed that the issue of
non-uniformity of enforcement at the state level was
serious and needs to be addressed immediately. The
Committee records that there should have been a
single agency to regulate the manufacture and quality
control of drugs in the country and that it should be
done centrally.
13
MASHELKAR REPORT 2003
 1. Division for Regulatory Affairs & Enforcement
 2. Division for New Drugs & Clinical Trials
 3. Division for Biological & Biotechnology Products*
 4. Division for Pharmacovigilance
 5. Division for Medical Devices and Diagnostics
 6. Division for Imports
 7. Division for Organizational Services
 8. Division for Training and Empowerment
 9. Division for Quality Control Affairs
 10. Division for Legal and Consumer Affairs
14
TASK FORCE REPORT – Dr Pronab Sen 2005
 Task Force to Explore Options other than Price Control for
Achieving the Objective of Making Available Life-saving
Drugs at Reasonable Prices
 As has already been mentioned, all things considered, in the
long run a merger of the NDA and the NPPA appears
desirable and should be worked towards. The Drugs and
Cosmetics Act would have to be amended for this purpose.
The NADT would also be the designated authority of the
government for implementation of DATA.
 Ideally the NADT should be an independent regulatory
agency under the Ministry of Health & Family Welfare with
appropriate statutory backing from DATA, but for the
immediate future it may be set up as an attached office
through the issue of the necessary government orders.
 The drug regulator must maintain a data base on brands
and their compositions, and all brand registration of drugs
must compulsorily be approved by the drug regulator. In
particular, no change should be permitted
in the
composition of a given brand.
15
Prof. RANJIT ROY CHAUDHURY REPORT
 FORMULATE POLICY AND GUIDELINES FOR APPROVAL OF NEW




DRUGS, CLINICAL TRIALS AND BANNING OF DRUGS
Clinical trials can only be carried out at centres which have been
accredited for such purpose. The principal investigator of the trial
should be an accredited clinical investigator. The ethics committee
of the institute must also have been accredited. Only those trials
conducted at centers meeting these stipulations will be accepted
by the Drugs Controller General of India (DCGI).
The 12 drug advisory committees which are functioning at present
will be replaced by one broad expertise-based Technical Review
Committee to ensure speedy clearance of applications without
compromising on quality of data and rules and regulations. The
Committee would be assisted as required by appropriate subject
experts selected from the Roster of Experts.
The CDSCO needs to be reorganized, upgraded and strengthened
if it is to perform the various functions envisaged
A Special Expert Committee should be set up independent of the
Drug Technical Advisory Board to review all drug formulations in
the market and identify drugs which are potentially hazardous
and/or of doubtful therapeutic efficacy AND A mechanism should
be put in place to remove these drugs from the market by the
CDSCO at the earliest.
16
CDA Bill, 2013
 The Preamble of the Act is “An Act to regulate the




import, Export, manufacture, distribution, and sale of
Drugs, cosmetics and medical devices to ensure their
safety, efficacy, quality and conduct of clinical trials and
for matters connected therewith or incidental thereto”
instead it may be called “The Drugs, cosmetics,
Clinical Trials and Medical Devices Act, 1940”
No power for State to inspect Medical devices companies
There are 19 members in CDA out of which 7 are
various dept Secrataries of GOI, DGHS, Addl or joint
secretary of Law ministry & Health Ministry, 4 Experts,
4 SLAs, DCGI. However No exclusive representation
for Pharmacy Association / Profession
CDA can suspend or cancel licenses issued by CLA or
SLAs
DCGI will act as CLA but can not delegate his / her
powers to subordinates
17
CDA Bill, 2013
 The DTAB has been reconstituted with 19 members.
 Medical Device Technical Advisory Board constituted






with 15 members but No state Govt. representation.
In new Section 18 the existing sentence in the beginning
Viz “From such date as may be fixed by the State
Govt. by notification in official Gazette in this
behalf” has been deleted.
