Lok Sabha Question No. 3958 (UNSTARRED), answered on 2019-01-04
Subject: Standardisation and Certification of AYUSH Medicines
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: Tejpratap Singh,Yadav, ANJU BALA

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

LOK  SABHA UNSTARRED  QUESTION NO. 3958 TO BE ANSWERED ON 4 TH JANUARY, 2019

## STANDARDISATION AND CERTIFICATION OF AYU SH MEDICINES

## 3958. SHRI TEJ PRATAP SINGH YADAV: SHRIMATI ANJU BALA:

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

- (a)  whether  problems  are  being  faced  by  the  indigenous  medical  streams  for  marketing practicing in foreign countries due to the lack of standardisation and certification of and other AYUSH medicines, if so, the details thereof and the remedial measures taken i regard;
- (b)  whether  the  Government  proposes  to  establish  a  separ ate  regulatory  body  for  the standardisation and certification of AYUSH products/ institutions and if so, the details t
- (c)  whether  there  is  a  need  for  establishing  a  start - up  venture  fund  for  young  AYUSH practitioners to set up new innovative ente rpris s and if so, the details thereof;
- (d)  whether  there  is  also  need  for  a  National  Healers  Network  to  ensure  rights  of communities on knowledge hitherto not disclosed in public domain; and
- (e) if so, the steps being taken by the Government in this regard?

## ANSWER

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

- (a): Yes,  Ayurveda,  Siddha,  Unani  and  Homoeopathy  (ASU&H)  systems  of  medicine  are  not recognized in many foreign countries and have to face problems in doing the practice and for want of enabling regulatory provisions. In India, the medicinal products of ASU&H systems are manufactured under license in accordance with the exclusive regulatory & quality control p standards and Good Manufacturing Practices prescribed in the Drugs and Cosmetics Act, 19 the  Rules  thereunder  and  these  product s  are  often  exported  as  food  supplements,  dietar supplements, health supplements etc fulfilling the specific regulatory requirement of the

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countries.  Quality  standards  of  ASU& H  drugs  including  the  parameters  of  identity,  purity strength and permissible limits of heavy metals, pesticide residue, aflatoxins and micro published  in  the  respective  Pharmacopoeias.  Certification  of  compliance  to  Good  Manufa Pra ctices (GMP) is mandatory for grant of manufacturing license by the State Licensing A and two voluntary certification systems based on WHO guidelines and international standar place to facilitate export of Ayurvedic, Siddha and Unani produ cts. A Central Scheme for promoting AYUSH related International Cooperation has been implemented inter alia with a provision industry  to  avail  financial  support  for  registration  of  ASU&H  products  in  foreign preparation of drug dossiers a nd participation in international fairs or exhibitions.

(b) : The Government of India has set up Pharmacopoeia Commission of Indian Medicine Homoeopathy and four Pharmacopoeia Committees to develop the standards of Ayurvedic, Si Unani and Homoeopathic drugs and publish respective Pharmacopoeias and Formularies, whic official compendia under the provisions of Drugs & Cosmetics Act, 1940 and Rules thereun far, standards of 847 Ayurvedic drugs, 448 Unani drugs, 139 Siddha drugs and 1 117 Homoeopathic drugs have been published in the respective pharmacopoeia.   Similarly, Ministry of AYU Drug Control Cell and a vertical structure of AYUSH has been created within Central Drugs Control  Organization  (CDSCO)  to  oversee  the regulation  of  Ayurvedic,  Siddha,  Unani  and Homeopathy  (ASU&H)  drugs  from  central  level  and  coordinate  with  the  state  drug  regu authorities.

(c): Government has set up Sub - Council on AYUSH under Healthcare Sector Skill Council and there is a proposal under the scheme for champion service sectors through which interested A stakeholders  may  be  supported  for  specific  skill  development  programs  and  young  AY practitioners may venture into innovative enterprises.

(d) & (e): An autono mous organization in the name of North Eastern Institute of Folk Medi Pasighat (Arunachal Pradesh) has been set up under the aegis of Ministry of AYUSH to strengthen and develop traditional health practices for the benefit of the nation, The main aims and objectives of this  institute  include  functioning  as  an  apex  research  centre  for  all  aspects  of  f knowledge with linkages / networking with other research centers, to create an interfa traditional healers and scientific research a nd generation of public awareness about the potentials folk medicine for enhancing public health and of rural communities in particular.

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