Lok Sabha Question No. 3258 (UNSTARRED), answered on 2018-08-07
Subject: Quality of Generic Medicines
Ministry: CHEMICALS AND FERTILIZERS
Asked by: NALIN KUMAR KATEEL

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

LOK SABHA UNSTARRED QUESTION No. 3258 TO BE ANSWERED ON THE 7 th  August, 2018

## Quality of Generic Medicines

## 3258. SHRI NALIN KUMAR KATEEL:

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

- (a) whether it is a fact that Generic medicines are very helpful for all, particularly the poor and disadvantaged, as it reduce out of pocket expenses in healthcare and if so, the details thereof;
- (b) whether the Government has taken steps to ensure the quality of medicines made under the Generic names and its availability at affordable prices to common people;
- (c) if so, the details thereof;
- (d)  whether  the  Government  proposes  to  introduce  a  strong  regulatory  structure  to  both certify and monitor drug testing and enforce the compliance with GMP (Good Manufacturing Practice) and if so, the details thereof;
- (e) whether the Government is aware that there is also a need to bring a legal framework to ensure quality in generic drug testing;
- (f) if so, whether the Government is taking any measures in this regard; and
- (g) if so, the details thereof?

## 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. Generally generic medicines are less expensive.  Medicines, surgicals and consumables under Pradhan Mantri Bhartiya Janaushadhi  Pariyojana  (PMBJP) are providing 50-90% savings to all. The details are as under:
- (b) & (c): In order to make quality generic medicines  available at affordable prices to all through specific outlets, 'Pradhan Mantri Bhartiya Janaushadhi Pariyojana' (PMBJP) was launched  by  Department  of  Pharmaceuticals,  Ministry  of  Chemicals  and  Fertilizers, Government  of  India  in  the  year  2008.  As  on  31.07.2018,  3894  PMBJP  Kendras  are functional  in  34  States/UTs  of  the  country.  Government  endeavors  to  cover  all  States, UTs, Districts,  Tehsils,  Blocks  and  Gram  Panchayats  of  the  country.  In  order  to  ensure good  quality  of  medicines  under  PMBJP,  medicines,  surgicals  and  consumables  are procured  from  more  than  150  private  drug  manufacturers  (WHO-GMP  Compliant)  and surgical  suppliers,  quite  a  few  of  which  are  procured  from  Central  Pharma  PSUs.  Apart from  procurement,  each  batch  of  drugs  is  tested  at  laboratories  accredited  by  'National Accreditation Board for Testing and Calibration Laboratories' (NABL). Only after passing the quality tests, the medicines are dispatched to PMBJP Kendras.

| No. of products   | Savings       |
|-------------------|---------------|
| 36 Products       | 90-99%savings |
| 130 Products      | 80-90%savings |
| 73 Products       | 70-80%savings |
| 80 Products       | 60-70%savings |
| 383 Products      | 50-60%savings |

Further, 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.  Central  Drugs  Standard  Control Organization  (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 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  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.

(d) to (g): 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. As per the Drugs & Cosmetics Act, 1940, Drugs Inspectors are authorized to  take  samples  of  any  drug  for  test/analysis.  Accordingly,  States  and  Central  Drugs Inspectors draw the sample from market/supply chains and get it tested in the Government Drugs  Testing  Laboratories.  If  the  samples  declared  Not  of  Standard  Quality/  Spurious drugs,  action  are  initiated  as  per  the  provisions  of  said  Act  and  Rules.  Licensees  are required  to  comply  with  all  the  condition  of  license  and  follow  the  Good  Manufacturing Practices (GMP) as prescribed under said Rules to ensure that the drugs manufactured by them are safe and of standard quality.