Lok Sabha Question No. 2246 (UNSTARRED), answered on 2025-12-12
Subject: Quality Concerns of Medicines at Jan Aushadhi Kendras
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Thiru Dayanidhi Maran

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

LOK SABHA UNSTARRED QUESTION No. 2246 TO BE ANSWERED ON THE 12 th  DECEMBER, 2025

## Quality Concerns of Medicines at Jan Aushadhi Kendras

## 2246. Thiru Dayanidhi Maran:

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

(a) whether the Union Government is aware of the growing crisis in the quality and availability of generic medicines supplied through Jan Aushadhi Kendras (JAKs) in the country and if so, the details of complaints received and supply gaps identified therein;

(b) the number of cases registered during the last five years against Pradhan Mantri Bhartiya Janaushadhi  Pariyojana  (PMBJP)  outlets  for  quality  failures,  contaminants  or  substandard formulations, year-wise;

(c) the concrete steps taken to enforce strict quality control, including mandatory batch testing, surprise inspections, blacklisting of non-compliant manufacturers and timelines for recalling substandard medicines supplied under PMBJP;

(d) the measures adopted to strengthen regulatory oversight and transparency in procurement, vendor selection and stocking of generic medicines; and

(e) whether an independent audit mechanism is being created to prevent further lapses, if so, the details thereof?

## ANSWER

## THE MINISTER OF STATE IN THE MINISTRY  OF  CHEMICALS  AND FERTILIZERS

(SMT. ANUPRIYA PATEL)

(a): Any person may lodge complaint regarding quality and availability of generic medicines supplied through JAKs in the country using the Centralised Public Grievance Redress and Monitoring  System  (CPGRAMS)  portal  of  the  Government  of  India,  or  by  emailing  to complaints@janaushadhi.gov.in,  or  calling  the  PMBJP  helpline  number  1800  180  8080. Although JAKs serve about 15 lakh consumers daily, only 2,102 grievances were lodged in the financial year (FY) 2024-25, constituting less than 0.0004% of consumers transactions. The grievances  lodged  related  primarily  to  non-availability  of  specific  medicines  at  particular outlets.

With a view to address any supply gaps and ensure smooth supply and product availability at JAKs,  the  Pharmaceuticals  and  Medical  Devices  Bureau  of  India  (PMBI),  which  is  the implementing agency for PMBJP, has undertaken the following measures:

- (i) An end-to-end information-technology-enabled supply chain system has been put in place, consisting currently of five warehouses and 39 distributors across the country.
- (ii) Since  September  2024,  stocking  by  JAKs  of  200  commonly  used  medicines, consisting of the 100 top-selling medicines in the product basket and 100 fast-selling

medicines in the market, has been incentivised, under which JAK owners are eligible for monthly incentive based on the stocks that they maintain of these medicines.

- (iii) In addition, with a view to ensure availability of commonly used products, 400 fastmoving  products  are  monitored  regularly  by  PMBI  and  demand  for  the  same  is forecasted  on  an  ongoing  basis.  Further,  steps  have  been  taken  to  digitise  the forecasting method to augment the procurement process through automation.

(b) and (c): No such cases have been registered against Janaushadhi outlets under PMBJP for quality  failures,  contaminants  or  substandard  formulations  as  the  action  is  liable  against manufacturers of such medicine. Further, with a view to ensure quality of medicines available at JAKs so that health of patients is not compromised, concrete mechanisms are in place to ensure continuous inspection, testing and standardisation, including the following:

- (i) Supply only from WHO Good Manufacturing Practices (GMP) certified plants: Only plants  that  are  certified  as  WHO-GMP  compliant  by  the  Central  Drugs  Standard Control Organisation (CDSCO) after direct inspection are eligible for supply.
- (ii) Distribution only after 100% pre-testing of all medicine batches: Samples are drawn from 100% of batches supplied at PMBI's warehouses for testing anonymously, and medicines are dispatched for supply to JAKs only after the quality test is passed.
- (iii) Testing only at labs compliant with Good Laboratory Practices (GLP): Samples are tested only at labs accredited and periodically inspected by the National Accreditation Board for Testing and Calibration Laboratories (NABL) and, in addition, assessed by PMBI for GLP compliance.

On detection of any medicine of Not of Standard Quality (NSQ) category, sale of the said batches  of  medicines  across  the  entire  supply  chain  is  stopped  forthwith  and  such  batches available in the supply channel are recalled. Further, in such cases, the tender clauses prescribe appropriate action against the manufacturer, such as forfeiture of security deposit, recovery of cost of entire batch and blacklisting/debarment of manufacturer/drug supplied.

