Lok Sabha Question No. 4149 (UNSTARRED), answered on 2017-08-11
Subject: Quality of AYUSH Products/Drugs
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: RAHUL KASWAN, DEVJI MANSINGRAM PATEL, RAMESH POKHRIYAL NISHANK, C.S. PUTTARAJU

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

LOK  SABHA UNSTARRED  QUESTION NO. 4149 TO BE ANSWERED ON 11 TH AUGUST , 2017

## Q UALITY OF AYUSH PROD UCTS/DRUGS

## 4149. SHRI RAHUL KASWAN:

SHRI DEVJI M. PATEL:

DR. RAMESH POKHRIYAL 'NISHANK':

SHRI C.S. PUTTA RAJU:

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

- (a) whether the Government has taken steps for standardization and quality control of AYUSH products/drugs in view of the increasing demand in the country;
- (b) if so, the details thereof indicating the medicines and composite drugs of Ayurveda f quality norms have been fixed by the Government;
- (c)  the steps  being  taken  for  abundant  availability  of  desired  medicinal  components manufacturing of medicines;
- (d) the policy to impart modern education and issuing license to persons associated w production and marketing in this sector; and
- (e)  t he  other  steps  being  taken  by  the  Government  to  ensure  nation  wide  quality  contro AYUSH medicines vis a vis keep unskilled and unqualified persons away from treating peo under the said system?

## ANSWER

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

(a)& (b): The Government has established Pharmacopoeia Commission for Indian Medicine an Homoeopathy (PCIM) under the Ministry of AYUSH to develop and revise the norms of qual standards of Ayurvedic, Siddha, Unani and Homoeopathic drugs and publish them in the f orm of monographs  in  respective  pharmacopieas  and  formularies.    As  per  the  provisions  of  D Cosmetics Rules, 1945, quality standards prescribed in the pharmacopoeias are mandatory manufacturing of AYUSH drugs and the enforcement of these provi sions is vested with the State Licensing  Authorities/Drug  Controllers  appointed  by  the  Government.  Ayurvedic  pharmacop contains 645 monographs of single drugs and 202 monographs of compound formulations (incl

24 Asava - Arishta, 12 Arka, 24 Avaleha, 7 Kwath Churna, 17 Guggul, 20 Ghrit, 25 Churna, 37 Tel, 8 Lavan & Kshar, 11 Lepa,  15 Vati - Gutika, 1 Kshar Sutra and 1 Mandoor); Unani Pharmacopoeia contains 298 monographs of single drugs and 150 monographs of compound formulations; Si pharmacopoei a contains 139 monographs of single drugs and Homeopathic Pharmacopoeia contai 1117  monographs.  Similarly,  Ayurvedic  Formulary  encompasses  985  standardized  formulati Unani Formulary 1229 standardized formulations and Siddha Formulary contains 399 sta ndardized formulations.

(c): Medicinal Plants are the major resource base of  raw materials used in the manufac AYUSH medicines. In order to augment the availability of plant raw materials, agro techn cultivation of medicinal plants and Good Agricultural & Collection Practices have been develope and financial support is provided to the states for large scale cultivation of medicinal p Centrally Sponsored Scheme of National AYUSH Mission.  Through the 'Central Sector Sc heme on Conservation, Development and Sustainable Management of Medicinal Plants' National Medicinal Plants Board is providing project based support for resource augmentation of medicinal forest areas and for establishment of Herbal Gardens.

(d ): Educational & training modules of pharmacy are included in the AYUSH course curri and  qualifications  &  experience  of  personnel  associated  with  the  manufacturing  of  Ay Siddha and Unani medicines and manufacturing & sale of Homoeopathic me dicines are prescribed in the Drugs & Cosmetics Rules, 1945 .

(e):    Acquisition  of  valid  license  and  compliance  to  quality  standards  of  drugs  presc respective  pharmacopoeias  and  Good  Manufacturing  Practices  is  legally  mandatory  for  th ma nufactuers.    State  Licensing  Authorities/Drug  Controllers  are  responsible  to  enfo provisions of quality control of AYUSH medicines.  Clinical practice of AYUSH is not without  registration  of  the  practitioner  and  the  qualifications  required for  registration  of  the practitioners are prescribed in the Indian Medicine Central Council Act, 1970 and Homo Central Council Act, 1973.

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