Lok Sabha Question No. 1683 (UNSTARRED), answered on 2022-12-16
Subject: Quality Control of AYUSH Products/Medicines
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: Ranjeeta Koli, Manoj Rajoria, Balak Nath, Sumedhanand Saraswati

## GOVERNMENT OF INDIA MINISTRY OF AYUSH

## LOK SABHA UNSTARRED QUESTION NO.1683 TO BE ANSWERED ON 16 TH  DECEMBER, 2022

## QUALITY CONTROL OF AYUSH PRODUCTS/MEDICINES

## 1683.  SHRIMATI RANJEETA KOLI: DR. MANOJ RAJORIA: SHRI BALAK NATH: SHRI SUMEDHANAND SARASWATI:

Will the Minister of AYUSH be pleased to state:

- (a)  whether  the  Government  has  taken  any  step  for  Standardization  and  Quality  Control  of AYUSH  Products/Medicines  keeping  in  view  of  their  increasing  demand  in  the  country including Rajasthan;
- (b) if so, the details thereof;
- (c) the details of such specific herbs/medicines of Ayurveda for which quality control standards have been set by the Government;
- (d) the details of the steps taken/being taken by the Government to make adequate availability of the required medicinal components for the production of medicines;
- (e)  whether  any  policy  is  being  formulated  to  provide  required  education  and  provision  of licences  to  the  people  engaged  in  production  and  marketing  of  such  medicines  in  the  country including in Rajasthan; and
- (f) if so, the details thereof ?

## ANSWER THE MINISTER OF AYUSH (SHRI SARBANANDA SONOWAL)

(a)  to  (c):  Yes  Sir.  As  prescribed  in  Drugs  and  Cosmetics  Act  1940  and  Rules  1945  made thereunder,  enforcement  of  the  legal  provisions  pertaining  to  Quality  Control  and  issuance  of drug license of Ayurveda, Siddha, Unani and Homoeopathic drugs, is vested with the State Drug Controllers/  State  Licensing  Authorities  appointed  by  the  concerned  State/  Union  Territory Government.  Rule  158-B  in  the  Drugs  and  Cosmetics  Rules,  1945  provides  the  regulatory guidelines for issue of license to manufacture Ayurvedic, Siddha, Unani medicines and Rule 85 (A to I) in the Drugs and Cosmetics Rules, 1945 provides the regulatory guidelines for issue of license to manufacture Homoeopathic medicines. 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 has taken following steps for Standardization and Quality Control of AYUSH Products/Medicines in the country:

i. Schemes to support Ayurvedic medicines production: Under National Ayush Mission (NAM) from 2014-2021, apart from other services Grant-in-aid were also provided for Strengthening of State Government ASU&H Pharmacies. At present, Central Sector Scheme for Ayush Oushadhi Gunavatta evam Uttpadan Samvardhan Yojana (AOGUSY) has been implemented for the year 2021-2026. The components of the AYUSH Oushadhi Gunvatta Evam Uttpadan Samvardhan Yojana (AOGUSY) Scheme are as under;

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.

ii. Consequent upon decision of Central Government (dated 3 rd June, 2020), the Government of India    has  re-established  Pharmacopoeia  Commission for  Indian Medicines and Homoeopathy (PCIM&H), as a subordinate office under Ministry of Ayush by merging into it, the two central laboratories namely PLIM and HPL (notified vide gazette dated 6 th July, 2020).  PCIM&H lays down Pharmacopoeial Standards and Formulary specifications for Ayurveda, Siddha, Unani & Homoeopathy (ASU&H) drugs, which serve as official compendia for ascertaining the identity, purity  and  strength  of  the  drugs  included  therein.  List  of  publications  published  till  date  is enclosed  at Annexure-I .  Further,  being  an  appellate  laboratory  for  testing  of  ASU&H  drugs;

samples received from Government agencies especially from the Hon`ble court. etc. are being tested by PCIM&H to ensure the quality of ASU&H drugs as per the prescribed standards.

iii.  In  addition  to  the  above,  for  facilitating  exports,  Ministry  of  Ayush  encourages  following certifications of AYUSH products as per details below:-

