Lok Sabha Question No. 41 (UNSTARRED), answered on 2024-02-02
Subject: Sale of Generic Medicines
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Keshari Devi Patel

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

LOK SABHA UNSTARRED QUESTION No. 41 TO BE ANSWERED ON 2 nd  February, 2024

## Sale of Generic Medicines

## †41. SHRIMATI KESHARI DEVI PATEL:

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

- (a) whether generic medicines manufactured by some of the Pharmaceutical companies are being sold in the markets that failed during the testing;
- (b) if so, the details thereof along with the total number of the said generic medicines sold in the market;
- (c) the number and names of the Pharmaceutical companies which have manufactured the said medicines in the country; and
- (d) the steps taken/proposed to be taken by the Government in this regard?

## ANSWER

## MINISTER OF STATE IN THE MINISTRY OF CHEMICALS AND FERTILIZERS (SHRI BHAGWANTH KHUBA)

(a)  to  (c):  As  per  information  received  from  Ministry  of  Health  &  Family  Welfare  (M/o H&FW), Govt. of India, various States/UTs Drugs Controllers have forwarded data regarding number of drug samples tested, number of drug samples reported spurious/adulterated, substandard drugs and action taken against the offenders during last three years.  The details are enclosed as Annexure.

- (d):   M/o  H&FW  and  Central  Drugs  Standard  Control  Organisation  (CDSCO)  have  taken following regulatory measures to ensure the quality of medicines in the country: -
1.       On 17-11-2022, the Drugs Rules, 1945 were amended vide G.S.R. 823(E) which has come into force on 1st of August, 2023 providing that the manufacturers of top 300 brands of drug formulation products, as specified in Schedule H2, shall print or affix Bar Code or Quick Response Code on its  primary  packaging  label  or,  in  case  of  inadequate  space  in  primary package  label,  on  the  secondary  package  label  that  store  data  or  information  legible  with software application to facilitate authentication.

The stored data shall include the following particulars, namely: -

- (i) unique product identification code;
- (ii) proper and generic name of the drug;
- (iii) brand name;
- (iv) name and address of the manufacturer;
- (v) batch number;
- (vi) date of manufacturing;

(vii) date of expiry; and (viii) Manufacturing licence number.

2.       On 18.01.2022, the Drugs Rules, 1945 were amended vide G.S.R. 20 (E) providing that every Active Pharmaceutical Ingredient (bulk drug) manufactured or imported in India shall bear Quick Response Code on its label at each level of packaging that store data or information readable  with  software  application  to  facilitate  tracking  and  tracing.  The  stored  data  or information  shall  include  the  minimum  particulars  including  Unique  product  identification code, Batch No, MFG date, Exp. Date etc.
3.           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.
4.           States/  UTs  have  set  up  Special  Courts  for  trial  of  offences  under  the  Drugs  and Cosmetics Act for speedy disposal.
5.           The  number  of  sanctioned  posts  in  Central  Drugs  Standard  Control  Organization (CDSCO) has been significantly increased over the last 10 years.
6.       To ensure efficacy of drugs, the Drugs and Cosmetics Rules, 1945 have been amended providing  that  applicant  shall  submit  the  result  of  bio-equivalence  study  along  with  the application for grant of manufacturing license of oral dosage form of some drugs.
7.       The Drugs and Cosmetics Rules, 1945 have been amended 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.
8.       The Drugs and Cosmetics Rules, 1945 have been amended, making it mandatory that the applicants shall submit evidence of stability, safety of excipients etc. to the State Licensing Authority before grant of manufacturing license by the Authority. Central regulator coordinates activities of State Drug Control Organizations and provides expert advice through the Drugs Consultative Committee (DCC) meetings held with State Drugs Controllers for uniformity in administration of the Drugs and Cosmetics Act.

## Annexure

Statement referred to in reply to part (a to c) of the LOK SABHA UNSTARRED Q. NO. 41 for answer on 02.02.2024 raised by SHRIMATI KESHARI DEVI PATEL regarding Sale of Generic Medicines

| Details of No. of drug samples tested, no. of drug samples reported spurious/adulterated, sub- standard drugs and action taken against the offenders during last three years   | Details of No. of drug samples tested, no. of drug samples reported spurious/adulterated, sub- standard drugs and action taken against the offenders during last three years   | Details of No. of drug samples tested, no. of drug samples reported spurious/adulterated, sub- standard drugs and action taken against the offenders during last three years   | Details of No. of drug samples tested, no. of drug samples reported spurious/adulterated, sub- standard drugs and action taken against the offenders during last three years   |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Year                                                                                                                                                                           | Number of drugs sample tested                                                                                                                                                  | Number of drugs samples declared not of standard quality                                                                                                                       | Number of drugs samples declared spurious/ adulterated                                                                                                                         |
| 2020-21                                                                                                                                                                        | 84874                                                                                                                                                                          | 2652                                                                                                                                                                           | 263                                                                                                                                                                            |
| 2021-22                                                                                                                                                                        | 88844                                                                                                                                                                          | 2545                                                                                                                                                                           | 379                                                                                                                                                                            |
| 2022-23                                                                                                                                                                        | 96713                                                                                                                                                                          | 3053                                                                                                                                                                           | 424                                                                                                                                                                            |

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