Lok Sabha Question No. 378 (STARRED), answered on 2024-12-20
Subject: Quality of AYUSH Medicines
Ministry: AYUSH
Asked by: Shri Ravindra Dattaram Waikar, Shri Naresh Ganpat Mhaske

## GOVERNMENT OF INDIA MINISTRY OF AYUSH LOK SABHA

## STARRED QUESTION NO. 378 TO BE ANSWERED ON 20 th  DECEMBER, 2024

## 'Quality of AYUSH Medicines'

## 378.     Shri Naresh Ganpat Mhaske: Shri Ravindra Dattaram Waikar:

Will the Minister of AYUSH be pleased to state:

(a)  whether  the  Government  proposes  to  formulate  any  mechanism  to  address  the  issue  of standardization and quality control of AYUSH medicines and products in the country;

(b) if so, the details thereof, State/UT-wise along with the efforts to improve the quality of AYUSH medicines/products, particularly in Maharashtra and Bihar;

(c) the measures taken/proposed to be taken to enhance research and development in the field of AYUSH along with the efforts to collaborate with international organizations;

(d)  the  plans  of  the  Government  to  promote  quality  AYUSH  medicines  and  products  for wider use by the consumers; and

(e)  whether  any shortfall has been noticed in manufacturing of various AYUSH medicines and if so, the details thereof?

## ANSWER

## THE MINISTER OF STATE (IC) OF THE MINISTRY OF AYUSH (SHRI PRATAPRAO JADHAV)

(a) to (e) A statement is laid on the Table of the House.

## THE  STATEMENT  REFERRED  TO  IN  REPLY  TO  LOK  SABHA  STARRED QUESTION NO. 378 FOR 20 th  DECEMBER, 2024.

(a) and (b) Yes sir. The Drugs & Cosmetics Act, 1940 and Drugs & Cosmetics Rules, 1945 have exclusive regulatory provisions for Ayurvedic, Siddha, Unani, and Homoeopathy drugs. Provisions relating to Ayurveda, Siddha and Unani Drugs are contained in Chapter IVA and Schedule- I of the Drugs and Cosmetics Act, 1940 and in Rules 151 to 169, Schedules E(I), T & TA of the Drugs and Cosmetics Rules, 1945. Further, second schedule (4A) of the Drugs and Cosmetics Act, 1940 provides standards for Homoeopathic drugs and Rules 2dd, 30AA, 67 (C-H), 85 (A to I), 106-A, Schedule K, Schedule M-I of the Drugs and Cosmetics Rules, 1945 pertain to Homoeopathic drugs. 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 Drugs and Cosmetics Rules, 1945 and quality standards of drugs given in the respective pharmacopoeia.

Ministry of Ayush, Government of India has established Pharmacopoeia Commission for  Indian  Medicine  &  Homoeopathy  (PCIM&H)  as  its  subordinate  office.  PCIM&H  on behalf  of  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.  As  per  the  Drugs  &  Cosmetics  Act,  1940  and  rules  thereunder,  the  compliance  to these  quality  standards  are  mandatory  for  the  production  of  ASU&H  drugs  being manufactured  in  India.  So  far,  2259  quality  standards  on  raw  materials  (single  drugs  of plant/  animal/  mineral/  metal/  chemical  origin)  used  in  ASU&H  drugs,  405  quality standards of ASU formulations and 2666 formulary specifications of ASU drugs   has been published. In addition to above, supporting documents in the form of Macro-Microscopic & TLC Atlas on 351 single drugs incorporated in Ayurvedic Pharmacopoeia of India (API) has also published. Details are available at Annexure-I.

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.

Rule  160  A  to  J  of  the  Drugs  and  Cosmetics  Rules,  1945  provides  the  regulatory guidelines for approval of Drug Testing Laboratory for carrying out such tests of identity, purity, quality and strength of Ayurvedic, Siddha and Unani drugs as may be required under the provisions of these rules, on behalf of licensee for manufacture of Ayurvedic, Siddha and Unani drugs. As on date, 34 State Drug Testing Laboratories have been supported for strengthening  their  infrastructural  and  functional  capacity.    Further,  106  laboratories  are approved or licensed under the provisions of Drugs and Cosmetics Rules, 1945 for quality testing of Ayurvedic, Siddha and Unani drugs and raw materials. Details of the State Drug Testing Laboratories and Private Drug testing laboratories licensed   under the provisions of Drugs and Cosmetics Rules, 1945 are available at https://ayush.gov.in/images/domains/quality\_standards/StateDrugTestingLaboratoryASUH Eng. and https://ayush.gov.in/images/domains/quality\_standards/ListofAyurvedaSiddhaUnani.pdf.