States are empowered to appoint its own SLAs
Only CLA has power to issue manufacturing licence for
the drugs specified under Third schedule to this Act
[section 18(3)]
No drug, cosmetics or Medical device shall be
Exported without a licence from CLA [Section 18 D]
CDA can suspend or cancel licences issued by CLA or
SLA (Section 33Q)
CDA is Appalent Authority [section 18 R]
18
The Health care Systems The World Over Is Under
Attack
 Reasons include the perception that the Healthcare
Systems, Providers and Administrators are
Insensitive to and Incapable of safeguarding Patient
Interests.
 Spurious
& Fraudulent Drugs and
Practices further endorse this perception.
Medical
 The
Pharmacist says it is the Doctor’s
responsibility, the
Doctor says it is the
manufacturer’s, the Manufacturer says it is the
Governments’, everyone is passing the buck. What
about the poor patient ?
19
Regulatory aspects of access to medicines
The mission of regulatory authorities is to
promote and protect public health. The lack
of access to medicines remains a huge
concern, whether these are essential
medicines, vaccines, orphan drugs or drugs
for tropical diseases. To facilitate access,
regulators and all other stakeholders need
to be actively involved in identifying
difficulties and seeking solutions leading to
balanced approaches to access which do not
compromise public health safeguards.
20
Regulatory aspects of access to medicines
 Regulators
have a role and responsibility to
facilitate access to drugs of public health
importance including proposing changes to the
respective regulations in order to facilitate access
without compromising quality, safety and efficacy.
 As
part of the medicines approval process,
regulators should carry out an appropriate risk
benefit assessment to allow for adjustment to the
needs and profile of the anticipated patient
populations.
21
Promoting Good Regulatory Practices
The issues that are necessary to promote good regulatory practices
nationally and internationally include:
1. sustainability of resources,
2.
optimal structure,
3.
effective cooperation within the agency and with other
agencies,
4.
transparency and accountability,
5.
competence in evaluating efficacy, safety, and quality,
timeliness, independence, collaboration as a service provider,
6.
sharing information, harmonization, and mutual recognition.
7.
Sources of information and the decision process should be
made publicly available whenever possible.
To meet the objectives of promoting and protecting public health,
Regulatory Authorities need to carry out their functions
effectively and efficiently within a set of principles based on
transparency and good governance.
22
Promoting Good Regulatory Practices
 In many cases, regulatory authorities do not have
sufficient resources to carry out these activities.
Most importantly, regulatory agencies must be
accountable and decision-making processes must
be transparent but this needs to be balanced
against the need for protecting the confidentiality of
the data that has been submitted by the
manufacturer.
 Good Regulatory Practices thus cover an evolutionary
process, with good practices built into the systems
which continuously reinforce collaboration and trust.
 Regulatory authorities should establish mechanisms to
ensure the quality of the procedures they operate to.
23
Promoting Good Regulatory Practices
 States
should
encourage
interagency
cooperation for effective implementation of drug
regulation
involving
national
regulatory
authorities, customs, judiciary, police, civil
society and other relevant bodies set up to
protect public health.
 Regulatory Authorities should formulate a clear
mission statement to reinforce effective and
efficient drug regulation and customer
satisfaction and make use of benchmarking to
improve their performance.
24
Promoting Good Regulatory Practices
 Regulatory Authorities should nurture good regulatory
governance (integrity, transparency, accountability,
public service ethics) to establish credibility and gain
confidence.
 The
political governance responsible for national
regulatory authorities should promote teamwork,
overcome bureaucracy and streamline work.
 CDSCO
should promote and provide technical
assistance for the evaluation of regulatory capacity of
regulatory authorities in order to analyse the situation
and to undertake necessary corrective measures.
25
Regulatory aspects - supply of quality
medicines
 Access to quality medicines contributes to improving human
health and promoting wellbeing. Rigorous implementation of
good manufacturing practices in the production of medicines
will ensure that only safe, quality products are allowed on
the market.
 The importance of quality has been repeatedly underlined by
the occurrence of counterfeit and substandard drugs.
Evidence shows an increase in production, distribution and
sale worldwide of counterfeit, spurious and substandard
medicines which do not comply with any quality standards.
 Such products are a waste of money for the people who buy
them, prolong treatment periods, increase the emergence of
drug resistance and can even cause death.
26
Strengthening of regulatory frameworks
 The establishment of a well-functioning national regulatory system as an
integral component of effective public health leads to better patient
protection through provision of medicines which are safe, efficacious and of
good quality.
