Lok Sabha Question No. 2620 (UNSTARRED), answered on 2020-03-06
Subject: Quality Tests for Medicines
Ministry: HEALTH AND FAMILY WELFARE
Asked by: K. Shanmuga Sundaram, Ravneet Singh

## GOVERNMENT OF INDIA MINISTRY OF HEALTH AND FAMILY WELFARE DEPARTMENT OF HEALTH AND FAMILY WELFARE

LOK SABHA UNSTARRED QUESTION NO. 2620 TO BE ANSWERED ON 06 TH MARCH, 2020

## QUALITY TESTS FOR ME DICINES

## 2620. SHRI SHANMUGA SUNDARAM K.:

## SHRI RAVNEET SINGH BITTU:

Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:

- (a) the details of the number of medicines being supplied by pharmaceutical companies f the standard quality test, State/UT - wis  during the last three y ears, year - wise;
- (b) whether the Central Drugs Standard Control Organisation (CDSCO) has found five batch of medicine manufactured by three Government controlled drug manufacturers failing the qua tests, if so, the details thereof;
- (c) whether the Government has received any report in this regard, if so, the details ther the name of the companies along with the drugs found sub - standard or spurious;
- (d) the steps taken by the Government against the erring employees; and
- (e) whether th ese drug companies conducted dissolution test before marketing the paracetam tablets, if so, the details thereof and the action taken to prevent any damages to the bought  these  medicines  in  good  faith  along  with  measures  to  ensure  maintenance of  quality standards by pharmaceutical companies?

## ANSWER

## THE MINISTER OF HEALTH AND FAMILY WELFARE (DR. HARSH VARDHAN)

- (a):  As  per  information  received  from  various  State/UT  Drugs  Controllers,  number  of  d samples tested, number of drugs samples declared sub - standard  and  spurious/  adulterated and action taken thereon during the last three years and current year is enclosed as Annexure - I.
- (b) to (e): Details of drugs declared as spurious/substandard/adulterated/misbranded by Cen Drug  TestingLaboratories  are regularly  uploaded  on  Central  Drugs  Standard  Control Organisation (CDSCO) website ( www.cdsco.nic.in ) under the heading 'Drug Alert'.

Details with regard to five batches of medicines manufactured by three Government controlled drug manufacturers failing the quality tests have also been uploaded on the website of ( www.cdsco.gov.in )  in  the  month  of  January  2020  and  a  copy  of  the  same  is  enclosed  a Annexu re- II .

Licence for manufacturing, sale & distribution of drugs are granted by the State Lic Authorities appointed by respective State Governments. State Governments are empowered to take action on violations of any of the provisions of Drugs & Cosmetics Act, 1940 and Rules made  thereunder. In  all  the  above  cases,  the State  Drugs  Controllers  of  the  concerned  State where the drugs were manufactured have been informed accordingly.

Out of above five cases, four had failed in the test for dissolution for Albendazole tablets and one failed in the test for disintegration for Diclofenac Sodium tablets I.P.

………………..