As per the information received from states/UTs governments including Maharashtra and Bihar, the details of the mechanism to address the issue of standardization and quality control of Ayush medicines and products in the country along with the efforts to improve the quality of Ayush medicines/products are attached at Annexure-II.

(c)  Government  of  India  has  established  Central  Council  for  Research  in  Ayurvedic Sciences, Central Council for Research in Unani Medicine, Central Council for Research in Homoeopathy, Central Council for Research in Siddha and Central Council for Research in Yoga & Naturopathy under the Ministry of Ayush as apex organizations for undertaking, coordinating, formulating, developing and promoting research in Ayush system on scientific lines.  Core  Research  activities  comprise  of  Medicinal  Plant  Research  (Medico-Ethno Botanical Survey, Pharmacognosy and in vitro-propagation technique), Drug Standardization, Pharmacological Research, Clinical Research, Literary Research  & Documentation and Tribal Health Care Research Programme. Research activities are carried out through its peripheral Institutes/Units located across the country and also in collaboration with various Universities, Hospitals and Institutes.

Further,  the  Ministry  of Ayush is implementing the Central Sector Scheme namely AYURGYAN Scheme from FY 2021-22. The Scheme has 03 components viz. (i) Capacity Building & Continuing Medical Education (CME) in Ayush (ii) Research & Innovation in Ayush from the FY 2021-22 and iii) Ayurveda Biology Integrated Health Research is also added under the scheme from this FY 2023-24. Under the Research & Innovation in Ayush

and  Ayurveda  Biology  Integrated  Health  Research  component,  financial  assistance  is provided to the Organizations/Institutions for research studies, for promotion of research in Ayush system.

To  promote  Ayush  practices  globally,  Ministry  of  Ayush  signs  Memorandum  of Understandings (MoUs) with International Institutes/Universities/Organizations for research collaboration in the field of Traditional Medicines including Ayush. As of now, the Ministry signed 46 MoUs with International Institutions.

- (d)  Ministry  of  Ayush  has  implemented Central  Sector Scheme Ayush Oushadhi Gunvatta Evam  Uttpadan  Samvardhan  Yojana  (AOGUSY).  The  total  financial  allocation  to  this scheme  is  Rs.  122.00  crores  for  five  years.  The  components  of  AOGUSY  scheme  are  as follows -

A. Strengthening  and  up-gradation  of  Ayush  Pharmacies  and  Drug  Testing  Laboratories  to achieve higher standards.

- B. Pharmacovigilance of ASU&H drugs including surveillance of misleading advertisements.
- C. Strengthening  of  Central  and  State  regulatory  frameworks  including  Technical  Human Resource & Capacity Building programs for Ayush drugs.

D. Support for development of standards and accreditation/certification of Ayush products & materials in collaboration with Bureau of Indian Standards (BIS), Quality Control of India (QCI)  and  other  relevant  scientific  institutions  and  industrial  R&D  centres.    Detailed guidelines of AOGUSY scheme are available at https://ayush.gov.in/images/Schemes/aoushdhi.pdf .

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

-  The  scheme  for  Certification  of  Pharmaceutical  Product  (CoPP)  as  per  World  Health Organization  (WHO)  guidelines  is  extended  to  Ayurvedic,  Siddha  and  Unani  (ASU) medicines.  This  scheme  is  administered  by  Central  Drugs  Standard  Control  Organization (CDSCO)  and  the  certificate  is  granted  on  the  basis  of  joint  inspection  of  the  applicant manufacturing unit by the representatives of CDSCO, Ministry of Ayush and the concerned State Licensing Authority.
- Quality Certifications Scheme implemented by the Quality Council of India (QCI) for grant of  Ayush  mark  to  Ayurvedic,  Siddha  and  Unani  products  on  the  basis  of  third  party evaluation of quality in accordance with the status of compliance to international standards.

(e) As per the information received from States/ UTs governments, details of shortfall noticed in the manufacturing of various Ayush medicines are available at Annexure-III.

