**Executive Summary**
This document is a response to Unstarred Question No. 1024 in Lok Sabha regarding the Government's assurance of scientific approach to manufacturing and price determination of AYUSH medicines, to be answered on December 5th, 2025. It outlines the quality control measures in place for ASU&H drugs and the system for determining their prices. The Ministry of AYUSH assures quality through standards and monitoring while price control applies only to certain medicines specified under the Drugs and Cosmetics Act, excluding Ayurveda, Siddha, Sowa-Rigpa, and Unani systems.
**Key Points / Main Content**
* **Quality Assurance of ASU&H Drugs:**
* The Ministry of Ayush established PCIM&H as its subordinate office, which lays down formulary specifications and pharmacopoeial standards for ASU&H drugs.
* Compliance with these quality standards, as per the Drugs & Cosmetics Act, 1940, is mandatory for ASU&H drug production in India.
* 2269 quality standards on raw materials, 426 quality standards of ASU formulations, and 2799 formulary specifications of ASU drugs have been published.
* Macro-Microscopic & TLC Atlas on 392 single drugs incorporated in API have been published.
* PCIM&H acts as the Appellate Drugs Testing Laboratory for ASU&H drugs.
* Capacity-building trainings on standardization, quality control, and testing of ASU&H drugs are conducted.
* Manufacturers must adhere to licensing requirements, GMP as per Schedule T of the Drugs Rules, 1945 and quality standards.
* 34 State and 108 private Drug Testing Laboratories are approved for quality testing.
* Quality of medicinal plants is ensured by promoting GACP. A digital supply-chain tracking system is available.
* Twelve National Institutes and five Research Councils are engaged in coordinating, formulating, developing, and promoting research on Ayush systems.
* **Pricing of AYUSH Medicines:**
* The Price Control Order applies only to medicines specified under the Drugs and Cosmetics Act, 1940, and listed in the Essential Commodities Act, 1955.
* Ayurveda, Siddha, Sowa-Rigpa, and Unani systems drugs are not included in this category.
* Market prices of Ayush medicines depend on raw material prices, intermediates, and packaging materials.
**Impact Analysis**
**Stakeholder: ASU&H Drug Manufacturers**
* **Impact:** Must comply with quality standards, Good Manufacturing Practices, and licensing requirements for manufacturing units and medicines to ensure quality and safety.
* **Action Required:** 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.
**Stakeholder: Drug Regulatory Authorities and Drug Analysts**
* **Impact:** Expected to enforce quality standards and participate in capacity-building trainings to ensure the quality of ASU&H drugs.
* **Action Required:** Standardize, quality control, and test or analyse ASU&H drugs
**Stakeholder: Ministry of AYUSH**
* **Impact:** Responsible for overseeing the quality assurance process and promoting research and development in Ayush systems.
* **Action Required:** Coordinate, formulate, develop, and promote research on scientific lines in the Ayush systems of healthcare
**Stakeholder: Consumers of ASU&H Medicines**
* **Impact:** Assured of the quality and safety of ASU&H medicines due to established standards and monitoring processes.
* **Action Required:** No action required, but benefit from the assurance of quality and safety in ASU&H medicines.
Key Entities Referenced
Ministry of AYUSH: The ministry responsible for the development and propagation of AYUSH systems of medicine in India.
Drugs & Cosmetics Act, 1940: The primary legislation governing the quality standards and manufacturing of drugs, including AYUSH drugs, in India.
Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H): A subordinate office under the Ministry of AYUSH responsible for laying down formulary specifications and pharmacopoeial standards for ASU&H drugs.
ASU&H drugs: Ayurveda, Siddha, Unani and Homoeopathy drugs.
Drugs Rules, 1945: Rules under the Drugs & Cosmetics Act, 1940 that specify the requirements for the licensing of manufacturing units & medicines including proof of safety & effectiveness, compliance with Good Manufacturing Practices (GMP) as per Schedule T.
GOVERNMENT OF INDIA
MINISTRY OF AYUSH
LOK SABHA
UNSTARRED QUESTION NO. 1024
TO BE ANSWERED ON 5th 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 Macro-
Microscopic & 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.
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