| Annexure - I Number of samples tested and enforcement actions taken by State Drugs Controller   | Annexure - I Number of samples tested and enforcement actions taken by State Drugs Controller   | Annexure - I Number of samples tested and enforcement actions taken by State Drugs Controller   | Annexure - I Number of samples tested and enforcement actions taken by State Drugs Controller   | Annexure - I Number of samples tested and enforcement actions taken by State Drugs Controller   | Annexure - I Number of samples tested and enforcement actions taken by State Drugs Controller            | Annexure - I Number of samples tested and enforcement actions taken by State Drugs Controller   | Annexure - I Number of samples tested and enforcement actions taken by State Drugs Controller   | Annexure - I Number of samples tested and enforcement actions taken by State Drugs Controller   | Annexure - I Number of samples tested and enforcement actions taken by State Drugs Controller   | Annexure - I Number of samples tested and enforcement actions taken by State Drugs Controller   |
|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| S.No.                                                                                           | States                                                                                          | No. of drugs samples tested                                                                     | No. of drugs samples declared not of standard quality                                           | 1st April No. of drugs samples declared spurious/ adulterated                                   | 2016 to No. of prosecution launched for manufacturing, sale and distribution spurious/ adulterated drugs | 31st March, of No. of cases (as mentioned in the earlier column) decided                        | 2017 No. of persons arrested                                                                    | Approx. value of drug seized                                                                    | No. of Raids Conducted                                                                          | Action taken w.r.t no. of raids conducted                                                       |
| 1                                                                                               | Andhra Pradesh                                                                                  | 2979                                                                                            | 22                                                                                              | Nil                                                                                             | Nil                                                                                                      | Nil                                                                                             | Nil                                                                                             | 13567403                                                                                        | Nil                                                                                             | Nil                                                                                             |
| 2                                                                                               | Arunachal Pradesh                                                                               | 47                                                                                              | 1                                                                                               | Nil                                                                                             | Nil                                                                                                      | Nil                                                                                             | Nil                                                                                             | Nil                                                                                             | Nil                                                                                             | Nil                                                                                             |
| 3                                                                                               | Assam                                                                                           | 745                                                                                             | 43                                                                                              | Nil                                                                                             | Nil                                                                                                      | Nil                                                                                             | Nil                                                                                             | Nil                                                                                             | Nil                                                                                             | Nil                                                                                             |
| 4                                                                                               | Bihar*                                                                                          | 397                                                                                             | 11                                                                                              | Nil                                                                                             | Nil                                                                                                      | 6                                                                                               | 16                                                                                              | 26311817                                                                                        | 78                                                                                              | 47                                                                                              |
| 5                                                                                               | Goa                                                                                             | 534                                                                                             | 17                                                                                              | Nil                                                                                             | Nil                                                                                                      | Nil                                                                                             | Nil                                                                                             | Nil                                                                                             | Nil                                                                                             | Nil                                                                                             |
| 6                                                                                               | Gujarat                                                                                         | 11071                                                                                           | 535                                                                                             | 22                                                                                              | 2                                                                                                        | Nil                                                                                             | Nil                                                                                             | Nil                                                                                             | 3                                                                                               | under Investigation                                                                             |
| 7                                                                                               | Haryana                                                                                         | 1901                                                                                            | 12                                                                                              | 1                                                                                               | 5                                                                                                        | 1                                                                                               | Nil                                                                                             | Nil                                                                                             | 6890                                                                                            | -                                                                                               |
| 8                                                                                               | Himachal Pradesh                                                                                | 1001                                                                                            | 36                                                                                              | 5                                                                                               | Nil                                                                                                      | Nil                                                                                             | Nil                                                                                             | Nil                                                                                             | Nil                                                                                             | Nil                                                                                             |
| 9                                                                                               | Jammu & Kashmir                                                                                 | 2958                                                                                            | 60                                                                                              | Nil                                                                                             | Nil                                                                                                      | Nil                                                                                             | Nil                                                                                             | 13983937                                                                                        | Nil                                                                                             | Nil                                                                                             |
| 10                                                                                              | Karnataka                                                                                       | 8217                                                                                            | 468                                                                                             | Nil                                                                                             | 2                                                                                                        | Nil                                                                                             | Nil                                                                                             | 21 Lakhs NSQ Drugs                                                                              | -                                                                                               | Nil                                                                                             |
| 11                                                                                              | Kerala                                                                                          | 8934                                                                                            | 140                                                                                             | Nil                                                                                             | Nil                                                                                                      | Nil                                                                                             | Nil                                                                                             | Nil                                                                                             | Nil                                                                                             | Nil                                                                                             |
| 12                                                                                              | Madhya Pradesh                                                                                  | 1624                                                                                            | 15                                                                                              | 3                                                                                               | Nil                                                                                                      | Nil                                                                                             | Nil                                                                                             | Nil                                                                                             | Nil                                                                                             | Nil                                                                                             |
| 13                                                                                              | Maharashtra                                                                                     | 4592                                                                                            | 335                                                                                             | 33                                                                                              | In all cases, prosecution orders are issued & In cases prosecution are filed in the Court.               | 4 Nil                                                                                           | 1                                                                                               | 392235                                                                                          | 10                                                                                              | 7                                                                                               |
| 14                                                                                              | Manipur*                                                                                        | 19                                                                                              | Nil                                                                                             | Nil                                                                                             | Nil                                                                                                      | Nil                                                                                             | Nil                                                                                             | Nil                                                                                             | Nil                                                                                             | Nil                                                                                             |
| 15                                                                                              | Meghalaya*                                                                                      | 97                                                                                              | Nil                                                                                             | Nil                                                                                             | Nil                                                                                                      | Nil                                                                                             | Nil                                                                                             | Nil                                                                                             | Nil                                                                                             | Nil                                                                                             |
| 16                                                                                              | Mizoram                                                                                         | 79                                                                                              | 8                                                                                               | Nil                                                                                             | Nil                                                                                                      | Nil                                                                                             | Nil                                                                                             | Nil                                                                                             | Nil                                                                                             | Nil                                                                                             |
| 17                                                                                              | Nagaland                                                                                        | 22                                                                                              | Nil                                                                                             | Nil                                                                                             | Nil                                                                                                      | Nil                                                                                             | Nil                                                                                             | Nil                                                                                             | Nil                                                                                             | Nil                                                                                             |
| 18                                                                                              | Orissa                                                                                          | 4036                                                                                            | 113                                                                                             | Nil                                                                                             | Nil                                                                                                      | Nil                                                                                             | Nil                                                                                             | Nil                                                                                             | 851                                                                                             | Nil                                                                                             |
| 19                                                                                              | Punjab                                                                                          | 2750                                                                                            | 58                                                                                              | 16                                                                                              | 12 (Action under process rest of cases)                                                                  | in 1                                                                                            | 3                                                                                               | 1,771,725                                                                                       | 1389                                                                                            | 1 court case has been launched rest of the cases are under investigation                        |