*******

## Annexure-I

Details  of  quality  standards  on  raw  materials  used  in  ASU&H  drugs,  quality  standards  of ASU formulations, formulary specifications of ASU drugs and Macro-Microscopic & TLC Atlas  on  single  drugs  incorporated  in  Ayurvedic  Pharmacopoeia  of  India  (API)  are  as follows-

| Publication                            | Part                            | Volume &Year                                                       |   Number of Monographs |
|----------------------------------------|---------------------------------|--------------------------------------------------------------------|------------------------|
| Ayurvedic Pharmacopoeia of India       | Part I (Single Drugs)           | Vol. I, 1986                                                       |                     80 |
| Ayurvedic Pharmacopoeia of India       | Part I (Single Drugs)           | Vol. II, 1999                                                      |                     78 |
| Ayurvedic Pharmacopoeia of India       | Part I (Single Drugs)           | Vol. III, 2001                                                     |                    100 |
| Ayurvedic Pharmacopoeia of India       | Part I (Single Drugs)           | Vol. IV, 2004                                                      |                     68 |
| Ayurvedic Pharmacopoeia of India       | Part I (Single Drugs)           | Vol. V, 2006                                                       |                     92 |
| Ayurvedic Pharmacopoeia of India       | Part I (Single Drugs)           | Vol. VI, 2008                                                      |                    101 |
| Ayurvedic Pharmacopoeia of India       | Part I (Single Drugs)           | Vol. VII, 2008 (Minerals &Metals)                                  |                     21 |
| Ayurvedic Pharmacopoeia of India       | Part I (Single Drugs)           | Vol. VIII, 2011 (Hydro-alcoholic& Water extracts)                  |                     60 |
| Ayurvedic Pharmacopoeia of India       | Part I (Single Drugs)           | Vol. IX, 2016 (Hydro-alcoholic& Water extracts)                    |                     45 |
| Ayurvedic Pharmacopoeia of India       |                                 | Vol. X, 2022 (Minerals &Metals                                     |                     20 |
| Ayurvedic Pharmacopoeia of India       | Total                           | Total                                                              |                    665 |
| Ayurvedic Pharmacopoeia of India       | Part II (Formulations)          | Vol. I, 2007 Vol. I, 2011 (Hindi Ed.)                              |                     50 |
| Ayurvedic Pharmacopoeia of India       | Part II (Formulations)          | Vol. II, 2008 Vol. II, 2011                                        |                     51 |
| Ayurvedic Pharmacopoeia of India       | Part II (Formulations)          | Vol. III, 2010                                                     |                     51 |
| Ayurvedic Pharmacopoeia of India       | Part II (Formulations)          | Vol. IV, 2017                                                      |                     50 |
| Ayurvedic Pharmacopoeia of India       | Part II (Formulations)          | Pharmacopoeial Monograph of Ayush Kvatha Curṇa (Stand- alone) 2021 |                     01 |
| Ayurvedic Pharmacopoeia of India       | Part II (Formulations)          | Total                                                              |                    203 |
| Supporting Pharmacopoeial Publications | Layer Chromatography            | API Drugs Pt. I, Vol. I, 2009                                      |                     80 |
| Supporting Pharmacopoeial Publications | Atlas                           | API Drugs Pt. I, Vol. III, 2016                                    |                     99 |
| Supporting Pharmacopoeial Publications | Macroscopy and Microscopy Atlas | API Drugs Pt.-I Vol. V, 2009                                       |                     92 |
| Supporting Pharmacopoeial Publications | Macroscopy and Microscopy Atlas | API Drugs Pt.-I Vol. I, 2011                                       |                     80 |

| Publication                  | Part &Year                                                       |   Number of Formulations |
|------------------------------|------------------------------------------------------------------|--------------------------|
| Ayurvedic Formulary of India | Part I, 2003 (2 nd Edition)                                      |                      444 |
| Ayurvedic Formulary of India | Part II, 2000                                                    |                      191 |
| Ayurvedic Formulary of India | Part III, 2011 (Bilingual)                                       |                      350 |
| Ayurvedic Formulary of India | Formulary specification of Ayush Kvatha Curṇa (Stand-alone) 2021 |                       01 |
| Ayurvedic Formulary of India | Part IV, 2022 (Veterinary)                                       |                       50 |
| Total                        | Total                                                            |                     1036 |

