1

I In ni it ti ia at ti iv ve es s, , A Ac ch hi ie ev ve em me en nt ts s a an nd d T Ta ar rg ge et ts s
C Ce en nt tr ra al l D Dr ru ug gs s S St ta an nd da ar rd d C Co on nt tr ro ol l O Or rg ga an ni iz za at ti io on n
( (2 20 00 01 1 - - 2 20 02 20 0) )


The Central Drugs Standard Control Organization (CDSCO) is the Central Drug
Authority for discharging functions assigned to the Central Government under the
Drugs and Cosmetics Act.
CDSCO has six zonal offices, four sub-zonal offices, 11 port offices and six
laboratories under its control.
CDSCO North Zone (Ghaziabad)
.
CDSCO West Zone (Mumbai)
CDSCO South Zone (Chennai)
CDSCO East Zone (Kolkata)
CDSCO Geographical Location Zonal /Sub Zonal Offices
Port Offices/Airports : 11
Laboratories : 6
29 States
6 Union Territories
CDSCO Zone (Ahmadabad)
CDSCO Zone (Hyderabad)
Proposed Sub Zonal Offices (2) :
Guwahati, Indore,
CDSCO Sub Zone (Bangaluru)
CDSCO Sub Zone (Chandigarh)
CDSCO Sub Zone (Jammu) and (Goa)

Major functions of CDSCO:
1. Regulatory control over the import of drugs, approval of new drugs and
clinical trials, meetings of Drugs Consultative Committee (DCC) and Drugs
Technical Advisory Board (DTAB), approval of certain licences as Central
Licence Approving Authority is exercised by the CDSCO hqrs.
2

2. Zonal offices carry out joint inspections and coordinate with the State Drugs
Controllers under their jurisdiction.
3. Quality control of drugs imported is exercised by the port offices.
4. Drugs testing laboratories test drug samples forwarded to them for test.

Achievements and Initiatives:
2000-2012
Year Achievements/ Initiatives
2001 Requirements for GMP amended to ensure quality of drugs.

2002

Notified In-vitro diagnostic kits (HIV, HBsAg and HCV) as Drugs to
regulate its Import, Manufacture, sale and distribution.

Setup of New Sub-Zonal office of CDSCO at Ahmadabad

Functioning of Regional Drugs Testing Laboratory at Guahwati
Release of Indian Pharmacopoeia Addendum 2002 and the
Veterinary products supplement in 2002

2003

Monitoring the quality of imported drugs by making mandatory for
Registration of Manufacturing site and products before import.

Prepared a list of National List of Essential Medicines (NLEM).

Publication of Transfusion Medicine, Technical Manual for Blood
Bank (second edition)

2004 National Regulatory Authority assessment in respect of Regulatory
Control over vaccines manufactured in the country.

Launched National Pharmacovigillance Program.

2005

Amended Schedule Y- Requirements and guidelines for
permission to import and/or manufacture of New Drugs for Sale or
to undertake Clinical Trials.

Good Clinical Practices (GCP) Guidelines for Clinical Trials in
India.
Notified 10 medical devices as Drugs to regulate its Import,
3

Manufacture, sale and distribution.
Launch of CDSCO official website.
Publication (Second Edition) of Drugs and Cosmetic Act and
Rules.
Compilation of all Drugs Consultative Committee (DCC) and Drugs
Technical Advisory Board (DTAB) minutes.
Notified recombinant drug products and Medical Devices (10
devices) under Central Licensing Approving Authority Scheme.
Release of Indian Pharmacopoeia Addendum 2005
2000-
2005


Enhanced Capacity of drug testing facilities at both state and
central drugs testing laboratories under Centrally Sponsored
Scheme.

Conducted various Consumer Awareness Program on Rational
Use of Medicines.

Major final notification issued pertain to the enhancement of
validity period of manufacturing and sale licences from 2 years to
5 years and upward revision of licence fees and to curb misuse of
Oxytocin injection, it has now been made mandatory to pack it in a
single unit blister pack only.