| 20    | Rajasthan            | 2545   | 147   | 30   | 3   | 2   | 15   | 1615137.47    | 13     | 1-process in court for withdraw retesting request by manufacturers 12-under investigation                                                                                            |
|-------|----------------------|--------|-------|------|-----|-----|------|---------------|--------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 21    | Sikkim               | 102    | 3     | Nil  | Nil | Nil | Nil  | Nil           | Nil    | Nil                                                                                                                                                                                  |
| 22    | Tamilnadu            | 9510   | 392   | 4    | 6 # | Nil | Nil  | Nil           | 447    | 370 #                                                                                                                                                                                |
| 23    | Tripura              | 1151   | 10    | Nil  | Nil | Nil | Nil  | Nil           | Nil    | Nil                                                                                                                                                                                  |
| 24    | Uttar Pradesh        | 7357   | 222   | 3    | 106 | 2   | 54   | 14,235,568    | 1119   | FIR- 57,persons arrested - 54,Total seizure - Rs. 14235568                                                                                                                           |
| 25    | West Bengal          | 683    | 36    | 4    | 6   | Nil | 4    | Nil           | 4      | Nil                                                                                                                                                                                  |
| 26    | Pondicherry          | 3      | Nil   | Nil  | Nil | Nil | Nil  | Nil           | Nil    | Nil                                                                                                                                                                                  |
| 27    | Andaman & Nicobar *  | Nil    | Nil   | Nil  | Nil | Nil | Nil  | Nil           | 10     | Nil                                                                                                                                                                                  |
| 28    | Chandigarh           | 86     | 2     | Nil  | Nil | Nil | Nil  | Nil           | Nil    | Nil                                                                                                                                                                                  |
| 29    | Delhi                | 278    | 18    | 2    | 5   | 5   | Nil  | 15000         | 35     | Total 289 firms were inspected of which 82 firms were found contravening various provisions Drugs and Cosmetics Rules,1945. Action has been taken against erring firms as per Rules. |
| 30    | Dadra & Nagar Haveli | 4      | Nil   | Nil  | Nil | Nil | Nil  | Nil           | Nil    | Nil                                                                                                                                                                                  |
| 31    | Daman & Diu          | Nil    | Nil   | Nil  | Nil | Nil | Nil  | Nil           | Nil    | Nil                                                                                                                                                                                  |
| 32    | Lakshadweep          | Nil    | Nil   | Nil  | Nil | Nil | Nil  | Nil           | Nil    | Nil                                                                                                                                                                                  |
| 33    | Chattisgarh          | 15     | 2     | Nil  | Nil | Nil | Nil  | 468895        | 1      | Case is under investigation                                                                                                                                                          |
| 34    | Jharkhand            | 148    | 13    | Nil  | 6   | Nil | 13   | 2807000       | 66     | Suspension - 34 Procecution - 35 Cancellation - 05 FIR - 28                                                                                                                          |
| 35    | Uttarakhand          | 217    | 22    | Nil  | Nil | Nil | Nil  | Nil           | 5      | Nil                                                                                                                                                                                  |
| 36    | Telangana            | 2619   | 39    | Nil  | Nil | Nil | Nil  | Nil           | Nil    | Nil                                                                                                                                                                                  |
| Total | Total                | 76,721 | 2,780 | 123  | 186 | 17  | 106  | 7,72,68,717.5 | 10,921 | -                                                                                                                                                                                    |

