Lok Sabha Question No. 45 (UNSTARRED), answered on 2017-12-15
Subject: Good Manufacturing Practice
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: SUSHMITA DEV, ANURAG SINGH THAKUR

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

LOK  SABHA UNSTARRED  QUESTION NO. 45 TO BE ANSWERED ON 15 TH DECEMBER, 2017

## GOOD MANUFACTURING P RACTICE

## 45. KUMARI SUSHMITA DEV:

## SHRI ANURAG SINGH THAKUR:

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

- (a) the number of drug manufacturers under AYUSH category at present in the country;
- (b) the present status of compliance of Good Manufacturing Practice (GMP) by manufacturing units across all States in the country;
- (c) whether non -compliance of GMP has been reported in various States particularly in Assam;
- (d)  if so,  the  details  thereof  and  action  taken/being  taken  by  the  Government  against companies in the States particularly in Assam; and
- (e)  the  steps  being  taken  by  the  Government  to  regulate  quality  and  pricing  of  AY medicines?

## ANSWER

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

- (a): There are 8667 licensed Ayurvedic, Siddha, Una ni and Homoeopathy (ASU&H) drug manufactures in the country.

- (b): 7488 ASU&H drug manufacturers are reported to be complying with the prescri Good Manufacturing Practices (GMP).

Contd………

(c  )  &( d): Non - compliance  of  GMP  by  1179  ASU& H  drug  manufacturers  has  been reported  in  16  States  including  12  Ayurvedic  drug  manufacturers  in  the  State  of State Governments are responsible to enforce the regulatory provisions for ASU&H The status of GMP compliance by the ASU&H drugs ma nufacturing units is periodically reviewed by the Ministry of AYUSH and the necessary directions are given to the co State Authorities to take action against the defaulters in accordance with the p Drugs & Cosmetics Rules, 1945. Drug Lic ensing Authority of Assam has issued notice to th companies not complying with the provisions of GMP.

(e): Regulatory  and  quality  control  provisions  for Ayurvedic,  Siddha,  Unani  and Homoeopathic drugs are prescribed in the Drugs & Cosmetics Act 1940 and the Rules 1945. The Central Government is vested with the powers to frame and amend the legal provisions provisions and their enforcement is done by the State Governments. The AYUSH medicines are not covered under the Price Control order of the Central Government.  Following steps have been taken for quality control of AYUSH medicines-

- i. Pharmacopoeia Commission of Indian Medicine & Homoeopathy and Pharmacopoiea Committees have been set up to lay down the quality standards of Ayurvedic, S Unani and Ho moeopathic drugs, which are published in the respecti pharmacopoeias and are mandatory for the manufacturers to follow in manufacturing of these medicines.
- ii. Good  Manufacturing  Practices  (GMP)  and  requirements  for issue  of  license  to manufacture various types of Ayurvedic, Siddha and Unani medicines on the ba evidence of safety and effectiveness are prescribed in the Drugs & Cosmetics 1945.
- iii. Rules for indicating shelf - life or expiry date on the labels of the ASU&H medicines have been notified.
- iv. Quality Certification systems have been introduced.
- v. Essential Drug Lists and Guidelines of Good Clinical Practices published.
- vi. Grant - in - aid  is  provided  through  the  Centrally  Sponsored  Scheme  of  Natio AYUSH  Mission  for  the  quality  control  activities  of  ASU&H  medicines  includ strengthening of state pharmacies, drug testing laboratories and enfo framework.