-  Certification  of  Pharmaceutical  Products  (CoPP)  as  per  WHO  Guidelines  for  herbal products.
-  Quality  Certifications  Scheme  implemented  by  the  Quality  Council  of  India  (QCI)  for grant of AYUSH 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 international standards.

iv. 27 State Drug Testing Laboratories have been supported for strengthening their infrastructural  and  functional  capacity.    As  on  date  81  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.

v. Pharmacovigilance Centres for Ayurveda, Siddha, Unani and Homoeopathy (ASU&H) Drugs set  up  in  different  parts  of  the  country  under  the  Central  Scheme  of  Ministry  of  Ayush  are mandated  to  monitor  and  report  the  misleading advertisements  to the respective State Regulatory Authorities. A three tier structure comprising of a National Pharmacovigilance Coordination  Centre  (NPvCC),  Intermediary  Pharmacovigilance  Centres  (IPvCs)  and  Peripheral Pharmacovigilance Centres (PPvCs) is established. All India Institute of Ayurveda (AIIA), New Delhi  under  Ministry  of  Ayush  is  the  National  Pharmacovigilance  Co-ordination  Centre (NPvCC)  for  the  implementation  of  the  National  Pharmacovigilance  program  for  Ayurveda, Siddha, Unani & Homoeopathy drugs.  Objectionable advertisements are being reported to the respective State Licensing Authorities by PPvC at regular intervals.

vi. Central Council for Research in Homoeopathy (CCRH) under Ministry of Ayush, has so far established  pharmacognostical  standards  on  317  drugs,  physico-chemical  standards  on  336 drugs and pharmacological standards on 151 drugs which include plants, chemicals, minerals and  animal  sources.  One  hundred  forty-nine  (149)  drugs  have  been  studied  in  all  the  three aspects.

vii.  Central  Council  for  Research  in  Unani  Medicine  (CCRUM)  under  Ministry  of  Ayush  is conducting  Drug  Standardization  Research  Programme  to  standardize  the  products  of  Unani Medicine for its quality and safety.

(d) Ministry of Ayush, Government of India had implemented Centrally Sponsored Scheme of National Ayush Mission (NAM) to promote the cultivation of medicinal plants since 2015-16 to  2020-21.  Under  'Medicinal  Plants'  component  of  the  National  Ayush  Mission  Scheme, market  driven  cultivation  of  140  prioritized  medicinal  plants  in  identified  clusters/zones  was supported and implemented in a mission mode through selected State Implementing agencies throughout the country. As per the scheme guidelines, the support was provided for:

- I. Cultivation of prioritized medicinal plants on farmer's land.
- II. Establishment  of  nurseries  with  backward  linkages  for  raising  and  supply  of  quality planting material.
- III. Post-harvest management with forwarding linkages.
- IV. Primary processing, marketing infrastructure etc.

Ministry of Ayush has approved / supported 56,305 hectare area, 220 nurseries, 354 postharvest management units etc. under medicinal plants component of National Ayush Mission (NAM) from the financial year 2015-16 to 2020-21.

Further, at present National Medicinal Plants Board, Ministry of Ayush is implementing a scheme  entitled  'Central  Sector  Scheme  on  Conservation,  Development  and  Sustainable Management of Medicinal Plants' wherein the following activities are supported:

- (i) In-situ conservation / Ex-situ conservation including establishment of herbal garden.
- (ii) Promotional activities including establishment of nurseries for raising the planting material for plantation, marketing and trade of medicinal plants produce.

(iii) Livelihood linkages with Joint Forest Management Committees (JFMCs) / Panchayats /Van Panchayats / Biodiversity Management Committees (BMCs) / Self Help Groups (SHGs).

(iv) Information Education and communication (IEC) activities like Training / Workshops /Seminars/ Conferences etc.

- (v) Research & Development activities on various aspects of medicinal plants

Central  Council  for  Research  in  Homoeopathy  (CCRH)  under  Ministry  of  Ayush  has Central  of  Medicinal  Plant  Research  Institute  (CMPRH)  at  Emerald,  Nilgiris  district,  is maintaining,  cultivating  the  germplasm  of  104  plant  species  (92  exotic  and  12  indigenous) medicinal  plants  used  in  homoeopathy.  The  raw  drugs  of  these  medicinal  plants  are  being supplied to manufacturers.

