**Executive Summary**
This document is the response from the Minister of AYUSH to a parliamentary question regarding regulatory compliance for Ayurvedic, Siddha, and Unani (ASU) drug manufacturers in Tamil Nadu, set to be answered on December 5th, 2025. The response details the regulatory framework, enforcement mechanisms, and capacity-building efforts in place to ensure the quality and safety of ASU drugs in Tamil Nadu. It further discusses the consultations with state authorities on these matters.
**Key Points / Main Content**
* **Regulatory Framework and Enforcement:**
* Enforcement of quality control and drug licensing for ASU and Homoeopathy drugs is vested with State drug controllers/licensing authorities under the Drugs & Cosmetics Act, 1940, and Drugs Rules 1945.
* Tamil Nadu State Drug Inspectors regularly inspect manufacturing premises to ensure safety, raw material quality, and compliance with Good Manufacturing Practices (GMP).
* **Drug Testing and Infrastructure:**
* Tamil Nadu has one State Drug Testing Laboratory (Indian Medicine) and one Government Analyst facilitating testing of ASU drugs.
* The Ministry of AYUSH has supported the State Drug Testing Laboratory with a grant of ₹1.12 crore for strengthening and upgrading under the AOGUSY scheme.
* 14 private drug testing laboratories are recognized in Tamil Nadu for testing raw materials and drugs under Rule 160 E of Drugs Rules 1945.
* 1925 statutory samples collected in Tamil Nadu were tested, out of which 1891 were of standard quality.
* 37 statutory samples were received from Andaman & Nicobar.
* **Labeling, Packaging, and Manufacturing Practices:**
* Labeling and packing provisions for ASU drugs are mentioned in Rule 161 of Drugs Rules 1945; exemptions for exports are in Rule 161A.
* Schedule T of Drugs Rules 1945 covers Good Manufacturing Practices for ASU drugs.
* Vaidyas and Hakims manufacturing ASU drugs for their own patients are exempted from certain provisions of the Drugs and Cosmetics Act and Rules.
* **Capacity Building:**
* The Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H) conducts quarterly capacity building training (CBT) programs for stakeholders involved with ASU&H drugs, including regulators, manufacturers, and technical personnel.
* Over the last three financial years, PCIM&H conducted 11 CBT programs, with 207 participants including 7 from the Siddha system.
* **Consultation and Coordination:**
* The Ministry of AYUSH consults with State/UT Governments, including Tamil Nadu, on ASSU drug matters.
* The Central Government has constituted the Ayurvedic, Siddha, and Unani Drugs Consultative Committee, with representatives from State/UT Governments, to advise on securing uniformity in administering the Drugs and Cosmetics Act, 1940 for ASSU drugs.
**Impact Analysis**
**Tamil Nadu ASU Drug Manufacturers**
* **Impact:** Must adhere to quality control standards, GMP, and labeling/packaging provisions as per the Drugs & Cosmetics Act and Rules. Compliance with State Drug Inspectors' inspections is required.
* **Action Required:** Ensure manufacturing premises meet GMP standards, and comply with labeling and packaging regulations.
**State Drug Controllers/Licensing Authorities (Tamil Nadu)**
* **Impact:** Responsible for enforcing quality control and issuing drug licenses for ASU drugs.
* **Action Required:** Continue regular inspections of manufacturing premises and enforce compliance with the Drugs & Cosmetics Act and Rules.
**State Drug Testing Laboratory (Tamil Nadu)**
* **Impact:** Facilitates the testing of Ayurveda, Siddha, Sowa-Rigpa, Unani, and Homoeopathy drugs.
* **Action Required:** Maintain and upgrade testing infrastructure to ensure accurate and timely testing of ASU drug samples.
**Vaidyas and Hakims in Tamil Nadu**
* **Impact:** While exempted from certain provisions when manufacturing for their own patients, they must still adhere to relevant safety and quality standards.
* **Action Required:** Stay informed on relevant guidelines and ensure their practices align with ethical and safety standards.
**PCIM&H**
* **Impact:** Responsible for conducting capacity building training programs.
* **Action Required:** Continue providing quarterly CBT Programs.
**Ministry of Ayush**
* **Impact:** Overseeing compliance of all ASU drugs.
* **Action Required:** Continue to provide funding and consult with state governments on ASU drug matters.
Key Entities Referenced
Drugs & Cosmetics Act, 1940: Governs the enforcement of legal provisions pertaining to quality control and issuance of drug licenses for Ayurveda, Siddha, Sowa-Rigpa, Unani and Homoeopathy drugs.
Drugs Rules 1945: Contains specific regulations and rules related to drugs, including those pertaining to ASU (Ayurveda, Siddha, Unani) drugs; referenced for rules on labelling, packaging, and manufacturing practices.
Ministry of AYUSH: The primary ministry overseeing Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy, responsible for addressing regulatory compliance issues faced by ASU drug manufacturers.
Tamil Nadu: The specific location where the regulatory compliance issues for ASU drug manufacturers are under review, including state drug testing laboratories and state licensing authorities.
Ayush Oushadhi Gunvatta Evam Uttpadan Samvardhan Yojana (AOGUSY): Central Sector Scheme that supports the strengthening and upgradation of State Drug Testing Laboratories.
