THE DRUGS (PRICES CONTROL) ORDER, 2013 (Notified by SO 1221 (E) dated 15.05.2013 and as amended up to vide SO 1192(E) dated 22-03-2016)

1 · Short title and commencement - (1) This Order may be called the Drugs (Prices Control) Order, 2013 (2) It shall come into force on the date of its publication in the Official Gazette

2 · Definitions: _ (1) In this Order, unless the context otherwise requires, (a) "Act" means the Essential Commodity Act, 1955 (10 of 1955); (b) "active pharmaceutical ingredients or bulk drug" means any pharmaceutical, chemical, biological or plant product including its salts, esters, isomers, analogues and derivatives, conforming to standards specified in the Drugs and Cosmetics Act, 1940 (23 of 1940) and which is used as such or as an ingredient in any formulation; (c) "brand" means a name, term, design, symbol, trademark or any other feature that identifies one seller's drug as distinct from those of other sellers; (d) "ceiling price" means a price fixed by the Government for Scheduled formulations in accordance with the provisions of this Order; (e) "dealer" means a person carrying on the business of purchase or sale of drugs, whether as a wholesaler or retailer and includes his agent; (f) "distributor" means & person engaged in the work of distribution of drugs and includes an agent or a stockist for stocking drugs for sale to a dealer; (g) "existing manufacturer" means manufacturer existing on the date of publication of this order in the Official Gazette. (h) "Form means & form specified in the Second Schedule; (i) "formulation means a medicine processed out of or containing one or more drugs with or without use of any pharmaceutical aids, for internal or external use for or in the diagnosis, treatment, mitigation or prevention of disease and, but shall not include (i) any medicine included in any bonafide Ayurvedic (including Sidha) or Unani (Tibb) systems of medicines;

3 · Directions to manufacturers of active pharmaceutical ingredients or bulk drugs or formulations: L The Government may, (i) with a view to achieve adequate availability and to regulate the distribution of drugs, in case of emergency or in circumstances of urgency or in case of non-commercial use in public interest, direct any manufacturer of any active pharmaceutical ingredient or bulk drug or formulation to increase the production and to sell such active pharmaceutical ingredient or bulk drug to such other manufacturer(s) of formulations and to direct formulators to sell the formulations to institutions, hospitals or any agency as the case may be;

4 · Calculation of ceiling price of a scheduled formulation - (1) The ceiling price of a scheduled formulation of specified strengths and dosages as specified under the first schedule shall be calculated as under:

5 · Calculation of retail price of a new drug for existing manufacturers of scheduled formulations: F (1) The retail price of the new drug available in domestic market shall be calculated as provided in sub-paragraph (1) of paragraph 4.

6 · Ceiling price of a scheduled formulation in case of no reduction in price due to absence of competition. 5 (1) where the average price to retailer of a scheduled formulation, arrived at as per the formula specified in sub-paragraph (1) of paragraph 4, has the effect of, (a) no reduction in average price to retailer with respect to the prices to retailer of the schedule formulation; and

7 · . Margin to retailer.- While fixing a ceiling price of scheduled formulations and retail prices of new drugs, sixteen percent of price to retailer as a margin to retailer shall be allowed.

8 · Maximum retail price: F (1) The maximum retail price of scheduled formulations shall be fixed by the manufacturers on the basis of ceiling price notified by the Government plus local taxes wherever applicable, as under: Maximum Retail Price = Ceiling price Local Taxes as applicable

10 · Pricing of the formulations covered under Drugs (Prices Control) Order, 1995.- 5 (1) The prices of scheduled formulations, which are also specified in the First Schedule to the Drugs (Prices Control) Order, 1995, fixed and notified under the provisions of the said order, up to 31st May , 2012, shall remain effective for further one year i.e_ up to 30th May' 2013 and the manufacturers may revise the prices of such scheduled formulations as per the annual wholesale price index for the previous calendar year announced by Department of Industrial Promotion and Policy and thereafter the formula as in sub- paragraph (1) of paragraph 4 of this Order shall be applied for fixing the ceiling prices of such formulations:

11 · Ceiling price or retail price of a pack -~ (1) The average price to retailer calculated as per the provisions in paragraphs 4, 5 and 6 shall be on the dosage basis, (per tablet, per capsule or injection in volume as listed in first schedule) and the ceiling price or retail price of a pack shall be reached by multiplying the same with the number or quantity in the pack as the case may be:

12 · Price of formulations (branded or generic version) listed in the National List of Essential Medicines, launched by a manufacturer. T (1) A manufacturer, launching a scheduled formulation, shall be free to fix the price of the scheduled formulation equal Price list; to or below the ceiling price fixed for that schedule formulation by the Government: (2) Where an existing brand is re-launched by another manufacturer the provisions of paragraph 13 shall be applicable.