## SIDDHA PHARMACOPOEIAL PUBLICATIONS

| Publication                   | Part                   | Volume &Year                                                           |   Number of Monographs |
|-------------------------------|------------------------|------------------------------------------------------------------------|------------------------|
| Siddha Pharmacopoeia of India | Part I (Single Drugs)  | Vol. I, 2008                                                           |                     73 |
| Siddha Pharmacopoeia of India | Part I (Single Drugs)  | Vol. II, 2011                                                          |                     66 |
| Siddha Pharmacopoeia of India | Part I (Single Drugs)  | Total                                                                  |                    139 |
|                               | Part II (Formulations) | Pharmacopoeial Monograph of Ayush Kuṭinīr Cūraṇam (Stand- alone), 2021 |                     01 |

| Publication               | Part &Year                                                           |   Number of Formulations |
|---------------------------|----------------------------------------------------------------------|--------------------------|
| Siddha Formulary of India | Part I (Tamil), 1984 Part I (English), 1992                          |                      248 |
| Siddha Formulary of India | Part II (Tamil), 2011                                                |                      151 |
| Siddha Formulary of India | Formulary specification of Ayush Kutinir Curanam (Stand-alone), 2021 |                       01 |
| Siddha Formulary of India | Total                                                                |                      400 |

## UNANI PHARMACOPOEIAL PUBLICATION

| Publication                      | Part                 | Volume &Year   |   Number of Monographs |
|----------------------------------|----------------------|----------------|------------------------|
| The Unani Pharmacopoeia of India | Part-I (Single Drug) | Vol. I, 2007   |                     45 |
| The Unani Pharmacopoeia of India | Part-I (Single Drug) | Vol. II, 2007  |                     50 |
| The Unani Pharmacopoeia of India | Part-I (Single Drug) | Vol. III, 2007 |                     53 |
| The Unani Pharmacopoeia of India | Part-I (Single Drug) | Vol. IV, 2007  |                     50 |
| The Unani Pharmacopoeia of India | Part-I (Single Drug) | Vol. V, 2008   |                     52 |
| The Unani Pharmacopoeia of India | Part-I (Single Drug) | Vol. VI, 2009  |                     48 |
|                                  |                      | Vol. VII, 2022 |                     40 |
|                                  | Total                | Total          |                    338 |

| Publication                      | Part                   | Volume &Year                                                             |   Number of Monographs |
|----------------------------------|------------------------|--------------------------------------------------------------------------|------------------------|
| The Unani Pharmacopoeia of India | Part II (Formulations) | Vol. I, 2009                                                             |                     50 |
| The Unani Pharmacopoeia of India | Part II (Formulations) | Vol. II, 2010                                                            |                     50 |
| The Unani Pharmacopoeia of India | Part II (Formulations) | Vol. III, 2016                                                           |                     50 |
| The Unani Pharmacopoeia of India | Part II (Formulations) | Vol. IV, 2019                                                            |                     50 |
| The Unani Pharmacopoeia of India | Part II (Formulations) | Pharmacopoeial Monograph of Ayush Safūf-i- Joshānda (Stand- alone), 2021 |                     01 |
| Total                            | Total                  | Total                                                                    |                    201 |

| Publication                          | Part &Year                                                            |   Number of Formulations |
|--------------------------------------|-----------------------------------------------------------------------|--------------------------|
| National Formulary of Unani Medicine | Part I, 1984                                                          |                      441 |
| National Formulary of Unani Medicine | Part II, 1994                                                         |                      202 |
| National Formulary of Unani Medicine | Part III, 2001                                                        |                      103 |
| National Formulary of Unani Medicine | Part IV, 2006                                                         |                      166 |
| National Formulary of Unani Medicine | Part V, 2008                                                          |                      178 |
| National Formulary of Unani Medicine | Part VI, 2011                                                         |                      139 |
| National Formulary of Unani Medicine | Formulary specification of Ayush Safūf-i-Joshānda (Stand-alone), 2021 |                       01 |
| National Formulary of Unani Medicine | Total                                                                 |                     1230 |

