Lok Sabha Question No. 391 (UNSTARRED), answered on 2019-02-05
Subject: Display of Generic Medicines
Ministry: CHEMICALS AND FERTILIZERS
Asked by: G. HARI

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

LOK SABHA UNSTARRED QUESTION No. 391 TO BE ANSWERED ON THE 05 th  February, 2019

## Display of Generic Medicines

391. SHRI G. HARI:

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

- (a)  whether  it  is  true  that  chemists  across  the  country  have  been  asked  to  display generic medicines in a dedicated rack in their shops;
- (b) if so, the details thereof;
- (c) whether several manufacturers of generic drugs did not meet this quality standards; and
- (d) if  so,  the  details  thereof  and the corrective steps taken by the Government in this regard?

## 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.
- (b):  On  12.06.2018,  Drugs  Controller  General  (I)  has  requested  all  the  State  Drugs Controllers to direct all the outlets licensed to sell drugs by retail under their jurisdiction to provide a separate shelf/rack reserved exclusively for stocking of generic medicines in the licensed premises separated from other medicines, which shall be visible to the consumers. Also, in order to make generic medicines more accessible, the Department of  Pharmaceuticals  on  21.02.2018  has  requested  all  the  States/Union  Territories  to explore and enforce the proposal of keeping a separate shelf/rack for generic medicines in every pharmacy in the country.
- (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. Drug manufactured in the country, irrespective of whether branded or generic, are required to comply with the same standards as prescribed in the Drugs and  Cosmetics  Act,  1940  and  Rules  made  thereunder  for  their  quality.  The  State Licensing  Authorities  are  empowered  to  take  action  against  violations  of  any  of  the above requirements.

As  per  the  information  received  from  Central  Drugs  Standard  Control  Organization (CDSCO), the details of drugs samples declared not of standard quality and   spurious/ adulterated, received from various State/U.T. Drugs Controllers for the last three years are as follows:

| Year    |   No. of drugs samples tested |   No. of drugs samples declared not of standard quality |   % of drugs samples declared not of standard quality |   No. of drugs samples declared spurious/ adulterat ed |   % of drugs samples declared spurious/ adulterated |
|---------|-------------------------------|---------------------------------------------------------|-------------------------------------------------------|--------------------------------------------------------|-----------------------------------------------------|
| 2015-16 |                         74586 |                                                    3703 |                                                  4.96 |                                                    234 |                                                0.31 |
| 2016-17 |                         76721 |                                                    2780 |                                                  3.6  |                                                    123 |                                                0.16 |
| 2017-18 |                         82599 |                                                    2783 |                                                  3.36 |                                                    236 |                                                0.28 |

Such information received from various Zonal/Sub-zonal offices of CDSCO are as under:

| Year    |   No. of drugs samples tested |   No. of drugs samples declared not of standard quality |   % of drugs samples declared not of standard quality | No. of drugs samples declared spurious/ adulterated   |   % of drugs samples declared spurious/ adulterated |
|---------|-------------------------------|---------------------------------------------------------|-------------------------------------------------------|-------------------------------------------------------|-----------------------------------------------------|
| 2015-16 |                          2897 |                                                     115 |                                                  3.96 | 5                                                     |                                               0.17  |
| 2016-17 |                          5207 |                                                     146 |                                                  2.8  | Nil                                                   |                                               0     |
| 2017-18 |                          7088 |                                                     381 |                                                  5.37 | 2                                                     |                                               0.028 |

CDSCO  and  Ministry  of  Health  and  Family  Welfare  have  taken  various  regulatory measures  to  ensure  the  quality  of  generic  medicines  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  nonbailable.
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  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.
5. The  number  of  sanctioned  posts  in  Central  Drugs  Standard  Control  Organization (CDSCO) has been increased from 111 in 2008 to 510 in 2018.
6. The testing capacities of Central Drugs Testing Laboratories under CDSCO are being constantly strengthened to expedite testing of drug samples in the country.
7. 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.
8. 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.
9. 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.
10. The Government has approved a proposal for strengthening the drug regulatory system in the country, both at the level of Central and the State Governments at a total expenditure of Rs.1750 crores.  Out of this, Rs. 900 crore is for strengthening the central drug regulatory structures and Rs.850 crore is for strengthening the drug regulatory  system  in  the  States.  During  the  years  2016-17  and  17-18,  Rs.  128.39 crore has been released under the Central component whereas Rs. 87.90 crore has been allocated during 2018-19 under this component. Under the State component, Rs. 81.36 crore has been released during 2016-17 and 17-18 whereas Rs. 206 crore has been allocated during 2018-19 under this component.

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