The State Government of Odisha is providing funds for procurement of reaw drugs from various  suppliers  and  utilization  of  the  same  in  the  two  Government  Ayurvedic  Pharmacies located at Bhubaneswar and Bolangir each year.

(e)  &  (f)  Yes  Sir.  Ministry  of  Ayush  has  implemented  Central  Sector  Scheme  for  Ayush Oushadhi Gunavatta evam Uttpadan Samvardhan Yojana (AOGUSY) for the year 2021-2026. Under  the  3 rd component  of  AOGUSY  Scheme,  i.e.  'Strengthening  of  central  and  state regulatory  frameworks  including  technical  human  resource  &  capacity  building  programs  for ayush  drugs',  Ministry  of  Ayush    has  initiated  comprehensive  program  for  development  of human  resources  for  the  ASU&H  industry  and  regulatory  personnel  in  the  states.  Details regarding the training conducted for Ayush drug regulators, industry personnel and other stake holders are as follows -

|   Sl No. | Participating States                                                                                             | Host institute/ Venue                                                       |
|----------|------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
|        1 | North Zone Jammu& Kashmir; Ladakh, Himachal Pradesh; Punjab; &Chandigarh, Haryana, Uttarakhand, Delhi            | Regional Ayurveda Institute, Mandi Himachal Pradesh                         |
|        2 | West Zone Rajasthan, Haryana, Uttar Pradesh, Gujarat, Goa, Maharashtra, Daman and Diu, Dadar and Nagar Haveli    | Regional Ayurveda Research Institute for Skin Disorders, Ahmadabad, Gujarat |
|        3 | Soth Zone Tamil Nadu; Andhra Pradesh; Telangana; Kerala; Karnataka; Puduchery; & Lakhsdweep, Andaman and Nicobar | National Institute of Unani Medicine (NIUM), Bangalore, Karnataka           |

As per the information received from State/UT government-

-  Government of Odisha, technical education is imparted in three Government Ayurvedic Medical Colleges of the State located in Puri, Behrampur and Bolangir.
-  Training sessions are being  organized  by  Ayurveda  Drugs  Control  Department, Government of Kerala. In 2022, three sessions of training were provided to manufacturers.

******

## SUMMARY OF PHARMACOPOEIAL AND RELATED PUBLICATIONS

## I. AYURVEDA PHARMACOPOEIAL PUBLICATION

| 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. VI, 2022 (Minerals &Metals                                    |                     20 |
| Ayurvedic Pharmacopoeia of India       | Total                                 | Total                                                              |                    665 |
| Ayurvedic Pharmacopoeia of India       | Part II (Formulations)                | Vol. I, 2007                                                       |                     50 |
| Ayurvedic Pharmacopoeia of India       | Part II (Formulations)                | Vol. II, 2008 Vol. II, 2011 (Hindi Ed.)                            |                     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 Kvātha Cūrṇa (Stand- alone) 2021 |                     01 |
| Ayurvedic Pharmacopoeia of India       |                                       | Total                                                              |                    203 |
| Supporting Pharmacopoeial Publications | Thin Layer Chromatography (TLC) Atlas | API Drugs Pt. I, Vol. I, 2009                                      |                     80 |
| Supporting Pharmacopoeial Publications |                                       | 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 |                                       | 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 Kvātha Cūrṇa (Stand-alone) 2021 |                       01 |
| Ayurvedic Formulary of India | Part IV, 2022 (Veterinary)                                       |                       50 |
| Total                        | Total                                                            |                     1036 |

## II. 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 |
| Siddha Pharmacopoeia of India | Part II (Formulations) | Pharmacopoeial Monograph of Ayush Ku ṭ in ī r Cūra ṇ am (Stand-alone) |                     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 Kuṭinīr Cūraṇam (Stand-alone) |                       01 |
| Siddha Formulary of India | Total                                                          |                      400 |

## III. 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 |
| The Unani Pharmacopoeia of India | Part-I (Single Drug) | Vol. VII, 2022 |                     40 |
| The Unani Pharmacopoeia of India | 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) |                     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) |                       01 |
| National Formulary of Unani Medicine | Total                                                             |                     1230 |

## IV. 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, 2016   | 101                    |
| Homoeopathic Pharmacopoeia of India | Total          | 1,117                  |