Lok Sabha Question No. 2155 (UNSTARRED), answered on 2025-08-01
Subject: Standardisation of AYUSH Medicine and Products
Ministry: AYUSH
Asked by: Smt. Pratima Mondal, Shri Naveen Jindal

## GOVERNMENT OF INDIA MINISTRY OF AYUSH LOK SABHA

## UNSTARRED QUESTION NO -2155

## TO BE ANSWERED ON 01/08/2025

## 'Standardisation of AYUSH Medicine and Products'

## 2155. Shri Naveen Jindal and Smt. Pratima Mondal

Will the Minister of Ayush be pleased to state:

(a)  the  measures  being  taken  by  the  Government  to  ensure  the  quality  and  standardisation  of AYUSH medicines and products including quality control measures and the implementation of standards like the Ayurvedic Pharmacopoeia of India;

(b) the quantifiable results of such measures towards ensuring standardisation and quality control of AYUSH medicines, State/UT -wise;

(c)  the  efforts  made  by  the  Government  to  enhance  the  acceptability  of  AYUSH  medicines globally through quality control and standardisation during last five years;

(d)  the  corrective  measures  taken  by  the  Government  to  prevent  the  use  of  adulterated  or  sub -standard AYUSH medicines during each of the last five years, year -wise,  State/UT -wise  along with the results thereof;

(e) the details of the initiatives launched by the Government to promote international cooperation and  recognition  of  AYUSH  systems,  particularly  in  the  context  of  export  promotion  and regulatory harmonization with other countries; and

(f)  the  steps  taken  by  the  Government  to  strengthen  evidence -based research  and  validation  of AYUSH  treatments  and  the  manner  in  which  Government  is  collaborating  with  scientific institutions to enhance clinical credibility of AYUSH treatments in the country?

## ANSWER

## THE MINISTER OF STATE (IC) OF THE MINISTRY OF AYUSH

## (SH. PRATAPRAO JADHAV)

(a) & (b)  The Drugs & Cosmetics Act, 1940 and Drugs Rules, 1945 have exclusive regulatory provisions for Ayurvedic, Siddha, Sowa -Rigpa, Unani, and Homoeopathy drugs. Rule 158 -B and Rule 85 (A to I) of the Drugs Rules, 1945 provides the regulatory guidelines for issue of license to manufacture Ayurvedic,  Siddha,  Sowa -Rigpa,  Unani  and  Homoeopathy  medicines  respectively. It  is  mandatory  for    the  manufacturers  to  adhere  to  the  prescribed  requirements  for  licensing of    manufacturing   units   &   medicines    including   proof   of   safety   &    effectiveness, compliance with the Good Manufacturing Practices (GMP) as per Schedule T & Schedule M -I of the Drugs Rules, 1945 for Ayurveda, Siddha, Unani drugs and Homoeopathy drugs respectively and also to follow the quality standards of drugs as prescribed in the respective pharmacopoeia.

2.  Drug  Inspectors  collect  medicine  samples  regularly  from  manufacturing  firms  or  sale  shops within  their  jurisdiction  and  send  them  to  Drug  Testing  Laboratory  under  Drug  Control department  for  quality  testing  and  if  any  sample  is  found  to  be  'Not  of  Standard  Quality', appropriate  action  is  initiated  such  as  preventing  the  sale  of  the  products  from  the  market  and appropriate legal actions as per Drugs and Cosmetics Act 1940 and Rules made thereunder

3.  Pharmacopoeia  Commission  for  Indian  Medicine  &  Homoeopathy  (PCIM&H),  subordinate office  under  Ministry  of  Ayush  lays  down  the  formulary  specifications  and  pharmacopoeial standards  for  Ayurveda,  Siddha,  Unani  and  Homoeopathy  (ASU&H)  drugs  which  serves  as official  compendia  for  ascertaining  the  quality  (identity,  purity  and  strength)  of  the  ASU&H drugs.  Details in this regard are at Annexure -I

4. PCIM&H also acts as the Central Drugs Laboratory for Indian Medicine and Homoeopathy for the  purpose  of  testing  or  analysis  of  ASU&H  Drugs.  Further,  it  imparts  Capacity  Building Trainings  at  regular  interval  for  standardization/quality  control/  testing  or  analysis  of ASU&H drugs to Drug Regulatory Authorities, State Drug Testing Laboratories (Drug Analyst) and other stakeholders on quality control of ASU&H drugs on laboratory techniques and methods used to maintain the quality of ASU&H drugs.

