Lok Sabha Question No. 3191 (UNSTARRED), answered on 2019-12-06
Subject: Suspension of Licences to Drug Manufacturers
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Mehboob Ali Kaiser

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

LOK SABHA UNSTARRED QUESTION NO. 3191 TO BE ANSWERED ON 6 TH DECEMBER, 2019

## SUSPENSION OF LICENC ES TO DRUG MANUFACTURERS

## 3191. CH. MEHBOOB ALI KAISER:

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

- (a)  whether  Central  Drugs  Standard Control  Organization  (CDSCO)  has recommended  to each and every State Drug Licensing Authority to suspend manufacturing Licenses of all 14 unqualified Lipid/Liposomal Amphotericin B of the 10 manufacturers that were identified as unqualified  for  the  lack  of  evidence  for Dose,  extent  of  antifungal  efficacy  and extant  of Kidney Toxicity and if so, the details thereof;
- (b) whether all State Drugs Licensing Authorities have complied with and if not, the reasons therefor;
- (c) whether the CDSCO has written to all State Drugs Licensing Authorities not to issue any new  manufacturing license  to  manufacture  Lipid/Liposomal Amphotericin  B  and  suspend manufacturing Licenses that escaped inclusion in the list of 14 unqualified Lipid/Liposomal Amphotericin B and if so, the details thereof;
- (d) whether CDSCO is aware that Amfy -Lipid/Liposomal Amphotericin B of Intax known to have  life - threatening Nephrotoxicity  that  ca use  high  morbidity and  mortality  are  being pushed in premier hospitals of the country including defence hospitals thereby risking the lives of patients and soldiers, if so, the details thereof;
- (e) whether any State Drug Licensing Authority revoked the su spension of any manufacturer of Liposomal Amphotericin B without having been provided the proof of quality, safety and efficacy of the product; and

was

- (f) if so, the names of such companies and manufacturers whose license reissued/suspension revoked withouthaving been provided the proof of quality, efficacy and safety?

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

## (SHRI ASHWINI KUMAR CHOUBEY)

- (a):  The  Central  Drugs  Standard  Control  Organisation  (CDSCO)  had,  on  11.03.2016 , requested  the  State  Licensing  Authorities  concerned  to  suspend  the  licenses  of manufacturers  of  Liposomal  Amphotericin  B  in  public  interest.  This  was  done  af examination by an expert Committee of the data regarding the quality, safety and effic of Liposomal  Amphotericin  B  which  was  submitted  by  these  manufacturers.  The  expert Committee had observed that the safety and efficacy of the products had not been establ

(b): CDSCO has received compliance reports from the four State Licensing Authorities where their manufacturing plants are located.

(c): No.

- (d): CDSCO has not received any such report.

(e) & (f): For  manufacture  of  any  new  drug,  the  applicant  is  required  to  obta permission from CDSCO before obtaining manufacturing license from the concerned Stat Licencing  Authority.  In  accordance  with  the  said  provisions  and based  on  the  documents submitted and recommendations  of  expert  committee,  CDSCO  granted  manufacturing  and marketing  permission  for  Liposomal  Amphotericin  B  Injection  50mg/vial  to  two  firm namely M/s Cipla Ltd & M/s Bharat Serums and Vaccine Ltd.