Lok Sabha Question No. 4692 (UNSTARRED), answered on 2018-03-23
Subject: Standards for Drugs
Ministry: HEALTH AND FAMILY WELFARE
Asked by: SRINIVAS KESINENI

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

LOK SABHA UNSTARRED QUESTION NO. 4692 TO BE ANSWERED ON 23 RD MARCH, 2018

## STANDARDS FOR DRUGS

## 4692. SHRI KESINENI NANI:

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

- (a) whether it is a fact that a number of Indian companies have received observations, letters and import alerts from the United States Food and Drug Administration (USFDA);
- (b) if so, the major reasons high lighted under these observations;
- (c) the existing mechanism for monitoring of such companies;
- (d) whether there are major disparities between the standard of testing of pharmaceuti drugs by the USFDA and the Central Drugs Standard Control Organ izations; and
- (e)  if  so,  the  details  thereof  along  with  the  steps  being  taken  by  the  Government  to convergence so as to achieve higher standards for pharmaceuticals and drugs manufacture the country?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE

(ASHWINI KUMAR CHOUBEY)

- (a) & (b):  No such data is available. However, i t may be noted that warning letters/ import alters from any overseas regulatory agency, including USFDA, are direct ly sent to the companies.
- (c) to (e):  For export of drugs, Indian Pharmaceutical Companies are required to compl the  regulatory  provisions  of  importing  country.  The  standards  of  drugs  to  be  followe specified in respective pharmacopoeia. These standards are continuously upgraded from time to time.

Government has taken/is taking following measures to establish strict enforcement regim stringent prosecution/penalties in cases of manufacture, supply and sale of drugs as well -adhere nce to the quality norms prescribed:

1. The  Drugs  and  Cosmetics  Act,  1940  was  amended  under  Drugs  &  Cosmetics (Amendment)  Act  2008  to  provide  stringent  penalties  for  manufacture  of  spurious  a adulterated drugs. Certain offences have also been made cognizabl e and non - bailable and setting of special Courts.

2. The States / UTs were requested to set up special Courts for trial of offences un Drugs and Cosmetics Act for speedy disposal. Twenty two States have set up designated spe Courts.
3. A Whistle Blower Scheme has been announced by the Government of India to encourage vigilant public participation in the detection of movement of spurious drugs in the countr
4. Guidelines for taking action on samples of drugs declared spurious or not of st andard quality in the light of enhanced penalties under the Drugs & Cosmetics (Amendment) Act, 2 were forwarded to the State Drugs Controllers for uniform implementation.
5. The inspectorate staffs have been instructed to keep a vigil and draw samples of drugs for test and analysis to monitor the quality of drugs moving in the country.
6. The  number  of  sanctioned  posts  in  Central  Drugs  Standard  Control  Organizatio (CDSCO) has been increased from 111 (in April, 2008) to 510 (in 2018).
7. The testing  capacities of Central Drugs Testing Laboratories under CDSCO are being constantly strengthened to expedite testing of drug samples in the country.

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