 Cooperation, communication and trust between regulatory authorities
based on common principles and harmonized approaches will strengthen
the effectiveness of national regulation and international collaboration.

Transparency is an important aspect of regulatory systems and helps to
build public confidence, while facilitating cooperation and information
exchange among regulators.
 Regulatory guidelines, procedures and criteria as well as data about
approved medicines should be made publicly available to all stakeholders.
 Regulatory
authorities should make available to the public, in
understandable language, negative and positive assessment reports
(including pharmacovigilance reports).
27
Problems of counterfeits
 Should adopt the WHO Guidelines on Developing Measures for
Combating Counterfeit Drugs, raise public and political awareness
of the problem of counterfeiting, increase national and
international cooperation, data exchange between all stakeholders,
including
national
regulatory
authorities,
interested
nongovernmental organizations, law enforcement agencies,
industries, and relevant international organizations.
 In collaboration with other stakeholders, it is necessary to develop
a draft concept paper on counterfeit drugs.
 Doping in sports is a serious health problem and is within the
remit of drug regulation. National regulatory authorities should
remain vigilant and provide the necessary resources to combat
such practices.
28
Extent of Spurious Drugs
Particulars
Extent
Spurious
Drugs
Difficulties
of It is reported in media that the
extent of menace of spurious
is ranging from 0.5% to 35%
(ascribed to WHO studies)
However, WHO itself has
written in response to a query
from the Indian Government
that ‘There is no actual study
by WHO, which concludes that
35% of Worlds spurious drugs
are produced in India’. The
reported media news is false
and baseless. The Honorable
Minister for State for Health
and Family Welfare, GOI has
informed that the extent of
spurious drug in the country
is from 0.3 to 0.4%.
Redress
Each state should have
their Intelligence wing
to detect / unearth the
movement of spurious
dugs and the officers
shall have skill to
investigate the matter.
29
Computerization!!!
At present there is a delay due to duplication of
work, lack of man power, infrastructure and
therefore loss of efficiency.
Enormous waste of precious man power and
resources due to paper work.
Lack of feedback to the citizens on the fate of
their complaints.
30
Salient features of the soft ware
1. L.M.S
2. F.M.S
3. Category Wise Manufacturers List
4. Banned Drugs List
5. Drugs Control Officer’s List
6. Product Wise Manufacturers List
7. Forms Fee List
8. Approved Manufacturers List
9. Manufacturers Products List
10.Own/Loan Wise Manufacturers List
11.New Drugs List
12.Manufacturers Licence History
13.Inspection Forward Report
14.Licence Expiry Report
15.Technical Staff List
31
IT Infrastructure
 Prompt and efficient recall of Not of Standard
Quality / Adulterated / Spurious drugs.
 Submission of monthly reports/daily diaries by
enforcement officers in time.
 Sending the drug alert circulars, drugs price
notifications, important notifications etc., by Head
Office to Sub-Offices.
32
CURRENT ISSUES FOR IMPLEMENTATION
 Shortage of Manpower
 Lack of Infrastructure
 Lack of Funds
 Lack of training facilities for officers and staff
 Difficulties in the management of the existing manual
filing system
 Time wastage and lack of efficiency due to manual
typing system
33
Solutions Requirement
 Sufficient manpower and Infrastructure
 Allocation of adequate budget
 Inter
and Intra departmental interactions and
collaboration tool including file tracking and knowledge
management
 Tools for effective monitoring of District level / block
level Officers’ performance
compilation of reports
and
collection
and
 Tools
for efficient training of officers and other
functionaries of the department
34
CONSUMER AWARENESS
• For increasing consumer awareness the senior
officers of the department should participate in
public meetings and impart knowledge about
drug quality.
• The senior officers of the department should
deliver lectures in workshops being conducted
for Druggists & Chemists Associations.
 Each State should constitute a Drug Advisory
Board comprising representative from medical
profession, police dept, social workers, industry
and trade.
