Lok Sabha Question No. 324 (STARRED), answered on 2017-03-24
Subject: Ayurvedic Manufacturing Units
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: RAMESH POKHRIYAL NISHANK

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

LOK SABHA STARRED QUESTION NO. 324 TO BE ANSWERED ON THE 24 th March, 2017

## AYURVEDIC MANUFACTUR ING UNITS

## *324. DR. RAMESH POKHRIYAL "NISHANK":

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

- (a) the mechanism in place to monitor the quality of Ayurvedic medicines;
- (b)  whether  the  efforts  are  to  introduce Good  Laboratory  Practice  (G LP)/Good Manufacturing Practice (GMP) Ayurvedic medicine in manufacturing units on the lines of Allopathy medicines and if so, the details thereof;
- (c) whether steps have been taken to improve the quality of Ayurvedic medicines and other AYUSH products an d if so, the details thereof; and
- (d) whether steps have also been taken to prevent the use of heavy metals and other harmful  elements  in  Ayurvedic medicines  and  AYUSH  products  and  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) to (d):      A statement is laid on the Table of the House.

## STATEM ENT REFERRED TO IN REPLY TO LOK SABHA STARRED QUESTION NO. 324 FOR 24 th March, 2017

- (a) The regulatory and quality control mechanism inter - alia for Ayurvedic medicines has been established in the country in accordance with the provisions of the & Cosmetics Act, 1940 and rules thereunder which are amended from time to ti . Exclusive  provisions  exist  in  the  Drugs  &  Cosmetics  Act,  1940  and  ru thereunder for the licensing, manufacturing, labeling, shelf - life and testing of these drugs.  State  Governments  are  responsible  to  enforce  the  legal  provision Ayurvedic  medicin es,  for  which  Licensing  Authorities/Drug  Controllers  ar appointed in the states.  Good Manufacturing Practices and Quality Standard manufacturing of Ayurvedic medicines as prescribed in the Drugs & Cosmeti Rules, 1945 and the Ayurvedic pharmacopoei a, respectively are mandatory for the manufacturers to follow. Quality and authenticity of the Ayurvedic medicin checked on the basis of standards of identity, purity and strength prescrib pharmacopoeia. For this purpose Central Government ha s set up Pharmacopoieal Laboratory  of  Indian  Medicine  in  Ghaziabad,  Uttar  Pradesh  as  an  appell laboratory and there are 27 State Drugs Testing Laboratories and 44 labora approved under the provisions of Drugs & Cosmetics Rules, 1945 for testing Ayurvedic  medicines  and  raw  materials.  States  have  appointed  inspectors inspect the Ayurvedic manufacturing units and take samples for testing or an Guidelines  for  issue  of  license  for  the  manufacturing  of  various  categor Ayurvedic medicin es are prescribed under Rule 158 - B of the Drugs & Cosmetics Rules,  1945  including  the  requirement  of  submission  of  proof  of  safety effectiveness  of  the  drug  applied  for  obtaining  manufacturing  license  fro Licensing Authority.
- (b) Provisions  for  Good Manufacturing  Practices  (GMP)  and  Laboratory  Practices with  regard  to  manufacturing  and  quality  testing  of  Ayurvedic  medicines prescribed in the Drugs & Cosmetics Rules, 1945 since 2003. These provisi describe  the  requirements  of  premises  and  distri bution  of  space,  equipment  & machinery,  manpower,  reference  materials,  record  keeping,  standard  operat procedures,  etc..  System  for  certification  of  GMP  compliance  and  qualit pharmaceutical  products  as  per  the  WHO  guidelines  is  applicable  to  Ayurve ic medicines on voluntary basis,which is administered under the aegis of the Controller General (India) [DCG (I)]. Joint inspection for this purpose is out by the representatives of the DCG (I), Ministry of AYUSH and the concer

State Licens ing Authority. NABL accreditation is also available for laboratori Ayurvedic medicines on voluntary basis.