(*)= data as on 1st April 2016 to 30th Sept. 2016)

(#)= Figure indicates the number of cases detected before 01.04.2016

| Number of samples tested and enforcement actions taken by State Drugs Controller during 1st April 2017 to 31st March, 2018   | Number of samples tested and enforcement actions taken by State Drugs Controller during 1st April 2017 to 31st March, 2018   | Number of samples tested and enforcement actions taken by State Drugs Controller during 1st April 2017 to 31st March, 2018   | Number of samples tested and enforcement actions taken by State Drugs Controller during 1st April 2017 to 31st March, 2018   | Number of samples tested and enforcement actions taken by State Drugs Controller during 1st April 2017 to 31st March, 2018   | Number of samples tested and enforcement actions taken by State Drugs Controller during 1st April 2017 to 31st March, 2018   | Number of samples tested and enforcement actions taken by State Drugs Controller during 1st April 2017 to 31st March, 2018   | Number of samples tested and enforcement actions taken by State Drugs Controller during 1st April 2017 to 31st March, 2018   | Number of samples tested and enforcement actions taken by State Drugs Controller during 1st April 2017 to 31st March, 2018   | Number of samples tested and enforcement actions taken by State Drugs Controller during 1st April 2017 to 31st March, 2018   | Number of samples tested and enforcement actions taken by State Drugs Controller during 1st April 2017 to 31st March, 2018   |
|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| S. No.                                                                                                                       | States/Uts                                                                                                                   | No. of drugs samples tested                                                                                                  | No. of drugs samples declared not of standard quality                                                                        | No. of drugs samples declared spurious/ adulterated                                                                          | No. of prosecution launched for manufacturing, sale and distribution spurious/ adulterated drugs                             | of No. of cases (as mentioned in the earlier column) decided                                                                 | No. of persons arrested                                                                                                      | Approx. value of drug seized (Rs)                                                                                            | No. of Raids Conducted                                                                                                       | Action taken w.r.t. no. raid conducted                                                                                       |
| 1                                                                                                                            | Andhra Pradesh                                                                                                               | 2366                                                                                                                         | 102                                                                                                                          | 10                                                                                                                           | 2                                                                                                                            | nil                                                                                                                          | 8                                                                                                                            | 2075759                                                                                                                      | 316                                                                                                                          | 67 seizures                                                                                                                  |
| 2                                                                                                                            | Arunachal Pradesh                                                                                                            | 180                                                                                                                          | 6                                                                                                                            | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          |
| 3                                                                                                                            | Assam                                                                                                                        | 766                                                                                                                          | 45                                                                                                                           | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          |
| 4                                                                                                                            | Bihar #                                                                                                                      | 169                                                                                                                          | 14                                                                                                                           | Nil                                                                                                                          | 2                                                                                                                            | Nil                                                                                                                          | 9                                                                                                                            | 4,84,048/ -                                                                                                                  | 35                                                                                                                           | FIR -13 Suspension - 2                                                                                                       |
| 5                                                                                                                            | Chattisgarh                                                                                                                  | 409                                                                                                                          | 34                                                                                                                           | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          |
| 6                                                                                                                            | Goa                                                                                                                          | 765                                                                                                                          | 10                                                                                                                           | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          |
| 7                                                                                                                            | Gujarat                                                                                                                      | 13221                                                                                                                        | 395                                                                                                                          | 4                                                                                                                            | 2                                                                                                                            | nil                                                                                                                          | nil                                                                                                                          | 19.92 lakhs                                                                                                                  | 8                                                                                                                            | 4                                                                                                                            |
| 8                                                                                                                            | Haryana                                                                                                                      | 1313                                                                                                                         | 29                                                                                                                           | 2                                                                                                                            | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          | 2842                                                                                                                         | license suspended- 5 license cancelled - 9                                                                                   |
| 9                                                                                                                            | Himachal Pradesh                                                                                                             | 1228                                                                                                                         | 42                                                                                                                           | nil                                                                                                                          | 1(case of year 2016)                                                                                                         | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          |
| 10                                                                                                                           | Jharkhand                                                                                                                    | 14                                                                                                                           | 3                                                                                                                            | 1                                                                                                                            | 1                                                                                                                            | nil                                                                                                                          | nil                                                                                                                          | 72100                                                                                                                        | 36                                                                                                                           | suspension - 26 prosecution - 7 cancellation - 3 FIR- 12                                                                     |
| 11                                                                                                                           | Jammu & Kashmir                                                                                                              | 3312                                                                                                                         | 69                                                                                                                           | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          | 22,47,745                                                                                                                    | nil                                                                                                                          | nil                                                                                                                          |
| 12                                                                                                                           | Karnataka                                                                                                                    | 7539                                                                                                                         | 480                                                                                                                          | nil                                                                                                                          | 2                                                                                                                            | nil                                                                                                                          | nil                                                                                                                          | 240250                                                                                                                       | nil                                                                                                                          | nil                                                                                                                          |
| 13                                                                                                                           | Kerala                                                                                                                       | 8237                                                                                                                         | 152                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          |
| 14                                                                                                                           | Madhya Pradesh                                                                                                               | 1715                                                                                                                         | 38                                                                                                                           | 3                                                                                                                            | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          |
| 15                                                                                                                           |                                                                                                                              | 4760                                                                                                                         | 361                                                                                                                          | 38                                                                                                                           | In all cases prosecution orders are issued & in 5 cases prosecution                                                          | are investigation in progress                                                                                                | 19                                                                                                                           | 62775034                                                                                                                     | 162                                                                                                                          | nil                                                                                                                          |
| 16                                                                                                                           | Manipur                                                                                                                      | 53                                                                                                                           | 2                                                                                                                            | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          |
| 17                                                                                                                           | Meghalaya                                                                                                                    | 75                                                                                                                           | 10                                                                                                                           | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          |
| 18                                                                                                                           | Mizoram                                                                                                                      | 263                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          |
| 19                                                                                                                           | Nagaland                                                                                                                     | 36                                                                                                                           | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          | nil                                                                                                                          |

