Lok Sabha Question No. 4676 (UNSTARRED), answered on 2025-03-28
Subject: AYUSH Drug Standardization and Quality Control
Ministry: AYUSH
Asked by: Dr. Rani Srikumar

## GOVERNMENT OF INDIA MINISTRY OF AYUSH

## LOK SABHA UNSTARRED QUESTION NO. 4676 TO BE ANSWERED ON 28 th  March 2025

## 'AYUSH Drug Standardization and Quality Control'

## 4676. Dr. Rani Srikumar:

Will the Minister of Ayush be pleased to state: (a) the total number of AYUSH medicines standardized and certified for quality under Central Government Schemes during the last five years, year-wise; (b)  the  details  of  the  funds  allocated,  released  and  utilized  for  establishing  drug  testing laboratories and ensuring quality control of AYUSH products during the same period; (c)  the  measures  being  taken  to  prevent  the  sale  of  substandard  or  adulterated  AYUSH medicines in the domestic and international markets; (d) whether there are plans to establish additional testing laboratories and regulatory bodies to strengthen quality assurance in AYUSH systems; and

- (e) if so, the details thereof?

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

- (a) Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H), a subordinate office under Ministry of Ayush lays down the Formulary specifications and Pharmacopoeial Standards for Ayurveda, Siddha, Unani & Homoeopathic (ASU&H) drugs, which serve as official compendia for ascertaining the Quality Control (identity, purity and strength) of the ASU&H  drugs,  included  therein,  as  per  Drugs  &  Cosmetics  Act,  1940  and  Rules  made thereunder  and  compliance  to  these  quality  standards  are  mandatory  for  the  production  of ASU&H  drug  being  manufactured,  sell  and  stocked  in  India.  The  pharmacopeial  and formulary standards of ASU&H drugs published in last five years are at Annexure-I .

(b),(d)and(e) In the year 2021, Ministry of Ayush has implemented a Central Sector SchemeAyush  Oushadhi  Gunavatta  Evam  Uttpadan  Samvardhan  Yojana  (AOGUSY)  with  total Budget allocation of Rs. 122.00 Crores for five years. The first component of the Scheme is to  Strengthen  and  upgrade  Ayush  Pharmacies  and  Drug  Testing  Laboratories  (DTL)  to achieve higher standards of World Health Organisation-Good Manufacturing Practices((WHOGMP)  and  National  Accreditation  Board  for  Testing  and  Calibration  Laboratories(NABL) standards, respectively.

Till date, Rs. 5.31 Crores have been sanctioned to 12 ASU&H drug testing laboratories under the scheme. The details are annexed as Annexure-II.

(c) 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,  Unani(ASU)  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.

Drug Inspectors collect medicine samples regularly from manufacturing firms or sale shops with in their jurisdiction and sent it to Drug Testing Laboratory under Drug Control department  for  quality  testing  and  if  any  sample  found  to  be  Not  of  Standard  Quality, appropriate  action  is  initiated  as  per  Drugs  and  Cosmetics  Act  1940  and  Rules  made thereunder.

*****

## The pharmacopeial and formulary standards of ASU&H drugs has been published in last five years

## Pharmacopoeia:

| Publication                                              | Volume &Year                     |   Number of Monographs |
|----------------------------------------------------------|----------------------------------|------------------------|
| Formulary Specification of Ayush Kvätha Cürna            | 2020                             |                     01 |
| Formulary Specification of Ayush Kuținir Cüraņam         | 2020                             |                     01 |
| Formulary Specification of Ayush Safüf-i-Joshända.       | 2020                             |                     01 |
| Ayurvedic Pharmacopoeia of India, Part I (Single Drugs)  | Vol. X, 2022 (Minerals &Metals)  |                     20 |
| Ayurvedic Pharmacopoeia of India, Part II (Formulations) | Vol. V, 2025                     |                     21 |
| The Unani Pharmacopoeia of India, Part-I (Single Drug)   | Vol. VII, 2022                   |                     40 |
| The Unani Pharmacopoeia of India, Part II (Formulations) | Vol. IV, 2022 (Improved version) |                     50 |
| Homoeopathic Pharmacopoeia of India                      | Vol. XI, 2025                    |                     68 |