To declare National Institute of Biological, Noida as an appellate
laboratory for testing blood grouping sera and certain diagnostic
kits.

The state licensing authorities seek approval for DCG(I) for new
drugs before licensing them for manufacture.

Kandla Port made as port of entry for import of drugs into the
country.


Computerization of state drugs control organisations and CDSCO
by providing computer hardware under Centrally Sponsored
Scheme.

Imparted Training to State and Central Drug Control Officials
through Drugs Inspectors Training Scheme (DITS).

4

Strengthening of the regulatory infrastructure by enhancing
capacity in existing drug laboratories at the sates and central level
through infrastructure and equipment strengthening and training of
personnel to upgrade their skill under Capacity Building Project.

2006 Set up of Regional Drugs Testing Laboratory at Chandigarh

2007 Constructed new independent building for CDSCO under Capacity
Building Project.

2000 -
2007
Drugs Banned-

1. Fixed Dose combination of corticosteroid with any other drug for
internal use except for preparations meant for meter dose
Inhalers and dry powder inhalers.

2. Fixed Dose combination of Rifampicin, Isoniazid and
Pyrazinamide, except those which provide daily adult dose given
below:-







3. Fixed Dose combination of Salbutamol or any other drug having
primarily bronchodilatory activity with centrally acting anti-tussive
and/ or antihistamine.

4. Fixed dose combination of Metoclopramide with other drugs
except combination of Metoclopramide with Aspirin/ Paracetamol.

5. Fixed dose combination of Diazepam and Diphenhydramine
Hydrochloride.

6. The Drug Astemizole and Terfinadine have been prohibited.

Drugs Minimum Maximum
Rifampicin 450 mg. 600 mg.
Isoniazid 300 mg. 400 mg.
Pyrazinamide 1000 mg. 1500 mg.

2008 June 2012:

NRA assessment:

WHO in the year 2007 had conducted a National Regulatory Authority (NRA)
assessment in respect of Regulatory Control over vaccines manufactured in the
5

country. The WHO was not satisfied and this resulted in disqualification of NRA in
January 2008. CDSCO took the initiatives beginning from March 2008 for
strengthening the biological division and imparting necessary skills, under
capacity building, with the cooperation of Health Canada. A document system for
quality assurance was developed and Common Technical Document (CTD)
format for filing the applications in accordance to ICH guidelines was introduced.
In the subsequent NRA assessment in April 2009, Guidelines, Standard Operative
Procedures and checklist for all critical functions of dossier review etc introduced
in the system by CDSCO were reviewed by WHO, CDSCO qualified the NRA
assessment with 100% scores in all the critical indicators.

Table- I



Strengthening of CDSCO:

CDSCO was facing an acute manpower crunch in 2008. Since the work load was
increasing at an average of 20% to 25%, the Ministry of Health and Family Welfare
sanctioned 216 additional new posts in the year 2008-2009. With this sanctioned
man power strength of CDSCO has risen to 327. The Ministry of Health and Family
6

Welfare appreciating the need of further manpower, sanctioned engagement of
additional 234 contractual staff to assist the CDSCO in discharging its duties.






Further the proposal to create 1195 additional posts is under consideration of the
Government to strengthen CDSCO.

Sanctioned Posts
as on 2007
Sanctioned Posts
as on 2009
Proposed additional Posts
in 12
th
Five Year Plan
111 327 1195

Present position of sanctioned and vacant post is placed in Table-I

Expansion of infrastructure:

During this period:
Sub zonal offices at Hyderabad and Ahmadabad were upgraded to
zonal offices

New Sub Zonal offices at Bangalore, Jammu, Chandigarh and Goa are
set up.

New Building of Zonal FDA Bhawan at Mumbai was inaugurated by
Union Health Minister on 11th Jan, 2010

New CDSCO Bhawan at Hyderabad was inaugurated by Union Health
Minister on 5th Feb, 2011.