GOVERNMENT OF INDIA
MINISTRY OF AYUSH
LOK SABHA
UNSTARRED QUESTION NO. 1002
TO BE ANSWERED ON 05th DECEMBER 2025
Regulatory Compliance for ASU Drug Manufacturers
1002. Dr. T Sumathy Alias Thamizhachi Thangapandian:
Will the Minister of AYUSH be pleased to state:
(a) whether the Government has undertaken any recent review of regulatory compliance issues
faced by drug manufacturers and practitioners of Ayurvedic, Siddha and Unani (ASU) in Tamil
Nadu and if so, the details thereof;
(b) whether the Government has assessed the capacity of State drug-testing laboratories and
Government Analysts in Tamil Nadu, if so, the details thereof and the steps being taken to
strengthen testing, reduce pendency and upgrade lab infrastructure;
(c) whether the Government proposes to issue simplified guidance or phased compliance support
for small Siddha and other ASU practitioners who face challenges in labelling, packaging and
documentation and if so, the details thereof; and
(d) the details of consultations held with State Licensing Authorities in Tamil Nadu on these
matters?
ANSWER
THE MINISTER OF STATE (IC) OF MINISTRY OF AYUSH
(SHRI PRATAPRAO JADHAV)
(a) As per the Drugs & Cosmetics Act, 1940 and Drugs Rules 1945, enforcement of the legal
provisions pertaining to quality control and issuance of drug license of Ayurveda, Siddha, Sowa-
Rigpa, Unani and Homoeopathy drugs is vested with the State drug controllers/ State licensing
authorities appointed by the concerned State/ Union Territory Government.
Further, as per the information received from State Government of Tamil Nadu, State
Drug Inspectors (Indian Medicine) of Govt. of Tamil Nadu regularly undertake inspections of
manufacturing premises to ensure Safety and quality of raw materials, compliance of final
products with prescribed regulatory standards and adherence to Good Manufacturing Practices
(GMP).
(b) In the State of Tamil Nadu, one State Drug Testing Laboratory (Indian Medicine) and one
Government Analyst are currently functioning to facilitate the testing of Ayurveda, Siddha,
1Sowa-Rigpa, Unani, and Homoeopathy drugs. The State Drug Testing Laboratory has been
supported by the Ministry of Ayush with a grant of ₹1.12 crore for its strengthening and
upgradation under the Central Sector Scheme Ayush Oushadhi Gunvatta Evam Uttpadan
Samvardhan Yojana (AOGUSY).
Further, 14 private drug testing laboratories are recognized in Tamil Nadu under Rule
160 E of Drugs Rules 1945 for testing of raw materials and drugs. As per the information
received from Tamil Nadu state, details of sample tested by state drug testing laboratory, Tamil
Nadu are placed at Annexure.
(c) Labelling and packing provisions for Ayurveda, Siddha, Sowa-Rigpa and Unani (ASSU)
drugs are mentioned under Rule 161 of Drugs Rules 1945. Exemption in labelling and packing
provisions for export of Ayurveda (including Siddha) and Unani Drugs are mentioned under
Rule 161A of Drugs Rules 1945. Further, the provisions for good manufacturing practices for
Ayurveda, Siddha, Sowa-Rigpa and Unani drugs are mentioned under schedule T of Drugs Rules
1945. As per section 33EEC of Drugs and Cosmetics 1940, Vaidyas and Hakims who
manufacture Ayurveda, Siddha or Unani drug for the use of their own patients are exempted
from the provisions of Drugs and Cosmetics Act and Rules made there under.
Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H) is a
subordinate office under Ministry of Ayush, conducts quarterly capacity building training (CBT)
Programmes for a wide range of stakeholders, including drug regulators/enforcement authorities,
quality control and technical personnel associated with ASU&H drugs, ASU&H drug
manufacturers, Ayush-accredited State/UT’s Drug Testing Laboratories, faculty of ASU&H
pharmacy colleges, and technical personnel from other scientific institutions. During the last
three financial years, PCIM&H has conducted a total of 11 CBT Programmes, in which 207
participants including 07 participants from Siddha system took part.
(d) Ministry of Ayush consult State/UT’s Government including Tamil Nadu Government on
various matters of ASSU drugs. As per section 33 D of Drugs and Cosmetics Act 1940, Central
Government constitutes Ayurvedic, Siddha and Unani Drugs Consultative Committee with
representatives from State/UT Governments including Tamil Nadu government to advise the
Central Government, the State Governments and the Ayurvedic, Siddha and Unani Drugs
Technical Advisory Board on any matter for the purpose of securing uniformity throughout India
in the administration of Drugs and Cosmetics Act, 1940 in respect of ASSU drugs.
2Annexure
As per the information received from Tamil Nadu state, details of sample tested by state drug
testing laboratory, Tamil Nadu are as follows: -
Samples Duration Total No of Standard Not of
Samples Quality Standard
Tested quality
Statutory samples collected in January 2025 to till 1925 1891 34
Tamil Nadu date
Statutory samples received January 2025 to till 37 37 -
from Andaman & Nicobar as date
per memorandum of
understanding
****
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