13 · Price of scheduled formulations for the existing manufacturers _ (1) AlI the existing manufactures of scheduled formulations, selling the branded or generic or

14 · Fixation of ceiling price of scheduled formulations: ~ (1) The Government shall fix and notify the ceiling prices of the scheduled formulations in accordance with the provisions of the paragraphs 4 and 6, as the case may be, and no manufacturer shall sell the scheduled formulations at a price higher than the ceiling price (plus local taxes as applicable) SO fixed and notified by the Government:

15 · Fixation of retail price of a new drug for existing manufacturers of scheduled formulations: " (1) The Government shall form a Standing Committee of such Experts, as it may deem fit, within sixty days of notification of this order with a view to recommend the retail prices of new drugs on the principles of "Pharmacoeconomics"

16 · Revision of ceiling price of scheduled formulations: F (1) The Government shall revise the ceiling prices of scheduled formulations as per the annual wholesale price index (WPI) for

17 · Amendment of the list of scheduled formulation: - (1) A decision to amend the first schedule, clearly stating the reasons thereof , shall be taken by the Government within sixty days of receipt of communication from the Ministry of Health and Family Welfare and the amendment(s) or revision, if required, in the first schedule shall be notified and thereafter, the ceiling price(s) for the medicine(s) added in the first schedule shall be fixed as per the provisions of this order within a period of sixty days from the date of the notification.

18 · Revision of ceiling price on the basis of moving annual turnover (MAT): L The revision of ceiling prices on the basis of moving annual turnover value shall be carried out, (i) as and when the National List of Essential Medicines is revised by the Ministry of Health and Family Welfare or five years from the date of fixing the ceiling price under this Order whichever is earlier; (ii) when the number of manufacturers of a scheduled formulation, having price of a scheduled formulation more than or equal to seventy five percent of the ceiling price fixed and notified by the Government, has decreased by twenty five percent or more than the number of manufacturers as existing on the reference date; (iii) when the number of manufacturers of a scheduled formulation, having prices of their scheduled formulation equal to or lower than twenty five percent of the ceiling price fixed by the Government, has increased by twenty five percent or more than the number of manufacturers as existing on the reference date_ Explanation. For the purpose of items (ii) and (iii) the "reference date" shall be for first revision of ceiling price May, 2012 and for second or subsequent revision the date of previous revision of the ceiling price:

19 · Fixation of ceiling price of a drug under certain circumstances.- Notwithstanding anything contained in this order, the Government may, in case of extra-ordinary circumstances, if it considers necessary SO to do in public interest, fix the ceiling price or retail price of any Drug for such period, as it may deem fit and where the ceiling price or retail price of the drug is already fixed and notified, the Government may allow an increase or decrease in the ceiling price or the retail price, as the case may be, irrespective of annual wholesale price index for that year.

20 · Monitoring the prices of non-scheduled formulations ~ (1) The Government shall monitor the maximum retail prices (MRP) of all the drugs, including the non-scheduled formulations and ensure that no manufacturer increases the maximum retail price of a drug more than ten percent of maximum retail price during preceding twelve months and where the increase is beyond ten percent of maximum retail price, it shall reduce the same to the level of ten percent of maximum retail price for next twelve months:

21 · Monitoring the availability of scheduled formulations ~ (1) The Government shall monitor the production and availability of scheduled formulations and the active pharmaceutical ingredients

22 · Recovery of dues accrued under the Drugs Prices Control) Order, 1979 and to deposit the same into the Drugs Prices Equalisation Account:- (1) Notwithstanding anything contained in this order, the Government may by notice, require a manufacturer, importer or distributor as the case may be, to deposit the amount which has accrued under the provisions of the Drugs (Prices Control) Order, 1979 on or before the commencement of this order, into the Drugs Prices Equalisation Account and the manufacturer , importer or distributor, as the case may be, shall deposit the said amount into the said account within such time as the Government may specify in the said notice.

