Lok Sabha Question No. 1587 (UNSTARRED), answered on 2016-07-26
Subject: Spurious Drugs
Ministry: CHEMICALS AND FERTILIZERS
Asked by: KRUPAL BALAJI TUMANE

## GOVERNMENT OF INDIA MINISTRY OF CHEMICALS & FERTILIZERS DEPARTMENT OF PHARMACEUTICALS

*******

## LOK SABHA

UNSTARRED QUESTION NO. 1587

TO BE ANSWERED ON 26 th  July, 2016

## Spurious Drugs

## 1587.  SHRI KRUPAL BALAJI TUMANE:

Will the Minister of CHEMICALS AND FERTILIZERS be pleased to state:

- (a) whether  the  Government  has  any  information  regarding  overcharging  and  selling  of spurious and substandard medicines and if so, the details thereof during each of the last three years;
- (b) the number of agencies working under the Government in this regard; and
- (c) the names of agencies which conducts periodic checks and inspections and detected the said illegal activities during the said period?

## ANSWER

## MINISTER OF STATE IN THE MINISTRY OF ROAD TRANSPORT AND HIGHWAYS;  MINISTRY  OF  SHIPPING  AND  MINISTRY  OF  CHEMICALS  AND FERTILIZERS (SHRI MANSUKH L. MANDAVIYA)

(a) to (c): Under Drugs and Cosmetics Act, 1940 and Rules made thereunder, the regulatory control over the drugs imported into the country is exercised by the Central Government through the  Central  Drugs  Standard  Control  Organization  (CDSCO),  while  the  manufacture,  sale  and distribution  of  drugs  is  regulated  by  the  State  Drugs  Control  Authorities  appointed  by  the respective State/U.T. Governments.

The  NPPA  monitors  the  prices  of  both  scheduled  and  non-scheduled  formulations including  imported  scheduled  formulations.  Wherever  instances  of  manufacturers/  importers charging prices higher than the prices fixed by the Government/ NPPA are noted/ reported, these cases are examined in detail. Since inception of NPPA, there are 1435 cases as on 31.05.2016

where  demand  notices  have  been  issued  by  NPPA  to  pharmaceutical  companies.  Action  for recovery  of  the  overcharged  amount  along  with  interest  thereon  is  a  continuous  process  and NPPA  takes  action  as  per  the  provisions  of  DPCO'1995/  DPCO'2013  read  with  Essential Commodities Act 1955.

Isolated cases of Not of Standard Quality drugs/Spurious drugs have been reported in the country.  A  statement  on  the  number  of  cases  of  Not  of  Standard  Quality  /  Spurious  drugs reported, during last three years 2013-14, 2014-15 and 2015-16 as received from all State Drug Control Authorities and Union Territories, are enclosed herewith as Annexure-I.