Testing capacities of the existing Central Drugs Testing Laboratories at
Kolkata, Mumbai, Chennai and Kasuali and Regional Drugs Testing
Laboratory Guwahati were enhanced.

A new laboratory was set up at Chandigarh and Hyderabad.


Initiatives at International forum:
7

During this period CDSCO collaborated with US FDA, Health Canada,
and Brazil and South Africa regulatory authorities.

Collaborative workshops were held with US FDA on the subjects of
clinical trial inspections and Regulation of Medical Devices.




Amendments in the Regulatory Provisions under the Drugs and
Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945

Drugs and Cosmetics Act, 1940 was amended under Drugs and Cosmetics
(Amendment) Act, 2008 and it came into force on 10
th
August 2009. Under this
Act stringent penalties for manufacture of spurious and adulterated drugs were
provided. Certain offences relating to spurious and adulterated drugs were
made cognizable and non-bailable.

Setting up of designated special Courts for trial of offences relating to the Drugs
and Cosmetics Act were also provided. 14 states set up designated courts.

Guidelines for taking action in the cases of spurious and substandard drugs in
the light of enhanced penalties under the amended Act were prepared and
forwarded to the State Drugs Control Authorities. These guidelines were also
forwarded by the Ministry of Health and Family Welfare to the State
Governments for compliance.

Drugs and Cosmetics Rules, 1945 were constantly updated to make the
provisions responsive to the present day needs of the society. The number of
notification issued during these periods are as under:

S. No. Year Draft Rules Final
Notification
Notification for
Banning of drugs
1 2008 2 2 1
2 2009 5 10 2
3 2010 4 3 1
4 2011 2 2 4

The salient amendments are as under:
1. Good Laboratories Practices were notified under notification GSR 780(E) dated
10.11.2008 and became operative since 1.11.2010.

8

2. A system of registration of import of cosmetics has been introduced under the
Gazette notification GSR 426(E) dated 19.05.2010. The registration of cosmetics
will become mandatory from 1.04.2012.

Banning of Drugs:

The drugs about which the Central Government is satisfied that their use is likely
to involve risk to human being and animals are prohibited under Section 26A of
the Drugs and Cosmetics Act. The following drugs have been banned during the
period 2008 - 2011.

2008
Diclofenac and its formulations for animal use

2009
Rimonabant

2010
Rosiglitazone
2011

1. Nimesulide and its formulations for human use in children below 12 years
of age,

2. Cisapride,

3. Phenylpropanolamine,

4. Human Placental Extract formulation excepts its injectable for pelvic
inflammatory diseases and topical application for wound healing

5. Sibutramine;

6. R-Sibutramine

7. Gatifloxacin formulation for systemic use in human by any route including
oral and injectable;

8. Tegaserod.

9. Letrozole for induction of ovulation in anovulatory infertility was suspended.

Initiatives in Enforcement of the Drugs and Cosmetics Rules:

9

a. More than 100 import licenses of drugs were cancelled in 2009 following
cancellation of registration certificates due to submission of non authentic
GMP certificates.

b. Surveillance by the CDSCO officers at the ports in 2008 resulted in
detection of certain cases of import of drugs from unregistered sources of
doubtful quality. The cases were handed over to the CBI for investigation
and taking further action.

c. Implementation of whistle blower scheme to motivate the public and
provide information to the regulators on movement of spurious drugs.

d. The surprise investigation/Inspection of Whole Sale/Retail/Hospital
premises for the availability of prohibited drugs (Gatifloxacin, Tegaserod
and Rosiglitazone) was carried out on dated 15
th
June 2011 at National
Capital Region New Delhi and Bhiwadi (Rajasthan).


Administrative measures to improve efficiency and transparency:

The approvals granted by the CDSCO are regularly posted on the website
www.cdsco.nic.in.

