Lok Sabha Question No. 3286 (UNSTARRED), answered on 2017-08-04
Subject: Grading System for Products
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: KINJARAPU RAM MOHAN NAIDU

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

LOK  SABHA UNSTARRED  QUESTION NO. 3286 TO BE ANSWERED ON 4 TH AUGUST, 2017

## GRADING SYSTEM FOR P RODUCTS

## 3286. SHRI RAM MOHAN NAIDU KINJARAPU:

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

- (a) whether there is grading systems for products which fall under the Indian system of med and Homoeopathy and if so, the details thereof;
- (b)  whether  there  are  differences  between  the  grading  and  standardisation  of  products Indian Systems of Medicine an d Homoeopathy (ISMH) and for those of practices which come under allopathy and if so, the details thereof;
- (c) whether any incidents have been reported to the Ministry which could have risen from -grading or standardisation of products of AYUSH and if so, the details thereof;
- (d) whether the Government proposes to introduce legislation in this regard in the future;
- (e) if so, the details thereof?

## ANSWER

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

- (a): Under  the  provisions  of  Drugs  & Cosmetics  Rules,  1945,  Good  Manufacturing Practices and Quality standards prescribed in the respective pharmacopoeias are ma for the manufacturing of licensed Ayurvedic, Siddha, Unani and Homoeopathic medic In addition, two voluntary certifica tion s hemes for Ayurvedic, Siddha and Unani medicines are implemented respectively by the Quality Council of India for grant of AYUSH St &  AYUSH  Premium  marks  and  quality  certification  of  products  as  per  WHO - GMP and COPP guidelines by the Central Dr ugs Standard Control Organization (CDSCO).
- (b): Ayurvedic, Siddha, Unani and Homoeopathic drugs are regulated in accordance w the  exclusive  provisions  for  them  in  the  Drugs  &  Cosmetics  Act,  1940  and thereunder . These drugs have to adhere to such standards and quality control parame given in the authoritative books, pharmacopoeias and formularies of Ayurvedic,Siddha,

Unani and Homoeopathic systems, which are different from that prescrib ed for allopathic medicines. Till date, monographs of quality standards of 645 single drugs & 202 co formulations  of  Ayurveda,  298  single  drugs  &  150  compound  formulations  of  Un system,  139  single  drugs  of  Siddha  and  1117  monographs  of  Homoeopathi c  drugs  have been published in the respective pharmacopoeias.  Similarly, Ayurvedic Formulary c 985 standardized formulations, Unani Formulary 1229 formulations and Siddha Formu has 399 standardised formulations.

(c ): Appellate Laboratori es for Indian Medicine and Homoeopathy under the provisions of Drugs & Cosmetics Rules, 1945 have reported testing of referred samples of Ayu Siddha, Unani and Homoeopathy drugs during last three years as under -

| Year     | Pharmacopoeial Laboratory of Indian Medicine   | Pharmacopoeial Laboratory of Indian Medicine   | Homoeopathic Laboratory   | Pharmacopoeial   |
|----------|------------------------------------------------|------------------------------------------------|---------------------------|------------------|
|          | Samples tested                                 | Samples failed                                 | Samples tested            | Samples failed   |
| 2014- 15 | 11                                             | 04                                             | 401                       | 142              |
| 2015- 16 | 25                                             | 01                                             | 351                       | 150              |
| 2016- 17 | 37                                             | 01                                             | 387                       | 49               |

The  Appellate  Laboratories  after  testing  of  the  referred  samples  se analysis  reports  to  the  concerned  authority  for  necessary  action.  Regulation  an control  of  Ayurvedic,  Siddha,  Unani  and  Homoeopathic  medicines  is  carried  out  b State Li censing Authorities / Drug Controllers. As per the information made availabl the States, 11889 samples of AYUSH medicines have been tested in 24 States durin last three years from 2013 - 14 to 2015 - 16 out of which 254 samples failed in quality tes ting. State  Licensing  Authorities  reported  to  have  initiated  appropriate  actions  ag samples not complying with the standards including issue of show cause notice, sus /cancellation of license, recall of the concerned batch of medicines from the  market  and prosecution.

(d): & (e) : Exclusive regulatory provisions for licensing, standards and quality co Ayurvedic, Siddha, Unani and Homoeopathic medicines exist in the Drugs & Cosmet Act,  1940  and  Rules  thereunder .  Drugs  and  Cosmetics  Rules,  1945  are  amended  on  the recommendations of the respective Drugs Technical Advisory Board for imposing effe quality  control  provisions  following  the  stipulated  procedure  of  consultation stakeholders and approval of the competent authorities. As of now there is no proposal the  Ministry  of  AYUSH  to  introduce  new  legislation  for  grading  and  standardizat AYUSH products.

……………………