Lok Sabha Question No. 1168 (UNSTARRED), answered on 2018-12-18
Subject: Survey on Substandard Drugs
Ministry: CHEMICALS AND FERTILIZERS
Asked by: MOHANBHAI KALYANJIBHAI KUNDARIYA

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

LOK SABHA UNSTARRED QUESTION No. 1168 TO BE ANSWERED ON THE 18 th  December, 2018

## Survey on Substandard Drugs

1168. SHRI KUNDARIYA MOHAN BHAI KALYANJI BHAI:

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

- (a) whether a recent survey has indicated a fall in substandard drugs being sold in the country;
- (b) if so, the details thereof indicating the major findings of the survey, Statewise;
- (c) whether the Government has taken steps to strengthen the monitoring mechanism to check substandard/fake drugs; and
- (d) if so, the details and the outcome 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)  &  (b):  In  the  year  2014-16  National  Institute  of  Biologicals,  Noida  (NIB)  with  the concurrence  of  Ministry  of  Health  conducted  a  National  Drug  Survey  to  assess  the extent of Not of Standard Quality (NSQ)/Spurious drugs in the country.

As  per  the  report  of  the  said  survey,  details  of  no.  of  samples  tested,  No.  of  drugs samples declared not of standard quality/spurious/adulterated and percent thereof, 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 |
|----------|-------------------------------|---------------------------------------------------------|-------------------------------------------------------|-------------------------------------------------------|-----------------------------------------------------|
| 2014- 16 |                         47012 |                                                    1850 |                                                  3.16 |                                                    13 |                                              0.0245 |

Whereas, as per the information received from various State/U.Ts Drugs Controllers No. of drugs samples tested, No. of drugs samples declared sub-standard quality, spurious/ adulterated drugs and percentage thereof during last three years 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 |                         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 |

Report of Drugs Survey & its findings are available on the website of NIB (www.http://nib.gov.in)  &  MoH&FW  (www.mohfw.gov.in).  Findings  of  the  Drug  Survey state-wise is attached as Annexure-A

(c) & (d): The Government of India have taken various regulatory measures to curb the menace of substandard/spurious drugs and to ensure the quality of drugs manufactured/sold 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  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  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.
7. 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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