The licences and approvals granted put on display daily on two LCDs for
the information of the general public at FDA Bhawan, Kotla Road, New
Delhi.

File tracking system introduced in the CDSCO headquarters as well as in
the North Zone office of CDSCO

The approval letters in respect of Clinical trials and registration certificate
and Import licenses of drugs posted on the website.

Guidance Documents for industry and other stake-holders in respect of
approval of new drugs including FDCs were posted on website.

Initiated Pre-screening of applications before acceptance for review.


Guidance documents:

In order to streamline the review of the applications for various regulatory approvals
the following guidance documents were prepared and uploaded on CDSCO
websites for general information to the stakeholders
10

S. No. Name of Document Date of Posting
on Website
Guidance for Industry
Submission of Clinical Trial Application for
Evaluating Safety and Efficacy
Requirements for permission of Drugs Approval
Post approval changes in biological products:
Quality safety and Efficacy Documents
Preparation of the Quality Information for Drug
Submission for Drug Approval:
Biotechnological/Biological Products
04.12.2008
1. Guidance document on common submission format
for registration of medical devices in India
04.08.2010
2. Requirements for conducting Clinical trial(s) of
medical Devices in India

04.08.2010
3. Guidance document on application for grant of
licence in Form-28 for manufacture of medical
devices in India under CLAA scheme

12.08.2010

4. Draft guidance for industry on fixed dose
combinations

20.08.2010
5. Guidance document on common submission format
for import licence in Form 10 of medical devices in
India
25.08.2010
6. Draft Guidance for industry on preparation of
Common Technical Document (CTD ) for import /
manufacture and marketing approval of new drugs for
human use (New Drug Application NDA)

28.10.2010
7. Guidance on clinical trial Inspection

01.11.2010
8. Draft guidelines on reporting of serious adverse
events in clinical trials

11.05.2011
9. Guidance document on common submission format
for issuance of No Objection Certificate for export of
unapproved/approved new drugs/Banned drugs.

15.05.2011
10. Guidance document on grant of licence in Form
11(test licence) for the purpose of examination
testing and analysis as per rule 33 of drugs and
cosmetics acts and rules 1945

30.05.2011
11. Guidance document for functions and responsibilities
of zonal, sub-zonal & port offices of CDSCO
17.06.2011
11


12. Draft Guidance document on Submission of
application for Import and Registration of bulk drugs
and finished formulations in India.

20.07.2011
13. Draft Guidelines on approval of clinical trial & new
drugs

23.07.2011
14. Guidelines for I.V fluids distribution, storage and
administration

04.08.2011

Revision of National List of Essential Medicines
The National list of essential medicines (NLEM) is one of the key instruments in
balanced healthcare delivery system of a country. The first National List of Essential
Medicines of India was prepared and released in 1996. This list was subsequently
revised in 2003.
The National list of essential medicines (NLEM) was further revised and
NLEM 2011 was prepared.
Country Wide Survey on Spurious Drugs:

A survey to assess the extent of spurious drugs in the country was conducted in the
year 2009, on the basis of statistical principles provided by Indian Statistical Institute
(ISI), Hyderabad. Under this survey 24,136 samples of 62 brands of drugs belonging
to 9 therapeutic categories of 30 manufacturers from over 100 different Pharmacy
outlets in different regions of the country and located in each stratum viz. metros, big
cities, district, towns and villages were collected. The survey had revealed that the
extent of drugs found spurious was 0.046% only.