| 20    | Odisha               | 3949   | 121   | nil   | nil   | nil   | nil    | nil              | 994   | Show cause notice issued                                                                                                  |
|-------|----------------------|--------|-------|-------|-------|-------|--------|------------------|-------|---------------------------------------------------------------------------------------------------------------------------|
| 21    | Punjab               | 3720   | 66    | 19    | 11    | 2     | nil    | 71484            | 1787  | cases are under investigation                                                                                             |
| 22    | Rajasthan            | 2346   | 218   | 123   | 3     | nil   | nil    | 26535506         | 11    | nil                                                                                                                       |
| 23    | Sikkim               | 25     | nil   | nil   | nil   | nil   | nil    | nil              | nil   | nil                                                                                                                       |
| 24    | Tamilnadu            | 11601  | 172   | 5     | 6*    | nil   | nil    | nil              | 177   | under investigation for taking legal action                                                                               |
| 25    | Telangana            | 2530   | 39    | nil   | nil   | nil   | nil    | nil              | nil   | NA                                                                                                                        |
| 26    | Tripura              | 1303   | 19    | nil   | nil   | nil   | nil    | 28 lakhs         | 2     | proseution launched                                                                                                       |
| 27    | Uttarakhand          | 180    | 10    | 2     | 3     | 3     | 8      | 20 lakhs         | 20    | 16                                                                                                                        |
| 28    | Uttar Pradesh        | 9421   | 282   | 23    | 56    | nil   | 101    | 60314082         | 592   | 105 FIR were lodged and 101 person were arrested                                                                          |
| 29    | West Bengal          | 515    | 40    | 3     | 2     | nil   | 3      | 3 lakhs          | 2     | prosecution started                                                                                                       |
| 30    | Pondicherry          | nil    | nil   | nil   | nil   | nil   | nil    | nil              | nil   | nil                                                                                                                       |
| 31    | Andaman & Nicobar    | nil    | nil   | nil   | nil   | nil   | nil    | nil              | nil   | nil                                                                                                                       |
| 32    | Chandigarh           | 64     | 1     | nil   | nil   | nil   | nil    | nil              | 1     | under investigation                                                                                                       |
| 33    | Delhi                | 464    | 22    | 3     | 2     | 11    | FIR-15 | 167 lakhs approx | 82    | 269 firms were found contravening various provisio of & C Act and Rules . Action against firm has been initiated per said |
| 34    | Dadra & Nagar Haveli | 12     | 1     | nil   | nil   | nil   | nil    | nil              | nil   | nil                                                                                                                       |
| 35    | Daman & Diu          | 48     | nil   | nil   | nil   | nil   | nil    | nil              | nil   | nil                                                                                                                       |
| 36    | Lakshadweep #        | Nil    | Nil   | Nil   | Nil   | Nil   | Nil    | Nil              | Nil   | Nil                                                                                                                       |
| TOTAL | TOTAL                | 82,599 | 2783  | 236   | 131   | 16    | 163    | 178,608,008      | 7067  |                                                                                                                           |

