Lok Sabha Question No. 182 (STARRED), answered on 2022-07-29
Subject: Increase in Prices of Drugs
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Sadashiv Kisan Lokhande

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

LOK SABHA STARRED QUESTION NO. †*182 TO BE ANSWERED ON 29 th  July, 2022

## Increase in Prices of Drugs

## †*182. SHRI SADASHIV KISAN LOKHANDE:

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

- (a) the percentage increase in prices of drugs during the last five years;
- (b) whether permission has been sought from the Government to increase the prices of any drugs;
- (c) if so, the details of permission granted to increase the prices of drugs including the names thereof; and
- (d) the details of the drugs whose prices have come down or have been reduced?

## ANSWER

MINISTER IN THE MINISTRY OF CHEMICALS & FERTILIZERS

(DR. MANSUKH MANDAVIYA)

(a) to (d): A statement is laid on the Table of the House.

## Statement referred to in reply to Lok Sabha Starred Question No. †*182 for answer on 29.07.2022 regarding Increase in Prices of Drugs.

- (a): As per extant provisions of Drugs (Prices Control) Order, 2013  (DPCO, 2013), the ceiling  prices  of  scheduled  formulations  as  per  Schedule-I  of  DPCO,  2013  based  on  the National  List  of  Essential  Medicines  (NLEM)  issued  by  the  Ministry  of  Health  &  Family Welfare  (MoH&FW)  are  fixed  by  the  National  Pharmaceutical  Pricing  Authority  (NPPA) under  the  Department  of  Pharmaceuticals.  All  manufacturers  of  scheduled  medicines  are required to sell their products within the ceiling price (plus applicable Goods and Service Tax) fixed by the NPPA. Annual revision of ceiling prices of scheduled medicines is permissible based on Wholesale Price Index (WPI) for all commodities for the preceding calendar year. The Compounded Annual Growth Rate (CAGR) of WPI for the last 5 years is 4.12%. In respect of non-scheduled formulations, while a manufacturer can fix its Maximum Retail Price (MRP) but cannot increase the same by more than 10% of what was prevalent during the preceding 12 months. Further, WPI increase in case of scheduled drugs and 10% increase in case of nonscheduled drugs is the maximum increase permissible, which may or may not be availed. The manufacturers normally  decide the market  price  of  their  drugs  based  on  market  dynamics, within the ceiling, wherever prescribed, by NPPA.
- (b) & (c): NPPA had received applications for upward price revision of 74 formulations claiming increase in price of Active Pharmaceutical Ingredients (APIs), increase in cost of production,  exchange  rate  variations,  repeated  price  control,  etc.  which  had  resulted  in unviability  in  sustainable  production  and  marketing  of  various  drugs.  Considering  these applications, NPPA allowed one-time price increase of up to 50% on the then applicable ceiling price in public interest as an exceptional measure by invoking para 19 of the DPCO, 2013 as under:
- -Heparin Injection 5000 IU/ml and 1000IU/ml in June, 2020.
- -21 scheduled formulations of 12 medicines in December, 2019;
-           9 scheduled formulations of 3 drugs in July 2021.

The  details  of  price  revision  as  notified  by  NPPA  vide  S.O.  No.  4461  (E)  dated 13.12.2019 and S.O. 2654(E) dated 01.07.2021 respectively are attached as Annexure .

- (d): NPPA has fixed ceiling prices of 890 scheduled formulations across various therapeutic categories including scheduled medical devices, viz., Intra Uterine Devices (IUD), condoms and coronary stents and retail price of approx. 2,023 new drugs. Further, it has capped the price of Liquid Medical Oxygen (LMO) and Oxygen Inhalation (Medicinal gas) in cylinders.

Further, the details of drugs, including medical devices, for which prices have been reduced under Para 19 of DPCO, 2013 in public interest are as under:

- a. Fixed ceiling price of Orthopaedic Knee Implants.
- b. Capped MRP of 106 non-scheduled drug formulations, including 22 diabetic and 84 cardiovascular drugs.
- c.  Capped  Trade  Margin  of  non-scheduled  formulations  of  42  select  Anti-cancer medicines as a pilot for proof of concept.
- d.  Regulated  price  of  Oxygen  Concentrators,  Pulse  Oximeter,  Blood  Pressure Monitoring Machine, Nebulizer, Digital Thermometer and Glucometer under 'Trade Margin Rationalisation' Approach during COVID period.

The details of ceiling prices and retail prices of various formulations fixed by NPPA are available at its website at nppaindia.nic.in.

Details  of  Price  revision  of  drugs  notified  by  NPPA  vide  S.  O.  No.  4461  (E)  dated 13.12.2019

