Lok Sabha Question No. 94 (UNSTARRED), answered on 2017-12-15
Subject: Standardisation of Ayurvedic Drugs
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: MANSHANKAR NINAMA

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

LOK  SABHA UNSTARRED  QUESTION NO. 94 TO BE ANSWERED ON 15 TH DECEMBER, 2017

## STANDARDISATION OF A YURVEDIC DRUGS

## 94. SHRI MANSHANKAR NINAMA:

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

- (a)  whether  any  steps  are  being  taken  by  the  Government  for  Global  Standardisation Ayurvedic drugs in view of the growing demand;
- (b) if so, the details thereof;
- (c) the steps being taken to ensure availability of required medicinal materials for manu of Ayurvedic drugs; and
- (d) the steps taken by the Government for standardisation quality control of Ayurvedic med in the market and ensure manufacture of every drug as per the international standards?

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

- (a): Yes.
- (b): The Pharmacopoeia Commission for Indian Medicine and Homeopathy (PCIM&H) has signed a MoU with United States Pharmacopoeial Convention (USP) for cooperation in the field of traditional medicine. First meeting with USP was conducted on 7 th November, 2017.
- (c): To ensure the availability of required raw material of medicinal plants for manufac of Ayurvedic drugs, the NMPB under its 'Central Sector Scheme on Conservation, Development and Sustainable Management of Medicinal Plants' provides project based support for resource augmentation  of  medicinal  plants  and  to  encourage  cultivation  of  Medicinal  Plants  i farmers' field. The Ministry of AYUSH under its National AYUSH Mission (NAM) scheme provides financial assistance as subsidy @ 30%, 50%, 75% of cost of cultivation.

Contd……….

(d): Government of Indian established Pharmacopeia Commission for Indian Medi c ne an Homeopathy  (PCIM&H)  under  Ministry  of  AYUSH  with  the  prime  mandate  to  develop standards  and  quality  specifications  for  identity,  purity  and  strength  of  raw  mater compound formulations and to develop SOPs for the process of manufacture incl uded or to be included in the Ayurvedic, Siddha, Unani and Homeopathic Pharmacopoeia/ formulary. Till d the PCIM&H has developed 645 monographs of single drug and 202 monographs of compound formulations used in Ayurveda.

- As  per  the  provisions  of  Drugs  & Cosmetics  Rules,  1945  it  is  mandatory  for  the manufacturers to follow the quality standards given in the Pharmacopeia and adher the Good Manufacturing Practices.
- Display of shelf life/expiry date of different kinds of Ayurvedic medicines on th has been made mandatory under provisions of Drugs & Cosmetics Rules, 1945.
- Rule 158(B) of the Drugs & Cosmetics Rules, 1945 provides the regulatory requiremen for  issue  of  license  for  the  manufacturing  of  different  types  of  Ayurvedic  medi includin g the proof of safety and effectiveness.
- Quality certification system as per the WHO - GMP guidelines has been made applicable for  Ayurvedic  medicines  under  the  administrative  control  of  Drug  Controller  Gene (India). Similarly, a volunteer mechanism for q uality certification of Ayurvedic products as AYUSH Premium Mark as per international standards has been implemented by the Quality Council of India.

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