Lok Sabha Question No. 986 (UNSTARRED), answered on 2019-11-22
Subject: Drug Regulatory System
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Abdul Khaleque

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

LOK SABHA UNSTARRED QUESTION NO. 986 TO BE ANSWERED ON 22 ND NOVEMBER, 2019

## DRUG REGULATORY SYST EM

## 986. SHRI ABDUL KHALEQUE:

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

- (a) the details of the scheme approved by Union Government in 2015 for strengthening of regulatory system of India both under Central and State Governments;
- (b)  the  details  of  the  funds  allocated  for  the  St ate  of  Assam  under  above  scheme  and  their utilisation thereof;
- (c) the details of the funds allocated for Regional Drugs Testing Laboratory (RDTL), Guw under the above scheme and their utilisation thereof;
- (d) the permanent manpower status of RDTL , Guwahati under his Ministry;
- (e) whether the manpower is sufficient to cater to the need of the entire North Eastern R so, the details thereof and if not, whether the Government has any plan to increase the p manpower of RDTL, Guwahati and if so, the details thereof; and
- (f) the manpower status of North East sub - zonal office of the Central Drugs Standard Control Organisation (CDSCO) along with their performance during the last year?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEA LTH AND FAMILY WELFARE (SHRI ASHWINI KUMAR CHOUBEY)

- (a): The Government had approved a proposal for strengthening the drug regulatory system in the country, both under the Central and State Governments at a total expenditure of Rs crores . The Scheme had two components viz (i) Strengthening of the Central Drugs Standa Control Organisation (CDSCO) at a cost of Rs.900 crores, and (ii) Strengthening of States' Drug Regulatory System at a cost of Rs.850 crore.

Contd……

The  Scheme  was  to  be  implemented  during  the  three  financial  years  viz.2015 - 16, 2016- 17 & 2017 - 18; however, the centrally sponsored scheme of strengthening the State Dr Regulatory System has been extended for another period of two years i.e . 2018 - 19 and 2019 - 20 with the approval of the Competent Authority.

(b): The  State  of  Assam  has  been  allocated  an  indicative  amount  of  Rs.49  crore.  T Government of Assam has not signed the MoU with the Government of India. Hence, no fund has been rel eased.

(c): A  sum  of  Rs.  18.14  crore  has  been  released  to  Regional  Drugs  Testing  Laborato (RDTL), Guwahati for construction of new laboratory building under the above scheme.  Cen Public  Works  Department  (CPWD),  Guwahati  has  utilised  Rs.  13.34 crore  out  of  the  said amount.

(d) & (e): A total of 17 posts have been sanctioned for RDTL, Guwahati.  In order to cate the increased workload, 41 contractual manpower has also been provided.

(f): Two Assistant Drugs Controllers and two Drug Inspectors have been provided to sub -zone  Guwahati  and  their  performance  was  found  to  be  satisfactory  during  the  last  yea addition, due to exigencies of work, regulatory staff from East Zone Kolkata is also de sub- zone Guwahati on need basis.

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