Lok Sabha Question No. 528 (UNSTARRED), answered on 2022-12-09
Subject: Fixation of Prices of Essential Drugs
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Dileshwar Kamait

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

## LOK SABHA UNSTARRED QUESTION NO. †528 TO BE ANSWERED ON 09 TH  DECEMBER, 2022

## FIXATION OF PRICES OF ESSENTIAL DRUGS

†528: SHRI DILESHWAR KAMAIT:

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

- (a) the details of the criteria/guidelines for fixing of prices of Essential Drugs including those used for the treatment of Cancer, Diabetes, HIV, Cardiovascular and Kidney diseases;
- (b) whether the prices of Essential Drugs have come down;
- (c) if so, the details thereof; and
- (d) the details of Jan Aushadhi Kendras established in each district of Bihar including Supaul for sale of generic drugs at cheaper prices under the Pradhan Mantri Jan Aushadhi Yojana?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (DR. BHARATI PRAVIN PAWAR)

(a): As informed by Department of Pharmaceuticals, the National List of Essential Medicines (NLEM) is adopted as the primary basis for determining essentiality and is incorporated  in  the  First  Schedule  of  Drugs  (Prices  Control)  Order  (DPCO),  2013,  which constitutes the list of scheduled medicines, including the medicines used for the treatment of cancer, diabetes, HIV and Heart and kidney diseases for the purpose of price control. The key principles for regulation of prices in the National Pharmaceuticals Pricing Policy, 2012 are essentiality of drugs; control of formulations prices only; and Market Based Pricing.

National Pharmaceutical Pricing Authority (NPPA), fixes the ceiling price of scheduled medicines specified in the first schedule of the DPCO, 2013.  All manufacturers of scheduled  medicines  have  to  sell  their  products  within  the  ceiling  price  (plus  applicable Goods and Service Tax) fixed by the  NPPA. DPCO, 2013 allows an annual price rise  for scheduled formulations based on Wholesale Price Index (WPI). NPPA also fixes retail price of  a  new  drug  under  DPCO,  2013  for  existing  manufacturers  of  scheduled  formulation. Hence, the annual increase allowed in the case of Scheduled formulations is upto the level of annual revision in WPI. Further, in case of non-scheduled formulation, no manufacturers can increase  MRP  by  more  than  10%  of  MRP  during  preceding  12  months.  Instances  of overcharging are dealt with by NPPA under the relevant provisions of DPCO 2013.

- (b)  & (c):  The details  of  drugs  brought  under price control/ regulation by NPPA are given below:
- i. Ceiling  prices  of  890  scheduled  formulations  across  various  therapeutic  categories under NLEM 2015 which includes four scheduled medical devices i.e. Intra Uterine

Devices (Hormone releasing IUD, IUD containing Copper), Condom and Coronary Stents (bare metal stent and drug eluting stent) have been fixed by NPPA.

- ii. Retail price of approx. 2185 new drugs under DPCO, 2013 till 18.11.2022 have been fixed.
- iii. In 2014, NPPA capped the MRP of 106 non-scheduled drug formulations under Para 19 of DPCO 2013 which includes 22 diabetic and 84 cardiovascular drugs.
- iv. Ceiling price of Orthopaedic Knee Implants fixed under Para 19 of DPCO, 2013 since 16 th August 2017 in public interest.
- v. Trade  Margin  of  non-scheduled  formulations  of  42  select  Anti-cancer  medicines capped  under  'Trade  Margin  Rationalization'  approach  as  a  pilot  for  proof  of concept,  wherein  price  of  above  500  brands  of  medicines  were  reduced  upto  90%. This  is  in  addition  to  86  anticancer  drugs  which  are  scheduled  drugs  and  whose ceiling prices have been fixed by NPPA (the figures are included in the 890 drugs in Para (i) above.
- vi. NPPA invoked  Paragraph  19  of  the  DPCO,  2013  to  regulate  the  price  of  Oxygen Concentrators,  Pulse  Oximeter,  Blood  Pressure  Monitoring  Machine,  Nebulizer, Digital Thermometer and Glucometer under 'Trade Margin Rationalisation' Approach in June/July 2021.

The fixation of prices has resulted in a notional savings of about Rs 12,447 Cr. per annum to the public after implementation of DPCO, 2013.

- (d): Under Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP), till 30.11.2022, 8916 Pradhan  Mantri  Bhartiya  Janaushadhi  Kendras  (PMBJKs)  have  been  opened  across  the country, of which, 341 PMBJKs have been opened in Bihar, the details of which are as under:

|   Sl. No. | Name of the District of Bihar State   |   No. of PMBJKs |
|-----------|---------------------------------------|-----------------|
|         1 | Araria                                |               1 |
|         2 | Arwal                                 |               2 |
|         3 | Aurangabad                            |               5 |
|         4 | Banka                                 |               2 |
|         5 | Begusarai                             |              12 |
|         6 | Bhagalpur                             |               7 |
|         7 | Bhojpur                               |              10 |
|         8 | Buxar                                 |               4 |
|         9 | Darbhanga                             |               9 |
|        10 | Gaya                                  |              17 |
|        11 | Gopalganj                             |               2 |
|        12 | Jamui                                 |               2 |
|        13 | Jehanabad                             |               2 |
|        14 | Kaimur (Bhabua)                       |               5 |
|        15 | Katihar                               |               3 |
|        16 | Khagaria                              |               1 |
|        17 | Kishanganj                            |               1 |
|        18 | Lakhisarai                            |               2 |

|   19. | Madhepura          |   3 |
|-------|--------------------|-----|
|    20 | Madhubani          |  26 |
|    21 | Munger             |   4 |
|    22 | Muzaffarpur        |  38 |
|    23 | Nalanda            |   4 |
|    24 | Nawada             |   9 |
|    25 | Pashchim Champaran |   9 |
|    26 | Patna              |  46 |
|    27 | Purbi Champaran    |  32 |
|    28 | Purnia             |   3 |
|    29 | Rohtas             |  13 |
|    30 | Saharsa            |   6 |
|    31 | Samastipur         |  13 |
|    32 | Saran              |   6 |
|    33 | Sheikhpura         |   4 |
|    34 | Sheohar            |   5 |
|    35 | Sitamarhi          |   9 |
|    36 | Siwan              |   4 |
|    37 | Supaul             |   7 |
|    38 | Vaishali           |  13 |