35
EXISTING
CORROSPONDANCE BETWEEN FIELD
OFFICE AND HEAD OFFICE
Outstanding work
District wise monthly reports
Head office
Monthly report of revenue Receipts
Case worker
Expenditure Statements
Details of A.C. Bills drawn
Shortages of drugs
Dy.Drugs Controller
samples drawn
Detection of spurious drugs & seizure of drugs
Additional Drugs controller
Tour Programs
Daily Diary
Drugs controller
Field office
Deputy Drugs Controllers /Assistant Drugs controller/ Drug Inspectors
36
PROPOSED SYSTEM OF CORROSPONDENCE BETWEEN FIELD
OFFICE AND HEAD OFFICE
Deputy Drugs Controllers/Assistant Drugs controller/ Drug Inspectors
Field Office
Head office
Drugs Controller
Tour Program
Outstanding work
manufacturing inspection
Additional drugs controller
District wise monthly reports
Head office
data base
Monthly report of revenue Receipts
Deputy drugs Controller
Expenditure Statements
Details of A.C. Bills drawn
Shortages of drugs
Assistant Drug controller/ Drug Inspectors
samples drawn
Case workers
Detection of spurious drugs & seizure of drugs
Tour Programs
Daily Diary
37
EXISTING SYSTEM OF INVESTIGATION OF
COMPLAINT
SAMPLE REGISTER
HEAD OFFICE
Not of Std. Quality
Drawl of Sample
COURT REGISTER
Drug Testing Lab.
Std. Quality Close
Investigate Seize
Withdraw
Complaint
CLOSE OR FILE COURT
38
PROPOSED SYSTEM OF INVESTIGATION OF
COMPLAINT
Head Office Officers
Case Workers
Complaints
Head Office Data Bank
Std. quality
Draw Sample
Drug Testing
Lab
Report
Investigate, seize,
Withdraw
File complaint
or Close
Not of Std Quality
Court Trial
39
KARNATAKA DCD ORGANOGRAM
Drugs Controller (1)
Pay Scale-48900-63600
Additional Drugs Controller (1)
Pay Scale-40050-56550
Deputy Drugs Controller (13)
Head Quarters -3
Regional Office (5)
Pay Scale- 36300-53850
Assistant Drugs Controller (60)
Vacant - Nil
Pay Scale 28100-50100
Drugs Inspectors (112)
Vacant – 11
Pay Scale-22800-43200
Gazetted Assistant (1)
Pay Scale 21600-40050
Chief Scientific Officer(4)
Drugs Testing Laboratory
Vacant (1)
Pay Scale -36300-53850
Scientific Officer(19)
Government Analysts
Vacant-10 Pay Scale 28100-50100
Junior Scientific Officer (113)
Vacant-30
Pay Scale-22800-43200
Principal (1)
Govt. College of Pharmacy
Board of Examining Authority
For Diploma students in Karnataka
Vacant-1, Pay Scale (37400-67000)
Professor( 6)
Vacant-1
Pay Scale (37400-67000)
(Principal Govt. College of Pharmacy)
Assistant Professor (8)
Vacant-2,
Pay Scale (37400-67000)
Member Secretary (1)
Deputy Drugs Controller
(HQ) on Deputation
Lecturer (22)
Gazetted Assistant (1)
Vacant:01
Pay Scale-21600-40050
Gazetted Assistant (3)
Vacant-2
Pay Scale 21600-40050
Pay Scale(15600-39000)
Total Staff Strength of
Group A.B.C.& D 288
Total Staff Strength of
Group A,B,C,& D 312
Working Strength 206, Vacant-82
Working Strength -168 Vacant 152
Gazetted Assistant (1)
Pay Scale-(21600-40050)
Vacant-04
State Intelligence Branch
Drugs Inspector (05) + 5
Pay Scale (22800-43200,)
Vacant:01
Chairman (1)
Ex-Officio
Total Staff Strength Group
A,B,C & D 16
Working Strength-11, Vacant-05
Total Staff Strength Group
A,B,C & D : 83
Working Strength-61, Vacant-22
40
ENFORCEMENT WING – STAFF PARTICULARS
Sl. No
Designation
Sanctioned
strength
Filled
posts
Vacant
Posts
1.
