Lok Sabha Question No. 4612 (UNSTARRED), answered on 2026-03-20
Subject: Variations in Generic Medicines
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Dr. Amol Ramsing Kolhe, Shri Sanjay Dina Patil, Prof. Varsha Eknath Gaikwad, Shri Mohite Patil Dhairyasheel Rajsinh, Shri Bhaskar Murlidhar Bhagare, Smt. Supriya Sule

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

## LOK SABHA UNSTARRED QUESTION No. 4612 TO BE ANSWERED ON THE 20 TH  MARCH 2026

## Variations in Generic Medicines

## 4612.   Dr. Amol Ramsing Kolhe:

Shri Sanjay Dina Patil:

Prof. Varsha Eknath Gaikwad:

Shri Mohite Patil Dhairyasheel Rajsinh:

Shri Bhaskar Murlidhar Bhagare:

Smt. Supriya Sule:

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

- (a)  whether  the  Government  is  aware  that  patients  and  healthcare  practitioners  in  public hospitals have raised concerns regarding perceived variations in quality, therapeutic effectiveness and onset time of certain generic medicines across the country, if so, the details thereof;
- (b)  whether  any  scientific  or  regulatory  assessment  has  been  conducted  to  evaluate  the bioequivalence,  absorption  rates  and  clinical  effectiveness  of  generic  medicines  supplied through  public  procurement  systems  in  the  country,  if  so,  the  details  thereof  including Maharashtra, Statewise;
- (c)  whether  the  Government  has  received  feedback  from  doctors  regarding  differences observed  between  branded  and  generic  medicines  in  treatment  outcomes,  even  as  generic prescribing  is  being  promoted  to  improve  affordability  in  Maharashtra,  if  so,  the  details thereof;
- (d)  the  quality  control  mechanisms,  batch-wise  testing  and  post-marketing  surveillance measures  put  in  place  to  ensure  the  safety  and  efficacy  of  generic  medicines  supplied  in Maharashtra; and
- (e) whether the Government proposes to strengthen regulatory oversight, testing infrastructure and transparency to ensure sustained public confidence in generic medicines in the said State, if so, the details thereof?

## ANSWER

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

(SMT. ANUPRIYA PATEL)

(a): As per the information provided by Ministry of Health and Family Welfare there is no definition of 'generic medicines' under Drugs & Cosmetics Act, 1940 and Rules made there under and Central Drugs Standard Control Organization (CDSCO) has not received any such reports  regarding  variations  in  quality,  therapeutic  effectiveness  and  onset  time  of  certain generic medicines.

The manufacture, sale and distribution of drugs are primarily regulated in the country under the provisions of Drugs & Cosmetics Act & Rules 1945 made thereunder through a system of licensing  and  inspection  by  State  Licensing  Authorities  appointed  by  respective  State Governments. Licensee is required to comply with all the condition of license as prescribed under Drugs & Cosmetics Rules, 1945. As per one of the conditions of license, licensee is required to test each batch or lot of the raw material used by him for the manufacture of his product  and  also  each  batch  of  the  final  product  and  shall  maintain  records  or  registers showing the particulars in respect of such tests.

Further,  Drugs  manufactured  in  the  country,  irrespective  of  whether  generic  medicines  or branded medicines or for domestic or international market are required to comply with the same  standards  as  prescribed  in  the  Drugs  and  Cosmetics  Act,  1940  and  Rules  made thereunder for their quality.

(b): Ministry of Health and Family Welfare has informed that CDSCO approves new drugs in accordance with the provisions of the New Drugs and Clinical Trials (NDCT) Rules, 2019, based  on  a  comprehensive  evaluation  of  their  quality,  safety,  and  efficacy  in  consultation with Subject Expert Committee (SEC) experts.

Further,  to  ensure  efficacy  of  drugs,  the  Drugs  Rules  1945  amended  vide  G.S.R.  327(E) dated 3rd April, 2017, wherein requirement of bio-equivalence study results was placed to the  concerned  State/UTs  Drugs  Authorities  for  grant  of  manufacturing  license  for  oral dosage  form  of  drugs  falling under  the  Category  II  and  Category  IV  of  the  Biopharmaceutical Classification System.