Comparison of present study with the study conducted by SEARPharm

Parameter Study conducted by
SEARPharm
Present study
No. of Samples Collected 10,743 24,136
No. of Therapeutic category 12 9
Name of the stratum from
where the samples were
collected
Metro Cities (MC)
Big Cities (BC)
District Head
Quarters (DHQ)
Metro Cities (MC)
Big Cities (BC)
District Head Quarters (DHQ)
Towns (T)
Village (Vill)
Number of brands 56 61
No. of samples checked 100% by the Study team 100% through respective
12

Physically manufacturer (Matching of following
Parameters)
Foil matching
Text matter matching
Font size of brand
Brand Symbol
Dimensions of the strip
Description of the product from
the transparent side of the
strip)
Extent of counterfeit suspects
on the basis of physical
examination
In the tune of 3.1% 0.046% (11 samples were not accepted
by the manufacturers as their
products)
No. of Samples Tested
Chemically
2,455 (Suspect and genuine
samples are mixed) through
PVT. Laboratories, which is
around 25% of the total
sample collected.
2976 samples (from 24,125
unsuspected samples) through Govt.
Testing Laboratories which is around
12.336% of the total samples collected.
Parameter tested for chemical
analysis
Identification and Assay Identification and Assay
Failing of Pharmacopoeia
standards in terms of label
claim on laboratory analysis
(Not of Standard Quality)
0.3% {Out of 2,455,08
samples do not conform to
claim}
0.101% {Out of 2976 unsuspected
samples, 03 samples do not conform
to claim with respect to Assay (84.8 to
89.3% of the claim)}



National Pharmacovigilance Programme
A Pharmacovigilance Programme of India (PVPI) was launched on 14.07.2010 to
capture Adverse Drug Reactions data in Indian populations in a systematic way in
CDSCO. The programme is now coordinated by the Indian Pharmacopeia
Commission, Ghaziabad. Currently, 60 medical colleges are functioning as Adverse
Drug Reaction monitoring centres.
Overseas Inspections
The office of CDSCO has started inspection of Pharmaceutical firms for import
registration of drugs. In May 2011, six bulk drugs manufacturing in China were
inspected out of which registration certificate and import license of one unit was
cancelled. Further, in February 2012, 4 drug manufacturing in China were inspected
as per the provisions.
Strengthening of clinical trials regulations
Various initiatives were taken for strengthening of clinical trial regulation to ensure
the protection rights, safety and well being of Clinical Trial subjects and authenticity
of bio medical data generated. Some of the initiatives taken are as under:
13

a. It was made mandatory for registration of clinical trials with the Centralized
Clinical Trial Registry of ICMR with effect from 15
th
June 2009.

b. Guidelines for conducting Clinical Trials inspections were posted on the
website of CDSCO (i.e. ww.cdsco.nic.in).

c. 12 New Drug Advisory Committees (NDAC) were constituted to examine
the applications for permissions for clinical trials and approvals for new
drugs.

d. The Drugs and Cosmetics Rules were further proposed to be amended to
make provisions for regulation of clinical trial. Draft notification specifying
the requirements and guidelines for registration of Clinical Research
Organization (CROs) have already been published on 19.01.11.


Some of the important proposals for the amendments which have already been
approved by DTAB are as under:

Provisions for payment of compensation in case of trial related injury or
death.
Enhancement of the responsibilities of Ethics Committee, Investigator and
Sponsor to ensure that financial compensation as well as medical care is provided
to the trial subjects who suffer trial related injury or deaths.

Registration of Ethics Committees

Provisions for clinical trial inspections



Creation of Pharmazones:

Initiatives was taken for creation of pharmaceutical zones at Delhi, and other
ports for providing dedicated areas for storage of drugs and sampling of drugs
meant for import or export of drugs. The pharma zone has been setup in Hyderabad
Air port while at Delhi IGI Airport it is in advanced stage.

Introduction of Good Laboratory Practices
The rules relating to Good Laboratory Practices have become operative since 1
st

day of November, 2010.These rules provide for Good housekeeping and safety
provisions for the maintenance of the laboratory. The manufacturers having in-house
laboratories are required to conform to the provisions of the said Schedule.
14


Registration of Cosmetics
The Drugs and Cosmetics Rules, 1945 were amended by a Gazette Notification
GSR 426(E) dated 19
th
May, 2010 for registration of cosmetics imported into the
country. The registration would become mandatory from 1st October, 2012.


Delegation of powers of CDSCO, HQ to Zonal Offices
of CDSCO:

The following powers were delegated on 1
st
June 2011 to Zonal offices:
No objection certificates for grant of license to manufacture drugs for the
purpose of examination, test or analysis(Rule 89)
No objection certificate for grant of permission for manufacture for export
only of unapproved/approved new drugs and drugs banned.
Permit for import of small quantities of drugs for personal use under Form
12 B of the Rules.
No objection certificate for grant of permissions for import of dual use items,
not for medicinal use.

Manpower in CDSCO (Current position vis--vis position in 2008)
STAFF POSITION CDSCO, March, 2012
S.No Name of
the post
No. of
sanctioned
posts as on
April 2008
Status as on April
2008
Posts created
Year 2008 & 2009
No. of
Sanctioned
Posts as on
March 2012
In Position
as on
March
2012
Vacant
Posts as
on March
2012
In Position Vacancies 2008 2009
1 DCG(I) 1 1 0 - - 1 0 1
2 JDC(I) 1 0 1 1 2 - 2
3 DDC(I) 9 1 8 - 10 19 10 9
4. ADC(I) 16 16 0 - 25 41 15 26
5. DI 32 12 20 62 75 169 65 104
6. Asst DI - - - 31 31 - 31*
7. Sr.
Biomedic
al
engineer
- - - 1 1 - 1
8. Biomedic
al
engineer
- - - 1 1 - 1
9. TO 14 5 9 10 - 24 14 10
10. STA 17 13 4 - - 17 9 8
11. T.A. 21 16 5 - - 21 6 15
Total 111 64 47 72 144 327 119 208

15


Targets/Roadmap/Capacity Building: 2013-2020
For CDSCO:
Strengthening of CDSCO manpower by creating additional 1195 new
posts, including 64 experts and additional 4300 personnel for new
laboratories, mobile drug testing labs, E-governance, training academy

E-Governance System- To increase transparency and credibility. With
this, all offices of Zonal/Sub-Zonal/Port offices/laboratories of CDSCO
and offices of State Drugs Controllers will be interlinked for fast
communication, IT enabled services, preparation of National Registry,
Video Conferencing, archiving of all files etc.

Consumer awareness programs to educated and sensitise consumers,
medical care providers etc on drug safety alerts, promotion of generic
drugs, self medication issues, etc

Setup of 8 new Central Drugs Testing Laboratories with a capacity to
test around 8000 samples per annum by each laboratory.

Up gradation of existing 6 Central Drugs Laboratories.

Up gradation of existing CDSCO zonal/sub-zonal and Port offices.
Setup of 5 new Central Cosmetics Testing labs, 3 new Central
Diagnostic kit labs and 5 new Central Medical Devices Testing
Laboratories.

Setup of 20 mini drug testing labs at port offices of CDSCO to monitor
quality of imported and exported drugs.

Purchase of 20 mobile drug testing vans to monitor quality of drugs
moving in the market.

Setup state of art Pharma Research laboratory to carry out sophisticated
analysis of drugs to detect foreign (contaminants) substances in drugs.

Setup of National Drug Regulators Training Academy to impart
continuous training to the drug regulators.

Setup of India Country Offices in 5 Countries to inspect foreign
manufacturing facilities and address other regulatory issues.

Effective implementation of Pharmacovigillance Program of India.

16

Conduct regular overseas inspections to verify GMP compliance and
other statutory requirements.

For State Drugs Regulatory System: Under Centrally
Sponsored Scheme.

Creation of additional 2500 manpower (regulators)

Setup of 20 new State drugs testing laboratories and 2000 additional
manpower for new labs.

Up gradation of all 26 state drug testing laboratories

Construction/expansion/up gradation of State Drugs Control Offices.