Lok Sabha Question No. 3252 (UNSTARRED), answered on 2019-01-01
Subject: Quality tests of Medicines
Ministry: CHEMICALS AND FERTILIZERS
Asked by: ANTO  ANTONY

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

LOK SABHA UNSTARRED QUESTION No. 3252 TO BE ANSWERED ON THE 1 st  January, 2019

## Quality tests of Medicines

3252. SHRI ANTO ANTONY:

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

- (a) whether any mechanism exists to test the quality of medicines supplied through the hospitals run by the Government;
- (b) if so, the details thereof;
- (c)  whether  the  Government  has  taken  note  of  the  fact  that  the  medicines  supplied through the hospitals run by it are of low quality;
- (d) if so, the steps taken/being taken by the Government in this regard;
- (e) whether the Government has received any complaint on the aforesaid matter; and
- (f) if so, the details thereof and the response of the Government thereto?

## 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) & (b): There is no specific mechanism under the provisions of Drugs and Cosmetics Rules  to  test  the  quality  of  medicines  supplied  through  the  hospitals  run  by  the Government.  There  may  be  such  mechanism  under  procurement  policy  to  test  the quality of medicines supplied through the hospitals run by the Government. For all the medicines procured in Central Government Hospitals, the lab report/ quality certificate (Form-39) of all the drugs is taken to ensure the quality of medicine.

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. One of the condition 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. All drugs manufactured in the country are required to comply with the same standards prescribed under  the said Act and  Rules. The  State  Licensing Authorities are empowered to take action in case of any violation of above requirements.

- (c) & (d): A nation-wide survey (2014-16) was conducted to assess the extent of Not of Standard Quality (NSQ)/Spurious drugs. Out of a total 47012 drug samples drawn from both  Governments  and  private  sources,  the  percentage  of  'Not  of  standard  quality' drugs  was  3.16  and  that  of  spurious/adulterated  drugs  was  0.0245.  Out  of  the  total samples, the number of samples drawn from Government sources was 8369 and the percentage of 'Not of standard quality' and spurious/adulterated drugs was 10.02 and 0.0597 respectively. The test Reports of the drug samples declared as Not of Standard Quality  (NSQ)  were  forwarded  to  the  concerned  State  Licensing  Authorities  with  a request  to  take  appropriate  action  and  also  to  take  legal  samples  of  same  batch  of drugs for testing.
- (e)  &  (f):  Isolated  complaints  regarding  suspected  quality  of  medicines  have  been received. As and when such complaints are received, based on the merit, the matter is taken up by CDSCO/ in coordination with State Licensing Authority for action as per the provisions of Drugs & Cosmetics Act, 1940 and Rules, 1945.

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