(c):  Ministry  of  Health  and  Family  Welfare  has  informed  that  no  such  feedback  has  been received.

(d) & (e): Ministry of Health and Family Welfare has informed that CDSCO and Ministry of Health  and  Family  Welfare  have  taken  following  regulatory  measures  to  ensure  the production of quality medicines across the country: -

- (i). In  order  to  assess  the  regulatory  compliance of  drug manufacturing premises in the country,  the  CDSCO  along  with  State  Drugs  Controllers  (SDCs)  have  conducted Risk-Based Inspections of more than 960 premises since December, 2022 and based on  findings,  more  than  860  actions  like  issuance  of  show  cause  notices,  stop production  order,  suspension,  cancellation  of  licenses  /product  licenses,  warning letters have been taken by the State Licensing Authorities.
- (ii). More  than  1100  cough  syrup  manufacturers  and  380  blood  centres  have  been subjected  to  intense  audit  in  coordination  with  State  authorities.  Increased  market surveillance sampling of syrup formulations by Central and State drugs regulators has also been done.
- (iii). Advisory  has  been  issued  on  03.10.2025  to  all  State/UT  Health  Departments  and healthcare  facilities  to  ensure  rational  use  of  paediatric  cough  syrups.  Further,  the Drugs  Controller  (India)  directed  all  State/UT  Drug  Controllers  on  07.10.2025  to ensure strict compliance with testing requirements under the Drugs Rules, 1945, and on 27.10.2025 instructed them to maintain heightened vigilance against spurious and substandard drugs and take prompt action under the Drugs & Cosmetics Act, 1940.
- (iv). In  addition  to  the  existing  requirements  of  testing  the  raw  materials,  the  Indian Pharmacopoeia Commission, Ghaziabad has issued an amendment to Indian Pharmacopoeia (IP) 2022, to also mandate the testing for DEG and Ethylene Glycol (EG) in oral liquids at finished product stage before market release.
- (v). List  of  drugs  of  various  companies,  which  are  declared  Not  of  Standard  Quality/ Spurious/  Misbranded/  Adulterated  by  the  Central  Drugs  Testing  Laboratories  is uploaded and available on the website of CDSCO under the heading of Drug Alert (www.cdsco.gov.in) and actions initiated.
- (vi). The Drugs Rules, 1945 have been amended  in year 2023 to mandate that manufacturers  of  the  top  300  drug  formulation  brands  listed  in  Schedule  H2  shall print  or  affix  a  Bar  Code  or  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  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  application  to  facilitate  tracking  and tracing.
- (vii). The  Central  Government  has  amended  the  Drugs  Rules  1945  vide  G.S.R.  922  (E) dated  28.12.2023  to  revise  the  schedule  M  to  the  said  rules  related  to  Good Manufacturing  Practices  and  requirements  of  premises,  plant  and  equipment  for pharmaceutical  products.  Revised  Schedule  M  has  become  effective  for  the  drug manufacturers with turnover > Rs. 250 crores from 29.06.2024 and for manufacturers having turnover of less than Rs. 250 Cr from 01.01.2026.
- (viii). In February 2024, CDSCO published regulatory guidelines for the sampling of drugs, cosmetics,  and  medical  devices  by  Central  and  State  Drugs  Inspectors.  These guidelines provide a structured approach to ensure the quality and efficacy of products available in the market through uniform drug sampling methodology.
- (ix). An online portal, SUGAM labs is in place since September 2023 for integrating the drug  testing  labs  of  the  CDSCO.  It  automates  the  entire  workflow  for  testing  of Medical Products (Drugs, Vaccine, Cosmetics & Medical devices) to meet the quality specification and tracing the testing status in the laboratories.
- (x). The Central regulator coordinates activities of State Drug Control Organisations 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.

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