(*) including the cases of previous year

(#) data 1st Apr, 2017 to 30th Sept, 2017

| Number of samples tested and enforcement actions taken by State Drugs Controller during   | Number of samples tested and enforcement actions taken by State Drugs Controller during   | Number of samples tested and enforcement actions taken by State Drugs Controller during   | Number of samples tested and enforcement actions taken by State Drugs Controller during   | Number of samples tested and enforcement actions taken by State Drugs Controller during   | Number of samples tested and enforcement actions taken by State Drugs Controller during              | Number of samples tested and enforcement actions taken by State Drugs Controller during   | Number of samples tested and enforcement actions taken by State Drugs Controller during   | Number of samples tested and enforcement actions taken by State Drugs Controller during   | Number of samples tested and enforcement actions taken by State Drugs Controller during   | Number of samples tested and enforcement actions taken by State Drugs Controller during   |
|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| S. No .                                                                                   | States/ Uts                                                                               | No. of drugs sampl es tested                                                              | No. of drugs sample s declare d not of standa rd quality                                  | No. of drugs samples declared spurious/ adulterate d                                      | No. of prosecution launched for manufacturi ng, sale and distribution of spurious/ adulterated drugs | No. of cases (as menti oned in the earlier colum n) decide                                | No. of persons arrested                                                                   | Approx. value of drug seized (Rs)                                                         | No. of Raids Conduct ed                                                                   | Action taken w.r.t. no. of conducted                                                      |
| 1                                                                                         | Andhra Pradesh*                                                                           | 1266                                                                                      | 57                                                                                        | 3                                                                                         | Nil                                                                                                  | d Nil                                                                                     | Nil                                                                                       | 3,00,800                                                                                  | 135                                                                                       | 630 shops inspected                                                                       |
| 2                                                                                         | Arunachal Pradesh                                                                         | 98                                                                                        | 4                                                                                         | 1 (Misbrand ed)                                                                           | Under investigation                                                                                  | Nil                                                                                       | Nil                                                                                       | Nil                                                                                       | Nil                                                                                       | Nil                                                                                       |
| 3                                                                                         | Assam                                                                                     | 451                                                                                       | 40                                                                                        | Nil                                                                                       | Nil                                                                                                  | Nil                                                                                       | Nil                                                                                       | Nil                                                                                       | Nil                                                                                       | Nil                                                                                       |
| 4                                                                                         | Bihar**                                                                                   | 169                                                                                       | 14                                                                                        | Nil                                                                                       | 2                                                                                                    | Nil                                                                                       | 9                                                                                         | 4,84,048/ -                                                                               | 35                                                                                        | FIR -13 Suspension - 2                                                                    |
| 5                                                                                         | Chattisgarh                                                                               | 438                                                                                       | 34                                                                                        | Nil                                                                                       | 2                                                                                                    | 2                                                                                         | Nil                                                                                       | 1800                                                                                      | 2                                                                                         | 2                                                                                         |
| 6                                                                                         | Goa                                                                                       | 693                                                                                       | 16                                                                                        | NIL                                                                                       | NIL                                                                                                  | NIL                                                                                       | NIL                                                                                       | NIL                                                                                       | NIL                                                                                       | Not applicable                                                                            |
| 7                                                                                         | Gujarat                                                                                   | 13854                                                                                     | 491                                                                                       | 4                                                                                         | 9                                                                                                    | NIL                                                                                       | NIL                                                                                       | 12.00 lacs                                                                                | 5                                                                                         | Under investigation                                                                       |
| 8                                                                                         | Haryana                                                                                   | 2904                                                                                      | 12                                                                                        | Nil                                                                                       | 51                                                                                                   | 54                                                                                        | Nil                                                                                       | Nil                                                                                       | 13836                                                                                     | 1081 Cancelled, 190 Suspended                                                             |
| 9                                                                                         | Himachal Pradesh*                                                                         | 1228                                                                                      | 42                                                                                        | nil                                                                                       | 1(case of year 2016)                                                                                 | nil                                                                                       | nil                                                                                       | nil                                                                                       | nil                                                                                       | nil                                                                                       |
| 10                                                                                        | Jharkhand                                                                                 | 109                                                                                       | 9                                                                                         | 1                                                                                         | Inprocess                                                                                            | Not reporte d                                                                             | 2                                                                                         | 30,596/ -                                                                                 | 148                                                                                       | Suspension - 59 FIR/Prosecution - 48 Cancellation - 4                                     |
| 11                                                                                        | Jammu & Kashmir                                                                           | 2526                                                                                      | 80                                                                                        | 4                                                                                         | 3 (3 prosecutions launched, 1 for current year, 1 for previous year, 1 for Stemil0MD under 17 B)     | Nil                                                                                       | Nil                                                                                       | Spurious Drugs Seizure = 25,527/= (Total Seizure made under D&C Act 1940 = 17,87,113/ - ) | 15887 (Total No. of Inspectio ns conduuct ed )                                            | Suspensions=327                                                                           |
| 12                                                                                        | Karnataka                                                                                 | 5683                                                                                      | 341                                                                                       | Nil                                                                                       | 1                                                                                                    | Nil                                                                                       | Nil                                                                                       | Nil                                                                                       | Nil                                                                                       | Nil                                                                                       |
| 13                                                                                        | Kerala                                                                                    | 8827                                                                                      | 127                                                                                       | Nil                                                                                       | Nil                                                                                                  | Nil                                                                                       | Nil                                                                                       | Nil                                                                                       | Nil                                                                                       | NA                                                                                        |
| 14                                                                                        | Madhya Pradesh                                                                            | 1836                                                                                      | 49                                                                                        | 6 (1 product permission cancelled, 5 referred to concerned d state                        | Nil                                                                                                  | Nil                                                                                       | Nil                                                                                       | Nil                                                                                       | Nil                                                                                       | Nil                                                                                       |
| 15                                                                                        | Maharashtra                                                                               | 2816                                                                                      | 194                                                                                       | 26                                                                                        | 30                                                                                                   | Nil                                                                                       | 16                                                                                        | 11007809                                                                                  | 28                                                                                        | FIR- 22                                                                                   |
| 16                                                                                        | Manipur*                                                                                  | 53                                                                                        | 2                                                                                         | Nil                                                                                       | Nil                                                                                                  | Nil                                                                                       | Nil                                                                                       | Nil                                                                                       | Nil                                                                                       | Nil                                                                                       |

