Lok Sabha Question No. 1002 (UNSTARRED), answered on 2025-12-05
Subject: Regulatory Compliance for ASU Drug Manufacturers
Ministry: AYUSH
Asked by: Dr. T Sumathy Alias Thamizhachi Thangapandian

## GOVERNMENT OF INDIA MINISTRY OF AYUSH

## LOK SABHA UNSTARRED QUESTION NO. 1002 TO BE ANSWERED ON 05 th  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, SowaRigpa, 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,

Sowa-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.

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 Samples Tested |   Standard Quality | Not of Standard quality   |
|--------------------------------------------------------------------------------------|---------------------------|------------------------------|--------------------|---------------------------|
| Statutory samples collected in Tamil Nadu                                            | January 2025 to till date |                         1925 |               1891 | 34                        |
| Statutory samples received from Andaman & Nicobar as per memorandum of understanding | January 2025 to till date |                           37 |                 37 | -                         |

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