Lok Sabha Question No. 2145 (UNSTARRED), answered on 2016-05-06
Subject: Regulatory Framework for AYUSH Drugs
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: K. C. VENUGOPAL, POONAMBEN HEMATBHAI MAADAM

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

LOK  SABHA UNSTARRED QUESTION NO. 2145 TO BE ANSWERED ON 6 TH MAY, 2016

## REGULATORY FRAMEWORK FOR AYUSH DRUGS

## 2145. SHRI K.C. VENUGOPAL:

## SHRIMATI POONAMBEN MAADAM:

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

- (a) whether the Government proposes to set up a Structured Central Regulatory Framework AYUSH drugs, if so, t he details thereof;
- (b) the manner in which the said regulatory framework is likely to deal with complaints misleading advertisements and tall claims of AYUSH medicines;
- (c) whether the same will be implemented across the country if so, the detai ls thereof; and
- (d)  whether  the  Government  also  proposes  to  provide  infrastructure,  financial  and  tec support to States to equip their respective regulatory framework, if so, the details there

## ANSWER

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

- (a):     Government has considered setting up a structured central regulatory regime for drugs. In this regard, the current proposal is to develop a vertical str ucture for AYUSH in the Central Drugs Standard Control Organization (CDSCO). Accordingly, amendments required in the Drugs & Cosmetics Act, 1940 pertaining to regulation of Ayurvedic, Siddha, Unani, So -rigpa  and  Homoeopathy  drugs  have  been  conceptualized and  conveyed  to  the  Department  of Health  &  Family  Welfare  under  whose  jurisdiction  the  proposals  of  amending  Drugs Cosmetics  Act,  1940  and  strengthening  of  Central  Drugs  Standard  Control  Organizati (CDSCO) are being processed. Ministry of AYUSH has no tified creation of 12 posts of Deputy Drugs Controllers, Assistant Drugs Controllers and Inspectors of Ayurvedic, Siddha, Unan Homoeopathy.

Contd……

(b) & (c):    The provisions of Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954 and Rules thereunder are equally applicable to AYUSH medicines and are enforced by State Governments through the Licensing Authorities.  There is a provision under Section the Drugs & Mag ic Remedies Act, 1954 to authorize Gazetted Officers for searching, seizing examining  advertisements  and  related  documents  believed  to  be  in  contravention  of provisions  of  Act  and  inform  Magistrate  the  seizure  of  anything  to  take  his  orders  as e custody thereof. The Drugs & Magic Remedies Act, 1954 extend to the whole of India except State  of  Jammu  and  Kashmir.  The  complaints  of  misleading  advertisements  and  exaggerate claims  of  AYUSH  medicines  are  forwarded  to  the  concerned  State  Licensin g Author ties  for taking action in accordance with the legal provisions.

(d):          During  9 th to  12 th Five  Year  Plan,  financial  support  has  been  provided  to  states  f strengthening of the enforcement framework, testing of drugs, capacity building of State Drugs Testing Laboratories and Pharmacies. In 12 th Five Year Plan, the Centrally Sponsored Scheme has been merged into National AYUSH Mission, through which financial support is provided the  States  in  accordance  with  their  Annual  Action  Plans  for  quali ty  control  activities, infrastructural  &  functional  development  of  Pharmacies  and  Drugs  Testing  Laboratories engagement of technical manpower. Ministry of AYUSH has published technical documents lik Essential Drugs Lists, Good Clinical Practice Guidel ines and manual of procedural guidelines for inspection of laboratories.

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