Lok Sabha Question No. 98 (UNSTARRED), answered on 2017-12-15
Subject: Clinical Trials for Ayurvedic Medicine
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: PARASURAMAN K.

## GOVERNMENT OF INDIA MINISTRY OF AYURVEDA, YOGA & NATUROPATHY, UNANI, SIDDHA AND HOMOEOPATHY (AYUSH)

LOK  SABHA UNSTARRED  QUESTION NO. 98 TO BE ANSWERED ON 15 TH DECEMBER, 2017

## CLINICAL TRIALS FOR AYURVEDIC MEDICINE

## 98. SHRI K. PARASURAMAN:

Will  the  Minister of AYURVEDA,  YOGA  AND  NATUROPATHY,  UNANI, SIDDHA AND HOMOEOPATHY (AYUSH) be pleased to state:

- (a) the total number of permissions granted by the Government for clinical trials for a medicines;
- (b) whether the Government has constituted regulatory board for Indian traditional medicine the line of Drugs Controller General of India; and
- (c) if so, the details thereof and the steps taken by the Government to regulate producti sale of Indian tra ditional medicines?

## ANSWER THE MINISTER OF STATE (IC) OF THE MINISTRY OF AYURVEDA, YOGA & NATUROPATHY, UNANI, SIDDHA AND HOMOEOPATHY

## (SHRI SHRIPAD YESSO NAIK)

- (a):          The  Government  has  granted  permission  for conducting  clinical  trials  on  ten Ayurvedic drugs.
- (b):     Ministry of AYUSH has notified the creation of twelve regulatory post Inspectors, Assistant Drug Controllers and Deputy Drug Controllers as a part of t regulatory framework for administering the provisions of Drugs & Cosmetics A ct, 1940 and Rules thereunder pertaining to Ayurvedic, Siddha, Unani and Homoeopathy drugs.
- (c ):     Recruitment rules for the said regulatory posts have been framed and th from  Department  of  Personnel  & Training,  Union  Public  Service  Commission  and  Law Ministry is in the process. Meanwhile, additional charge of these posts has been g respective  Technical  Officers  of  the  Ministry  of  AYUSH  till  the  regular  offi appointed. Manufacturing o f Ayurvedic, Siddha and Unani medicines for sale is regulate the country with the exclusive provisions provided in chapter IVA of the Drugs & C Act, 1940 and in Rules 151 to 169 of the Drugs & Cosmetics Rules, 1945.  These reg provision s are framed and amended by the Central Government on the advice of Ayurve Siddha and Unani Drugs Technical Advisory Board and are enforced by the State

Governments.  License is mandatory for the commercial manufacturing of Ayurvedic, Siddha and Unani medicines and following steps have been taken to regulate their production and sale -

- i. Pharmacopoeia Commission of Indian Medicine & Homoeopathy and Pharmacopoiea Committees have been set up to lay down the quality standards of Ayurvedic, S Unan i and Homoeopathic drugs, which are published in the respect pharmacopoeias and are mandatory for the manufacturers to follow in manufacturing of these medicines.
- ii. Good  Manufacturing  Practices  (GMP)  and  requirements  for issue  of  license  to manufactu re various types of Ayurvedic, Siddha and Unani medicines on the bas evidence of safety and effectiveness are prescribed in the Drugs & Cosmetics 1945.
- iii. Rules for indicating shelf - life or expiry date on the labels of the ASU&H medicin have  be en  notified  and  similarly,  a  provision  to  display  'caution'  for  consuming medicines made from potentially hazardous ingredients under medical supervisi mandatory in the Drugs & Cosmetics Rules.
- iv. Quality Certification systems for the ASU products ha ve been introduced.
- v. Central  and  State  Drug  Testing  Laboratories  for  ASU  drugs  are  in  place  a private laboratories have been approved under the Drugs & Cosmetics Rules, 19 the quality analysis of ASU drugs and raw materials.
- vi. Grant - in - aid  is provided  through  the  Centrally  Sponsored  Scheme  of  Nationa AYUSH  Mission  for  the  quality  control  activities  of  ASU&H  medicines  includ strengthening of state pharmacies, drug testing laboratories and enfo framework.

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