| 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.N o.                                                                                    | States                                                                                    | No. of drugs sampl es tested                                                              | No. of drugs sampl es declar ed not of standa rd qualit y                                 | No. of drugs samples declared spurious / adultera ted                                     | No. of prosecutio n launched for manufactu ring, sale and distributio n of spurious/ adulterated drugs | No. of cases (as mention ed in the earlier column) decided                                | No. of perso ns arres ted                                                                 | Approx. value of drug seized                                                              | No. of Raids Conduc ted | Action taken w.r.t no. of raids conducted                                          |
| 1                                                                                         | Andhra Pradesh                                                                            | 2711                                                                                      | 113                                                                                       | 90                                                                                        | Nil                                                                                                    | Nil                                                                                       | Nil                                                                                       | 1614601                                                                                   | -                       | -                                                                                  |
| 2                                                                                         | Arunachal Pradesh                                                                         | 231                                                                                       | 17                                                                                        | 2 (1 Surious + 1 misbrand ed)                                                             | Nil                                                                                                    | Nil                                                                                       | Nil                                                                                       | Nil                                                                                       | Nil                     | Nil                                                                                |
| 3                                                                                         | Assam                                                                                     | 795                                                                                       | 21                                                                                        | Nil                                                                                       | Nil                                                                                                    | Nil                                                                                       | Nil                                                                                       | Nil                                                                                       | Nil                     | Nil                                                                                |
| 4                                                                                         | Bihar***                                                                                  | 354                                                                                       | 3                                                                                         | Nil                                                                                       | Nil                                                                                                    | Nil                                                                                       | 3                                                                                         | Nil                                                                                       | 33                      | FIR-03 Suspend-01 Cancaled-11 Prosecution-15                                       |
| 5                                                                                         | Goa                                                                                       | 521                                                                                       | 8                                                                                         | Nil                                                                                       | Nil                                                                                                    | Nil                                                                                       | Nil                                                                                       | Nil                                                                                       | Nil                     | Nil                                                                                |
| 6                                                                                         | Gujarat                                                                                   | 13425                                                                                     | 448                                                                                       | 8                                                                                         | 42                                                                                                     | 0                                                                                         | 0                                                                                         | 0                                                                                         | 18                      | Under Investigation                                                                |
| 7                                                                                         | Haryana                                                                                   | 2262                                                                                      | 38                                                                                        | 3                                                                                         | 3                                                                                                      | Nil                                                                                       | 1                                                                                         | Nil                                                                                       | 65                      | Licenses suspended/cancelled/p rosecution launched, under Drugs and Cosmetics Act. |
| 8                                                                                         | Himachal Pradesh                                                                          | 936                                                                                       | 24                                                                                        | Nil                                                                                       | 1                                                                                                      | Nil                                                                                       | Nil                                                                                       | Mostly Govt. Supply                                                                       | 1                       | a) Under Investigation b) FIR filed                                                |
| 9                                                                                         | Jammu& Kashmir                                                                            | 2565                                                                                      | 54                                                                                        | 1                                                                                         | 1                                                                                                      | Nil                                                                                       | Nil                                                                                       | 2,704,443                                                                                 | Nil                     | Nil                                                                                |
| 10                                                                                        | Karnataka                                                                                 | 8086                                                                                      | 563                                                                                       | Nil                                                                                       | 1                                                                                                      | 02 Cases filed earlier decided during this period                                         | Nil                                                                                       | Value of NSQ drug seized Rs. 33,66,850                                                    | Nil                     | Nil                                                                                |
| 11                                                                                        | Kerala                                                                                    | 5220                                                                                      | 152                                                                                       | Nil                                                                                       | Nil                                                                                                    | Nil                                                                                       | Nil                                                                                       | Nil                                                                                       | Nil                     | Nil                                                                                |
| 12                                                                                        | Madhya Pradesh                                                                            | 1622                                                                                      | 24                                                                                        | Nil                                                                                       | Nil                                                                                                    | Nil                                                                                       | Nil                                                                                       | Nil                                                                                       | Nil                     | Nil                                                                                |
| 13                                                                                        | Maharashtra                                                                               | 3778                                                                                      | 351                                                                                       | 31                                                                                        | (31) In all cases, prosecution orders are                                                              | 8                                                                                         | 1                                                                                         | Rs.1,01,58, 938/-                                                                         | 14                      | -                                                                                  |
| 14                                                                                        | Manipur                                                                                   | Nil                                                                                       | Nil                                                                                       | Nil                                                                                       | Nil                                                                                                    | Nil                                                                                       | Nil                                                                                       | Nil                                                                                       | Nil                     | Nil                                                                                |
| 15                                                                                        | Meghalaya                                                                                 | 131                                                                                       | 16                                                                                        | Nil                                                                                       | Nil                                                                                                    | Nil                                                                                       | Nil                                                                                       | Nil                                                                                       | Nil                     | Nil                                                                                |

