Lok Sabha Question No. 141 (UNSTARRED), answered on 2019-06-21
Subject: Quality of Ayurvedic Medicines
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: T.N. Prathapan

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

LOK  SABHA UNSTARRED  QUESTION NO . 141 TO BE ANSWERED ON 21 ST JUNE, 2019

## QUALITY OF AYURVEDIC MEDICINES

## 141. SHRI T.N. PRATHAPAN:

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

(a)  whether  the  Government  has  taken  any  measures  to  monitor  the  quality  of  Ayurved medicines in the country, particularly in the State of K eral  which is home to many traditional Ayurvedic treatment centres and medicine manufacturing units;

(b) if so, the details thereof;

(c) the steps taken by the Government to check the circulation and production of fake Ayu products which are haz ardous to health;

(d) whether there is any mechanism to check the advertisements of such fake products; and

- (e) if so, the details thereof?

## ANSWER

## THE MINISTER OF STATE (IC) OF THE MINISTRY OF AYURVEDA, YO GA & NATUROPATHY, UNANI, SIDDHA AND HOMOEOPATHY (SHRI SHRIPAD YESSO NAIK)

(a) & (b): The regulatory and quality control mechanism for Ayurvedic medicines is establi the country in accordance with the exclusive provisions of the Central Drugs & Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945. In this regard, Central Government is vested powers to make and amend the legal provisions and to give direction to the State Gover achieve the objectives of Central Act and th e State Governments are responsible to enforce the le provisions for manufacturing and quality of Ayurvedic drugs.  Requirements of complyin quality standards and proof of safety & effectiveness for licensed manufacturing of Ayurv areprescribed in the Drugs & Cosmetics Rules, 1945 and the standards of these drugs are in the Ayurvedic Pharmacopoiea. Similarly, practice of Ayurveda in the country and in well is regulated under the provisions of Indian Medicine Central Council Act, 1970.

Government  of  Kerala  has  reported  to  have  taken  adequate  measures  to  monitor manufacturing and sale of Ayurvedic medicines including appointment of Licensing Authorit

Inspectors, Government Analyst and Drug Testing Laboratories. Inspection of manufacturing units is carried out by the Drugs Inspectors, drug samples are tested in the laboratories and leg initiated against violation of the provisions of Drugs & Cosmetics Act 1940 & Rules 1945 and Drugs & Magic Remedies (Objectionable Advertisements) Act 1954 and Rules1955. Efforts of the K State  have  been  supported  with  grant -in - aid  through  Centrally  Sponsored  Scheme  of  National AYUSH Mission.

(c): Government hasset up Pharmacopoeia Commission of Indian Medicine & Homoeopathy and Ayurvedic  Pharmacopoiea  Committee  to  develop  the  standards  of  Ayurvedic  medicines.    G Manufacturing Practices are prescribed under the Drugs & Cosmetics Rules, 1945 and Ayurvedic Pharmacopoiea and Formulary containing standardized formulations and quality standards hav published,  which  are  mandatory  for  the  manufacturing  and  distribution  of  Ayurvedic  med Misbranded, spurious, adulterated or substandard Ayurve dic medicines, which could be hazardous to human health,  are defined in the Drugs & Cosmetics Act along with the penal provisions quality testing of Ayurvedic medicines, a central laboratory and 27 State laboratories ar and 58 labora tories are licensed under the provisions of Drugs & Cosmetics Rules, 1945.

( d)  &  e): In order to check the veracity of misleading advertisements and exaggerated c Ayurvedic and other medicinal products, the Central Government has taken foll owing steps -

- i) Regulatory  mechanism  for  prohibition  of  misleading  advertisements  and  exagge claims of drugs including Ayurvedic medicinal products is prescribed in the Dr Magic  Remedies  (Objectionable  Advertisements)  Act,  1954  and  Rules  thereund er. Accordingly, State Governments are empowered and have appointed Gazetted Officer enter and search any premises or examine or seize any record, which contraven provisions of the said Act.
2. ii) Rule 170 under Drugs & Cosmetics Rules, 1945 has been recently notified specifically for prohibition of misleading advertisements of Ayurvedic, Siddha and Unani drugs.
3. iii) Department  of  Consumer  Affairs  has  launched  an  online  portal  for  public  comp against misleading advertisements including advertisemen ts of Ayush products. Complaints registered in the portal against the advertisement of Ayurvedic pro forwarded to the respective State Licensing Authority for appropriate action in with the legal provisions.
4. iv) Ministry  of  AYUSH  signed  a MoU  with  the  Advertising  Standards  Council  of  India (ASCI) to undertake monitoring of the misleading advertisements of AYUSH appear in print and TV media and bring the instances of improper advertisements to the the State Regulatory Authoritie s for taking necessary action.
- v) Ministry  of  AYUSH  has  implemented  a  central  scheme  of  pharmacovigilance  und which  surveillance  of  AYUSH  drugs  related  advertisements  is  done  by  the  iden centres and the defaulters are reported to the concerned State Authorities.

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