|   17 | Meghalaya         | 46    | 11   | Nil   | Nil                                         | Nil   | Nil   | Nil             | Nil                                                                              | Nil                                                                              |
|------|-------------------|-------|------|-------|---------------------------------------------|-------|-------|-----------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
|   18 | Mizoram           | 440   | 6    | Nil   | Nil                                         | Nil   | Nil   | Nil             | Nil                                                                              | Nil                                                                              |
|   19 | Nagaland          | 88    | 4    | Nil   | Nil                                         | Nil   | Nil   |                 | Nil                                                                              | Nil                                                                              |
|   20 | Odisha            | 2358  | 71   | Nil   | Nil                                         | Nil   | Nil   | Nil             | 1020                                                                             | SCN issued                                                                       |
|   21 | Punjab            | 2956  | 122  | 23    | 14                                          | 2     | Nil   | 2169170         | 783                                                                              | 1 Court case launched, 2 cases manufacturer challenged the reports, Rest process |
|   22 | Rajasthan         | 2671  | 150  | 24    | 9                                           | 0     | 3     | 846875          | 9                                                                                | 03 FIR launched                                                                  |
|   23 | Sikkim            | 68    | nil  | nil   | nil                                         | nil   | nil   | nil             | nil                                                                              | nil                                                                              |
|   24 | Tamilnadu         | 10750 | 304  | 9     | 6 (no. of cases detected before 01.04.2018) | NIL   | NIL   | NIL             | 304 raids have been conducte d during the said period against the sales premises | 96 (the number cases detedcted before 01.04.2018)                                |
|   25 | Telangana*        | 2530  | 39   | Nil   | Nil                                         | Nil   | Nil   | Nil             | Nil                                                                              | NA                                                                               |
|   26 | Tripura           | 2306  | 48   | Nil   | Nil                                         | NA    | Nil   | 15000           | 2                                                                                | Under process                                                                    |
|   27 | Uttarakhand       | 203   | 25   | 10    | 3                                           | 3     | 5     | Approx. 2.25 Cr | 18                                                                               | 15                                                                               |
|   28 | Uttar Pradesh     | 7404  | 231  | 84    | 341                                         | 6     | 111   | 34645846        | 1085                                                                             | 132 FIR were lodged and 111 perrssons were arrested                              |
|   29 | West Bengal       | 348   | 12   | 1     | 3                                           | Nil   | 2     | Not Calculated  | 4                                                                                | Sub- judice                                                                      |
|   30 | Pondicherry       | NIL   | NIL  | NIL   | NIL                                         | NIL   | NIL   | NIL             | NIL                                                                              | NIL                                                                              |
|   31 | Andaman & Nicobar | 73    | NIL  | NIL   | NIL                                         | NIL   | NIL   | NIL             | 12                                                                               | NIL                                                                              |
|   32 | Chandigarh        | 117   | 1    | Nil   | Nil                                         | Nil   | Nil   | Nil             | 39                                                                               | Under process/invetigatio n                                                      |

