Lok Sabha Question No. 2331 (UNSTARRED), answered on 2021-08-03
Subject: Spurious Drugs
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Ranjanben Dhananjay Bhatt

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

LOK SABHA UNSTARRED QUESTION No. 2331 TO BE ANSWERED ON THE 3 rd  AUGUST, 2021

## Spurious Drugs

## †2331. SHRIMATI RANJANBEN DHANANJAY BHATT:

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

- (a) whether there is excess of spurious drugs in different parts of the country;
- (b) if so, whether the Government will consider taking concrete and effective steps to check it;
- (c) if so, the details thereof along with the time by which the said steps are likely to be taken; and
- (d) if not, the reasons therefor?

## ANSWER

## MINISTER IN THE MINISTRY OF CHEMICALS & FERTILIZERS (SHRI MANSUKH MANDAVIYA)

(a) to (d):    As per Central Drugs Standard Control Organisation (CDSCO), isolated complaints regarding spurious drugs are received in CDSCO. As and when such complaints are received, based on merit, the matter is taken up by the CDSCO in coordination with State/UT Drugs Controller for action as per the provisions of the Drugs & Cosmetics Act, 1940 and the Drugs &  Cosmetics  Rules,  1945.  The  information  received  from  Drugs  Controllers  of  various States/UTs during last three years and current year in this context is as under:

| Financial Year   |   No. of drug samples tested |   No. of drug samples declared spurious/ adulterated |   Percentage of drug samples declared spurious/ adulterated |
|------------------|------------------------------|------------------------------------------------------|-------------------------------------------------------------|
| 2017-18          |                        82599 |                                                  236 |                                                        0.28 |
| 2018-19          |                        79604 |                                                  205 |                                                        0.27 |
| 2019-20          |                        81329 |                                                  199 |                                                        0.24 |
| 2020-21 *        |                        69272 |                                                  139 |                                                        0.2  |

Corresponding information received from various Zonal/Sub-zonal offices of CDSCO is as under:

| Financial Year   |   No. of drug samples tested |   No. of drug samples declared spurious/ adulterated |   Percentage of drug samples declared spurious/ adulterated |
|------------------|------------------------------|------------------------------------------------------|-------------------------------------------------------------|
| 2017-18          |                         7088 |                                                    2 |                                                       0.028 |
| 2018-19          |                        10382 |                                                    5 |                                                       0.048 |
| 2019-20          |                         9299 |                                                   12 |                                                       0.12  |
| 2020-21 *        |                         4237 |                                                    1 |                                                       0.02  |

Further,  amidst  reports  received  of  fake  &  spurious  Covid-19  management  drugs, CDSCO has requested all States/UTs Drugs Controllers through several advisories to instruct their enforcement staff to keep strict vigil especially at sensitive places and to take stringent action against the offenders by conducting special drive of monitoring and investigation.

As per information available from various State Licensing Authorities, in cases of fake & spurious Covid management drugs, various enforcement actions like Drug seizure, Arrests of accused persons / registration of FIR etc. have been carried out by the States/UTs Drugs Controllers. CDSCO and Ministry of Health and Family Welfare have taken various regulatory measures to ensure the quality of medicines distributed in the country which are as under:

- (i) The Drugs and Cosmetics Act, 1940 was amended under the 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.
- (ii) 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, 33 States have already set up designated special Courts.
- (iii) 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.
- (iv) The number  of sanctioned posts in the Central Drugs Standard Control Organization (CDSCO) has been increased from 111 in 2008 to 492 (in Jan, 2021).
- (v) The testing capacities of Central Drugs Testing Laboratories under the CDSCO are being constantly strengthened to expedite testing of drug samples in the country.
- (vi) 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 license of oral dosage form of drugs falling under the Category II and Category IV of the Biopharmaceutical Classification System.
- (vii) 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.

Joint  inspection  of  the  licensed  manufacturing  premises  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 is also provided for.

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.