Lok Sabha Question No. 4231 (UNSTARRED), answered on 2017-03-28
Subject: Quality of Drugs
Ministry: CHEMICALS AND FERTILIZERS
Asked by: BALASUBRAMANIAM SENGUTTUVAN

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

## LOK SABHA

## UNSTARRED QUESTION No. 4231

## TO BE ANSWERED ON THE 28 th  March, 2017

## Quality of Drugs

4231. SHRI B. SENGUTTUVAN:

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

- (a) whether the Government is aware of the observation made by the US Department of Food and Drugs Administration in the annual conference of the drugs manufacturers' forum to the effect that the drugs sold in India lacks quality and efficacy;
- (b) if so, the details thereof and the reaction of the Government thereto;
- (c)  whether  any  drug  or  drugs  manufactured  by  any  Indian  pharmaceutical  company was found to fall short of the desired norms when tested for quality and if so, the details thereof; and
- (d) the details of the proactive steps likely to be taken by the Government to ensure that the drugs sold in India are up to the international quality and efficacy?

## 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 (d): Report has appeared in the press that Director, United States Food and Drug Administration (USFDA) India office, had raised concerns about the quality and efficacy of medicines being sold in India.

As per information received from States/U.Ts Drug Controllers, during last three years, the extent of Not of Standard quality/ spurious/ adulterated drugs reported in the country is as under;

|   S. no | Year    | No. of drugs samples tested   |   No. of samples declared not of standard quality |   % of drugs samples declared not of standard quality |   No. of samples declared spurious / adulterated |   % of drugs samples declared spurious/ adulterated |
|---------|---------|-------------------------------|---------------------------------------------------|-------------------------------------------------------|--------------------------------------------------|-----------------------------------------------------|
|       1 | 2013-14 | 72717                         |                                              3028 |                                                  4.16 |                                              118 |                                                0.16 |
|       2 | 2014-15 | 74199                         |                                              3702 |                                                  4.98 |                                               83 |                                                0.11 |
|       3 | 2015-16 | 74,586                        |                                              3703 |                                                  4.96 |                                              234 |                                                0.31 |

..2/-

Further, the extent of  'Not of Standard Quality' (NSQ) and spurious drugs in the recently (2014-16) held country wide survey was observed to be 3.16 % and 0.0245 % of the 47012 drug samples tested during the said survey. Drugs manufactured in the country are regulated under the provisions of Drugs & Cosmetics Act, 1940 and Rules, 1945 made thereunder through a system of inspection & licensing. All Licensees are required to comply with the quality standards as prescribed under Second Schedule of Drugs & Cosmetics Act, 1940. However,the Government of India has taken the following steps to strengthen regulatory mechanism for Manufacturing, sale and distribution of drugs in the country.

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 474 in 2017.

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