Lok Sabha Question No. 127 (UNSTARRED), answered on 2017-12-15
Subject: Quality Control of AYUSH Drugs
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: HEMAMALINI, VINCENT H PALA, HARISH DWIVEDI

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

LOK  SABHA UNSTARRED  QUESTION NO. 127 TO BE ANSWERED ON 15 TH DECEMBER, 2017

## QUALITY CONTROL OF A YUSH DRUGS

## 127. SHRIMATI HEMA MALINI: SHRI VINCENT H. PALA: SHRI HARISH CHANDRA ALIAS HARISH DWIVEDI:

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

- (a)  the  number  of  companies  registered  in  Indian  and  foreign  categories  for production  of AYUSH medicines along with the quantum of medicines produced during each of the last thr years and the current year;
- (b)  whether the  Government  has  taken  note  that  a  number  of  unregistered  companies  are manufacturing AYUSH drugs in the country, if so, the details thereof and the action taken Government against such companies;
- (c) whether the Government has any system in pl ace to monitor the production and marketing of medicines by these companies, if so, the details thereof;
- (d)whether the Government is going to make clinical tests of ayurvedic medicines compul and if so, the details thereof; and
- (e)  the  steps  being taken  by  the  Government  for  ensuring  sufficient  availability  of  desi medicinal components for manufacturing of medicines along with standardisation and qual control of AYUSH drugs/products?

## ANSWER

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

- (a): 8667 manufacturing companies of Ayurvedic, Siddha, Unani and Homoeopathic drugs are licensed in the country and about 2 50 companies of herbal & Ayurvedic products are registered withPharmaceuticals Export Promotion Council ( PHARMEXCIL ) for the purpose of exporting their products to foreign markets. Direct annual production data of ASU&H drug industry has not been assessed .  However, it is estimated on the basis of demand & supply assessment surv of  medicinal  plants  in  the  country  that  about  1,95,000  metric  tons  of  plant  materi consumed by the domestic industry for the production of herbal and AYUSH medicines in t

year 2014 - 15. Export of AYUSH products & value added extracts of medicinal plant product during  2014 - 15,  2015 - 16  and  2016 - 17  amounted  to  the  tune  of  US  Dollars  354.87  million, 358.60 million and 403.90 million respectively.

(b):     As per the provisions of Drugs & Cosmetics Rules, 1945 it is mandatory for  eve drug manufacturer to take license from the concerned State Drug Licensing Authority and Governments are empowered to take action against such persons who do drug manufacturing for sale in contravention of the legal provisions.

(c  ):        Compliance  to  the  prescribed  Good  Manufacturing  Practices  and  quality  stan provided  in  the  respective  pharmacopoeias  is  mandatory  for  the  manufacturing  of  Ayu rvedic, Siddha, Unani and Homoeopathic medicines under the supervision of qualified persons as s in  the  Drugs  &  Cosmetics  Rules.  Regulatory  Authorities/Drug  Control  Officers  in  the  s responsible  to  enforce  the  provisions  of  quality  control of  medicines  being  manufactured  and marketed.    Drugs  &  Magic  Remedies  (Objectionable  Advertisement)  Act,  1954  and  Rul thereunder  have  provisions  to  prohibit  misleading  advertisements  and  Ministry  of  AYUS entered  into  an  MoU  with  Advertising  Standar ds  Council  of  India  to  monitor  the  misleading  o improper advertisements of AYUSH products appearing in print and TV media and report the of default to the regulatory authorities for taking action in accordance with the legal pr

(d):    Dru gs & Cosmetics Act, 1940 and Rules thereunder as on date do not have explicit pro for the clinical trials of Ayurvedic medicines. Rule 158 -B of the Drugs & Cosmetics Rules, 1945 does provide the requirement of pilot study to generate proof of safety & effectiveness of certain categories  of  Ayurvedic  medicines.    Ministry  of  AYUSH  has  published  Good  Clinical  Pra Guidelines for conduct of clinical trials on Ayurvedic, Siddha and Unani medicines on basis.

(e):      Government has set up N ational Medicinal Plants Board (NMPB) to coordinate and suppor cultivation, conservation and sustainable development of medicinal plants for supply of material  to  the  AYUSH  industry  and  Pharmacopoeia  Commission  of  Indian  Medicine Pharmacopoeia  Committees  are  in  place  to  lay  down  the  standards  of  AYUSH  drugs.    Qua standards  of  847  Ayurvedic  drugs,  448  Unani  drugs,  139  Siddha  drugs  and  1117  Homoeopa drugs are published in the respective pharmacopoeias. Quality control provisions for AYU SH drugs including  their  shelf  life  or  expiry  date  are  prescribed  in  the  Drugs  &  Cosmetics  R enforced by the state authorities.

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