Lok Sabha Question No. 2514 (UNSTARRED), answered on 2019-12-03
Subject: Essential  Medicines
Ministry: CHEMICALS AND FERTILIZERS
Asked by: N.K. Premachandran

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

LOK SABHA UNSTARRED QUESTION NO. 2514

TO BE ANSWERED ON 3 rd  December, 2019

## Essential Medicines

## 2514. SHRI N.K. PREMACHANDRAN:

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

- (a)  whether  it  has  come  to  the  notice  of  the  Government  that  the  price  of  about  100 medicines including medicines for Alzheimers, diabetes, hypertension and cancer could rise by up to 10% after they were removed from the National List of Essential Medicines (NLEM);
- (b) if so, the details thereof alongwith the action taken by the Government to control the price hike of medicines;
- (c) the details of the criteria adopted by the Government for removing those medicines from the national list of essential medicines;
- (d)  the  list  of  medicines  included  by  the  National  Pharmaceutical  Pricing  Agency (NPPA) in the list of essential medicines; and
- (e) whether the Government proposes to include more medicines in the list of essential medicines so as to ensure the availability of medicines at a reasonable price and if so, the details thereof?

## ANSWER

## MINISTER IN THE MINISTRY OF CHEMICALS AND FERTILIZERS (SHRI D. V. SADANANDA GOWDA)

- (a): In recent past, no medicine has been removed from the National List of Essential Medicine (NLEM).
- (b): In view of reply at (a) above, the question does not arise.
- (c): The criteria adopted for addition/deletion of medicines is in the report of NLEM 2015  available on  the website  of Central  Drugs  Standard  Control  Organization (CDSCO) i.e. www.cdsco.gov.in.

The criteria for inclusion of a medicine is reproduced below from NLEM 2015:-

- (i) The medicine should be approved/licensed in India.
- (ii) The medicine should be useful in  disease which  is  a  public  health  problem  in India.
- (iii) The  medicine  should  have  proven  efficacy  and  safety  profile  based  on  valid scientific evidence.
- (iv) The medicine should be cost effective.
- (v) The  medicine  should  be  aligned  with  the  current  treatment  guidelines  for  the disease.
- (vi) The medicine should be stable under the storage conditions in India.
- (vii) When more than one medicine are available from the same therapeutic class, preferably  one  prototype/  medically  best  suited  medicine  of  that  class  to  be included  after  due  deliberation  and  careful  evaluation  of  their  relative  safety, efficacy, cost-effectiveness.
- (viii) Price of total treatment to be considered and not the unit price of a medicine.
- (ix) Fixed Dose  Combinations (FDCs) are generally not included unless the combination  has  unequivocally  proven  advantage  over  individual  ingredients administered separately, in terms of increasing efficacy, reducing adverse effects and/or improving compliance.
- (x) The listing of medicine in NLEM is based according to the level of health care, i.e. Primary (P), Secondary (S) and Tertiary (T) because the treatment facilities, training,  experience  and  availability  of  health  care  personnel  differ  at  these levels.

The criteria for deletion of a medicine is reproduced below from NLEM 2015:

- (i) The medicine has been banned in India.
- (ii) There are reports of concerns on the safety profile of a medicine.
- (iii) A  medicine  with  better  efficacy  or  favorable  safety  profiles  and  better  costeffectiveness is now available.
- (iv) The  disease  burden  for  which  a  medicine  is  indicated  is  no  longer  a  national health concern in India.
- (v) In  case  of  antimicrobials,  if  the  resistance  pattern  has  rendered  a  medicine ineffective in Indian context.

(d): The  Ministry  of  Health  &  Family  Welfare  notifies  the  National  List  of  Essential Medicines  (NLEM).  All  the  medicines  specified  in  the  National  List  of  Essential Medicines (NLEM) are included in the First Schedule of Drugs (Prices Control) Order, 2013 (DPCO, 2013) and brought under price control by National Pharmaceutical Pricing Authority (NPPA). The details of drugs under the list of Essential Medicines, as included in the National List of Essential Medicines (NLEM), 2015, are available on the website of Central Drugs Standard Control Organization (CDSCO) i.e. www.cdsco.gov.in/Notifications/Public-Notices.

(e): A Standing National Committee on Medicines (SNCM) has been constituted by Ministry of Health & Family Welfare in July, 2018 to review and revise the National list of Essential Medicines (NLEM) by way of additions and deletions in the existing NLEM in the  context  of  contemporary  knowledge  of  use  of  therapeutic  products  in  health  & hygiene of general public.

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