23 · Recovery of overcharged amount under Drugs Prices Control Orders 1987 and 1995. 5 Notwithstanding anything contained in this order, the Government shall by notice, require the manufacturers, importer or distributor or as the case may be, to deposit the amount accrued due to charging of prices higher than those fixed or notified by the Government under the provisions of

24 · Carrying into effect the price fixed or revised by the Government, its display and proof thereof._ (1) For all the scheduled formulations having maximum retail price (MRP) higher than ceiling price (plus local taxes as applicable), the manufactures shall revise the maximum retail price (MRP) not exceeding the ceiling price (plus local taxes as applicable):

25 · Display of prices of non-scheduled formulations and price list thereof._ (1) Every manufacturer of a non-Scheduled formulation intended for sale shall display in indelible print mark, on the label of container of the formulation and the minimum pack thereof offered for retail sale, the maximum retail price of that formulation with the words "Maximum Retail Price" preceding it and the words 'inclusive of all taxes' succeeding it.

26 · Control of sale prices of formulations ~ No person shall sell any formulation to any consumer at a price exceeding the price specified in the current price list or price indicated on the label of the container or pack thereof, whichever is less:

28 · Manufacturer, distributor or dealer not to refuse sale of drug: T Subject to the provisions of the Drug and Cosmetics Act, 1940 (23 of 1940) and the rules made thereunder, (a) no manufacturer or distributor shall withhold from sale or refuse to sell to a dealer any drug without good and sufficient reasons; (b) no dealer shall withhold from sale or refuse to sell any drug available with him to & customer intending to purchase such drug:

30 · Power of entry, search and seizure. " (1) Any Gazetted Officer of the Central Government or of a State Government, as the case may be, authorised by a general or special order by the Central Government or by the State Government, as the case may be, in this behalf may, with a view to securing compliance with this Order or to satisfy himself that the provision of this Order have been complied with - (a) enter and search any place; (b) seize any drug, alongwith the containers, packages or coverings in which the drug is found, in respect of which he suspects that any provision of this Order has been, is being, or is about to be contravened, and thereafter take all measures necessary for securing production of the drug, containers, packages or coverings,

31 · Power to review.' L Any person aggrieved by any notification issued or order made under paragraphs 4, 5 and 6 of this Order, may apply to the Government for a review of the notification or order within a period of thirty days of the date of publication of the notification in the Official Gazette or the receipt of the order by him, as the case may be, and the Government may make such order on the application as it may deem proper:

1 · 1.1

1 · 1.2

1 · 1.3

1 · 1.4

1 · 1.6

1 · 1.7

1 · 1.8

1 · 2.1

1 · 2.2

1 · 2.3

1 · 2.4

1 · 3-Preoperative medication and sedation for short term procedures Medicine Level of Dosage form and strength Healthcare

1 · 3.1

1 · 3.2

1 · 3.3

1 · 3.44

2 · 1- Non-opioid analgesics, antipyretics and no steroidal anti ~inflammatory medicines Medicine Level of Dosage form and strength Healthcare