| Sl. No.   | Name of the Scheduled Formulation                         | Dosage form& Strength             | Unit      | Ceiling Price (Rs.)   | Existing S.O. No. &Date   | Existing S.O. No. &Date   |
|-----------|-----------------------------------------------------------|-----------------------------------|-----------|-----------------------|---------------------------|---------------------------|
| (1)       | (2)                                                       | (3)                               | (4)       | (5)                   | 6(a)                      | 6(b)                      |
| 1         | BCG vaccine                                               |                                   | Each Dose | 8.75                  | 1485(E) Sl. No. 95        | 29.03.2019                |
| 2         | Benzathine benzylpenicillin                               | Powder for Injection 12 lac units | Each Pack | 17.84                 | 1485(E) Sl. No. 96        | 29.03.2019                |
| 3         | Benzathine benzylpenicillin                               | Powder for Injection 6 lac units  | Each Pack | 11.81                 | 1485(E) Sl. No. 97        | 29.03.2019                |
| 4         | Benzyl penicillin                                         | Powder for Injection 10 Lac Units | Each Pack | 7.64                  | 1485(E) Sl. No. 100       | 29.03.2019                |
| 5         | Chloroquine                                               | Tablet 150mg                      | 1 Tablet  | 1.16                  | 1485(E) Sl. No. 176       | 29.03.2019                |
| 6         | Dapsone                                                   | Tablet 100 mg                     | 1 Tablet  | 0.35                  | 1485(E) Sl. No. 243       | 29.03.2019                |
| 7         | Furosemide                                                | Tablet 40 mg                      | 1 Tablet  | 0.74                  | 1485(E) Sl. No. 344       | 29.03.2019                |
| 8         | Furosemide                                                | Injection 10mg/ml                 | 1 ml      | 2.43                  | 1485(E) Sl. No. 345       | 29.03.2019                |
| 9         | Metronidazole                                             | Oral Liquid 200 mg/5ml            | 1 ml      | 0.44                  | 1485(E) Sl. No. 555       | 29.03.2019                |
| 10        | Metronidazole                                             | Tablet 200 mg                     | 1 Tablet  | 0.68                  | 1485(E) Sl. No. 556       | 29.03.2019                |
| 11        | Metronidazole                                             | Tablet 400 mg                     | 1 Tablet  | 1.25                  | 1485(E) Sl. No. 557       | 29.03.2019                |
| 12        | Metronidazole                                             | Injection 500mg/100ml             | 1 ml      | 0.20                  | 1485(E) Sl. No. 554       | 29.03.2019                |
| 13        | Ascorbic Acid (Vitamin C)                                 | Tablet 500 mg                     | 1 Tablet  | 1.34                  | 1485(E) Sl. No. 74        | 29.03.2019                |
| 14        | Co-trimoxazole (Sulphamethoxazo le (A)+ Trimethoprim (B)] | Tablet 400 mg(A)+80 mg(B)         | 1 Tablet  | 0.77                  | 1485(E) Sl. No. 227       | 29.03.2019                |
| 15        | Co-trimoxazole (Sulphamethoxazo le (A)+ Trimethoprim (B)] | Tablet 800 mg(A)+160 mg(B)        | 1 Tablet  | 1.98                  | 1485(E) Sl. No. 228       | 29.03.2019                |
| 16        | Co-trimoxazole (Sulphamethoxazo le (A)+ Trimethoprim (B)] | Oral Liquid 200mg(A)+40m g(B)/5ml | 1 ml      | 0.32                  | 1485(E) Sl. No. 226       | 29.03.2019                |

|   17 | Pheniramine   | Injection 22.75 mg/ml (10ml pack)   | 1 ml      |   1.67 | 1485(E) Sl. No. 639   | 29.03.2019   |
|------|---------------|-------------------------------------|-----------|--------|-----------------------|--------------|
|   18 | Pheniramine   | Injection 22.75 mg/ml (2ml pack)    | 1 ml      |   2.24 | 1485(E) Sl. No. 638   | 29.03.2019   |
|   19 | Prednisolone  | Drops 1%                            | 1 ml      |   4.92 | 1485(E) Sl. No. 672   | 29.03.2019   |
|   20 | Clofazimine   | Capsule 50 mg                       | 1 Capsule |   2.13 | 1485(E) Sl. No. 199   | 29.03.2019   |
|   21 | Clofazimine   | Capsule 100 mg                      | 1 Capsule |   3.63 | 1485(E) Sl. No. 198   | 29.03.2019   |

Details of Price revision of drugs notified by NPPA vide S.O. 2654(E) dated 01.07.2021

| Sl. No.   | Name of the Scheduled Formulation   | Dosage form& Strength   | Unit     | Ceiling Price (Rs.)   | Existing S.O. No. &Date   | Existing S.O. No. &Date   |
|-----------|-------------------------------------|-------------------------|----------|-----------------------|---------------------------|---------------------------|
| (1)       | (2)                                 | (3)                     | (4)      | (5)                   | 6(a)                      | 6(b)                      |
| 1.        | Carbamazepine                       | Oral Liquid 100 mg/5ml  | 1 ml     | 0.29                  | 1330(E) Sl. No. 139       | 25.03.2021                |
| 2.        | Carbamazepine                       | CR Tablet 200 mg        | 1 tablet | 2.34                  | 1330(E) Sl. No. 140       | 25.03.2021                |
| 3.        | Carbamazepine                       | CR Tablet 400 mg        | 1 tablet | 4.61                  | 1330(E) Sl. No. 141       | 25.03.2021                |
| 4.        | Carbamazepine                       | Tablet 100 mg           | 1 tablet | 1.02                  | 1330(E) Sl. No. 142       | 25.03.2021                |
| 5.        | Ranitidine                          | Oral Liquid 75 mg/5ml   | 1 ml     | 1.08                  | 1330(E) Sl. No. 722       | 25.03.2021                |
| 6.        | Ranitidine                          | Tablet 150 mg           | 1 tablet | 1.10                  | 1330(E) Sl. No. 723       | 25.03.2021                |
| 7.        | Ranitidine                          | Injection 25mg/ml       | 1 ml     | 2.43                  | 1330(E) Sl. No. 724       | 25.03.2021                |
| 8.        | Ibuprofen                           | Tablet 200 mg           | 1 tablet | 0.59                  | 1330(E) Sl. No. 431       | 25.03.2021                |
| 9.        | Ibuprofen                           | Tablet 400 mg           | 1 tablet | 1.04                  | 1330(E) Sl. No. 432       | 25.03.2021                |

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