| 33    | Delhi                | 725    | 13    | 9   | 3   | 7   | Total no. of FIR register ed = NIL   | 60 lacs (Approx.)   | 109    | 330 Firms were found contraventions variouus provisions of Drugs & Cosmetics Act, 1940 and Rules, 1945. Action against erring has been intiated/taken per Rules.   |
|-------|----------------------|--------|-------|-----|-----|-----|--------------------------------------|---------------------|--------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 34    | Dadra & Nagar Haveli | 19     | NIL   | NIL | NIL | NIL | NIL                                  | NIL                 | NIL    | NIL                                                                                                                                                                |
| 35    | Daman & Diu*         | 48     | nil   | nil | nil | nil | nil                                  | nil                 | nil    | nil                                                                                                                                                                |
| 36    | Lakshadwee p**       | Nil    | Nil   | Nil | Nil | Nil | Nil                                  | Nil                 | Nil    | Nil                                                                                                                                                                |
| TOTAL | TOTAL                | 76,101 | 2,549 | 205 | 484 | 77  | 153                                  | 80389057 (Approx.)  | 33,492 |                                                                                                                                                                    |

* Upto 31st March 2018 ** Upto 30th Sept 2017

## Annexure - II

|   S. N. | Name of Drugs/medical device/cosmetics   | Batch No./Date of Manufacture/Date of Expiry/Manufactured By                                                                                                      | Reason for failure   |
|---------|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
|       1 | Diclofenac Sodium Tablets I.P.           | B. No.: DF - R008, Mfg dt: 02/2019, Exp dt: 01/2021, Mfd by: M/s. Bengal Chemicals Pharmaceuticals Ltd., -115 C, Industrial Estate, Pologround, Indore - 452 015. | & Disintegration     |
|       2 | Albendazole Tablets IP 400MG             | B. No.: 8600219, Mfg dt: 01/2019, Exp dt: Mfd by: M/s. Karnataka Antibiotics & Pharmaceuticals Limited Plot no.14, II Phase, Peenya, Bangalore560058.             | 12/2021, Dissolution |
|       3 | Albendazole Tablets IP 400MG             | B. No.: 8600119, Mfg dt: 01/2019, Exp dt: Mfd by: M/s. Karnataka Antibiotics & Pharmaceuticals Limited Plot No.14, II Phase, Peenya, Bangalore560058.             | 12/2021, Dissolution |
|       4 | Albendazole Tablets I.P. 400 mg          | B. No.: 8491015, Mfg :dt 03/2019, Exp dt: 02/2021, Mfd by: M/s. Bengal Chemicals & Pharmaceuticlas Ltd. 164, Maniktala Main Road, Kolkata - 700054.               | Dissolution          |
|       5 | Albendazole Tablets I.P. 400 mg          | B. No.: 9622, Mfg dt: 02/2019, Exp dt: Mfd by: M/s. Orissa Drugs & Chemicals Ltd. 1, Mancheswar Industrial Estate, Bhubaneswar Odisha.                            | 01/2022, Dissolution |