5. Drug Testing Laboratories are being recognized under Rule 160 A to J of the Drugs Rules, 1945 for  carrying  out  such  tests  of  identity,  purity,  quality  and  strength  of Ayurvedic,  Siddha,  Sowa -Rigpa,  Unani  and  Homoeopathy  drugs.  As  on  date,  108  private  laboratories  are  approved  or licensed  under  the  provisions  of  Drugs  Rules,  1945  for  manufacturers.  34  Drug  Testing Laboratories  of  State/UTs  are  testing  quality  of  Ayurvedic,  Siddha,  Sowa -Rigpa,  Unani  and Homoeopathy drugs and raw materials for legal samples.

6. Ministry of Ayush has implemented Central Sector Scheme Ayush Oushadhi Gunvatta Evam Uttpadan  Samvardhan  Yojana  (AOGUSY)  to  support  Ayush  Pharmacies  and  Drug  Testing Laboratories  to  achieve  higher  standards  under  one  of  the  components.  The  total  financial allocation to this scheme is Rs. 122.00 crores for five years.

7. Further Ministry of Ayush encourages following certifications of Ayush products as per details below: -

· An  Ayush  vertical  has  been  created  in  Central  Drugs  Standard  Control  Organization (CDSCO) to strengthen regulatory measures ensuring safety and quality of Ayush drugs. Further, CDSCO issues WHO Certificate of Pharmaceutical Product (WHO -CoPP) to Ayush drugs having compliance to such standards.

· Quality  Certifications  Scheme  implemented  by  the  Quality  Council  of  India  (QCI)  for grant  of AYUSH standard and premium mark to Ayurvedic, Siddha and Unani products on the basis of third -party evaluation of quality in accordance with the status of compliance to domestic and international standards.

(c), (d) & (e)  The Ministry of Ayush, developed the central sector scheme for Promotion of International Cooperation for AYUSH (IC Scheme). Under this scheme the Ministry provides support to Indian AYUSH drug Manufacturers/ Ayush Service providers to give boost to the export of AYUSH products and services; facilitates  the  International  promotion,  development  and  recognition  of  AYUSH  systems  of  medicine; foster  interaction  of  stakeholders  and  market  development  of  AYUSH  at  international  level;  promote academics and research through the establishment of AYUSH Academic Chairs in foreign countries and holding  training  workshop/symposiums  for  promoting  and  strengthening  awareness  and  interest  about AYUSH Systems of Medicine at international level including Ayurveda.

As per the information received from State/UT the details of the corrective measures taken by the Government to prevent the use of adulterated or substandard Ayush medicines during each of  the  last  five  years,  year -wise,  State/UT -wise  along  with  the  results  thereof  are  available  at Annexure -II.

Under  the  CSS  IC  Scheme  25  Country  to  Country  MoUs,  15 Ayush  Chair  MoUs  and 52  Institute  to Institute level MoUs have been signed.

(f)      Ministry  of  Ayush  undertakes  various  research  initiatives  through  its  various  Research Councils and National Institutes which includes pre -clinical & clinical research, drug standardization research, Fundamental Research, literary research, survey etc. Mo Ayush is also collaborating with various scientific institutions such as ICMR, DBT, DST, IITs, AIIMS, NIPER, ICAR etc. through MoUs.

