Lok Sabha Question No. 42 (STARRED), answered on 2016-02-26
Subject: Quality and Safety of AYUSH Medicines
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: R. VANAROJA

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

## LOK SABHA STARRED QUESTION NO.42 TO BE ANSWERED ON THE 26 TH FEBRUARY, 2016 QUALITY AND SAFETY O F AYUSH MEDICINES

## *42. SHRIMATI VANAROJA R.:

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

- (a)  whether the  Government  has  received  recommendations/suggestions  to  tak steps for ensuring quality of AYUSH medicines including changes in the rel rules/laws;
- (b) if so, the details thereof and the response of the Government thereto the reasons for delay in formulating necessary rules/laws; and
- (c) the corrective steps being taken in this regard along with the time necessary changes are likely to be made?

## ANSWER

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

- (a) to (c):  A statement is laid on the Table of the House

## STATEMENT REFERRED TO IN REPLY TO LOK SABHA STARRED QUESTION NO 42 FOR 26 TH FEBRUARY, 2016

- a) to (c) Yes Madam, Department-related Parliamentary Standing Committee on Demand for Grants made recommendations in its reports for strengthening of laboratories and enforcement mechanism at Central and State level, control of misleading advertisements, revision of the quality control  scheme  and establishment  of  separate  Central  Drugs  Controller  of  AYUSH  to  ensure quality control of AYUSH medicines. Ministry of AYUSH has also received the recommendations of the AYUSH Task Force set up by the Government under Chairmanship of Prof. H.R. Nagendra. Following actions have been taken in pursuance of these recommendations observing the stipulated procedures:-
- i. Quality  Control  Scheme  of  ASU&H  drugs  has  been  approved  by merging the same in National AYUSH Mission with enhanced funding pattern  and  addition  of  more  components.  Financial  support  is  being provided to the States through National AYUSH Mission for strengthening of infrastructural and functional capacities of the laboratories and pharmacies, engagement of technical manpower, strengthening  of  the  enforcement  mechanism,  testing  of  drugs  and documentation and dissemination of quality control materials related to ASU&H drugs. Twenty Nine (29) states have availed financial support for this purpose during 2015-16 and forty one laboratories for testing of Ayurvedic, Siddha and Unani drugs are approved under the provisions of the Drugs and Cosmetics Rules, 1945.
- ii. Amendment  of  Drugs  &  Cosmetics  Rules  notified  in  May  2015  for prohibiting  the  use  of  prefix  and  suffix  with  the  names  of  Ayurvedic, Siddha and Unani drugs as defined under section 3(a) of the Drugs & Cosmetics Act, 1940.
- iii. Draft  Rules  for  the  shelf  life  or  expiry  date  of  the  ASU  medicines notified on 24 th November, 2015 for inviting comments and suggestions of the stakeholders. Comments and suggestions of the stakeholders have been received and are being examined for finalizing the proposed rules.
- iv. In  order  to  prohibit  the  menace  of  misleading  advertisements  and exaggerated claims of ASU drugs, draft rules have been framed and sent to  Law  Ministry  for  vetting.  Ministry  of  Health  &  Family  Welfare  has informed that one of the proposals under consideration is that provisions of the Drugs and Magic Remedies Act can also be integrated into the new Act for the Drugs, Medical Devices and Cosmetics.
- v. Regulatory provisions for the education and profession of pharmacy of Ayurveda,  Siddha,  Unani,  Sowa-rigpa and  Homeopathy  have  been drafted in the  form  of  'The  Indian  Medicine  and  Homoeopathy Pharmacy  Central  Council  Bill,  2016'.  The  Bill  has  been  circulated  for inter-ministerial appraisal and consultation with the States.
- vi. Ministry of AYUSH  has  made specific recommendations to the Department of Health and Family Welfare for making enabling provisions inter-alia for  inclusion  of    Sowa-Rigpa  and  Homoeopathy drugs in the ambit of Chapter IV-A of the Drugs & Cosmetics Acts, 1940, which  is  intended  for  amendment  for  various  regulatory  provisions. Ministry  of  Health  &  Family  Welfare  has  informed  that  the  proposed amendment Bill has been considered by a Group of Ministers and the likely proposal now is to draw a completely new Bill.
- vii. Setting  up  of  a  structured  Central  Regulatory  Framework  for  AYUSH drugs  is  in  process  and  twelve  posts  of  Deputy  /  Assistant  Drug Controllers  and  Inspectors  of  ASU&H  have  been  notified  on  17 th February, 2016.
- viii. Report  with  recommendations  of  the  AYUSH  Task  Force inter-alia for quality control and certification of AYUSH medicines is being examined in the Ministry of AYUSH.

Steps taken above in pursuing the recommendations  required detailed consultative process involving stakeholders and concerned departments to finalize the intended outcomes. The timelines for making or amending the legal provisions in accordance with the given recommendations cannot be fixed since the procedural steps required for amendment of Rules and framing of legislation have to be followed.