Lok Sabha Question No. 2849 (UNSTARRED), answered on 2016-12-02
Subject: Quality Control of Ayurvedic Medicines
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: J. JAYASINGH THIYAGARAJ NATTERJEE, PARVESH SAHIB SINGH

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

## LOK  SABHA UNSTARRED QUESTION NO.28 49 TO BE ANSWERED ON 2 ND DECEMBER, 2016

## QUALITY CONTROL OF A YURVEDIC MEDICINES

## 2849. SHRI J.J.T. NATTERJEE: SHRI PARVESH SAHIB SINGH:

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

- (a) whether the Government has taken any steps in order to ensure nation wide quality con ayurvedic medic ines;
- (b) if so, the details thereof and if not, the reasons therefor;
- (c)  whether  certain  medicines  developed  by  the  Central  Council  of  Research  in  Ayurve Sciences have been embroiled in a controversy as to misleading advertisements in the rece and if so, the details thereof; and
- (d) whether the Government has issued a draft notification related to ban on advertiseme products from the Indian traditional medicine category, if so, the details thereof?

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

(a)& b): Regulatory provisions for Ayurvedic medicines are in place under the Drugs and Cosmetics Act, 1940, which is a Central Act applicable throughout the country. Under thi Rules 151 to 159 of the Drugs and Cosmetics Rules, 1945 have specific regulatory provisio grant  of  license  to  m anufacture  Ayurvedic  medicines  and  ensure  their  safety,  quality  an standards by enforcing Good Manufacturing Practices. The standards of Ayurvedic drugs their shelf life or date of expiry are prescribed in the Drugs and Cosmetics Rules, 1945 158- B  specifically  prescribes  the  requirement  of  proof  of  safety  and  effectiveness  of categories  of  Ayurvedic  drugs.  Compliance  to  Good  Manufacturing  Practices  (GMP)  and submission  of  evidence  of  safety  and  effectiveness  are  required  for  obtaining license  to manufacture Ayurvedic medicines. Need - based  regulatory  amendments for imposing effective quality control of Ayurvedic medicines are made in consultation with the Ayurvedic, Siddh Unani Drugs Technical Advisory Board following a stipulated p rocedure. Central Government has published Ayurvedic pharmacopoeia in two parts containing quality standards of 645 s

Ayurvedic drugs and 202 Ayurvedic compound formulations. Ministry of AYUSH also provides financial support and guidance to the States for quality control activities related to Ayurvedic drugs  and  a  statutory  body  in  the  name  of  Ayurvedic,  Siddha  and  Unani  Drugs  Consultat Committee is constituted of members from all States and Central Government to advise in matters of securing un iformity throughout India in the administration of Drugs & Cosmetics Ac 1940 pertaining to Ayurvedic, Siddha and Unani drugs. In order to facilitate emerging tr export  opportunities  for  Ayurvedic  medicines,  voluntary  quality  certification  syst s administered  by  Drugs  Controller  General  of  India  in  accordance  with  the  WHO - GMP  and COPP  guidelines  and  by  Quality  Council  of  India  for  granting  AYUSH  Standard  Mark  and AYUSH Premium Mark to the eligible products.

( c) : An  anti - diabetic  Ayurvedic formulation,  AYUSH - 82  for  management  of  Type  II Diabetes has developed by the Central Council for Research in Ayurvedic Sciences (CCRAS has recently been transferred through National Research Development Council, Department Scientific and Industrial R esearch, Ministry of Science & Technology & Earth Sciences, Govt. of India  to  the  interested  manufacturers  for  its  commercial  manufacturing  under  propri category of Ayurvedic drugs.  Complaints about the misleading content of the advertiseme thisAyurvedic  drug  have  been  forwarded  to  the  concerned  State  Licensing  Authorities necessary action in accordance with the provisions of Drugs and Magic Remedies (Objection Advertisements) Act, 1954 and Drugs & Cosmetics Act, 1940 and rules thereunde r.

( d) : Notification of the draft rules for prohibition of misleading advertisements of Ay Siddha and Unani drugs was issued in the Official Gazette vide GSR No. 396(E) dated 4 th April, 2016 to amend the Drugs and Cosmetics Rules, 1945. Copy o f the notification providing relevant details is annexed. Comments of the stakeholders and drug manufacturers have been received on the proposed rules.