Drugs Controller
1
1
--
2
Additional Drugs
Controller
1
1
--
3
Deputy Drugs
Controller
8+5
7
01 + 5
4
Assistant Drugs
Controller
39 + 21
39
21
5
Drugs Inspectors
62 +50
50
12 + 50
187
98
89
Total
41
STATISTICS
Particulars
Sl No
1
2
Drugs manufacturing units
Drug Manufacturing Loan licences
No of Units
236
370
3
Cosmetics manufacturing units
93
4
Cosmetics Manufacturing Loan licences
29
5
Repacking Units
06
6
Approved Laboratories
11
7
Sales Establishments
23345
8
Blood Banks
171
42
STATISTICS
Sl. No
Particulars
Nos
01
Govt. Hospital Blood Banks
034
02
Pvt Hospital attached & Voluntary Blood Banks
138
03
Central Govt. & Autonomous Blood Banks
05
04
Total Number of Blood banks in Karnataka
177
05
Govt. Hospital Blood Storage centers
108
06
Private Hospital Blood Storage Centers
34
43
STATISTICS
Particulars
Sl No
1
2
Manufacturing inspections carried out
Sales inspections carried out
No
141
15487
3
Blood Banks Inspections carried out
141
4
No of Samples drawn
No of Samples declared as Not of Standard Quality
1859
131
5
No of licences suspended
No of licences cancelled
812
507
6
No of cases filed
39
7
No of cases pending in various courts
500
44
DRUGS TESTING LABORATORY
STAFF PARTICULARS
Sl. No
Designation
Sanctioned
strength
Filled
posts
Vacant
Posts
1.
Chief Scientific
Officer
4
3
1
2
Scientific Officer
19
9
10
3
Junior Scientific
Officer
113
83
30
4
Supporting Staff Technical
78
46
32
5
Supporting Staff Non Technical
110
27
83
Total
324
168
156
45
PERFORMANCE
No. of
Inspections
2010-11
2011-12
Manufacturing units
263
232
148
Sales
Establishments
23752
24069
16884
372
326
356
248
478
355
Hospital stores
attached to Govt.
Hospitals
2012-13
Upto 31.12.2012
Blood Banks
46
PERFORMANCE
Regulatory
Actions
2012-13
2010-11
2011-12
Cancellation
01
45
20
Suspension
02
--
02
Cancellation
830
836
768
Suspension
1078
883
995
18
72
14
-
14
05
Upto 31.12.2012
Manufacturing
1.
2.
Sales
1.
2.
Blood Banks
1
No. of Show
Cause Notice
2
No. of Stop
collection
order
47
DETAILS OF PROSECUTIONS
No. of Cases Filed :
Sl.
No
Particulars
2010-11
2011-12
2012-13
1
D&C Act
36
54
52
2
DPCO
02
-
-
(Upto 31.12.2012)
No of Cases Decided :
Sl.
No
1
2
ACTs
2010-11
2011-12
2012-13
(Upto 31.12.2012)
Con
Acq
Total
Con
Acq
Total
Con
Acq
Total
51
02
53
44
06
50
22
08
30
DPCO 04 02
06
03
03
06
01
02
03
D&C
48
Steps taken by DCD, Karnataka
 Separate State Intelligence Branch at State
HQ has been set up to unearth and combat
the menace of Spurious Drugs. Five
Intelligence branches have been established
in Five Regional Offices.
 32 Special Courts have been notified to try
the offences related to Spurious and
Adulterated Drugs In Karnataka .
 Home Department of Govt. Of Karnataka
has directed all the police stations in
Karnataka to extend co-operation to Drugs
control dept. Officers.
49
DCD, KARNATAKA
50
DRUGS TESTING LABORATORIES
Animal House
Microbiology Section
Hi-tech Section
Biochemistry section
51
.
REGIONAL DRUGS TESTING LABORATORIES
HUBLI REGIONAL D.T.L
BELLARY REGIONAL D.T.L
It is estimated that about 10,000 drugs and cosmetics
samples will be analyzed annually from all the three
laboratories of the department.
52
SPECIAL ACTIVITIES
 First state to constitute Special courts in accordance
with D&C (Amendment ) Act, 2008
 The Dept. computerized the sales Licensing Activities.
Letter and File Movement System (LMS / FMS) has
been installed in HO to trace the document / file.