- (c) Following steps have been taken to improve the quality of Ayurvedic medici and other AYUSH products:
1. Pharmacopoeial Commission of Indian Medicine and Homoeopathy (PCIM&H) and Pharmacopoeia Committees have been set up to develop the standards  and  the  Standard  Operating  Procedures  of  Ayurvedic,  Siddh Unani and Homoeopathic medicines.
2. Quality standards of 847 Ayurvedic drugs, 139  Siddha drugs, 448 Unani drugs and  1117  Homoeopathic  drugs  have  been  developed  and  published  in  t respective  pharmacopoeias.    Permissible  limits  of  heavy  metals,  pe residue, aflatoxins and microbial load are also prescribed.
3. Standard ized formulations (985 formulations of Ayurveda, 399 of Siddha, 1229 of Unani) along with their methods of manufacturing are published respective Formularies.
4. Guidelines  of  Good  Manufacturing  Practices  (GMP)  for  Ayurvedic,  Sidd Unani  and  Homoeopathic  medicines  are  inserted  in  the  Drugs  &  Cosmeti Rules, 1945 and it is mandatory for licensing of ASU&H drug manufactu units.
5. Rule 158 - B  inserted  in  the  Drugs  and  Cosmetics  Rules,  1945  to  provide guidelines  for  issue  of  license  to  manufac ture  Ayurvedic,  Siddha  and  Unani medicines in accordance with the evidence of safety and effectiveness.
6. Schedule  E  (1)  containing  the  list  of  potentially  hazardous  substa Ayurvedic, Siddha and Unani systems has been notified under the Drugs Cos metics Rules, 1945 including the provision to display on the label 'Caution' for the use of the formulations containing such ingredients  under th supervision.
7. Two Central Laboratories -Pharmacopoeial Laboratory of Indian Medicine and the Homoeopathic Pharmacopoeial Laboratory are established and notifie appellate laboratories under the provisions of the Dugs and Cosmetics 1945.
8. 27  State  Drug  Testing  Laboratories  in  public  sector  and  44  Labora approved under the provisions of the Drugs and Cosmetics Rules, 1945 are in place for quality testing of ASU&H drugs and raw materials.
9. Financial  support  has  been  provided  to  46  state  pharmacies,  27  Stat Testing  Laboratories  and  30  State  Licensing  Authorities  for  improvin infras tructural and functional capacities for manufacturing, testi enforcement of the provisions related to ASU&H drugs.
10. Grant - in - aid is provided to the States and UTs under National AYUSH Miss (NAM) for augmenting quality control activities for ASU&H drugs, including strengthening of Pharmacies, Drug Testing Laboratories, enforce framework and testing of drugs.
- 11.Documents of Evidence based safety of Ayurvedic medicines, Essential Lists, Good Clinical Practices for conducting Clinical Trials o n ASU medicines, and procedural guidelines for inspection of Drug Testing Laboratory hav published.
12. In order to promote safe use of AYUSH medicines, the Ministry of AYUSH signed  anMoU with  the  Advertising  Standards  Council  of  India  (ASCI) undertake monitoring of misleading advertisements appearing in the pri TV mediaand bring the defaulters to the notice of the Central Governme the State regulators for taking necessary a ction.
- d). Minerals and metals form an integral part of specific category of A Siddha and Unani formulations called 'Rasaushadhies'. Such ingredients are used in  the  preparation  of  medicines  after  subjecting  them  to  certain  pharm processes including 'shodhana (detoxification)', 'marana (incineration  & calcination)', and 'amritikarana (qualitative improvement)' to render them safe and therapeutically effective, with rational use. In this regard, Part - I, Volume - VII of

the  Ayurvedic Pharmacopoeia  of  India  mentions  the  quality  standards  of minerals & metals for regulating the use of these ingredients in the manu of Ayurvedic, Siddha and Unani drugs. Schedule -E (1) of the Drugs & Cosmetics Rules,  1945  contains  the  list  of  6 9  potentially  hazardous  substances  of  plan mineral and animal origin including heavy metals. As per Rule 161 of the D Cosmetics Rules, 1945, in case of formulations containing any of the Schedul - E (1)  ingredients, it  is  mandatory  for  the  manufactu rer  to display  on  the  label 'Caution:  to  be  taken  under  medical  supervision'  both  in  English  and  Hindi languages.

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