Lok Sabha Question No. 870 (UNSTARRED), answered on 2018-12-14
Subject: Definition of Herbal Medicines in the Drugs and Cosmetics Act, 1940
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: SHOBHA KARANDLAJE, PRATHAP SIMHA

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

## LOK  SABHA UNSTARRED  QUESTION NO. 870 TO BE ANSWERED ON 14 TH DECEMBER, 2018

## DEFINITION OF HERBAL MEDICINES IN THE DRU GS AND COSMETICS ACT, 1 940

## 870. KUMARI SHOBHA KARANDLAJE: SHRI PRATHAP SIMHA:

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

- (a) whether it is a fact that there is no exclusive definition of herbal medicines in th Drugs and Cosmetics Act, 1940 and Rules thereunder;
- (b)  whether  the  Ayurvedic,  Siddha  and  Unani  (ASU)  medicines  made  from  herbal/  plan materials and other ingredients are regulated in the country, if so, the details thereof;
- (c)  whether  a  number  of  allegedly  misleading  advertisements  of  Ayurvedic  and      other products have been reported, during the last three years, if so, the details thereof, year - wise; and
- (d) the remedial steps proposed by the Government in this regar d, year - wise?

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

- (a):     Yes, the herbal medicines as such are not defined in the Drugs & Cosmetics Act Rules thereunder. However, with effect from 30 th November, 2015 a new category of drugs derived from herbal materials or medicinal plants called as 'Phytopharmaceutical drugs' has been included under Rule 2(eb) of the Drugs and Cosmetics Rules, 1945 to provide regulatory provisions drugs made from purified and standardized fraction with defined minimum four bio - active or phyto -chemical compounds of an extract of a medicinal plant or its part.
- (b):            Ayurvedic,  Siddha  and  Unani  (ASU)  medicines  made  from  plant  materials  and ingredients  are  regulated  under  the  exclusive  provisions  contained  in  chapter  IVA  of Cosmetics Act, 1940 and Rules 151 to 169 of Drugs & Cosmetics Rules, 1945. Compliance to Good Manufacturing  Practices  (GMP)  and  quality  standards  of  drugs  prescribed  in  the  re pharmacopoeias and submission of proof of safety and evidence of effectiveness are manda the  l icensed  manufacturing  of  ASU  medicines.  These  legal  provisions  for  ASU  medicines

enforced by the Licensing Authorities/Drug Controllers appointed by the State Governments. Government have time to time made regulatory amendments for effective qu ality control of ASU medicines  and  issued  specific  directions/advisories  to  the  State  Governments  for  enfo provisions of Drugs & Cosmetics Act, 1940 and Rules thereunder.

(c  ):          Yes,  Ministry  of  AYUSH  has  come  across  increasing  instances  of  mi sleading advertisements/claims allegedly of herbal, Ayurvedic and other such products including 6 2015, 204 cases in 2016, 547 cases in 2017 and 358 in the current year 2018 as reported Grievances Against Misleading Advertisements (GAMA) portal maintained by the Department of Consumer Affairs and the complaints received in this regard from different sources.The Ad Standards Council of India (ASCI) has reported to have dealt with 732 complaints pert misleading advertiseme nts of AYUSH for the period from 20th January, 2017 to 19th January, 20

(d):     For checking the veracity of misleading advertisements and to undertake monitori advertisements,  powers  are  vested  with  the  State  Governments  to  authorize  Gazett ed  Officers  to search, seize, examine any record, register, document or any other material object rel objectionable advertisement under the provisions of Section 8(1) of the Drugs and Magic (Objectionable Advertisements) Act, 1954.  Min istry of AYUSH has repeatedly taken up the matter with  the  State  Governments  to  appoint  Gazetted  officers  for  monitoring  of  advertise ASU&H drugs. It is reported that States have appointed 621 Gazetted officers to enforce provisions  for  t aking  necessary  action  against  the  defaulters  in  advertising  AYUSH  drugs Ministry of AYUSH also signed a MoU with Advertising Standards Council of India (ASCI January, 2017 for suo - moto monitoring of misleading advertisements of AYUSH drugs etcapp earing in  the  print  media  and  TV  channels  and  bring  the  defaulters  to  the  notice  of  respe regulators.  Media regulators have also been approached to prevent the publication of in advertisements promoting sale of Ayurvedic and other AY USH medicines in public interest. On this account,  Ministry  of  Information  &Broadcasting    issued  instructions/guidelines  dated  1 2017 to all media channels to advertise only those products which have valid manufacturi and to abstain from telecasting such misleading advertisements, which are in contravention provisions of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 and thereunder.  Consumers'  complaints  about  misleading  claims  or  advertisements  of  AYUS H  and herbal  medicines  registered  in  the  GAMA  portal  of  the  Department  of  Consumer  Affair examined  by  a  Nodal  Officer  appointed  in  the  Ministry  of  AYUSH  and  are  forwarded  to concerned State Regulatory Authorities for necessary action in accordance with the legal provisions. Recently, Ministry of AYUSH issued an Advisory dated 31.08.2018 to the manufacturers and the advertising agencies to refrain from using the name of Government Departments or Institutions in the  advertisements  of  ASU& H  Drugs.  Also,  Caution  has  been  issued  in  leading  newspapers  f General public not to fall prey to fake calls and advertisements of ASU&H Drugs.

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