 Special Drive inspections of all the Blood Banks in the
state are carried out along with member of NGO twice
in a year.
 Survey samples of drugs are drawn from the sales
outlets, Govt. hospitals by the NGOs and analysed at
the approved laboratories
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SPECIAL ACTIVITIES

Five services under Karnataka Guarantee of Services to Citizens Act 2011(SAKALA) are delivered as per time limit.

The licensing of Sales premises through On-line system has been
implemented in all the circle offices in the State and it is being upgraded
stage by stage.

The licensing of Manufacturing activities through On-line system has
been initiated in the State with the help of Software developed by NIC.

The Department Web Site has been posted under www.drugs.kar.nic.in.
The availability of Blood and Blood Components in the blood banks is
available on this website ON DAY TO DAY BASIS . Information about the
24Hrs operating medical shops, is also made available on the website.

With the help of NIC, Bangalore software has been developed about
testing of samples sent by Enforcement Officers.
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SPECIAL ACTIVITIES
• The Dept. signed MOU with Karnataka
Power Corporation Ltd. (KPCL) to construct
twin building behind the present building in
the existing vacant land of approx. 1.81
acres – one for KPCL and other for DCD
• Karnataka Power Corporation agreed to
construct the building with plinth area of
1.16 Lac Sq.Ft for Drugs Control
Department at its cost.
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Survey Sampling
• Survey of blood bank inspection was carried out by
officers of Drugs Control Department along with NGO’s
during June-2011. The Samples of Whole Human
Blood drawn for test and analysis during blood bank
survey have been subjected to test and analysis and
all the samples are found be standard quality.
• The Survey sampling of Drugs distributed in the State
has been carried out twice, once in six months,
along with NGO’s and drawn more than 500 samples
each time on informal basis and the same have been
analyzed in the approved private laboratories of
different States. Less than 1.5% of the sampled drugs
were declared as Not of Standard Quality.
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TRAINING
• For the first
time all the Drugs Inspectors and Assistant Drugs
Controllers working in HQ have undergone industrial training in 7
manufacturing units in Karnataka spread over a period of 4
months to update their knowledge in the manufacturing and
analysis of Drugs.
• All the officers and staff working in HQ and circles in Bangalore
have undergone training in K.C.S.R., Accounts, K.F.C, RTI Act,
Sakala etc., spread over a period of 2 months to update their
knowledge in the respective area. All the PIOs have under gone
training in R.T.I at Administrative Training Institute, Mysore.
• Newly recruited 71 Jr. Scientific Officers under went the training in
the Central laboratories with the approval of DCG(I).
• The enforcement officers are sent for various training programmes
like Management Training conducted by AIDCOC, Mumbai, GMP
training at NIPER, Medical Devices at Hyderabad. Etc.,
• Jr. Scientific Officers and Scientific Officers have undergone
training in Good Laboratories Practices at NIPER/CDL Kolkata, at
Singapore for two days training in HPLC Techniques.
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DRUGS TESTING LABORATORIES PERFORMANCE
Presently Samples of Drugs and Cosmetics, except Vaccines,
Sera, Blood and Blood Components are being analysed.
Details of Samples Analysed
Year
Analysed
STD quality
NSQ
2010-11
3710
3554
135
2011-12
5270
5110
140
4002
3858
144
2012-13
(Upto
31/12/2012)
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NABL – Accreditation
Drugs Testing Laboratory at
Bangalore is in the process of
obtaining NABL Accreditation –
Within a fortnight
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CHALLENGES
• Inadequate field staff and ministerial staff for
enforcement as well as for laboratories (at
present we are having only 60% of the
sanctioned posts filled )
• As per recommendation of Dr. Mashelkar
Committee constituted by Government of India
 for every 200 sales establishment 01 Inspector
 for every 50 Manufacturing units 01 Inspector
 The total no. of Inspector required in Karnataka 164
 Existing sanctioned posts are 112
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ThanQ
 Phone: 080-22262846 (Off)


080-22374047 (Off-D)
 080-22286492 (Fax)
 080-26681520 (Res)
+91-9449818892 (Mob)
 Email: dc.dcd-ka@nic.in
 dckarnataka@gmail.com
 jagashetty@gmail.com
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