Lok Sabha Question No. 3716 (UNSTARRED), answered on 2017-03-24
Subject: Quality of AYUSH Drugs
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: JAYADEV GALLA

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

## LOK  SABHA UNSTARRED  QUESTION NO. 3716 TO BE ANSWERED ON 24 TH MARCH, 2017

## QUALITY OF AYUSH DRU GS

## 3716. SHRI JAYADEV GALLA:

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

- (a)  whether  the  Government  has  any  regulatory  mechanism  to  check  the  quality  of  AYUSH drugs in the country and if so, the details thereof;
- ( b)  the  manner  in  which  AYUSH  drugs  can  be  compared  and  quality  control  issues  wit allopathic medicines; and
- (c)  the  measures  taken  by  the  Government  in  coordinating  with  States  in  implementatio quality control issues related to AYUSH drugs?

## ANSWER

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

- (a):          The  regulatory  and  quality  control  mechanism  for    Ayurvedic, Siddha,  Unani  and Homeopathic drugs has been established  in the country in accordance with the provisio Drugs & Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945.  Exclusive provision in the Drugs & Cosmetics Act, 1940 and rules thereunder for the licensing, manufacturing, labeli shelf - life  and  testing  of  these  drugs.  Central  Government  is  vested  with  the  powers  to amend the legal provisions and to give directions to the State Governments. State Govern respons ible to enforce the legal provisions for AYUSH drugs, for which Licensing Authoriti Controllers are appointed in the states.  Good Manufacturing Practices and Quality Sta manufacturing of Ayurvedic, Siddha, Unani and Homeopathic drugs as p escribed in the Drugs & Cosmetics Rules, 1945 and the respective pharmacopoeias are mandatory for the manufactu follow. Quality and authenticity of the drugs is checked on the basis of standards of id and  strength  prescribed  in  the  ph armacopoeia.  For  this  purpose  Central  Government  has  set  u Pharmacopoieal  Laboratory  of  Indian  Medicine  and  Homoeopathic  Pharmacopoeia  Laboratory Ghaziabad,  Uttar  Pradesh  and  there  are  27  State  Drugs  Testing  Laboratories  and  44  lab approved un der the provisions of Drugs & Cosmetics Rules, 1945 for testing of medicines a materials.  Pharmacopoieal  Commission  of  Indian  Medicine  &  Homoeopathy  and  Pharmacopoie Committees are in place to lay down quality standards and Standard Operating Proced ures for the manufacturing of ASU&H drugs.

Contd…….

(b): Both AYUSH and allopathic drugs are regulated under the provisions of the same Act the Drugs and Cosmetics Act, 1940 and the regulatory provisions are framed on more or less lines. However, AYUSH drugs differ from allopathic drugs in respect of legal definitio reference  books,  ingredients,  methods  of  preparation,  quali y  standards,  dosage  forms,  Good Manufacturing  Practices  requirements,  shelf  life,  labeling  provisions,  penal  provision parameters for drugs testing, mechanism of action and licensing requirements. Moreover, drugs are not allowed to be adm inistered by parenteral route i.e. injectable form.

(c ): A Drug Control Cell is functioning in the Ministry of AYUSH to co - ordinate with the States and the Central Drug Standards Control Organization (CDSCO) for enforcement of the regu provisio ns and quality control of AYUSH drugs. The Drug Control Cell is also the secretaria Ayurvedic, Siddha and Unani Drugs Consultative Committee, which is a statutory body comp of representatives of all States and constituted under the provision s of Drugs & Cosmetics Act, 1940 to  advise  the  Central  Government,  State  Governments  and  Ayurvedic,  Siddha  and  Unani  D Technical  Advisory  Board  (ASUDTAB)  in  technical  matters  related  to  AYUSH  drugs  f harmonization  in  enforcement  of  the  regulatory  pro visions.  The  meetings  of  ASUDTAB  and ASUDCC are held at regular intervals to discuss the issues related to inter - alia quality control of AYUSH  drugs.  The  meetings  of  State  Licensing  authorities  are  also  held  to  review  the control status of ASU drug s in the States.

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