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## Annexure to Part (b) of LSUSQ No.2155 to be answered on 01.08.2025

So  far, 2269 quality  standards  on  raw  materials  (Single  Drugs  of  plant/animal/Mineral/metal/ Chemical origin) used in ASU&H has been published, the details as follows:

| Name of Pharmacopoeia                                  |   Published quality standards of single drugs |
|--------------------------------------------------------|-----------------------------------------------|
| Ayurvedic Pharmacopoeia on India (Part I, Vol. I to X) |                                           665 |
| Siddha Pharmacopoeia on India (Part I Vol. I to II)    |                                           139 |
| Unani Pharmacopoeia on India (Part I Vol. I to VII)    |                                           338 |
| Homoeopathic Pharmacopoeia on India (Vol. I to XI)     |                                          1127 |

426 quality  standards  of ASU  formulations  also  been  published  in  respective  Pharmacopoeias. The details as follows:

| Name of Pharmacopoeia                                   | Published quality standards of formulations   |
|---------------------------------------------------------|-----------------------------------------------|
| Ayurvedic Pharmacopoeia on India (Part II, Vol. I to V) | 223 and 01 standalone quality standard        |
| Siddha Pharmacopoeia on India (Part II)                 | 01 standalone quality standard                |
| Unani Pharmacopoeia on India (Part II Vol. I to IV)     | 200 and 01 standalone quality standard        |

Further, 2799 formulary specifications of ASU drugs also published in Formularies of respective system. The details as follows:

| Formulary                            | Specifications                                                |
|--------------------------------------|---------------------------------------------------------------|
| Ayurvedic Formulary of India         | 1035 (Part I to IV) and 01 standalone formulary specification |
| Siddha Formulary of India            | 532 (Part I to II) and 01 standalone formulary specification  |
| National Formulary of Unani Medicine | 1229 (Part I to VI) and o1 standalone formulary specification |

In addition to above, supporting documents in the form of Macro -Microscopic & TLC Atlas on 392 single drugs incorporated in API also published.

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## Annexure to Part (d) of LSUSQ No.2155 to be answered on 01.08.2025

State/ UT -wise details of the corrective measures taken by the Government to prevent the use of adulterated  or  substandard  Ayush  medicines  during  each  of  the  last  five  years,  year -wise, State/UT -wise along with the results thereof are as follows -