Year-wise details of cases registered against manufacturers who supplies drugs for PMBJP for quality failures are as under:

|   S. No. | Financial year   | Number of batches of products purchased   |   Number of batches reported as NSQ by drug regulatory authorities and cases registered |
|----------|------------------|-------------------------------------------|-----------------------------------------------------------------------------------------|
|        1 | 2020-21          | 6,955                                     |                                                                                      21 |
|        2 | 2021-22          | 9,143                                     |                                                                                      29 |
|        3 | 2022-23          | 12,001                                    |                                                                                      49 |
|        4 | 2023-24          | 13,000                                    |                                                                                      61 |
|        5 | 2024-25          | 18,686                                    |                                                                                      46 |

(d) and (e): With regard to regulatory oversight over drugs in the country, CDSCO and the Ministry of Health and Family Welfare have taken following measures:

- (i) In order to assess the regulatory compliance of drug manufacturing premises in the country, CDSCO along with State Drugs Controllers (SDCs) have conducted riskbased inspections of more than 960 premises since December 2022 and based on findings,  more  than  860  actions  such  as  issuance  of  show  cause  notices,  stop production  order,  suspension,  cancellation  of  licenses/product-licenses,  warning letters etc., have been taken by the State Licensing Authorities as per the provisions of the Drugs Rules, 1945.
- (ii) The Drugs Rules, 1945 have been amended in 2023 to require manufacturers of the top-300 drug formulation brands listed in Schedule H2 to the said rules to print or

affix a bar code or Quick Response (QR) code on the primary packaging label, or on the  secondary  label  where  space  is  insufficient,  to  store  data  readable  through software  applications  for  authentication.  Similarly,  the  said  rules  have  also  been amended to require that every active pharmaceutical ingredient (bulk drug), whether manufactured  or  imported,  shall  bear  a  QR  code  on  each  level  of  packaging containing  data  readable  through  software  applications  to  facilitate  tracking  and tracing.

- (iii) As part  of  quality  monitoring,  CDSCO  uploads  details  of  drug  samples  that  fail quality checks on its website as monthly drug alerts. For samples declared Not of Standard Quality (NSQ)  by the drugs testing laboratories  under  CDSCO, manufacturers  are  directed  to  immediately  recall  the  product  and  stop  further distribution. Based on investigation findings, licensing authorities concerned take action under the Drugs and Cosmetics Act, 1940 and the rules made thereunder, including stop-production/testing orders, license suspension or cancellation, warning letters and show cause notices.
- (iv) Schedule M to the Drugs Rules, 1945 has been revised vide Ministry of Health and Family Welfare's notification dated 28.12.2023, in line with international standards {of the World Health Organization (WHO)}, and the same has come into effect for drug manufacturers with turnover more than ₹250 crore from 29.6.2024. However, for manufacturers having turnover of up to ₹250 crore, the timeline for implementation has been extended till 31.12.2025, vide notification dated 11.2.2025.
- (v) In  February  2024,  CDSCO  published  regulatory  guidelines  for  the  sampling  of drugs, cosmetics and medical devices by Central and State drugs inspectors. These provide a structured approach to ensure the quality and efficacy of products available in the market through uniform drug sampling methodology.
- (vi) An online portal, SUGAM, is in place since September 2023 for integrating the drug testing  labs  of  CDSCO.  It  automates  the  entire  workflow  for  testing  of  medical products (drugs, vaccine, cosmetics and medical devices) to meet quality specifications and trace testing status in laboratories.
- (vii) The Drugs Rules, 1945 have been amended to make it mandatory that, in case an applicant  intends  to  market  the  drug  under  a  brand  name  or  trade  name,  such applicant shall furnish an undertaking in prescribed form to the licensing authority that such or similar brand name or trade name is not already in existence with respect to any drug in the country and the proposed brand name or trade name shall not lead to any confusion or deception in the market.
- (viii) For  uniformity  in  the  administration  of  the  Drugs  and  Cosmetics  Act,  1940,  the Central drugs regulator coordinates activities of the State Drugs Control Organisations and provides expert advice through the Drugs Consultative Committee meetings held with the State Drugs Controllers.
- (ix) Central Government organises residential and regional training and workshops on an ongoing basis to officials of CDSCO and State Drugs Regulatory Authorities on Good Manufacturing Practices. Since April 2023, CDSCO has trained over 43,000 persons.

As regards transparency, it is informed that PMBI selects manufacturers and suppliers through an open tendering process, using the Government's Central Public Procurement Portal, for rate contracts. Further, distributors are appointed based on requirement by inviting expressions of interest (EoI) and following a transparent selection process. Whenever there is requirement, an invitation for EoI or tender is uploaded on the scheme website (www.janaushadhi.gov.in) for authorised distributorship.

With regard to independent measures to prevent lapses, it is stated that independent regulatory oversight as detailed above and testing of samples of medicines supplied to JAKs is done at labs accredited and independently overseen by the National Accreditation Board for Testing and Calibration Laboratories (NABL) serve to safeguard against any lapses.

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