Lok Sabha Question No. 1376 (UNSTARRED), answered on 2018-12-18
Subject: Quality of Generic Drugs
Ministry: CHEMICALS AND FERTILIZERS
Asked by: JANARDAN MISHRA, RODMAL NAGAR

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

LOK SABHA UNSTARRED QUESTION No. 1376 TO BE ANSWERED ON THE 18 th  December, 2018

## Quality of Generic Drugs

†1376.

SHRI JANARDAN MISHRA: SHRI NAGAR RODMAL:

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

- (a) whether the Government has received any complaints regarding the quality of generic drugs;
- (b)if  so,  the  number  of  complaints  received  in  Madhya  Pradesh  and  the  action  taken thereon by the Government;
- (c) the steps taken by the Government to improve the quality of drugs; and
- (d) the measures taken/being taken by the Government to further improve the quality of generic drugs?

## 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): Yes, Madam. 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 Central Drugs Standard Control Organization (CDSCO) in coordination with concerned State Licensing Authority for action as per the provisions of Drugs & Cosmetics Act, 1940 and the Drugs & Cosmetics Rules, 1945.
- (b):  As  per  information  obtained  from  Food  &  Drugs  Authority,  Madhya  Pradesh  in  this regard, no complaints have been received by them.
- (c) & (d): The Government of India has taken various measures to ensure quality of drugs including generic drugs manufactured/ marketed 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. 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.
4. The number of sanctioned posts  in  Central  Drugs  Standard  Control  Organization (CDSCO) has been increased from 111 in 2008 to 510 in 2018.
5. The  testing  capacities  of  Central  Drugs  Testing  Laboratories  under  CDSCO  are being constantly strengthened to expedite testing of drug samples in the country.
6. On 3.4.2017, in order to ensure efficacy of drugs, the Drugs and Cosmetics Rules, 1945 have been amended providing that applicant shall submit the result of bioequivalence study along with the application for grant of manufacturing licence of oral dosage form of drugs falling under the Category II and Category IV of the Biopharmaceutical Classification System.
7. On 10.04.2018, the Drugs and Cosmetics Rules, 1945 have been amended vide Gazette  notification  no.  G.S.R.  360  (E),  making  it  mandatory  for  all  drugs,  that  the applicants  shall  submit  evidence  of  stability,  safety  of  excipients  etc.  to  the  State Licensing Authority before grant of product manufacturing license by the Authority.
8. Draft Rules have been published vide GSR 999 (E), dated 05.10.2018 to amend the Schedule   M of the Drugs and Cosmetics Rules, 1945 to make  it more comprehensive at par with the WHO-GMP guidelines
9. On 27.10.2017, the Drugs and Cosmetics Rules, 1945 have been amended vide Gazette  notification  no.  G.S.R.  1337  (E)  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.

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.

10. 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.

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