2 · 1.1

2 · 1.2

2 · 1.3

2 · 1.44

2 · 15

2 · 2-Opioid analgesics

2 · 2.1

2 · 2.2

2 · 2.3

2 · 3-Medicines used to treat gout

2 · 3.1

2 · 3.2

2 · 4.1

2 · 4.2

2 · 4.3

2 · 4.4

2 · 4.5

3 · 1 3.2

3 · 3

3 · 4

3 · 5

3 · 6

3 · 7

4 · 1- Nonspecific

4 · 1.1

4 · 2-Specific

4 · 2.1

4 · 2.2

4 · 2.3

4 · 2.4

4 · 2.5

4 · 2.6

4 · 2.7

4 · 2.8

4 · 2.9

4 · 2.10

4 · 2.11

4 · 2.12

4 · 2.13

5 · 1

5 · 2

5 · 3

5 · 4

5 · 5

5 · 6

5 · 7

5 · 8

5 · 9

6 · 1.1-Intestinal anthelminthics

6 · 1.1.1 6.1.1.2

6 · 1.2- Antifilarial

6 · 1.2.1

6 · 1.3-Anti-schistosomal & anti-trematodal medicine

6 · 1.3.1

6 · 2-Antibacterials

6 · 2.1-Beta lactam medicines

6 · 2.1.1

6 · 2.1.2

66 · 2.1.3

6 · 2.1.4

6 · 2.1.5

6 · 2.1.6

16 · 2.1.7

6 · 2.1.8

6 · 2.1.9

6 · 2.1.10

6 · 2.1.11

6 · 2.1.12

6 · 2.1.13

6 · 2.2-Other antibacterials

6 · 2.2.1

6 · 2.2.2

6 · 2.2.3

6 · 2.2.4

6 · 2.2.5

16 · 2.2.6

6 · 2.2.7

6 · 2.2.8

6 · 2.2.9

6 · 2 3-Antileprosy medicines

6 · 2.3.1

6 · 2.3.2

6 · 2.3.3

6 · 2.4-Antituberculosis medicines

6 · 2.4.1

6 · 2.4.2

6 · 2.4.3

6 · 2.4.4

6 · 2.4.5

6 · 2.4.6

6 · 2.4.7

6 · 2.4.8

6 · 2.4.9

6 · 2.4.10

6 · 2.4.11

6 · 2.4.12

6 · 2.4.13

6 · 2.4.14

6 · 3-Antifungal medicines

6 · 3.1

6 · 3.2

6 · 3.3

6 · 3.4

6 · 3.5

6 · 4-Antiviral medicines

6 · 4.1-Antiherpes medicines

6 · 4.1.1

6 · 4.2-Anti Cytomegalovirus (CMV) medicines 6.4.2.1 Ganciclovir S,T

6 · 4.3-Antiretroviral medicines

6 · 4.3.1-Nucleoside reverse transcriptase inhibitors

6 · 4.3.1.1

6 · 4.3.1.2

6 · 4.3.1.3

6 · 4.3.1.4

6 · 4.3.1.5

6 · 4.3.1.6

6 · 4.3.1.7

6 · 4.3.1.8

6 · 4.3.1.9

6 · 4.3.2-Non-nucleoside reverse transcriptase inhibitors

6 · 4.3.2.1

6 · 4.3.2.2

6 · 4.3.3-Integrase inhibitors

6 · 4.3.3.1

6 · 4.3.4-Protease inhibitors

6 · 4.3.4.1 6.4.3.4.2

6 · 4.3.4.3

6 · 4.3.4.4

6 · 4.4-Medicines for hepatitis B and hepatitis €C

6 · 4.4.1

6 · 4.4.2

6 · 4.4.3

6 · 4.4.4

6 · 4.4.5

6 · 5-Antiprotozoal Medicines

6 · 5.1-Antiamoebic and antigiardiasis medicines

16 · 5.1.1

6 · 5.1.2