|   16 | Mizoram             | 98   | 7 (1 Sampl e is Misbra nded)   | Nil   | Nil                                     | Nil         | Nil   | Rs. 15 Lacs.            | Nil                                                                              | Nil                                                                                                                                                                                                                                                                          |
|------|---------------------|------|--------------------------------|-------|-----------------------------------------|-------------|-------|-------------------------|----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|   17 | Nagaland            | 25   | 1                              | Nil   | Nil                                     | Nil         | Nil   | Nil                     | Nil                                                                              | Nil                                                                                                                                                                                                                                                                          |
|   18 | Orissa*             | 3678 | 93                             | 1     | 26                                      | Nil         | 1     | 641583/- Spurious drugs | 845                                                                              | 52 Seizure                                                                                                                                                                                                                                                                   |
|   19 | Punjab              | 2791 | 165                            | 37    | 3 Action under process in rest of cases | Under trial | 2     | 2,51,06,982 /-          | 416                                                                              | 3 court cases have been launched, 18 FIR have been lodged, Rest of the cases are under investigation                                                                                                                                                                         |
|   20 | Rajasthan           | 3297 | 208                            | 3     | 26                                      | -           | -     | 2026.50                 | -                                                                                | -                                                                                                                                                                                                                                                                            |
|   21 | Sikkim              | 105  | Nil                            | Nil   | Nil                                     | Nil         | Nil   | Nil                     | Nil                                                                              | Nil                                                                                                                                                                                                                                                                          |
|   22 | Tamilnadu           | 9842 | 478                            | 4     | 3                                       | Nil         | Nil   | Nil                     | 555 raids have been conducte d during the said period against the sales premises | 460 Sanction orders have been issued for launching prosectuions before the concerned court (Cases detected before 01.04.2015)                                                                                                                                                |
|   23 | Tripura             | 627  | 16                             | Nil   | Nil                                     | Nil         | Nil   | Nil                     | Nil                                                                              | Nil                                                                                                                                                                                                                                                                          |
|   24 | Uttar Pradesh       | 7326 | 782                            | 45    | 119                                     | Nil         | 48    | Rs 85,32,071/-          | 1316                                                                             | FIR-56, persons arrested-48, Total seizure- Rs.85,32,071/-                                                                                                                                                                                                                   |
|   25 | West Bengal         | 722  | 24                             | 1     | Nil                                     | Nil         | Nil   | Nil                     | Nil                                                                              | Nil                                                                                                                                                                                                                                                                          |
|   26 | Pondicherry         | 84   | Nil                            | Nil   | Nil                                     | Nil         | Nil   | Nil                     | Nil                                                                              | Nil                                                                                                                                                                                                                                                                          |
|   27 | Andaman & Nicobar   | Nil  | Nil                            | Nil   | Nil                                     | Nil         | Nil   | Nil                     | Nil                                                                              | Nil                                                                                                                                                                                                                                                                          |
|   28 | Chandigarh          | 151  | 5                              | Nil   | Nil                                     | Nil         | Nil   | Rs. 22,976/-            | 4                                                                                | Two Prosecution launched against the firm in the Hon'ble Court &remaining three under investigation                                                                                                                                                                          |
|   29 | Delhi               | 40   | 9                              | 5     | 5                                       | Nil         | 3     | 10 Lakhs                | 18 **                                                                            | 59 firms were found contravening various provision ofD&C Rules, 1945. Action against erring firms has been inititated as per rules. In 2 cases sub-standard/spurious drugs worth approximately 59 lakhs were seized by delhi police and in one case drug (Oxytocin) worth 10 |
|   30 | Dadra& Nagar Haveli | Nil  | Nil                            | Nil   | Nil                                     | Nil         | Nil   | Nil                     | Nil                                                                              | laksh were seized. Nil                                                                                                                                                                                                                                                       |