## Formulary Specifications:

| Publication                                        | Part &Year                   |   Number of Formulations |
|----------------------------------------------------|------------------------------|--------------------------|
| Formulary Specification of Ayush Kvätha Cürna      | 2020                         |                       01 |
| Formulary Specification of Ayush Kuținir Cüraņam   | 2020                         |                       01 |
| Formulary Specification of Ayush Safüf-i-Joshända. | 2020                         |                       01 |
| Ayurvedic Formulary of India (Veterinary)          | Part IV, 2022                |                       50 |
| Siddha Formulary of India                          | Part III (Tamil), 2024       |                      133 |
| Siddha Formulary of India                          | Part I Revised (Tamil), 2025 |                      248 |
| National Formulary of Unani Medicine               | Part IV (Revised), 2022      |                      166 |
| National Formulary of Unani Medicine               | Part I (Revised), 2025       |                      441 |

## Supporting document:

| Publication                           | Volume &Year                   |   Number of Monographs |
|---------------------------------------|--------------------------------|------------------------|
| Thin Layer Chromatography (TLC) Atlas | API Drugs Pt. I, Vol. II, 2025 |                     42 |

## Annexure -II

Details of Funds Released under AOGUSY Central Sector Scheme under component- Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards

| S.No.     | F.Y.              | State   | Pharmacy/DTL                                      | Particulars                                           | Amount released   | Amount released   |
|-----------|-------------------|---------|---------------------------------------------------|-------------------------------------------------------|-------------------|-------------------|
| 1         | 2021-22           | Mizoram | DTL                                               | State Govt. of Mizoram                                | Rs.               | 1,800,000         |
| 2 2022-23 | Uttar Pradesh     |         | DTL                                               | Amar Pharmaceuticals and labs (I) Pvt. Ltd. U.P (DTL) | Rs.               | 7,767,000         |
| 3 2023-24 | Tripura           | DTL     | State Govt. of Tripura                            | Rs.                                                   |                   | 7,668,000         |
| 4         | Jammu& Kashmir    | DTL     | State Govt. J&K                                   | Rs.                                                   |                   | 8,629,500         |
| 3 2023-24 | Mizoram           | DTL     | State Govt. Drug Testing Laboratory, Mizoram      | Rs.                                                   | 6,720,884         | 5                 |
| 3 2023-24 | Tamil Nadu        | DTL     | State Govt. Drug Testing Laboratory, Tamil Nadu   | Rs.                                                   | 2,000,000         | 6                 |
| 3 2023-24 | Arunachal Pradesh | DTL     | State Drug Testing Laboratory , Arunachal Pradesh | Rs.                                                   | 1,799,813         | 7                 |
| 2024-25   | Arunachal Pradesh | DTL     | State Drug Testing Laboratory , Arunachal Pradesh | Rs.                                                   | 1,724,400         | 8                 |
| 2024-25   | Tamil Nadu        | DTL     | State Govt. Drug Testing Laboratory, Tamil Nadu   | Rs.                                                   | 5,100,000         | 9                 |
| 2024-25   | Mizoram           | DTL     | State Govt. Drug Testing Laboratory, Mizoram      | Rs.                                                   | 3,940,500         | 10                |
| 2024-25   | Tamil Nadu        | DTL     | State Govt. Drug Testing Laboratory, Tamil Nadu   | Rs.                                                   | 4,157,062         | 11                |
| 2024-25   | Mizoram           | DTL     | State Govt. Drug Testing Laboratory, Mizoram      | Rs.                                                   | 1,800,000         | 12                |
|           |                   |         |                                                   | Total                                                 | Rs.               | 53,107,159        |