Lok Sabha Question No. 2472 (UNSTARRED), answered on 2018-01-02
Subject: Medicine Quality
Ministry: CHEMICALS AND FERTILIZERS
Asked by: GEETHA KOTHAPALLI

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

LOK SABHA UNSTARRED QUESTION No. 2472

TO BE ANSWERED ON THE 2 nd  January, 2018

## Medicine Quality

## 2472. SHRIMATI KOTHAPALLI GEETHA:

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

- (a) whether it is a fact that as per a recent released report, the medicines available in the hospitals and markets for various diseases are of low quality and potency and there is  no  proper  monitoring  of  such  medicines  in  the  market  to  detect  the  duplicate medicines, if so, the details thereof and the reasons therefor;
- (b)  whether  medicines  like  oral  rehydration  salt,  stents,  medicines  for  fever,  vomiting and loose motions which are being supplied by Government and private hospitals are of low quality or duplicate medicines, if so, the details thereof and the reasons therefor;
- (c)  whether  there  is  no  proper  Regulation  and  Acts  to  detect  the  duplicate  medicines and even though such laws exist in some States, it is very weak and ineffective, if so, the details thereof and the reasons for such situation; and
- (d)  whether in  some States like Himachal Pradesh, Telangana, Uttarakhand, Gujarat, Sikkim,  Daman  and  Diu,  Haryana,  etc.,  duplicate  medicines  are  being  supplied  to patients thereby putting therein lives in danger, if so, the details thereof and the reasons therefor?

## 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): In the year 2014-16 a National Drug Survey was conducted to assess the extent of Not of Standard Quality (NSQ)/Spurious drugs in the country. Details of no. of samples tested under the survey and the findings are as under:

| Year    |   No. of drugs samples tested |   No. of samples not of quality | drugs declared standard   |   % of drugs samples declared not of standard quality |   % of drugs samples declared spurious/ adulterated |
|---------|-------------------------------|---------------------------------|---------------------------|-------------------------------------------------------|-----------------------------------------------------|
| 2014-16 |                         47012 |                            1850 |                           |                                                  3.16 |                                              0.0245 |

Moreover, in the said survey, 10.02% (total 839 out of the 8369 samples) of the drug samples drawn from Government sources were found Not of Standard Quality (NSQ). The test Reports of  the  drug samples declared as Not of Standard Quality (NSQ were forwarded to concerned State  Licensing  Authorities  with  a  request  to  take  appropriate  action  and  also  to  take  legal samples of same batch of drugs for testing.

There is no separate mechanism/ provisions under the Drugs & Cosmetics Act, 1940 and Rules, 1945 for monitoring the quality of medicines supplied to Govt. Agencies. Whether the drugs is for Govt. supply or for domestic marketing, manufacturing sale and distribution of drugs in the country are regulated under the provisions of Drugs & Cosmetics Act, 1940 and Rules, 1945 made thereunder through a system of licensing and inspection. License for manufacturing, sale and  distribution  of  Drugs  are  granted  by  State  Licensing  Authorities  appointed  by  respective State  Governments.  Licensees  are  required  to  comply  with  all  the  conditions  of  license  and follow Good Manufacturing Practices (GMP) to ensure that the drugs manufactured by them are safe and of standard quality . One of the conditions of the license is that licensee shall either in his own lab or in any other laboratory approved by the Licensing Authority test each batch of the raw  material  used  by  him  for  the  manufacture  of  products  and  also  each  batch  of  the  final product and shall maintain records showing the particulars in respect of such tests. The State Licensing  Authorities  are  empowered  to  take  action  in  case  of  any  violation  of  above requirements.

The Government of India has taken various steps to check the quality of drugs manufactured, sale and distribution in the country. Details are as under:

1. The Drugs and Cosmetics Act, 1940 was amended under Drugs & Cosmetics (Amendment) Act 2008 to provide stringent penalties for manufacture of spurious and adulterated drugs. Certain offences have also been made cognizable and non-bailable.
2. The States /  UTs  were requested to  set  up  special  Courts  for  trial  of  offences  under  the Drugs  and  Cosmetics  Act  for  speedy  disposal.  So  far,  22  States  have  already  set  up designated special Courts.
3. A Whistle Blower Scheme was announced by the Government of India to encourage vigilant public  participation  in  the  detection  of  movement  of  spurious  drugs  in  the  country.  The scheme provides for suitably rewarding the informers for providing concrete information to the regulatory authorities in respect of movement of spurious drugs. The details of policy are available at the website of CDSCO (www.cdsco.nic.in).
4. Guidelines  for  taking  action  on  samples  of  drugs  declared  spurious  or  not  of  standard quality in the light of enhanced penalties under the Drugs & Cosmetics (Amendment) Act, 2008 were forwarded to the State Drugs Controllers for uniform implementation.
5. The inspectorate staffs have been instructed to keep a vigil and draw samples of drugs for test and analysis to monitor the quality of drugs moving in the country.
6. The number of sanctioned posts in Central Drugs Standard Control Organization (CDSCO) has been increased from 111 in 2008 to 510 in 2017.
7. The  Government  has  decided  to  strengthen  both  the  Central  and  States  drug  regulatory system  during  the  12th  Five  Year  Plan  enabling  them  to  keep  more  effective  watch  on unscrupulous  elements  indulging  in  unlawful  activities  relating  to  quality  of  drugs.  The Cabinet Committee on Economic Affairs (CCEA) has approved the proposal for strengthening the drug regulatory system in the country, both under the Central and State Governments at a total expenditure  of  Rs.  1750  crores.  Out  of  this,  Rs.  850  crore  is  the Central  Government's  share.  The  share  of  the  Centre  and  the  States  in  case  of  state component will be in the ratio of 60:40 for all States except Jammu and Kashmir, Himachal Pradesh, Uttarakand, Sikkim and North-Eastern States, for which the ratio will be 90:10.
8. The Drugs and Cosmetics Rules, 1945 have been amended vide Gazette notification no. G.S.R. 1337  (E) dated 27.10.2017, making  it mandatory  that before the grant of manufacturing  license,  the  manufacturing  establishment  is  to  be  inspected  jointly  by  the Drugs  Inspectors  of  Central  Government  and  State  Government.  Further,  the  licensed manufacturing  premises  shall  be  inspected  jointly  by  the  Drugs  Inspectors  of  Central Government and State Government to verify the compliance with the conditions of license and the provisions of the Drugs & Cosmetics Act and Rules for not less than once in three years or as needed as per risk based approach.

(b):  Central Drugs Standard Control Organization (CDSCO) has not received any such report that medicines like oral rehydration salt, stents, medicines for fever, vomiting and loose motions which are being supplied by Government and private hospitals are of low quality or duplicate medicines.

(c)  &  (d):  Manufacturing  sale  and  distribution  of  drugs  in  the  country  are  regulated  under  the provisions of Drugs & Cosmetics Act, 1940 and Rules, 1945 made thereunder through a system of  licensing  and  inspection.  License  for  manufacturing,  sale  and  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 follow Good Manufacturing Practices (GMP) to ensure that the drugs manufactured by them are safe and of standard quality .

The State Licensing Authorities are empowered to take action on violation of any conditions of the  license.  As  per  information  received  from  States/U.Ts  Drugs  Controllers,  No.  of  drug samples tested,  no.  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 enclosed as Annexure.

## Annexure referred to in the answer to part (c) & (d) to the Lok Sabha Unstarred Q. No. 2472 for 02.01.2018

| Number of samples tested and enforcement actions taken by State Drugs Controller during April 2014-2015   | Number of samples tested and enforcement actions taken by State Drugs Controller during April 2014-2015   | Number of samples tested and enforcement actions taken by State Drugs Controller during April 2014-2015   | Number of samples tested and enforcement actions taken by State Drugs Controller during April 2014-2015   | Number of samples tested and enforcement actions taken by State Drugs Controller during April 2014-2015   | Number of samples tested and enforcement actions taken by State Drugs Controller during April 2014-2015   | Number of samples tested and enforcement actions taken by State Drugs Controller during April 2014-2015   | Number of samples tested and enforcement actions taken by State Drugs Controller during April 2014-2015   | Number of samples tested and enforcement actions taken by State Drugs Controller during April 2014-2015   | Number of samples tested and enforcement actions taken by State Drugs Controller during April 2014-2015   | Number of samples tested and enforcement actions taken by State Drugs Controller during April 2014-2015                                                             |
|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| S. N o.                                                                                                   | States                                                                                                    | No. of drug s samp les teste d                                                                            | No. of drugs samples declared not of standar d quality                                                    | No. of drugs sample s declare d spuriou s / adultra ted                                                   | No. of prosecution launched for manufacturi ng , sale and distribution of spurious/ adulterated drugs     | No. of cases (as mention ed in the earlier column) decided                                                | No. of person s arrest ed                                                                                 | Appro x value of drug seized                                                                              | No. of Raids condu cted                                                                                   | Action taken w.r.t. no. of raids conducted                                                                                                                          |
| 1                                                                                                         | Himachal Pradesh                                                                                          | 881                                                                                                       | 31                                                                                                        | Nil                                                                                                       | Nil                                                                                                       | NA                                                                                                        | NA                                                                                                        | NA                                                                                                        | Nil                                                                                                       | NA                                                                                                                                                                  |
| 2                                                                                                         | Telangana                                                                                                 | 3716                                                                                                      | 35                                                                                                        | Nil                                                                                                       | Nil                                                                                                       | Nil                                                                                                       | Nil                                                                                                       | 94,20, 600 (in the month of April)                                                                        | Nil                                                                                                       | Nil                                                                                                                                                                 |
| 3                                                                                                         | Uttarakha nd                                                                                              | 182                                                                                                       | 10                                                                                                        | Nil                                                                                                       | Nil                                                                                                       | Nil                                                                                                       | Nil                                                                                                       | Nil                                                                                                       | 4                                                                                                         | Manufacturing license of 06 mfg. units has been suspended for further order sure due found violation of provisions of D&C Act &Rules thereunder                     |
| 4                                                                                                         | Gujarat                                                                                                   | 1130 0                                                                                                    | 499                                                                                                       | 5                                                                                                         | 5                                                                                                         | Nil                                                                                                       | Nil                                                                                                       | Nil                                                                                                       | 5                                                                                                         | Under investigation                                                                                                                                                 |
| 5                                                                                                         | Sikkim                                                                                                    | 87                                                                                                        | 1                                                                                                         | 1                                                                                                         | Nil                                                                                                       | Nil                                                                                                       | Nil                                                                                                       | Nil                                                                                                       | Nil                                                                                                       | Nil                                                                                                                                                                 |
| 6                                                                                                         | Daman& Diu                                                                                                | 60                                                                                                        | Nil                                                                                                       | Nil                                                                                                       | Nil                                                                                                       | Nil                                                                                                       | Nil                                                                                                       | Nil                                                                                                       | Nil                                                                                                       | Nil                                                                                                                                                                 |
| 7                                                                                                         | Haryana                                                                                                   | 2150                                                                                                      | 25                                                                                                        | 2                                                                                                         | 2                                                                                                         | Nil                                                                                                       | Nil                                                                                                       | Nil                                                                                                       | 8306                                                                                                      | 101 - License Cancelled 187- License suspended 12-cpirt case launched 01- Warning issued 118- under investigation where show cause notice issued 01-FIRs Registered |

