Lok Sabha Question No. 678 (UNSTARRED), answered on 2016-11-18
Subject: Export of AYUSH Medicines
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: ASHWINI KUMAR CHOUBEY

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

## LOK  SABHA UNSTARRED QUESTION NO. 678 TO BE ANSWERED ON 18 TH NOVEMBER, 2016

## EXPORT OF AYUSH MEDI CINES

## 678. SHRI ASHWINI KUMAR CHOUBEY:

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

- (a)  whether  India's  share  in  the  global herbal  medicinal  market  is  less  than  1  per cent  in comparison  to  the  growing  demand 210 for  Herbal  expo rts  including  medicines  of AYUSH products;
- (b) if so, the reasons therefor;
- (c) the action taken/proposed to be taken by the Government to increase the share of export of the AYUSH medicines;
- (d) whether drug companies follow India's Good Manufacturing Practice (GMP) regulation and regulatory guidelines for herbal drugs, if so, the details thereof; and
- (e) whether regular inspections have been followed for the same and if so, the details thereof and if not, the reasons therefor?

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

- a) There is no specific data available. However, estimated global herbal market is aro USD bn. As per the available information Ind ia's export of Ayush and value added products of medicinal plants during 2015 - 16 was 358.60 USD mn.
- b) The reasons for lacking the India's share in the global herbal market including medicines of AYUSH  products are as under:
3. Lack of awareness of International opportunities that Ayush products can be expo with  improved  standards  in  different  categories  like  Dietary  supplements,  He supplements, nutraceuticals depending upon the local regulatory requirements.
4. Ayush syste m of medicine/practice is recognised in only few countries like Sri Lan Nepal, Bhutan, Malaysia, and Bangladesh.
5. Need for scientific research and generation of data as required by overseas countr
6. Enforcement of Biodiversity act, where several medici nal plants are covered under the act restricting the access to resources and thereby exports are getting affected.
7. Financial support to Herbal & AYUSH Industry.

c)    For  enhancing  export  of  the  AYUSH  medicine, Ministry  of  AYUSH  takes  various  steps, which in clude signing of Memoranda of Understanding for country to country 'Cooperation in the field of traditional medicine' to promote and propagate AYUSH systems of medicines across the world  and  by  offering incentives, under  the  Ministry's  Central  Sector  Schem e  for International Cooperation. AYUSH Drug manufacturers participating in the Trad Fairs/Exhibitions and Road shows held in the foreign countries; and getting ma authorizations/ registration for their AYUSH products with USFA/EMEA/UK - MHRA and other I nternational Regulatory Agencies are reimbursed the expenditure incurred by them with ce ceilings.

d) Drugs  &  Cosmetics  Rules,  1945  provide  for  compliance  of  the  Good  Manufacturing Practices  (GMP)  for  licensed  manufacturing  of  Ayurvedic,  Siddha,  Una ni  and  Homoeopathic drugs.  Certification  in  this  aspect  is  done  by  the  State  Licensing  Authorities.  V certification  of  Pharmaceutical  Products  (COPP)  under  WHO  Guidelines  is  extended  t Ayurvedic, Siddha and Unani medicines. This scheme is administ ered by the Office of Drugs Controller General (India) and the certification is done on the basis of joint inspect applicant  manufacturing  unit  by  the  representatives  of  Drugs  Controller  General,  Minis AYUSH and the State Licensing Authorit y. Another voluntary quality certification scheme is implemented by the Quality Council of India (QCI) for grant of AYUSH Standard and AYUSH Premium marks to Ayurvedic, Siddha and Unani products on the basis of third party evalua of quality in accordan ce with the status of compliance to domestic regulations and internati norms respectively.

e)      There is a provision in the Drugs and Cosmetics Rules, 1945 for conducting inspe the manufacturing units as well as approving of Drug Testing Lab oratories by the  Inspectors appointed under the provisions of Drugs & Cosmetics Act, 1940 and Rules thereunder. The j inspection  is  also  done  by  the  Central  Officer  and  State  Officer  for  verification  o equipment,  technical  manpower,  reference  b ooks  and  reference  samples  in  the  AYUSH laboratory. Thereafter, license to the laboratory is issued by the State Licensing Authori the joint inspection report recommends grant of approval.