Lok Sabha Question No. 1024 (UNSTARRED), answered on 2025-12-05
Subject: AYUSH System of Medicine
Ministry: AYUSH
Asked by: Shri Arun Govil

## GOVERNMENT OF INDIA MINISTRY OF AYUSH

## LOK SABHA UNSTARRED QUESTION NO. 1024 TO BE ANSWERED ON 5 th  December, 2025

## 'AYUSH System of Medicine'

## 1024. Shri Arun Govil:

Will the Minister of AYUSH be pleased to state:

- (a)  the  manner  in  which  the  Government  assures  the  scientific  approach  towards  the manufacturing of the medicines of AYUSH system; and
- (b) the system adopted for determining the prices of AYUSH medicines in the country?

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

- (a) Ministry of Ayush, Government of India has established Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H) as its subordinate office. PCIM&H 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, 2269 quality standards on raw materials (single drugs of plant/ animal/ mineral/ metal/ chemical origin) used in ASU&H drugs, 426 quality standards of ASU formulations and 2799 formulary specifications of ASU drugs have been published. In addition to above, supporting documents in the form of MacroMicroscopic  &  Thin  Layer  Chromatography  (TLC)  Atlas  on  392  single  drugs incorporated in Ayurvedic Pharmacopoeia of India (API) have also been published.

PCIM&H  also  acts  as  the  Appellate  Drugs  Testing  Laboratory  for  testing  or analysis  of  ASU&H  drugs.  In  addition,  it  conducts  capacity-building  trainings  at regular  intervals  for  the  standardization,  quality  control,  and  testing  or  analysis  of ASU&H drugs for Drug Regulatory Authorities, Drug Analysts, and other relevant stakeholders, with a focus on laboratory techniques and methodologies essential for ensuring the quality of ASU&H drugs.

Further,  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 Good Manufacturing Practices (GMP) as per Schedule  T  of  the  Drugs  Rules,  1945  and  quality  standards  of  drugs  given  in  the respective pharmacopoeia.  As on date, there are 34 State Drug Testing Laboratories and 108 private Drug Testing Laboratories approved or licensed under Rule - 160 A to  J  of  the  Drugs  Rules,  1945,  for  quality  testing  of  Ayurvedic,  Siddha  and  Unani drugs and raw materials.

The quality of medicinal plants is ensured by promoting Good Agricultural and Collection  Practices  (GACP).  Digital  supply-chain  tracking  system  is  available  for raw material sourcing and authentication.

Twelve  National  Institutes  and  five  Research  Councils  under  the  Ministry  of Ayush are engaged in coordinating, formulating, developing, and promoting research on scientific lines in the Ayush systems of healthcare. Their research covers a wide range of areas, including clinical studies, medicinal plant research, and the standardization and quality control of Ayush medicines.

(b) The Price Control Order applies only to those medicines that are specified under clause (b) of Section 3 of the Drugs and Cosmetics Act, 1940 and  are listed in the Schedule provided under Section 2A of the Essential Commodities Act, 1955. These scheduled medicines do not include drugs of the Ayurveda, Siddha, Sowa-Rigpa, and Unani systems.

However,  the  market  prices  of  Ayush  medicines  depend  on  several  factors, including fluctuating prices of raw materials, intermediates, packaging materials, etc.

At present, the determination of these costs depends on prices fixed by several other sectors.

***************