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| 31                                                 | Daman& Diu                                         | Daman& Diu                                         | 7                                                  | Nil                                                | Nil                                                | NA                                                 | Nil                                                | Nil                                                | Nil                                                | Nil                                                | Nil   | NA                                                                                                                               |
|----------------------------------------------------|----------------------------------------------------|----------------------------------------------------|----------------------------------------------------|----------------------------------------------------|----------------------------------------------------|----------------------------------------------------|----------------------------------------------------|----------------------------------------------------|----------------------------------------------------|----------------------------------------------------|-------|----------------------------------------------------------------------------------------------------------------------------------|
| 32                                                 | Lakshadwee p                                       | Lakshadwee p                                       | Nil                                                | Nil                                                | Nil                                                | Nil                                                | Nil                                                | Nil                                                | Nil                                                | Nil                                                | Nil   | Nil                                                                                                                              |
| 33                                                 | Chattisgarh                                        | Chattisgarh                                        | 33                                                 | 12                                                 | Nil                                                | Nil                                                | Nil                                                | Nil                                                | 2,000                                              | 2,000                                              | 2     | Case is under investigation                                                                                                      |
| 34                                                 | Jharkhand                                          | Jharkhand                                          | 573                                                | 29                                                 | Nil                                                | 26                                                 | Nil                                                | -                                                  | -                                                  | -                                                  | 52    | 18 FIR                                                                                                                           |
| 35                                                 | Uttarakhand                                        | Uttarakhand                                        | 88                                                 | 17                                                 | -                                                  | -                                                  | -                                                  | -                                                  | -                                                  | -                                                  | -     | -                                                                                                                                |
| 36                                                 | Telangana                                          | Telangana                                          | 2462                                               | 25                                                 | 3                                                  | 2                                                  | -                                                  | -                                                  | 661000/-                                           | 661000/-                                           | 309   | 3- NSQ 2-Under Investigation 20 Seized under investigation 7 Prosecution Launched and others are under departmental Action taken |
| Total                                              | Total                                              | 74,58 6                                            | 3703                                               | 234                                                | 289                                                | 2                                                  | 59                                                 | 55313470.5 +                                       | 55313470.5 +                                       | 3648                                               | -     |                                                                                                                                  |
| (*) = Data as on April 2015 to Feb 2016            | (*) = Data as on April 2015 to Feb 2016            | (*) = Data as on April 2015 to Feb 2016            | (*) = Data as on April 2015 to Feb 2016            | (*) = Data as on April 2015 to Feb 2016            | (*) = Data as on April 2015 to Feb 2016            | (*) = Data as on April 2015 to Feb 2016            | (*) = Data as on April 2015 to Feb 2016            | (*) = Data as on April 2015 to Feb 2016            | (*) = Data as on April 2015 to Feb 2016            | (*) = Data as on April 2015 to Feb 2016            |       |                                                                                                                                  |
| (**)= Includes 02 raids with Delhi Police officers | (**)= Includes 02 raids with Delhi Police officers | (**)= Includes 02 raids with Delhi Police officers | (**)= Includes 02 raids with Delhi Police officers | (**)= Includes 02 raids with Delhi Police officers | (**)= Includes 02 raids with Delhi Police officers | (**)= Includes 02 raids with Delhi Police officers | (**)= Includes 02 raids with Delhi Police officers | (**)= Includes 02 raids with Delhi Police officers | (**)= Includes 02 raids with Delhi Police officers | (**)= Includes 02 raids with Delhi Police officers |       |                                                                                                                                  |
| (***)= data as on 1st April 2015-30th Sept. 2015)  | (***)= data as on 1st April 2015-30th Sept. 2015)  | (***)= data as on 1st April 2015-30th Sept. 2015)  | (***)= data as on 1st April 2015-30th Sept. 2015)  | (***)= data as on 1st April 2015-30th Sept. 2015)  | (***)= data as on 1st April 2015-30th Sept. 2015)  | (***)= data as on 1st April 2015-30th Sept. 2015)  | (***)= data as on 1st April 2015-30th Sept. 2015)  | (***)= data as on 1st April 2015-30th Sept. 2015)  | (***)= data as on 1st April 2015-30th Sept. 2015)  | (***)= data as on 1st April 2015-30th Sept. 2015)  |       |                                                                                                                                  |