Lok Sabha Question No. 876 (UNSTARRED), answered on 2025-02-07
Subject: Surveillance of AYUSH Medicine
Ministry: AYUSH
Asked by: Shri Sachithanantham R

## GOVERNMENT OF INDIA MINISTRY OF AYUSH

## LOK SABHA UNSTARRED QUESTION NO. 876 TO BE ANSWERED ON 7 th  February 2025

## 'Surveillance of AYUSH Medicine'

## 876. Shri Sachithanantham R:

Will the Minister of Ayush be pleased to state:

- (a) whether the Government has taken any initiatives to conduct post-marketing surveillance of AYUSH medicines to track their safety and efficacy, harmonise standards of AYUSH medicines with international norms and develop systems to report adverse events related to medicines in the country  in view of the recommendation of the Standing Committee on Health and Family Welfare related to high metal content;
- (b) if so, the details thereof; and
- (c) if not, the reasons therefor?

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

(a) to (c) The 156 th report of Department-Related Parliamentary Standing Committee on Health and Family welfare has raised its concern over the high metal contents in the Ayush drugs, further the Committee recommended Ministry of Ayush to strengthen regulatory framework to conduct regular post-marketing surveillance. The Ministry has taken following initiatives in this regard;

1.  Ministry  of  Ayush  has  implemented  a  Central  Sector  Scheme-  Ayush  Oushadhi  Gunavatta evam  Uttpadan  Samvardhan  Yojana  (AOGUSY).  One  of  the  components  of  this  scheme  is Pharmacovigilance Program for Ayurveda, Siddha, Unani, and Homoeopathy (ASU & H) Drugs including surveillance of misleading advertisements. A three tier structure  is  established across the  country  since  2018  comprising  of  a  National  Pharmacovigilance  Co-ordination  Centre (NPvCC),  Five  Intermediary  Pharmacovigilance  Centres  (IPvCs)  and  Ninety-nine  Peripheral

Pharmacovigilance Centres (PPvCs). 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. The vision of the program is to improve patient safety in Indian population by monitoring the drug safety in ASU & H drugs by keeping vigilance over the post marketing use  of  ASU&H  drugs  and  reporting  culture  of  suspected  Adverse  Drug  Reactions,  keeping surveillance  of  misleading  advertisements  appearing  in  print  and  electronic  media,  organising awareness  events  regularly  across  the  country  to  generate  awareness  regarding  the  Ayush therapeutic approaches and educating healthcare professionals about the systematic use of Ayush drugs.

2. As prescribed in Drugs and Cosmetics Act 1940 and Rules made thereunder, enforcement of the  legal  provisions  pertaining  to  Quality  Control  and  issuance  of  drug  license  of  Ayurveda, Siddha, Unani and Homoeopathy 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 Homoeopathy  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.  Drug  Inspectors  collect  medicine  samples  regularly  from  industries and  Markets  and  sent  it  to  State  Drug  Testing  Laboratory  for  quality  testing  and  take  further necessary action(s) on the basis of such tests reports as per Drugs and Cosmetics Act 1940 and Rules made thereunder .

3.  Pharmacopoeia  Commission  for  Indian  Medicine  &  Homoeopathy(PCIM&H)  on  behalf  of Ministry  of  Ayush  lays  down  the  Formulary  specifications  and  Pharmacopoeial  Standards  for ASU&H drugs, which serve as official compendia for ascertaining the Quality Control (identity, purity and strength) of the ASU&H drugs, included herein, as per Drugs & Cosmetics Act, 1940 and Rules 1945 and compliance to these quality standards are mandatory for manufacturing, sale and stock of ASU&H drugs in India. The quality parameters included in the Pharmacopoeias and

Formularies of Ayurveda, Siddha, Unani &  Homoeopathic (ASU&H)  drugs prescribing mandatory  regulatory  standards  have  been  identified  to  align  the  parameters  prescribed  by WHO/other major pharmacopoeias prevalent worldwide. Implementation of these pharmacopoeial standards ensures optimum quality standards in terms of identity, purity and strength of ASU&H drugs. The details of work done by PCIM&H are attached at Annexure.

## Details of work done by PCIM&H

1. 2259 quality standards on raw materials (Single Drugs of plant/animal/Mineral/metal/ Chemical origin) used in ASU&H have been published, the details are as below;
2. 405 quality standards of ASU  formulations have also been published in respective Pharmacopoeias. The details as follows:
3. 2799 formulary  specifications  of  ASU  drugs  are  also  published  in  Formularies  of  respective system. 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 X)      |                                          1117 |

| Name of Pharmacopoeia                                    | Published quality standards of formulations   |
|----------------------------------------------------------|-----------------------------------------------|
| Ayurvedic Pharmacopoeia on India (Part II, Vol. I to IV) | 202 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        |

| Formulary                            | Specifications                                                |
|--------------------------------------|---------------------------------------------------------------|
| Ayurvedic Formulary of India         | 1035 (Part I to IV) and 01 standalone formulary specification |
| Siddha Formulary of India            | 533 (Part I to III) and 01 standalone formulary specification |
| National Formulary of Unani Medicine | 1229 (Part I to VI) and 01 standalone formulary specification |

4. In addition to above, supporting documents in the form of Macro-Microscopic & TLC Atlas on 351 single drugs incorporated in API are also published.

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