6 · 5.2-Antileishmaniasis medicines

6 · 5.2.1

6 · 5.2.2

6 · 5.2.3

6 · S.3-Antimalarial medicines

6 · 8.3.1-For curative treatment

65 · 3.1.1

6 · 5.3.1.2

6 · 5..1.3

6 · 5.3.1.4

6 · 5.3.1.5

6 · 5.3.1.6

6 · 5.3.1.7

6 · 5.3.2-For prophylaxis

6 · 5.3.2.1

6 · 5.4-Antipneumocystosis and anti toxoplasmosis medicines

6 · 5.4.1

6 · 5.4.2

7 · -Antimigraine medicines

7 · 1.1

7 · 1.2

7 · 1.3

7 · 2-For prophylaxis

7 · 2.1

7 · 2.2

8 · -Antineoplasticlimmunosuppressives and medicines used in palliative care

8 · 1-Antineoplastic medicines

8 · 1.1

8 · 1.2

8 · 1.3

8 · 1.4

8 · 15

8 · 1.6

8 · 1.7

8 · 1.8

8 · 1.9

8 · 1.10

8 · 1.11

8 · 1.12

8 · 1.13

8 · 1.14

8 · 1.15

8 · 1.16

8 · 1.17

8 · 1.18

8 · 1.19

8 · 1.20

8 · 1.21

8 · 1.22

8 · 1.23

8 · 1.24

8 · 1.25

8 · 1.26

8 · 1.27

8 · 1.28

8 · 1.29

8 · 1.30

8 · 1,.331

8 · 1.332

8 · 1.33

8 · 1.34

8 · 1.35

8 · 1.36

8 · 2-Hormones and antihormones used in cancer therapy

8 · 2.1

8 · 2.2

8 · 2.3

8 · 2.4

8 · 3-Immunosuppressive medicines

8 · 3.1

8 · 3.2

8 · 3.3

8 · 3.4

8 · 4.1

8 · 4.2

8 · 4.3

8 · 4.4

8 · 4.5

8 · 4.6

8 · 4.7

8 · 4.8

8 · 4.9

8 · 4.10

8 · 4.11

8 · 4.12

8 · 4.13

8 · 4.14

8 · 4.15

9 · 1

9 · 2

10 · 1- Antianaemia medicines

10 · 1.1

10 · 1.2

10 · 1.4

10 · 1.5

10 · 1.6

10 · 1.7

10 · 2-Medicines affecting coagulation

10 · 2.1

10 · 2.2

10 · 2.3

10 · 2.4

10 · 2.5

10 · 2.6

11 · 1-Blood and Blood components

11 · 1.1

11 · 1.2

11 · 1.3

11 · 1.4

11 · 2-Plasma substitutes

11 · 2.1

11 · 3-Plasma fractions for specific use

11 · 3.1

11 · 3.2

11 · 3.3

12 · 1-Medicines used in angina

12 · 1.1

12 · 1.2

12 · 1.3

12 · 1.4

12 · 15

12 · 1.6

12 · 1.7

12 · 2-Antiarrhythmic medicines

12 · 2.1

12 · 2.2

12 · 2.3

12 · 2.4

12 · 2.5

12 · 3-Antihypertensive medicines

12 · 3.1

12 · 3.2

12 · 3.3

12 · 3.4

12 · 3.5

12 · 3.6

12 · 3.7

12 · 3.8

12 · 3.9

12 · 4-Medicines used in shock and heart failure

12 · 4.1

12 · 4.2

12 · 4.3

12 · 4.4

12 · 5-Antithrombotic medicine (Cardiovascular/ Cerebrovascular)

