Lok Sabha Question No. 604 (UNSTARRED), answered on 2022-12-09
Subject: Medicines added under National List of Essential Medicines
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Su Thirunavukkarasar, P. Ravindhranath

## GOVERNMENT OF INDIA MINISTRY OF CHEMICALS & FERTILIZERS DEPARTMENT OF PHARMACEUTICALS

LOK SABHA UNSTARRED QUESTION NO. 604 TO BE ANSWERED ON 09 th  December, 2022

## Medicines added under National List of Essential Medicines

## 604. SHRI THIRUNAVUKKARASAR SU: SHRI P. RAVINDHRANATH:

Will the Minister of CHEMICALS AND FERTILIZERS be pleased to state:

- (a)  whether  the  Department  of  Pharmaceuticals  has  revised  the  National  List  of  Essential Medicines and included several medicines under NLEM with price control;
- (b)  whether  the  Government  has  constituted  any  monitoring  mechanism  to  ensure  the controlled price of such essential medicines, if so, the details thereof;
- (c) the number of medicines added so far under essential medicines - National List of Essential Medicines (NLEM);
- (d) whether the Government has recently added more drugs including four major anti-cancer drugs under the NLEM, if so, the details thereof;
- (e) whether some drugs were dropped from the NLEM and the steps taken/proposed to be taken to ensure affordable and quality medicines to all citizens in the country; and
- (f) if so, the details thereof and if not, the reasons therefor?

## ANSWER

## MINISTER OF STATE IN THE MINISTRY OF CHEMICALS & FERTILIZERS (SHRI BHAGWANTH KHUBA)

- (a): National List of Essential Medicines, 2022 (NLEM, 2022) was notified on 13.09.2022 by Ministry of Health and Family Welfare. Accordingly, Department of Pharmaceuticals (DoP) revised Schedule-I of the Drugs (Prices Control) Order, 2013 (DPCO, 2013) vide S.O. 5249 (E) dated 11.11.2022. The National Pharmaceutical Pricing Authority (NPPA) under the DoP is mandated to fix the ceiling prices for the medicines included in revised schedule-I of DPCO 2013 within sixty days from the date of notification issued by the DoP.
- (b): The NPPA under the DoP fixes the ceiling price for all scheduled drugs notified under Schedule-I  of  DPCO,  2013.  No  manufacturer  of  a  scheduled  formulation  can  sell  a  such formulation at a price higher than the ceiling price (plus local taxes as applicable) fixed and notified by the Government, failing which such manufacturers shall be liable to deposit the overcharged  amount  along  with  interest  thereon,  from  the  date  of  such  overcharging.  A manufacturer  is  at  liberty  to  fix  the  maximum  retail  price  of  a  non-scheduled  formulation (branded or generic) launched by it. However, as per the DPCO, the manufacturers of nonscheduled  formulations  are  not  allowed  to  increase  the  maximum  retail  price  of  such formulations by more than 10% per annum.
- (c): NLEM 2022 consists of 388 medicines (including 2 animal vaccines and 2 stents for heart) (d): A total of thirty-four (34) new medicines comprising of 4 anti-cancer drugs have been included in NLEM 2022. These are lenalidomide, leuprolide acetate, Irinotecan HCI Trihydrate and Bendamustine Hydrochloride.

(e) and (f): Twenty-six medicines have been dropped in NLEM 2022. NPPA is mandated to fix  ceiling  prices  of  the  essential  medicines  contained  in  Schedule-I  of  DPCO,  2013  and monitors price trends so that drugs remain affordable to all citizens in the Country.

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