- ………

## Annexure

THE GAZETTE OF INDIA : EXTRAORDINARY [PART II -SEC. 3(i )] MINISTRY OF AYURVEDA, YOGA AND NATUROPATHY, UNANI, SIDDHA AND HOMOEOPATHY NOTIFICATION New Delhi, the 4th April, 2016 G.S.R 396(E). -The following draft of certain rules further to amend the Drugs and Cosmetics Rules, 1945, the Central Government p roposes to make in exercise of the powers conferred by section 33 -N of the Drugs and Cosmetics Act, 1940 (23 of 1940), is hereby published as required b said section, for the information of all persons likely to be affected thereby and hereb y given that the objections or suggestions of the stakeholders on the said draft r be taken into consideration after the expiry of a period of forty -five days from the date on which  copies  of  the  Official  Gazette  in  which  this  notification  is  publ ished,  are  made available to the public. Any objection or suggestion, which may be received from any p with  respect  to  the  said  draft  rules  within  the  period  specified  above,  will  be  t consideration  by  the  Central  Government.  The  objections  o r  suggestions,  if  any,  may  be addressed to the Secretary, Ministry of Ayurveda, Yoga and Naturopathy, Unani, Siddha Homoeopathy (AYUSH), AYUSH Bhawan, 'B' Block, GPO Complex, INA, New Delhi -110023.  DRAFT  RULES  1.  (i)  These  rules  may  be  called  the  Dru gs  and  Cosmetics  (5th Amendment) Rules, 2016. (ii) They shall come into force after their final publication Official Gazette. 2. In the Drugs and Cosmetics Rules, 1945, - (i) after rule 169, following rule shall be inserted, namely: -'170 Prohibitio n of advertisements of Ayurveda, Siddha and Unani drugs. -(1) Manufacturer of Ayurvedic, Siddha and Unani drugs or his agent acting his behalf shall not take any part in the publication of any advertisement referring to in terms which suggest o r calculated to lead to the use of that drug for the diagnosis, mitigation, treatment or prevention of any disease, disorder or condition as given be Appendicitis  (ii)  Baldness  and  greying  of  hair  (iii)  Blindness  (iv)  Bust  creams  or development  (v)  Cancer  or  Tumour  (vi)  Cataract  (vii)  Change  of  foetal  sex  (v Chikungunya (ix) Cirrhosis (x) Complexion or fairness (xi) Diabetes mellitus (xii) De ¹Hkkx IIµ[k.M 3(i)º Hkkjr dk jkti=k % vlk/kj.k 7 (xiii) Dengue (xiv) Encephalitis (xv ) Gall stones  (xvi)  Gangrene  (xvii)  Genetic  and  congenital  disorders  (xviii)  Goitre  (xix) enhancement (xx) Hepatitis 'B' and 'C' (xxi) Hernia (xxii) HIV / AIDS (xxiii) Hydrocele (xxiv) Hypertension (xxv) Hysteria (xxvi) Mental Retardation (xxvii) My ocardial infarction (xxviii) Parkinson's disease (xxix) Schizophrenia (xxx) Sexual organ growth (xxxi) Sexual power,  desire  or  performance  enhancement  (xxxii)  Stammering  (xxxiii)  Sterility Infertility  (xxxiv)  Rheumatic  Heart  Disease  (xxxv)  Tuberculosis (xxxvi)  Valvular  heart disease (xxxvii) Varicose Veins (2) The manufacturer of the Ayurvedic, Siddha and Un drugs may advertise the drug as per the contents noted or recorded by the State Lic Authority  or  Drugs  Controller.  (3)  The  application  for making  advertisement  of  any Ayurvedic, Siddha and Unani Drug shall be submitted to the State Licensing Authorit Form  26  E4  specifying  therein  the  claims  such  as  textual  references,  rationale  fr authoritative books, scientific evidence regarding safety, efficacy and quality of the drug. (4) The application fee of rupees one thousand per advertisement shall be deposited along Form 26 E4 and other supporting documents: Provided that the Ayurvedic, Siddha and Una drug  is  manufactured  and  licen sed  in  more  than  one  State,  the  application  for  the advertisement shall be submitted to the Licensing Authority or Drugs Controller of the where the corporate office of the manufacturer is located. 8 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II -SEC. 3(i)] (5) Application for the advertisement may be rejected, if its contents directly or indirectly tantamount to vulgarity or obscenity false impression about the true character of Ayurvedic, Siddha and Unani drug or ma misleading  or  exagg erative  claim  about  the  effectiveness  of  the  said  drug.  (6)  The  S Licensing  Authority  or  Drugs  Controller  may  process  the  application  (if  required consultation with the concerned technical experts) for disposal within thirty days f date  of  r eceipt  of  application  and  may  allot  unique  identity  number  to  the  inten advertisement.  (7)  The  applicant  shall  furnish  the  required  information  to  the  Li Authority or Drugs Controller as and when called for, failing which the application m r ejected and the application fee shall stand forfeited. (8) The State Licensing Auth Drugs  Controller  on  being  satisfied  with  the  application  or  otherwise,  shall  reco convey  in  Form  26  E5  the  recorded  contents  of  advertisement,  reasons  for  rej ection  of application or any clarification required from the applicant. (9) The advertisement r by the Licensing Authority or Drugs Controller in Form 26 E5 shall be valid till the validity of license. (10) An appeal may be filed before the Central Government against the orders  of  the  State  Licensing  Authority  or  Drugs  Controller  under  sub - rule  (8)  and  the decision of Central Government shall be final and binding on the appellant and the Licensing Authority or Drugs Controller. (11) Sta te Government may notify in the Official Gazette the officers of Ayurvedic, Siddha and Unani system to monitor the surveillan the advertisements of Ayurvedic, Siddha and Unani drugs in the print, electronic, inter audio - visual  media  and  maintai printed  register  as  well  as  online  register  of  th advertisements with appropriate entries including those found inappropriate or inval action  taken  against  such  faulty  advertisements  and  the  State  Government  shall  pro information of the advert isements to the Central Government on quarterly basis and also a and when sought by the Central Government. (12) Central Government may give specifi directions to the State Government in public interest for banning, suspending or can advertisement of Ayurvedic, Siddha and Unani drug, which is found prima facie not to b appropriate.', (ii) in Schedule A, after Form 26 E3, the following Forms shall be inserted, namely: 'FORM 26 E4 [See Rule 170] Application Form for Advertisement of Ayurvedic, Siddha and Unani drug (Note: Application may be made only for one advertisement) 1. …… (name of the applicant with designation) am the authorised signatory of………………………………………(name  and  full  address of the manufacturing company) License number…………. valid up - to ………………hereby apply for consideration of following contents of the intended advertisement: Name of the Ayurve

