Lok Sabha Question No. 440 (STARRED), answered on 2016-12-16
Subject: Inspection by DCGI
Ministry: HEALTH AND FAMILY WELFARE
Asked by: SUSHMITA DEV

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

## LOK SABHA STARRED QUESTION NO. 440 TO BE ANSWERED ON THE 16 TH DECEMBER , 2016 INSPECTION BY DCGI

## *440. KUMARI SUSHMITA DEV:

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

- (a) whether the Drug Controller General of India/Central drug regulator alon various State drug regulators have recently carried out inspections against drug manufacturers for allegedly selling poor q uality medicines and non - compliance ofnorms and if so, the details thereof;
- (b) the details of action taken against such companies; and
- (c) the steps proposed to be taken by the Government to ensurethat the drugs meet the stipulated norms?

## ANSWER THE MINISTER OF HEALTH AND FAMILY WELFARE (SHRI JAGAT PRAKASH NADDA)

- (a) to ( c):  A statement is laid on the Table of the House

## STATEMENT REFERRED TO IN REPLY TO LOK SABHA STARRED QUESTION NO. 440* FOR 16 TH DECEMBER , 2016

(a)  Based  on  the  current  Good  Manufacturing  Practices  and  Good  Laborato Practices  under  the  Drugs  &  Cosmetics,  Rules,  1945,  the  World  Heal Organisation,  Good  Manufacturing  Practices  and  requirements  in  terms Pharmaceutical  Inspection  Cooperation  Sch eme  (PICS),  the  Central  Drugs Standard Control Organisation (CDSCO) developed a comprehensive checklist for Risk Based Inspection of pharmaceutical manufacturing units in the co in 2016 and placed it in the public domain. Further, on the basis of a reful analysis  of  the  risks  involved,  the  CDSCO  identified  a  number  of  compan manufacturing drugs in the country for being inspected in terms of the af criteria. Separately, one week training was imparted to the officers draw CDSCO,  Drug  Te sting  Laboratories  and  State  Regulators.  The  trainees  we subjected to assessment both before and after the training. A team of five each  headed  by  a  mid  level  officer  were  thereafter  deputed  to  carry inspections of indentified manufacturing units for a period of three days. So far five rounds of such inspections involving 136 units have been carried ou manufacturing units have also been advised to use the checklist for carry self - assessment and rectify deficiencies.

(b) The de ficiencies noticed during these inspections have been shared wit manufacturing units and the State Licensing Authorities (SLAs). manufacturing units and the SLAs have been advised to remove the deficien and also informed that further inspectio ns are planned during 2017 to cross check action taken to rectify the deficiencies noticed during inspection. Manufa drugs  is,  in  terms  of  the  Drugs  &  Cosmetics  Act,  regulated  by  SLAs  a therefore, action against the manufacturers is required to be taken by the State Licensing Authorities. Details of action taken are not maintained centrally .

(c)Besides, the Risk Based Inspections, large number of samples of drugs drawn for test and analysis. The regulators, the laboratory personnel bo m the Centre and the States have been trained in modern techniques for ensuri quality  of  medicines  in  the  country.  At  the  same  time,  the  industry  pe have also been trained on various aspects of manufacturing of drugs incl quality  control. Such  training  programmes  have  been  organized  by  the  Indian Government/Regulator in association with WHO and other leading regulators world. Penal action as per provisions of Drugs and Cosmetics Act, 1940 is in case of non - conformance with the Dru gs and Cosmetics Act, 1940 and Rules thereunder.