## HOMOEOPATHY PHARMACOPOEIAL PUBLICATION

| Publication                         | Volume &Year   | Number of Monographs   |
|-------------------------------------|----------------|------------------------|
| Homoeopathic Pharmacopoeia of India | Vol. I, 1971   | 180                    |
| Homoeopathic Pharmacopoeia of India | Vol. II, 1974  | 100                    |
| Homoeopathic Pharmacopoeia of India | Vol. III, 1978 | 105                    |
| Homoeopathic Pharmacopoeia of India | Vol. IV, 1984  | 107                    |
| Homoeopathic Pharmacopoeia of India | Vol. V, 1987   | 114                    |
| Homoeopathic Pharmacopoeia of India | Vol. VI, 1990  | 104                    |
| Homoeopathic Pharmacopoeia of India | Vol. VII, 1999 | 105                    |
| Homoeopathic Pharmacopoeia of India | Vol. VIII,2000 | 101                    |
| Homoeopathic Pharmacopoeia of India | Vol. IX,2006   | 100                    |
| Homoeopathic Pharmacopoeia of India | Vol. X, 2013   | 101                    |
| Homoeopathic Pharmacopoeia of India | Total          | 1,117                  |

## Annexure-II

State/UT wise details of the mechanism to address the issue of standardization and quality control of Ayush medicines and products with the efforts to improve the quality of Ayush medicines/products are as follows:

|   S.no. | Name of the State/ UT   | Details                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      |
|---------|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|       1 | Rajasthan               | Drug manufacturing firms are inspected by drug inspectors regularly. Samples are collected and government Testing is done from approved laboratories.                                                                                                                                                                                                                                                                                                                                                                                                                                        |
|       2 | Tamil Nadu              | There are 23 Drug Inspectors available in Tamil Nadu state. All drug inspectors are instructed to take minimum of 08 statutory samples per month with effect from 01.03.2015 and it send to the State Drug Testing Laboratory (IM) for testing. These samples are tested as per concerned pharmacopoeia. The action has been taken against declared spurious/ misbranded/ adulterated drugs as per section 33-I and 33-J and Rule 159 of the Drugs and Cosmetics Act 1940 and Rules, 1945.                                                                                                   |
|       3 | Karnataka               | Technical Expert Committee has been constituted comprising experts in field of Dravyaguna & Rasashastra and Drug regulatory authorities. Technical Expert committee is convened every 21 days and Patent &Proprietary Drug master formulas are approved after verifying the submission of documents relating to safety study, evidence of effectiveness and stability studies as per Rule 158B, Rule 161 B & Rule 169 of Drugs and Cosmetics Rules 1945.                                                                                                                                     |
|       4 | Kerala                  | The Government of Kerala has constituted an expert committee to study the various challenges and problems regarding Ayurveda drug standardization. The Secretary of Ayush Department, Government of Kerala is the chairman of the Committee in which the Deputy Drugs Controller (Ayurveda) serves as the convener. The State Government has also constituted a committee to study the problems related to cultivation, collection and storage of raw materials for manufacture of Ayurveda siddha and Unani drugs. The Deputy Drugs Controller (Ayurveda) is the Chairman of the committee. |
|       5 | Uttarakhand             | State government nominated 14 Drug Inspectors in the State to check the quality and production of Ayurvedic &Unani medicines. There are 06 Drug testing laboratories are working in Uttarakhand in which 01 Government and 05 drug testing laboratories are approved by Ministry of Ayush in Private sector are sanctioned under Drug & Cosmetic Act 1940, Ruls1945 under rule 160A to 160J, for checking the quality of Ayurvedic &Unani medicines.                                                                                                                                         |

|   6. | Odisha            | One state drug testing and Research laboratory (ISM), Bhubaneshwar is functioning in the state for quality testing of the drugs and address the issue of standardization. The drug inspectors are in the state to supervise the manufacture of the Ayurvedic medicines to improve the quality of those medicines/products.                                                                                                                                                                                                                                                                                                                                                                                                                                                        |
|------|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|    7 | Maharashtra       | As per the provisions of the Drugs and Cosmetics Act 1940 and Rules 1945, the measures are taken to check Quality of Drugs are as follows: 1. Periodic inspections are carried out of the Ayurvedic manufacturers to ensure compliance of the provisions of the Drugs & Cosmetics Act 1940 & Rules thereunder. The GMP compliance as per Schedule T is checked. Action against the manufacturers for non-compliance of the provisions of the Drugs & Cosmetics Act 1940 & Rules thereunder. 2. Samples of Ayurvedic medicines are drawn from manufacturers and distributors to ensure the quality of Ayurvedic medicines. Administrative / Legal action is taken against the concerned for non-compliance of the provisions of the Drugs & Cosmetics Act 1940 & Rules thereunder. |
|    8 | Himachal Pradesh  | The provisions of Drugs &Cosmetic Act/Rules made there under strictly followed.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   |
|    9 | Mizoram           | Government of Mizoram has state drug testing laboratory for checking sample and quality testing of ASU & H drugs and peripheral Pharmacovigilance centre under the scheme of AOGUSY.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              |
|   10 | Delhi             | Routine inspections and testing of samples is done to improve the quality of Ayush medicines/products.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            |
|   11 | Chhattisgarh      | Standardization and quality control of Ayush medicines/ products are done as per the Ayurvedic Pharmacopoeia of India.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            |
|   12 | Puducherry        | As per the Rules 168 of Chapter XIX of the Drugs and Cosmetics Act, 1940 &Rules 1945.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             |
|   13 | Arunachal Pradesh | Ayush DTL is set up for quality control of Ayush Drugs.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           |
|   14 | Jammu and Kashmir | One Ayush Drug Pharmacy and one Ayush Drug testing Laboratory are envisaged to address the issue of Standardization and quality control of Ayush medicines and products in the UT of J&K.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         |
|   15 | Bihar             | The department is strictly follows the conditions laid down in Drug Rule 158B- (1)(A)&(B),(11)(A)&B,(111), (iv) and (v) the State Govt. has also notified government Analyst and Laboratories for the test and Analysis of Ayurvedic, Unani and Homoeopathic Medicines.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           |

