Lok Sabha Question No. 942 (UNSTARRED), answered on 2016-07-22
Subject: Sub-Standard Medicines
Ministry: HEALTH AND FAMILY WELFARE
Asked by: GEETHA KOTHAPALLI

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

## LOK SABHA UNSTARRED  QUESTION NO. 942 TO BE ANSWERED ON 22 ND JULY, 2016

## SUB - STANDARD MEDICINES

## 942. SHRIMATI KOTHAPALLI GEETHA:

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

(a) whether bar coding for medicines, training for drug manufacturers and an integrated a towards zero tolerance for sub - standard medicines in the country is on the anvil and if so, details there of;

(b)  whether  the  Government  ensures  that  awareness  among  manufacturers  and  287  †Original notice of the question received in Hindi. training is a part of holistic approach to dea -standard medicines, if so, the details thereof;

(c) whether t here is any system to check the medicines that are brought from other countri India or the ones sold there; and

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

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (SHRI FAGGAN SINGH KULASTE)

(a) & (b): The Government is committed to ensuring that the quality, safety and efficac drugs are not compromised. With this in view, and to check the marketing and manufacturin spurious, adulterated, misbranded, sub - standard and expired drugs in the country, the Government has taken a series of measures. These include stringent penalties including m certain offences cognizable and non - bailable; establishment of special designated Courts for tri of offences under the Drugs and Cosmetics Act for speedy disposal of cases; announcement Whistle Blower Scheme to encourage vigilant public participation for detection of movemen spurious drugs in the country; issuance of guidelines to the State D rugs Con rollers for taking action  on  samples  of  drugs  declared  spurious,  adulterated,  misbranded  or  'not  of  standard quality' instructions to the concerned staff to keep a vigil and draw samples of drugs for test and analysis for monitoring the quality of drugs moving in the country; increase in the number of posts in Central Drugs Standard Control Organization (CDSCO); re - equipping the drug testing laboratories with state of art equipment;  large scale nation -wide survey to determine the 'not of standard quality' drugs; conducting workshops and training programmes for skill enhancement in areas such as Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Goo Distribution Practices (GDP), Good Clinical Practice (GCP) and  Good Storage and D istribution Practices (GSP) to regulators and industry in partnership with other Departments, indus regulators of other countries including USA and European Union. Several training program have also been conducted for laboratory personnel of Stat e and Central laboratories to upgrade their analytical capabilities and skill sets.  As far as bar coding is concerned, a draf had been issued on 03.06.2015 to invite objections and suggestions from the stakeholders notification  was,  ho wever,  not  finalized  keeping  in  view  the  reservations  expressed  b manufacturers  including  regarding  the  high  cost  of  bar  coding.    Separately,  CDSCO commenced  risk  based  inspections  of  manufacturing  facilities.    These  measures  will  he substantiall y reducing the incidence of 'Not of Standard Quality' drugs.

(c) & (d): Requirements of import & registration under the Drugs & Cosmetics Act, 1940 and Rules, 1945 made thereunder are to be complied with before import of drugs into Indi import of an y drug into the country, the foreign manufacturing site and the drug to be imp are required to be registered and Import Licence is required to be obtained from CDSCO. permissions/licences are granted only after due scrutiny.