|   S.No. | Name of the State/ UT   | Details                                                                                                                                                                                                                                                                                                                                                                | Details                                                                                                                                                             | Details                                                                                                                                                             | Details                                                                                                                                                             |
|---------|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|       1 | Puducherry              | Directorate of AYUSH is involved in conducting IEC activities and sensitizing the public to prevent the use of adulterated of substandard Ayush medicines.                                                                                                                                                                                                             | Directorate of AYUSH is involved in conducting IEC activities and sensitizing the public to prevent the use of adulterated of substandard Ayush medicines.          | Directorate of AYUSH is involved in conducting IEC activities and sensitizing the public to prevent the use of adulterated of substandard Ayush medicines.          | Directorate of AYUSH is involved in conducting IEC activities and sensitizing the public to prevent the use of adulterated of substandard Ayush medicines.          |
|       2 | Delhi                   | Routine inspections by the Drugs Control Officials and lifting of samples of Ayurvedic and Unani medicines for test/analysis from government approved laboratories.                                                                                                                                                                                                    | Routine inspections by the Drugs Control Officials and lifting of samples of Ayurvedic and Unani medicines for test/analysis from government approved laboratories. | Routine inspections by the Drugs Control Officials and lifting of samples of Ayurvedic and Unani medicines for test/analysis from government approved laboratories. | Routine inspections by the Drugs Control Officials and lifting of samples of Ayurvedic and Unani medicines for test/analysis from government approved laboratories. |
|       3 | Lakshadweep             | This U.T does not have any Manufacturing Units and Drugs Testing Laboratories forASU&H Drugs.                                                                                                                                                                                                                                                                          | This U.T does not have any Manufacturing Units and Drugs Testing Laboratories forASU&H Drugs.                                                                       | This U.T does not have any Manufacturing Units and Drugs Testing Laboratories forASU&H Drugs.                                                                       | This U.T does not have any Manufacturing Units and Drugs Testing Laboratories forASU&H Drugs.                                                                       |
|       4 | Tripura (Agartala)      | One State Drug Testing Laboratory (Ayush) has been established for quality testing of Ayush drugs in the state of Tripura.                                                                                                                                                                                                                                             | One State Drug Testing Laboratory (Ayush) has been established for quality testing of Ayush drugs in the state of Tripura.                                          | One State Drug Testing Laboratory (Ayush) has been established for quality testing of Ayush drugs in the state of Tripura.                                          | One State Drug Testing Laboratory (Ayush) has been established for quality testing of Ayush drugs in the state of Tripura.                                          |
|       4 | Tripura (Agartala)      | Year report Misbranded Ayush Medicines Ayush Medicines 2020 - 2021 04 - 2021 - 2022 - - 2022 - 2023 62 03 - 2023 - 2024 07 - 2024 - 2025 36 - 2025 - till date - 01 Recently state government has been notified State Authority (ASU Drugs) and Inspecting Officers of (ASU drugs) to enforce and regulate Drugs and Remedies (Objectionable Advertisements) Act, 1954 | wise                                                                                                                                                                | Not of standard                                                                                                                                                     |                                                                                                                                                                     |
|       4 | Tripura (Agartala)      | Licensing Drugs Magic which prohibits misleading advertisements for Ayush drugs.                                                                                                                                                                                                                                                                                       | Licensing Drugs Magic which prohibits misleading advertisements for Ayush drugs.                                                                                    | Licensing Drugs Magic which prohibits misleading advertisements for Ayush drugs.                                                                                    | Licensing Drugs Magic which prohibits misleading advertisements for Ayush drugs.                                                                                    |
|       4 | Tripura (Agartala)      |                                                                                                                                                                                                                                                                                                                                                                        |                                                                                                                                                                     |                                                                                                                                                                     |                                                                                                                                                                     |
|       4 | Tripura (Agartala)      |                                                                                                                                                                                                                                                                                                                                                                        |                                                                                                                                                                     |                                                                                                                                                                     |                                                                                                                                                                     |
|       4 | Tripura (Agartala)      |                                                                                                                                                                                                                                                                                                                                                                        |                                                                                                                                                                     |                                                                                                                                                                     |                                                                                                                                                                     |
|       4 | Tripura (Agartala)      |                                                                                                                                                                                                                                                                                                                                                                        |                                                                                                                                                                     |                                                                                                                                                                     |                                                                                                                                                                     |
|       4 | Tripura (Agartala)      |                                                                                                                                                                                                                                                                                                                                                                        |                                                                                                                                                                     |                                                                                                                                                                     |                                                                                                                                                                     |
|       4 |                         |                                                                                                                                                                                                                                                                                                                                                                        |                                                                                                                                                                     |                                                                                                                                                                     |                                                                                                                                                                     |

|   5. | Uttarakhand       | The Government has taken stringent corrective measures to prevent the use of adulterated or substandard Ayush medicines. Those measures, along with their results, over the last five years include: - Regular Inspections: Regular inspections are being diligently carried out by drug inspectors on a continuous basis to monitor manufacturing units and market products • Systematic Sample Testing: Over the last two years, more than 390 samples of Ayush medicines were rigorously tested in state laboratories to ascertain their quality and compliance with prescribed standards Any instances of non - compliance lead to immediate regulatory action. - Training Programs: Regular training is being conducted for drug inspectors and for Pharmacies, making them aware of the acts' provisions and ensuring compliance.   |
|------|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|    6 | Manipur           | Inspections are conducted at the Ayush retail/wholesale outlets by the Drug Inspectors along with the staffs. Ayush medicines were tested at Government approved Laboratory outside state to check the quality and genuineness. i. 2020 - 21 - 26 (Twenty Six) samples of Ayush medicines were tested, ii. 2021 - 22 - 23 (Twenty Three) samples of Ayush medicines were tested. iii. 2022 - 23 - NIL iv. 2023 - 24 - NIL v. 2024 - 25 - NIL                                                                                                                                                                                                                                                                                                                                                                                              |
|    7 | Kerala            | Department initiate action, filed FIR against not of standard quality Ayush medicines and suspend the products.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           |
|    8 | Haryana           | NIL                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       |
|    9 | Arunachal Pradesh | NIL                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       |

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