|   16. | Manipur   | Officials of the Drugs section conducted Regular inspections of the Ayush Medicines selling in the local markets.   |
|-------|-----------|---------------------------------------------------------------------------------------------------------------------|
|    17 | Goa       | NIL                                                                                                                 |
|    18 | Assam     | NIL                                                                                                                 |
|    19 | Gujrat    | NIL                                                                                                                 |

## Annexure-III

State/ UT-wise details of shortfall noticed in the manufacturing of various Ayush medicines are as follows -

|   S.no. | Name of the State/ UT   | Details of shortfall noticed                                                                                                                                                                                                                                                                                                                                                                                                                                               |
|---------|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|       1 | 1Maharashtra            | The details of the actions taken against the Ayush companies that are identified for selling adulterated Ayurveda Drugs in the Country since 01.04.2023 to 31.11.2024 is as follow: - 1. Period - 01/04/2023 to 31/03/2024  Ayurvedic Samples collected -761  Ayurvedic Samples tested - 476  No. of samples declared NSQ - 08 2. Period - 01/04/2024 to 31/11/2024  Ayurvedic Samples collected-569  Ayurvedic Samples tested -327  No. of samples declared NSQ -86 |
|       2 | 2Rajasthan              | Samples of Ayush medicines were tested and if a deficiency was found in the manufacturing of these medicines. Action is taken against them as per rules.                                                                                                                                                                                                                                                                                                                   |
|       3 | 3Tamil Nadu             | NIL                                                                                                                                                                                                                                                                                                                                                                                                                                                                        |
|       4 | 4Jammu and Kashmir      | In the UT of J&K there is no separate Ayush Drug Controlling Authority which can monitor any shortfalls in manufacturing of various Ayush medicines.                                                                                                                                                                                                                                                                                                                       |
|       5 | Bihar                   | Shortfall has been noticed in manufacturing of Ayush Medicines under provisions mentioned in Schedule-T & M-1 i.e., Good Manufacturing Practice respectively. Action taken like seizure of drugs, show cause. cancelation of Mfg. Licence was done.                                                                                                                                                                                                                        |
|       6 | 6Puducherry             | NIL                                                                                                                                                                                                                                                                                                                                                                                                                                                                        |
|       7 | 8Goa                    | NIL                                                                                                                                                                                                                                                                                                                                                                                                                                                                        |
|       8 | Mizoram                 | NIL                                                                                                                                                                                                                                                                                                                                                                                                                                                                        |
|       9 | Kerala                  | NIL                                                                                                                                                                                                                                                                                                                                                                                                                                                                        |
|      10 | 2Karnataka              | NIL                                                                                                                                                                                                                                                                                                                                                                                                                                                                        |
|      11 | 4Delhi                  | NIL                                                                                                                                                                                                                                                                                                                                                                                                                                                                        |
|      12 | Gujrat                  | NIL                                                                                                                                                                                                                                                                                                                                                                                                                                                                        |
|      13 | 5Arunachal Pradesh      | NIL                                                                                                                                                                                                                                                                                                                                                                                                                                                                        |
|      14 | 6Odisha                 | NIL                                                                                                                                                                                                                                                                                                                                                                                                                                                                        |