| Number of samples tested and enforcement actions taken by State Drugs Controller during April 2015-2016   | Number of samples tested and enforcement actions taken by State Drugs Controller during April 2015-2016   | Number of samples tested and enforcement actions taken by State Drugs Controller during April 2015-2016   | Number of samples tested and enforcement actions taken by State Drugs Controller during April 2015-2016   | Number of samples tested and enforcement actions taken by State Drugs Controller during April 2015-2016   | Number of samples tested and enforcement actions taken by State Drugs Controller during April 2015-2016   | Number of samples tested and enforcement actions taken by State Drugs Controller during April 2015-2016   | Number of samples tested and enforcement actions taken by State Drugs Controller during April 2015-2016   | Number of samples tested and enforcement actions taken by State Drugs Controller during April 2015-2016   | Number of samples tested and enforcement actions taken by State Drugs Controller during April 2015-2016   | Number of samples tested and enforcement actions taken by State Drugs Controller during April 2015-2016                         |
|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| S. N o.                                                                                                   | States                                                                                                    | No. of drug s samp les teste d                                                                            | No. of drugs samples declared not of standar d quality                                                    | No. of drugs sample s declare d spuriou s / adultra ted                                                   | No. of prosecution launched for manufacturi ng , sale and distribution of spurious/ adulterated drugs     | No. of cases (as mention ed in the earlier column) decided                                                | No. of person s arrest ed                                                                                 | Appro x value of drug seized                                                                              | No. of Raids condu cted                                                                                   | Action taken w.r.t. no. of raids conducted                                                                                      |
| 1                                                                                                         | Himachal Pradesh                                                                                          | 936                                                                                                       | 24                                                                                                        | Nil                                                                                                       | 1                                                                                                         | Nil                                                                                                       | Nil                                                                                                       | Mostly Govt. Supply                                                                                       | 1                                                                                                         | a) Under Investigation b) FIR Filed                                                                                             |
| 2                                                                                                         | Telangana                                                                                                 | 2462                                                                                                      | 25                                                                                                        | 3                                                                                                         | 2                                                                                                         | -                                                                                                         | -                                                                                                         | 66100 0/-                                                                                                 | 309                                                                                                       | 3-NSQ 2- Under investigation 20 Seized under investigation 7prosecution launched and others are under departmental Action taken |
| 3                                                                                                         | Uttarakha nd                                                                                              | 88                                                                                                        | 17                                                                                                        | -                                                                                                         | -                                                                                                         | -                                                                                                         | -                                                                                                         | -                                                                                                         | -                                                                                                         | -                                                                                                                               |
| 4                                                                                                         | Gujarat                                                                                                   | 1342 5                                                                                                    | 448                                                                                                       | 8                                                                                                         | 42                                                                                                        | 0                                                                                                         | 0                                                                                                         | 0                                                                                                         | 18                                                                                                        | Under investigation                                                                                                             |
| 5                                                                                                         | Sikkim                                                                                                    | 105                                                                                                       | Nil                                                                                                       | Nil                                                                                                       | Nil                                                                                                       | Nil                                                                                                       | Nil                                                                                                       | Nil                                                                                                       | Nil                                                                                                       | Nil                                                                                                                             |
| 6                                                                                                         | Daman& Diu                                                                                                | 7                                                                                                         | Nil                                                                                                       | Nil                                                                                                       | NA                                                                                                        | Nil                                                                                                       | Nil                                                                                                       | Nil                                                                                                       | Nil                                                                                                       | NA                                                                                                                              |
| 7                                                                                                         | Haryana                                                                                                   | 2262                                                                                                      | 38                                                                                                        | 3                                                                                                         | 3                                                                                                         | Nil                                                                                                       | 1                                                                                                         | Nil                                                                                                       | 65                                                                                                        | License suspended/ cancelled/prosecu tion launched, under Drugs and Cosmetics Act.                                              |

