Lok Sabha Question No. 33 (UNSTARRED), answered on 2018-02-02
Subject: Spurious Medicines
Ministry: HEALTH AND FAMILY WELFARE
Asked by: HARISH DWIVEDI

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

LOK SABHA UNSTARRED QUESTION NO. 33 TO BE ANSWERED ON   2 ND FEBRUARY,  2018

## SPURIOUS MEDICINES

## 33. SHRI HARISH CHANDRA ALIAS HARISH DWIVEDI:

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

- (a) whether any complaints regarding issue of spurious medicines from Government hospit have come to the notice of the Government;
- (b) if so, the details thereof;
- (c) whether any M onitoring Committee has been constituted at the Central level to examine complaints regarding the medicines;
- (d) if so, the details thereof; and
- (e) the action taken against erring manufacturers?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE

(SHRI ASHWINI KUMAR CHOUBEY)

- (a) & (b):Since Heath is a state subject, it is the responsibility of State Governments t the complaints in regard to spurious medicines.

As far as three Central Government Hospitals located in Delhi viz. Safdarjung Hospi Dr. RML Hospital and Lady Hardinge Medical College (LHMC) & Associated Hospitals are concerned, no such complaints reported to have been received in the recent past.

Furthe r, no such complaints from Government hospitals have been received by Centra Drugs Standard Control Organization (CDSCO) in the recent past.

Contd……..

(c) & (d): CDSCO has not constituted any such Monitoring Committee in this regard.

(e): Isolated complaints on suspected quality of medicines, as and when received, actio initiated, based on merit, as per provisions of Drugs & Cosmetics Act, 1940 and Rules, 194

Manufacturing,  sale  and  distribution  of  Drugs  in  the  country  are  re gulated  under  the provisions  of  Drugs  &  Cosmetics  Act,  1940  and  Drugs  &  Cosmetics  Rules,  1945  made thereunder through a system of licensing and inspection. License for manufacturing, sa distribution of Drugs are granted by State Licensing Authorities appointed by respective State Governments.  Licensees  are  required  to  comply  with  all  the  condition  of  license  and  f Good Manufacturing Practices (GMP) to ensure that the drugs manufactured by them are sa and of standard quality.

The State Licens ing Authorities are empowered to take action against any violation of conditions of licenses.

As per information received from States/U.Ts Drug Controllers, number of drug sample tested, number of drug samples reported spurious/ adulterated and sub- standard drugs, value of drugs seized and action taken against the offenders during each of the last three years is as A nnexure .

Annexure

| Number of samples tested and enforcement actions taken by State Drugs Controller 1st April, 2 016 to 31th March, 2017   | Number of samples tested and enforcement actions taken by State Drugs Controller 1st April, 2 016 to 31th March, 2017   | Number of samples tested and enforcement actions taken by State Drugs Controller 1st April, 2 016 to 31th March, 2017   | Number of samples tested and enforcement actions taken by State Drugs Controller 1st April, 2 016 to 31th March, 2017   | Number of samples tested and enforcement actions taken by State Drugs Controller 1st April, 2 016 to 31th March, 2017   | Number of samples tested and enforcement actions taken by State Drugs Controller 1st April, 2 016 to 31th March, 2017   | Number of samples tested and enforcement actions taken by State Drugs Controller 1st April, 2 016 to 31th March, 2017   | Number of samples tested and enforcement actions taken by State Drugs Controller 1st April, 2 016 to 31th March, 2017   | Number of samples tested and enforcement actions taken by State Drugs Controller 1st April, 2 016 to 31th March, 2017   | Number of samples tested and enforcement actions taken by State Drugs Controller 1st April, 2 016 to 31th March, 2017   | Number of samples tested and enforcement actions taken by State Drugs Controller 1st April, 2 016 to 31th March, 2017   |
|-------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| S.No.                                                                                                                   | States                                                                                                                  | 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                              | of No. of cases (as mentioned in the earlier column) decided                                                            | 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                                                                                                                     | drugs 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 4 cases prosecution are filed in the Court.                            | 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 |
| 30   | Dadra & Nagar Haveli | 4      | Nil      | Nil  | Nil | Nil | Nil  | Nil           | Nil    | as per Rules. 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                                                                                                                                                          |
| 34   | Jharkhand            | 148    | 13       | Nil  | 6   | Nil | 13   | 2807000       | 66     | Suspension - 34 Procecution - 35 Cancellation - 05 28                                                                                                                  |
| 35   | Uttarakhand          | 217    | 22       | Nil  | Nil | Nil | Nil  | Nil           | 5      | FIR - Nil                                                                                                                                                              |
| 36   | Telangana            | 2619   |          | Nil  | Nil | Nil | Nil  | Nil           | Nil    | Nil                                                                                                                                                                    |
|      | Total                | 76,721 | 39 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