Lok Sabha Question No. 380 (STARRED), answered on 2017-08-11
Subject: Spurious Ayurvedic and Unani Medicines
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: SATISH KUMAR GAUTAM

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

## LOK SABHA STARRED QUESTION NO. 380 TO BE ANSWERED ON 11 TH AUGUST , 2017 SPURIOUS AYURVEDIC A ND UNANI MEDICINES

## †*380. SHRI SATISH KUMAR GAUTAM:

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

- (a)  whether  the  Government  has  received  information  about  supply  of  sp Ayurvedic and Unani medicines and if so, the details thereof;
- ( b)  whether  the  Government  has  prepared  any  effective  action  plan  to  che supply of such medicines and if so, the details thereof; and
- (c) if not, the reasons therefor?

THE MINISTER OF STATE(IC) OF THE MINISTRY OF AYURVEDA, YOGA & NATUROPATHY, UNANI, SIDDHA AND HOMOEOPATHY

## ANSWER (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. 380* FOR 11 TH AUGUST, 2017

(a)States  have  reported  cases  of  sub - standard  including  spurious  medicines  and actions taken against them like issue of show cause notices, suspension of quality  testing  and  legal  proceedings.  Such  instances  of  alleged  de fault  and contravention of legal provisions, brought to the notice of Ministry of AYUS Central  Government,  are  forwarded  to  the  respective  State  Authorities  fo necessary action in accordance with the legal provisions of drugs quality con l.

(b) & (c ) TheDrugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rule , 1945 have provisions for the regulation and quality control of Ayurvedic an medicines in the country, which are enforced by the State Governments.  It man datory  for  the  manufacturers  to  adhere  to  the  prescribed  requireme licensing of manufacturing units & medicines, Good Manufacturing Practices (GMP) and quality standards of drugs given in the pharmacopoeia. Spurious, Adulterated and Misbranded kinds of these medicines and the penal provisions therefor are defi the Act. Accordingly, t he Licensing Authorities/Drugs Controllers appointed by State  Governments  are  empowered  to  take  necessary  action  against  the  def acting in contravention of the legal provisions.

Following  steps  have  been  taken  by  the  Government  for effective  quality control of AYUSH medicines:

- 1) Pharmacopoeia Commission for Indian Medicine and Homoeopathy (PCIM&H) and Pharmacopoeia Committees have been set up to develop and revise  the  quality  standards  and  the  Standard  Operating  Procedures man ufacturing of medicines.
- 2) Quality  standards  of  847  Ayurvedic  drugs  and  448  Unani  drugs  have  b developed and published in the respective pharmacopoeias.  Permissible of  heavy  metals,  pesticide  residue,  aflatoxins  and  microbial  load medicine s are also prescribed.
- 3) National Ayurvedic and Unani Formularies containing 985 and 12 standardized formulations along with the methods of their manufacturin been published.
- 4) Rule 158 - B in the Drugs and Cosmetics Rules, 1945 provides the regula ry guidelines for issue of license to manufacture Ayurvedic and Unani med in accordance with the proof of safety and effectiveness.
- 5) Scheduled  list  of  potentially  hazardous  substances  of  Ayurvedic  and systems is notified under the provisions of Drugs and Cosmetics Rules, 1945. It is  mandatory  for  the  manufacturer  to  label  the  container  with  the 'Caution: To be taken under medical supervision' both in English and Hindi languages for the formulations containing such ingredients.
- 6) Pharmacopoeial  Laboratory  of  Indian  Medicine  has  been  established notified as appellate laboratory under the provisions of D r ugs  and  Cosmetics Rules, 1945 for testing of referred drug samples.
- 7) 27  State  Drug  Testing  Laboratories  and  46  State  Pharmacies  have supported for strengthening of their infrastructural and functional cap on date ,55 laboratories  are approved or licensed under the provisions o and Cosmetics Rules, 1945 for quality testing of Ayurvedic, Siddha and drugs and raw m aterials. Grant - i - aid is provided to the States and UTs unde National  AYUSH  Mission  (NAM)  for  augmenting  quality  control  of  thes drugs,  including  strengthening  of  Pharmacies,  Drug  Testing  Laborat enforcement framework and testing of drugs.
- 8) In ord er to promote safe use of AYUSH medicines, the Ministry of AYUSH ha signed  a  MoU  with  the  Advertising  Standards  Council  of  India  (ASCI undertake monitoring of misleading advertisements appearing in the pri TV media and bring the defaulters to th e notice of the Central Government and the State Regulators for taking necessary action.
- 9) The Medical Store In - charges of respective systems of medicine and Medicin Inspection  Committee  (MIC)  randomly  check  the  medicines  supplied  und Central  Government Health  Scheme.  If  the  store  receives  any  complaint respect of any medicine, the supply of that medicine is stopped immedia process  of  withdrawal  of  the  issued  medicine  from  dispensary  or  hosp started.    Samples  of  medicines  are  sent  for  t esting  to  Central  Laboratory  or NABL accredited /Government approved laboratory.
- 10) Powers are vested with the Central Government under Section 33P of Drugs & Cosmetics Act, 1940 to give directions to the State Governmen and when required for enforc ement of the legal provisions related to Ayurved Siddha and Unani drugs.