Lok Sabha Question No. 4595 (UNSTARRED), answered on 2016-08-12
Subject: Quality Test
Ministry: HEALTH AND FAMILY WELFARE
Asked by: NAGARAJAN P.

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

LOK SABHA UNSTARRED  QUESTION NO. 4595 TO BE ANSWERED ON 12 TH AUGUST, 2016

## QUALITY TEST

## 4595. SHRI P. NAGARAJAN:

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

- (a)  whether  the  medicines  made  by several  Indian  pharmaceutical  companies hav   failed  to qualify quality tests conducted recently by the Drugs Controller General of India (DCGI) and if so, the details thereof;
- (b) the total n umber of drug manufacturing companies failed to qualify quality test and identified by DCGI, company-wise; and
- (c) the action taken/proposed to be taken by the Government against these companies?

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

(SHRI FAGGAN SINGH KULASTE)

(a)to (c): The Drugs & Cosmetics Act, 1940 and Rules made thereunder are administered both by the Central Government through Central Drugs Standard Control Org anisation (CDSCO) and  State/UT  Governments  through  respective  Drug  Controllers.  As  per  data  available  w CDSCO,  the  percentage  of  'Not  of  Standard  Quality'  and  spurious/adulterated  drugs  are  as below:

| Year     | Samples picked by CDSCO   | Samples picked by CDSCO   | Samples picked by State Regulators   | Samples picked by State Regulators   |
|----------|---------------------------|---------------------------|--------------------------------------|--------------------------------------|
|          | Not of Standard Quality   | Spurious/ adulterated     | Not of Standard Quality              | Spurious/adulterated                 |
| 2011- 12 | 3.33                      | 0.03                      | 4.54                                 | 0.27                                 |
| 2012- 13 | 2.80                      | Nil                       | 4.03                                 | 0.11                                 |
| 2013- 14 | 2.82                      | 0.09                      | 4.16                                 | 0.16                                 |
| 2014- 15 | 3.35                      | Nil                       | 4.98                                 | 0.11                                 |
| 2015- 16 | 3.96                      | 0.17                      | 4.96                                 | 0.31                                 |

The percentage of 'Not of Standard Quality' drugs in the country are broadly comparable to percentage of NSQs in other countries. The Government has taken a series of steps to im the quality of drugs in the recent past. These include:

- Risk  based  inspect ion  of  manufacturing  facilities  after  training  of  officials  from regulatory structures and laboratories both from the Centre and the States together;
- Conducting workshops and training programmes for skill enhancement in areas such a Good  ManufacturingPractices  (GMP),  Good  Laboratory  Practices  (GLP),  Good Distribution  Practices  (GDP),  Good  Clinical  Practice  (GCP)  and  Good  Storage  an Distribution  Practices  (GSP)  to  regulators  and  industry  in  partnership  with Departments,  industry  and  regulators  o f  other  countries  including  USA  and  European Union;
- Conduct  of  training  programmes  for  laboratory  personnel  of  the  State  and  Cent laboratories to upgrade their analytical capabilities and skill sets;
- Undertaking a large scale nation - wide survey to deter mine the 'not of standard quality' drugs;
- Issuance  of  guidelines  to  the  State  Drugs  Controllers  for  taking  action  on  samp drugs declared spurious, adulterated, misbranded or not of standard quality;