Siddha/ Unani drug Contents of the advertisement including picture/audio/video (s) (En copy)  Reference  of  indication(s)  Language  of  advert isement  Medium  of  advertisement (print/electronic/  internet/  audio - visual)  2.  The  prescribed  fee  of  rupees  one  thousand  has been deposited to the Government under the head of account……………………….and the relevant  Treasury  Challan  is  enclosed  herewith.  ¹Hkkx  II µ[k.M  3(i)º  Hkkjr  dk  jkti=k  % vlk/kj.k 9 3. Copies of the following documents are attachedi) Valid license ii) Refer indications/claims iii) Proof of safety iv) Proof of efficacy v) Quality standards vi) (please specify) a. … b. … c. … Date…………………………… Signature…………………….. (Applicant) Address and contact details FORM 26 E5 [See Rule 170] State Licensing Authority or Drugs Controller for Ayurveda, Siddha and Una Drugs Name of the State or Union territory ……………. [Note: Out of (a), (b) and (c ) paras, only one shall be ticked and filled] It is recorded that M/s.........(Name manufacturer/company )  situated  at……………….  …………….(Address),  is  holding Ayurvedic  /  Siddha  /  Unani  drug  manufacturing  License  Number……….valid  upto……... and  it  is  conve yed  that - (a)  Following  contents  of  the  intended  advertisement  for  the ……….(name of the drug) are noted in the register vide Identity Number……………..(Name of the State/ number/ year): - '………………………………………………………………………………………………… ………………… ………………………………………………………………..' The

advertisement  contents  as  above  are  valid  till  the  validity  of  the  current  license

advertisement  or  any  distortion  in  the  contents  of  advertisement  shall  be  liable  f

action as per rules. (b) Following clarification with relevant suppo

rting information is needed

within thirty days of issue of this communication, failing which application shall be

and application fee forfeited.

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10

THE

GAZETTE

OF

INDIA

:

EXTRAORDINARY [PART II

-SEC. 3(i)] (c) Application dated …….is hereby declined

due to following reason(s)

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-------------------------------------------------------------------------------- Note: The permission shall  not  be  reflected  or  shown  in  the  advertisement in  any  form.  Date:  Seal  of  issuing Officer (Signature and Name) State Licensing Authority/ Drug Controller Name of State Union Territory'. [F.No.K.11024/03/2013 - DCC (AYUSH)] JITENDRA SHARMA, Jt. Secy. Foot  Note. - The  Principal  Rules  were  published  in  Off icial  Gazette  of  India  vide Notification  No.  F.28 - 10/45 - H(I),  dated  21st  December,  1945  and  was  last  amended  vide notification G.S.R. No. 313(E), dated 16th March, 2016. Uploaded by Dte. of Printin Government of India Press, Ring Road, Mayapuri, New De lhi - 110064 and Published by the Controller of Publications, Delhi - 110054.