12 · 5.1

12 · 5.2

12 · 5.3

12 · 5.4

12 · 6-Hypolipidemic medicines

12 · 6.1

13 · 1

14 · 1- Antifungal medicines

14 · 1.1

14 · 2- Antiinfective medicines

14 · 2.1

14 · 2.2

14 · 2.3

14 · 2.4

14 · 2.5

14 · 3-Antiinflammatory and antipruritic medicines

14 · 3.1

14 · 3.2

14 · 4-Medicines affecting skin differentiation and proliferation

14 · 4.1

14 · 4.2

14 · 4.3

14 · 4.4

14 · 5-Scabicides and pediculicides

14 · 5.1

14 · 6-Miscellaneous

14 · 6.1

14 · 6.2

15 · Diagnostic agents

15 · 1-Ophthalmic medicines

15 · 1.1

15 · 1.2

15 · 1.3

15 · 2-Radiocontrast media

15 · 2.1

15 · 2.2

15 · 2.3

15 · 2.4

16 · 1

16 · 2

17 · 1-Antiseptics

17 · 1.1

17 · 1.2

17 · 1.3

17 · 1.4

17 · 1.5

17 · 1.6

17 · 2-Disinfectants

17 · 2.1

17 · 2.2

17 · 2.3

18 · 1

18 · 2

18 · 3

18 · 4

19 · 1

19 · 2

19 · 3

19 · 4

20 · 1-Antiulcer medicines

20 · 1.1

20 · 1.2

20 · 1.3

20 · 1.4

20 · 2-Antiemetics

20 · 2.1

20 · 2.2

20 · 2.3

20 · 3- Anti- inflammatory medicines

20 · 3.1

20 · 4-Antispasmodic medicines

20 · 4.1

20 · 4.2

20 · 5-Laxatives

20 · 5.1

20 · 5.2

20 · 5.3

20 · 6-Medicines used in diarrhoea

20 · 6.1

20 · 6.2

20 · 7-Other medicines

20 · 7.1

21 · 1-Adrenal hormones and synthetic substitutes

21 · 1.1

21 · 1.2

21 · 1.3

21 · 1.4

21 · 1.5

21 · 2-Contraceptives

21 · 2.1-Hormonal contraceptives

21 · 21.1

21 · 2.1.2

21 · 2.2-Intrauterine devices

21 · 2.2.1

21 · 2.22

21 · 2.3-Barrier methods

21 · 2.3.1

21 · 3-Estrogens

21 · 3.1

21 · 3.2

21 · 4- Medicines used in diabetes mellitus

21 · 4.1-Insulins and other antidiabetic agents

21 · 4.1.1

21 · 4.1.2

21 · 4.1.3

21 · 4.1.4

21 · 4.1.5

21 · 4.2-Medicines used to treat hypoglycemia

21 · 4.2.1

21 · 5-Ovulation Inducers

21 · 5.1

21 · 6- Progestogens

21 · 6.1

21 · 6.2

21 · 7- Thyroid and antithyroid medicines

21 · 7.1

21 · 7.2

22 · 1-Diagnostic agents

22 · 1.1

22 · 2-Sera and immunoglobulins (Liquid/ Lyophilized)

22 · 2.1

22 · 2.2

22 · 2.3

22 · 2.4

22 · 2.5

22 · 2.6

22 · 2.7

22 · 3-Vaccines

22 · 3.1-For universal immunisation

22 · 3.1.1

22 · 3.1.2

22 · 3.1.3

22 · 3.1.4

22 · 3.15

22 · 3.1.6

22 · 3.1.7

22 · 3.1.8

22 · 3.2-For Specific Group of Individuals

22 · 3.2.1

23 · 1

23 · 2

23 · 3

23 · 4

23 · 5

24 · 1

24 · 2

24 · 3

25 · 1- Anti-infective medicine

25 · 1.1

25 · 1.2

25 · 1.3

25 · 1.4

25 · 1.5

25 · 1.6

25 · 2-Antiinflammatory medicine

25 · 2.1

25 · 3-Local anaesthetics

25 · 3.1

25 · 4-Miotics and anti glaucoma medicines

25 · 4.1

25 · 4.2

25 · 4.3

25 · 5-Mydriatics

25 · 5.1

25 · 5.2

25 · 5.3

25 · 5.4

25 · 6-Ophthalmic surgical aids

25 · 6.1

25 · 7 -Miscellaneous

25 · 7.1

26 · 1-Oxytocics and abortifacient

26 · 1.1

26 · 1.2

26 · 1.3

26 · 1.4

26 · 1.5

26 · 2-Medicines used in pre term labour

26 · 2.1

26 · 2.2

27 · 1-Medicines used in psychotic disorders

27 · 1.1

27 · 1.2

27 · 1.3

27 · 1.4

27 · 2-Medicines used in mood disorders

27 · 2.1-Medicines used in depressive disorders

27 · 2.1.1

27 · 2.1.2

27 · 2.1.3

27 · 2.2-Medicines used in Bipolar disorders

27 · 2.2.1

27 · 2.2.2

27 · 3-Medicines used for Generalized Anxiety and Sleep Disorders

27 · 3.1

27 · 3.2

27 · 4-Medicines used for obsessive compulsive disorders and panic attacks

27 · 4.1

27 · 4.2

28 · 1.1

28 · 1.2

28 · 1.3

28 · 1.4

28 · 1.5

28 · 1.6

29 · 1

29 · 2

29 · 3

29 · 4

29 · 5

29 · 6

29 · 7

29 · 3- Miscellaneous

29 · 3.1

30 · 1

30 · 2

30 · 3

30 · 4

30 · 5

130 · 6

130 · 7

130 · 8

30 · 9

1 · 2 3

1 · Name of the formulation:

2 · Name and address of the manufacturer/importer

3 · Name of the Marketing Company, if any:

4 · Composition as per label claimed and approved by Drug Control Authorities:

5 · Drugs Control Authority Permission Number and Date (copy to be enclosed):

6 · Celling Price and date of notification:

7 · Existing maximum retail price (MRP) and its effective date:

8 · Therapeutic category as per NLEM:

9 · Date of commencement of production import

10 · Proposed date of discontinuation:

11 · Reasons for discontinuation of production import:

12 · Year-wise Production/Import during the last 5 years including current year

14 · Whether any new drug as defined under Proviso of Definition of "New Drug" under DPCO, 2013 has been launched or intended to be launched: If s0, the details thereof:

15 · Any other information relevant to discontinuation of scheduled formulation: