DRUGS CONTROL ADMINISTRATION

??????????? The Director of Drugs Control is the Head of Department and he is the Controlling and Licensing Authority for the Drugs Manufacturing Units in Tamil Nadu.? He is assisted by One Joint Director, Three Deputy Directors? and One Assistant Director (Administration) in the Directorate, in matters relating to General Administration, Monitoring the activities of enforcement wing, issue of Licences to Drugs and Cosmetics Manufacturing Units in Tamil Nadu.? There is a Legal-cum-Intelligence Wing to process legal matters and for taking up special investigations.? It is headed by a Deputy Director of Drugs Control who is assisted by a Legal Adviser.

??????????? The State has been divided into 13 Zones and each zone is headed by an Assistant Director of Drugs Control who is the Licensing Authority for the Grant and Renewal of Sales Licences in their Zones.? A Mobile Squad at Madurai headed by an Assistant Director of Drugs Control is functioning for attending to the complaints relating to Spurious Drugs.? A Drugs Testing laboratory is functioning at Chennai for testing the samples of Drugs and Cosmetics drawn by Drugs Inspectors.

The Department of Drugs Control Administration has the following Staffs:

Sl No

Name of the Post

No. of Posts

1

Director of Drugs Control

01

2

Joint Director of Drugs Control

01

3

Deputy Director of Drugs Control

03

4

Assistant Director of Drugs Control

14

5

Assistant Director of Drugs Control (Administration)

01

6

Senior Drugs Inspector

10

7

Drugs Inspectors

74

8

Legal Adviser

01

9

Assistant Accounts Officer

01

10

Ministerial Staff

117

11

Office Assistant

79

12

Driver

04

13

Telephone Operator

01

?

TOTAL

307

?

Drugs Testing Laboratory, Chennai has the following Staffs:

Sl No

Name of the Post

No. of? Posts

1

Government Analyst

01

2

Deputy Government Analyst

02

3

Senior Analyst

15

4

Junior Analyst

24

5

Junior Administrative Officer

01

6

Technician Grade-I

04

7

Technician Grade-II

04

8

Gas Mechanic

01

9

Electrician Grade-I

01

10

Plumber

01

11

Laboratory Attendant

04

12

Animal Attendant

01

13

Ministerial Staff

10

14

Office Assistant

05

15

Sweeper

01

16

Sweeper-cum-Watchman

01

?

TOTAL

76

The King Institute, Guindy, Chennai has the following Staffs for the purpose of testing Schedule 'C' & 'C1' Drugs:

Sl No

Name of the Post

No. of? Posts

1

Deputy Director

01

2

Assistant Professor

01

3

Chief Chemist

01

4

Chemical Assistant

02

5

Junior Assistant

01

6

Typist

01

7

Technician Grade-I

02

8

Technician Grade-II

01

9

Office Assistant

03

?

TOTAL

13

ACHIEVEMENTS DURING 2003-2004:

This directorate has drawn number of samples of drugs and specific instructions were also issued to the Inspectors for the drawal of samples with reference to antibiotics etc.,? The samples drawn were sent for analysis as per the provision of Drugs and Cosmetics Act and based on analytical reports both administrative and legal action have been taken against the persons, based on the merit of each case. Accordingly this directorate has given sanction to prosecute 10 manufacturers / dealers for having manufactured and supplied Not of Standard Quality Drugs.?

Further, this directorate has also cancelled the licence in respect of the product of two manufacturers, which have been reported as Not of Standard Quality.? The drug licences of 37 manufacturers were suspended for the product reported as Not of Standard Quality.?

This directorate is carrying out surprise inspections of manufacturing units by the Inspectors of the intelligence wing and based on the inspection report the licences of five licensee's were directed to stop production and distribution of drugs as per Rule 85(2) of Drugs and Cosmetics Rules 1945.

Based on specific pattern of drawal of samples, by the Inspectors, this directorate was able to detect the movement of spurious drugs in the market and was able to limit the supply of such drugs in the market.? This detection was carried out at an early stage itself and almost entire stock manufactured and supplied have been seized, further investigation is under process.

This directorate has also detected manufacture of drugs without licence by two manufacturers and legal action is being initiated against them.? This directorate is also closely watching the activities of the Blood Bank and in the process one Hospital running a Blood Bank without licence was detected and sanction has been accorded for the prosecution of the same.? Further the sale of CPD Blood Bags required to operate a Blood Bank was also monitored and accordingly one Stockiest of? Blood Bag was prosecuted for contravention of Drugs & Cosmetics Act 1940.

Four cases under Drugs and Magic Remedies (Objectionable Advertisement) Act have been detected for having caused objectionable advertisement (1) for the treatment of Asthma, Sinus, Smoke and Dust Allergy; (2) for the treatment of crambs, Menses too late; (3) for the cure of disorder of Mensterual Flow and for having advertised for the treatment of Sexual Potency and (4)? for having stocked material with objectionable advertisement attracting the provisions of Drugs and Magic Remedies (Objectionable Advertisement) Act.

This directorate is also conducting surprise inspections of all the Sales Concerns to detect (1) the sale of habit forming drugs (i.e.) Calmpose, Fortwin, Altrox; (2) to detect the sale of Physician Samples; (3) to detect the sale of date expired drugs; (4) to detect the sale of drugs without bills; (5) to detect the sale of drugs without licence; (6) to detect the sale of drugs without the supervision of qualified person and from these above categories this directorate has given sanction of prosecution to prosecute 150 Individuals / Concerns.? Thus this directorate is taking every steps to enforce the Drugs & Cosmetics Act and Rules in public interest

?

Financial requirements:

??????????????????????? ??????????????????????? ??????????????????????? ?????????????????? (Rupees in Lakhs)

Sl No

Sub-Head of Account

Revised Estimate for 2003-2004

Non-Plan

Plan

TOTAL

?

2210-06-104

?

?

?

1

AA - Administration of Drugs Act 1940

344.67

-

344.67

2

AB - Administration of Drugs Act 1940 King Institute, Guindy.

13.20

-

13.20

3

AC - Establishment of Drugs Testing Laboratory.

76.70

-

76.70

4

AD - Intelligence Wing of the Drugs Control Administration.

10.71

-

10.71

5

JA - Establishment of Drugs Testing Laboratory.

-

9.25

9.25

6

JB - State Drug Control Administration

-

2.00

2.00

?

TOTAL

445.28

11.25

456.53

Summary of work carried out by the Drugs Control Administration in Tamil Nadu during the period from 2000-2001 to 2003-2004 (Upto 31-01-2004)

Sl. No.

?

Details of Inspection

2000-2001

2001-2002

2002-2003

?

2003-2004

(upto

31-01-2004)

1.

Number of Inspections of Sales Concerns

42692

40193

36355

24961

2.

No. of Inspections of Manufacturing Concerns

2405

2708

1980

1533

3.

No. of Inspections of Hospitals and Medical

??? Stores.

617

591

521

503

?

Details of Licences Issued/Renewed/Cancelled

1.

Sales Licences Granted

3023

3140

3396

3130

2.

Sales Licences Renewed

11460

11745

8307

6039

3.

Manufacturing Licences Granted

191

173

162

106

4.

Manufacturing Licences Renewed

550

588

563

174

5.

Licences Granted for Manufacturing Ayurvedic, Siddha and Unani.

47

44

49

20

6.

Homoeopathic Licences Granted

2

1

-

-

?

Details of Samples Tested (as on 31-01-2004)

?

1.

No. of Samples Tested

3828

3959

4149

3341

?

2.

No. of Samples declared as Standard Quality

3313

4607

3798

2996

?

3.

?No. of Samples declared as Not of Standard Quality.

515

352

351

345

?

?

No. of Sales Concerns (as on 31-01-2004)

33354

32345

34099

35729

?

List of Manufacturers in Tamil Nadu as on 31-01-2004

?

Type of Licences

Allopathic Medicine

Indian Medicine

Homeopathic Medicine

Cosmetics

a.

Regular Licences

668

558

7

183

b.

Loan Licences

334

35

-

2

c.

Repackers Licences

20

-

-

-

TOTAL

1022

593

7

185

Details of Prosecution Launched:

Details of Inspection

2000-2001

2001-2002

2002-2003

?

2003-2004

(upto

31-03-2004)

1. Total No. of Prosecutions sanctioned

106

70

194

150

(a)??? No. of Prosecutions sanctioned under the

????? Drugs & Cosmetics Act 1940.

103

65

192

146

(b)?? No. of Prosecutions sanctioned under the Drugs & Magic Remedies (Objectionable Advertisements) Act 1954.

01

05

02

04

(c)??? No. of Prosecutions under Drugs Price Control Order.

02

-

-

-

(d)?? No. of Prosecutions under Narcotic Drugs & Psychotrophic Substances Act.

-

-

-

-

?

Blood Bank Licences as on 31-03-2004??? ..??????????? ..??????????? 214?????

?

OBJECTWISE CLASSIFICATION:

??????????????????????? ??????????????????????? ??????????????????????? ??????????????????????? ??????????? ??????????? (Rs. in Lakhs)

?

Detailed Head

B.E.2003-04

R.E.2003-04

Non-Plan

Plan

Total

Non-Plan

Plan

Total

01 Salaries

289.33

-

289.33

277.40

-

277.40

02 Wages

0.10

-

0.10

0.10

-

0.10

03 Dearness Allowances

153.30

-

153.30

127.97

-

127.97

04 Travel Expenses

5.45

-

5.45

5.45

-

5.45

05 Office Expenses

8.65

-

8.65

11.80

-

11.80

06 Rent, Rates & Taxes

10.89

-

10.89

11.17

-

11.17

08 Advertising & Publicity

0.02

-

0.02

0.02

-

0.02

19 Machinery & Equipments

2.00

9.25

11.25

3.50

9.25

12.75

21 Motor Vehicles

0.10

-

0.10

0.10

-

0.10

24 Materials & Supplies

4.50

-

4.50

4.50

-

4.50

33 Payment for Professional &

???? Special Service

0.05

-

0.05

0.05

-

0.05

45 Petroleum, Oil & Lubricants

0.69

-

0.69

0.69

-

0.69

49 Festival Advance - Credit

3.26

-

3.26

3.31

-

3.31

49 Festival Advance - Debit

-3.26

-

-3.26

- 3.31

-

- 3.31

59 Prizes & Awards

0.06

-

0.06

0.06

-

0.06

66 Medicines

2.01

-

2.01

2.01

-

2.01

68 Cost of Books/Note?

???? Books/Slates etc.,

0.46

-

0.46

0.46

-

0.46

76 Computer & Accessories

-

2.00

2.00

-

2.00

2.00

TOTAL

477.61

11.25

488.86

445.28

11.25

456.53

?