Lok Sabha Question No. 2095 (UNSTARRED), answered on 2021-12-10
Subject: Quality Control and Standaridisation of Ayurvedic Products
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: Vishnu Dutt Sharma

## GOVERNMENT OF INDIA MINISTRY OF AYUSH

## LOK SABHA UNSTARRED QUESTION NO.2095 TO BE ANSWERED ON 10 TH  DECEMBER, 2021

## QUALITY CONTROL AND STANDARIDISATION OF AYURVEDIC PRODUCTS

## 2095.  SHRI VISHNU DATT SHARMA:

Will the Minister of AYUSH be pleased to state:

(a)  whether the Government is making efforts to ensure quality control and standardisation of ayurvedic products and scientific validation of Ayurvedic principles using modern guidelines to make it more acceptable to consumers.

(b) if so, the details of measures taken in this regard; and

(c) If not, the reasons therefor?

## ANSWER THE MINISTER OF AYUSH (SHRI SARBANANDA SONOWAL)

(a)  to  (b)Yes  Sir,  the  Drugs  and  Cosmetics  Act  1940  and  rules  made  thereunder  specifies procedure  for  granting  license  to  manufacture,  inspection  of  premises,  permission  for  sale, Inspection, examination, audit, display requirement, registers, records, return filing & statutory reporting, Good Manufacturing Practice (GMP), online submission(through portal 'eaushadhi.gov.in')  and  processing  of  application  for  licensing  of  AYUSH  drugs  and  related matters for ensuring quality, safety and efficacy of AYUSH medicines.

For standardization of Ayurvedic, Siddha, Unani and Homoeopathy (ASU&H) medicines in the country, the Government has established a central drug laboratory, namely 'Pharmacopoeia  Commission  for  Indian  Medicine  and  Homoeopathy'(PCIM&H)  under  the Ministry of AYUSH. The prime mandate of the Commission is to publish and revise Ayurvedic Pharmacopoeia of India (API), Siddha Pharmacopoeia of India (SPI), Unani Pharmacopoeia of India (UPI) and Homoeopathic Pharmacopoeia of India (HPI). The Pharmacopoeial standards are basic need to ensure quality, safety and efficacy of Ayurvedic, Siddha, Unani and Homoeopathic medicines. The Pharmacopoeia Commission is also responsible to publish and revise Ayurvedic, Siddha and Unani official formularies and regulatory compendiums. These published standards become part  of  Drugs  and  Cosmetics  Act,  1940  and  Rules,  1945  for  ascertaining  the  quality standards of Raw materials/drugs and implemented uniformly across India. It is mandatory for the  manufacturer  of  ASU&H  drugs  to  obtain  licence  from  the  concerned  State  Licensing Authority  (SLA)  and  comply  with  the  prescribed  Good  Manufacturing  Practices  (GMP)  and quality standards of drugs given in the respective Pharmacopoeias. The SLA grants the licence after verification of the required infrastructural facilities, equipment / machinery, manpower of the manufacturing unit through inspection(s) conducted by the inspector.

Government  has  also  set  up  separate  Central  Research  Councils  for  undertaking, promoting,  coordinating  research  and  scientific  validation  of  Ayurvedic,  Unani,  Siddha  and Homoeopathic medicines.

So far Government has published Ayurvedic Formulary of India (Part I-III) containing 986  Formulations,  Siddha  Formulary  of  India  (Part  I-II)  containing  400  Formulations  and National Formulary of Unani Medicine (Vol. I-VI) containing 1230 Formulations. Monographs of quality standards of 645 Single drugs and 203 Formulations of Ayurveda; 139 Single drugs and 1 Formulation of Siddha; 298 Single drugs and 201 Formulations of Unani; and 1117 drugs of Homoeopathy (Vol. I-X).

(c) Does not arise.