Lok Sabha Question No. 4967 (UNSTARRED), answered on 2023-03-31
Subject: Drug Regulatory System
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Jai Prakash

## GOVERNMENT OF INDIA MINISTRY OF HEALTH AND FAMILY WELFARE DEPARTMENT OF HEALTH AND FAMILY WELFARE

## LOK SABHA UNSTARRED QUESTION NO.4967 TO BE ANSWERED ON 31 ST  MARCH, 2023

## DRUG REGULATORY SYSTEM

## 4967: SHRI JAI PRAKASH:

Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:

(a) whether the Government considers it appropriate to work together with States to remove loopholes in the drug regulatory system especially in the aftermath of two recent incidents reported from Uzbekistan and Gambia where it was alleged that medical products exported by  two  Indian  firms  to  the  two  countries  had  certain  contaminants  which  led  to  adverse reactions and death of some patients; and

(b) if so, the details thereof and if not, the reasons therefor?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (DR. BHARATI PRAVIN PAWAR)

(a) & (b): The Government has taken various regulatory measures to ensure the quality of  medicines  in  the  country.  These  includes  notification  for  affixing  Bar  Code  or  Quick Response  Code  in  Active  Pharmaceutical  Ingredients  (APIs)  and  some  drug  formulations, increase  in  sanctioned  regulatory  posts  of  CDSCO  and  notification  providing  marketers  of any drug to be responsible for its quality.

Testing  capacities  of  Central  Drugs  Testing  Laboratories  under  CDSCO  have  been strengthened, and Drugs and Cosmetics Rules, have been amended making it mandatory that the  applicants  shall  submit  evidence  of  stability,  safety  of  excipients  etc.  to  the  State Licensing Authority before grant of product manufacturing license by the Authority, and that applicant shall submit the result of bioequivalence study along with the application for grant of  manufacturing  license  of  oral  dosage  form  of  drugs  falling  under  the  Category  II  and Category IV of the Biopharmaceutical Classification System.

CDSCO and Ministry of Health and Family Welfare have taken regulatory measures to ensure the quality of medicines in the country as below:

1. The Drugs and Cosmetics Act, 1940 was amended  under Drugs &  Cosmetics (Amendment)  Act  2008  to  provide  stringent  penalties  for  manufacture  of  spurious  and adulterated drugs. Serious offences have also been made cognizable and non-bailable.

2. States/UTs have set up special Courts for trial of offences under the Drugs and Cosmetics Act for speedy disposal.
3.  The  number  of  sanctioned  posts  in  CDSCO  has  been  significantly  increased  in  last  10 years.
4.  To  ensure  efficacy  of  drugs,  the  Drugs  and  Cosmetics  Rules,  1945  have  been  amended providing  that  applicant  shall  submit  the  result  of  bioequivalence  study  along  with  the application for grant of manufacturing license of oral dosage form of some drugs.
5.  The  Drugs  and  Cosmetics  Rules,  1945  have  been  amended  making  it  mandatory  that before the grant of manufacturing license, the manufacturing establishment is to be inspected jointly by the Drugs Inspectors of Central Government and State Government.

6. The Drugs and Cosmetics Rules, 1945 have been amended, making it mandatory that the applicants shall submit evidence of stability, safety of excipients etc. to the State Licensing Authority before grant of manufacturing license by the Authority.

The Central Government has provided Rs. 665.05 crores for strengthening the drug regulatory system including upgradation of existing State laboratories, setting up of new drug testing  laboratories  and  upgradation  of  existing  State  drug  control  offices  as  part  of 'Strengthening of State Drug Regulatory System'.

******