Lok Sabha Question No. 642 (UNSTARRED), answered on 2016-02-26
Subject: Regulatory Body for AYUSH
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: NARANBHAI KACHHADIA, FEROZE VARUN GANDHI, MANOJ RAJORIA, SANJAY JAISWAL, DILIP KUMAR MANSUKHLAL GANDHI, JAGDAMBIKA PAL, CHANDRA PRAKASH JOSHI, P.P. CHAUDHARY, B.V. NAYAK, S.P. MUDDAHANUMEGOWDA

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

## LOK  SABHA UNSTARRED QUESTION NO. 642 TO BE ANSWERED ON 26 TH FEBRUARY, 2016

## REGULATORY BODY FOR AYUSH

## 642. SHRI NARANBHAI KACHHADIYA:

SHRI FEROZE VARUN GANDHI:

DR. MANOJ RAJORIA:

DR. SANJAY JAISWAL:

SHRI DILIPKUMAR MANSUKHLAL GANDHI:

SHRI JAGDAMBIKA PAL:

SHRI CHANDRA PRAKASH JOSHI:

SHRI P.P. CHAUDHARY:

SHRI B.V. NAIK:

SHRI S.P. MUDDAHANUME GOWDA:

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

- (a)  whether  the  Government  is  aware  the  problems  being  faced  by  the  indigenous  medic streams for marketing and practicing in foreign countries due to the 196 lack of standar and certification of Ayurveda and other medicines and if so, the details thereof;
- (b) whether the Government proposes to establish a centralized/separate regulatory body/a for the standardisation and certification on AYUSH products and related inst itutions;
- (c)  if  so,  the  details  thereof  along  with  the  role/function  and  the  composition body/agency and if not, the reasons therefor for delaying the process for establishing a body/agency;
- (d) the manner in which the Government ma intains the balance between the drugs promotion pattern under DCGI and the new body/agency for AYUSH; and
- (e) the further steps taken/being taken by the Government to promote scheme for standardi and certification in this regard?

## ANSWER

## THE MINIST ER 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 regulated in many foreign countries; therefore the practice of these systems and marke

their medicinal productsper se is not allowed in such countries. In India, the medicines of ASU& H systems are licensed and manufactured in the country in accordance with the regula provisions, standards and Good Manufacturing Practices prescribed in the Drugs and Cosme Act, 1940 and the Rules thereunder and these are often exported as food su pplements or dietary supplements  because  of  non - fulfillment  of  the  regulatory  requirements  of  the  importin countries.  The  Government  has  set  up  Pharmacopoeia  Commission  of  Indian  Medicine  & Homoeopathy and Pharmacopoeia Committees to develop the standards of Ayurvedic, Siddha, Unani and Homoeopathic drugs. Quality standards of ASU&H drugs including the parameters o identity, purity and strength and permissible limits of heavy metals, pesticide residue, and microbial load are published in the re spective Pharmacopoeias. Certification of compliance to Good Manufacturing Practices (GMP) in the manufacturing unit is mandatory for grantin license by the State Licensing Authority and two voluntary certification systems based on guidelines and Q uality Council of India scheme are in place for the industry interested to Ayurvedic,  Siddha  and  Unani  drugs.    A  Central  Scheme  for  promoting  AYUSH  related International  Cooperation  has  a  provision  for    the  industry  to  avail  financial  sup re gistration of products in foreign countries,  preparation of drug dossiers and partic international fairs or exhibitions.

(b) to (d): Government has considered setting up a structured central regulatory regime AYUSH drugs. In this regard , the current proposal is to develop a vertical structure for AYU in  the  Central  Drugs  Standard  Control  Organization  (CDSCO).  Accordingly,  amendments required in the Drugs & Cosmetics Act, 1940 pertaining to regulation of Ayurvedic, Si Unani,  Sowa - r igpa  and  Homoeopathy  drugs  have  been  conceptualized  and  conveyed  to  the Department of Health & Family Welfare under whose jurisdiction the proposals of amendi Drugs & Cosmetics Act, 1940 and strengthening of CDSCO are being processed. Ministry o AYUSH  h as  notified  creation  of  12  posts  of  Deputy  Drugs  Controllers,  Assistant  D Controllers and Inspectors of ASU&H and the matter of vertical structure for AYUSH drugs CDSCO has been followed up regularly with the Department of Health & FW.

( e) : Voluntary  certification  scheme  of  Quality  Council  of  India  has  been  developed  w support from Ministry of AYUSH. 323 products of seven Ayurvedic manufacturers are reporte to  have  been  certified  under  this  scheme.        Government  set  up  a  Task  Force  unde r  the chairmanship  of  Prof.  H.R.  Nagendra  with  specific  terms  of  reference  for  development AYUSH.    Report  of  the  Task  Force  has  been  received  and  its  recommendations  about standardization and certification scheme are being examined in the Ministry of AY USH.

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