| Number of samples tested and enforcement actions taken by State Drugs Controller during April 2016-2017   | Number of samples tested and enforcement actions taken by State Drugs Controller during April 2016-2017   | Number of samples tested and enforcement actions taken by State Drugs Controller during April 2016-2017   | Number of samples tested and enforcement actions taken by State Drugs Controller during April 2016-2017   | Number of samples tested and enforcement actions taken by State Drugs Controller during April 2016-2017   | Number of samples tested and enforcement actions taken by State Drugs Controller during April 2016-2017   | Number of samples tested and enforcement actions taken by State Drugs Controller during April 2016-2017   | Number of samples tested and enforcement actions taken by State Drugs Controller during April 2016-2017   | Number of samples tested and enforcement actions taken by State Drugs Controller during April 2016-2017   | Number of samples tested and enforcement actions taken by State Drugs Controller during April 2016-2017   | Number of samples tested and enforcement actions taken by State Drugs Controller during April 2016-2017   |
|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| S. N o.                                                                                                   | States                                                                                                    | No. of drug s samp les teste d                                                                            | No. of drugs samples declared not of standar d quality                                                    | No. of drugs samples declared spurious / adultrate d                                                      | No. of prosecution launched for manufactur ing , sale and distribution of spurious/ adulterated drugs     | No. of cases (as mention ed in the earlier column) decided                                                | No. of person s arrest ed                                                                                 | Appro x value of drug seized                                                                              | No. of Raids condu cted                                                                                   | Action taken w.r.t. no. of raids conducted                                                                |
| 1                                                                                                         | Himach al Pradesh                                                                                         | 1001                                                                                                      | 36                                                                                                        | 5                                                                                                         | Nil                                                                                                       | Nil                                                                                                       | Nil                                                                                                       | Nil                                                                                                       | Nil                                                                                                       | Nil                                                                                                       |
| 2                                                                                                         | Telanga na                                                                                                | 2619                                                                                                      | 39                                                                                                        | Nil                                                                                                       | Nil                                                                                                       | Nil                                                                                                       | Nil                                                                                                       | Nil                                                                                                       | Nil                                                                                                       | Nil                                                                                                       |
| 3                                                                                                         | Uttarak hand                                                                                              | 217                                                                                                       | 22                                                                                                        | Nil                                                                                                       | Nil                                                                                                       | Nil                                                                                                       | Nil                                                                                                       | Nil                                                                                                       | 5                                                                                                         | Nil                                                                                                       |
| 4                                                                                                         | Gujarat                                                                                                   | 1107 1                                                                                                    | 535                                                                                                       | 22                                                                                                        | 2                                                                                                         | Nil                                                                                                       | Nil                                                                                                       | Nil                                                                                                       | 3                                                                                                         | Under investigation                                                                                       |
| 5                                                                                                         | Sikkim                                                                                                    | 102                                                                                                       | 3                                                                                                         | Nil                                                                                                       | Nil                                                                                                       | Nil                                                                                                       | Nil                                                                                                       | Nil                                                                                                       | Nil                                                                                                       | Nil                                                                                                       |
| 6                                                                                                         | Daman & Diu                                                                                               | Nil                                                                                                       | Nil                                                                                                       | Nil                                                                                                       | Nil                                                                                                       | Nil                                                                                                       | Nil                                                                                                       | Nil                                                                                                       | Nil                                                                                                       | Nil                                                                                                       |
| 7                                                                                                         | Haryana                                                                                                   | 1901                                                                                                      | 12                                                                                                        | 1                                                                                                         | 5                                                                                                         | 1                                                                                                         | Nil                                                                                                       | Nil                                                                                                       | 6890                                                                                                      | -                                                                                                         |

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