3 Covered under DPCO1. SCHEDULED DRUGS : Strength & Dosage Forms of 348 drugs in Schedule 1Those selling at higher MRP shall bring downtheir MRP as notified by NPPA.Those selling at lower MRP shall not increasetheir MRP as per notified price; but willContinue to sell at their existing price.
4 Covered under DPCO2. NEW DRUGS as defined under 2(u) ; Applicable to Existing Manufacturers for launch of New Drug and will require price approval.3. IMPORTED DRUGS:ceiling price shall be as applicable on indigenous drugs
5 Covered under DPCO4. Monitoring of MRP of NON – SCHEDULED DRUGS (only 10% price increase per Annum allowed)5. Control over BULK DRUGS MANUFACTURERFor bulk drug availability in case of emergency, urgency, non-commercial use, public interest.6. Control over FORMULATION MANUFACTURER Directing for supply of formulations to sell to institutions, hospitals or agencies.
6 7. Control over FORMULATION MANUFACTURER Covered under DPCO7. Control over FORMULATION MANUFACTURERDirecting not to stop manufacturing or reduce manufacturing of requiredquantities of formulation covered under NLEM.
7 Covered under DPCO8. Pricing of formulations covered under DPCO shall remain valid upto or 1 year from date of issue and thereafter prices can be increased as per annual whole sale price index for previous calendar year (2012) and thereafter formula as per para 4(1) shall be applied.
8 Covered under DPCO10. Profit margin to retailers fixed 16% on retail price on scheduled formulations and New Drugs.11. Ceiling Price / Retail Price will be notified on the basis of dosage unit – Per Tab / Per Cap / Per Vial.12. Deposit of over charged amount with interest and penalty.13. Power of entry, search and seizure by any Gazetted officer.
10 NOT Covered under DPCO1. Ayurvedic, Siddha, Unani Medicines.2. Homoeopathic Medicines.3. Any Substance not covered under Drugs & Cosmetics Act.4. Non-Scheduled Drugs.5. Non-Scheduled Drug combined with non schedule drug.
11 NOT Covered under DPCO6. Non-Scheduled Drugs – when combined with a Schedule Drug with different strength.7. Non-Scheduled Drugs – when combined with a Schedule Drug with different dosage form.8. New Drugs Manufactured by a New Manufacturer, New Drug already being manufactured by an existing Manufacturer.
12 NOT Covered under DPCO9. A formulation defined as New Drug involving NDDS under rule 122E of D&C Act and for which DCGI has granted its approval for five years from the date of its approval.10. Patented Drug (Product Patent or process patent or new drug delivery system) for five Years.
13 NOT Covered under DPCO11. All innovations in dosage as SR, ER, etc., unless already specified in Schedule; a separate manufacturing licence has been granted as such.
15 “Scheduled Drug/Formulation” Scheduled Drugs“Scheduled Drug/Formulation”consisting of 348 drugs / 652 formulations Under 27 therapeuticsmentioned in First Schedule appended to DPCO 2013With same strength andWith same dosage forms,Whether referred to by generic version orBy brand name.
16 As per NPPA clarification Paracetamol Syrup and Paracetamol Suspension Scheduled DrugsAs per NPPA clarificationParacetamol Syrup and Paracetamol Suspensionare same DOSGAE FORMSAnd therefore same ceiling price is applicable
17 Amoxicillin capsules 250mg and 500mg are covered under schedule: Scheduled Drugs2. If Strength of a scheduled formulation is changed, it ceases to be a Scheduled drugs e.g. –Amoxicillin capsules 250mg and 500mg are covered under schedule:Amoxicillin capsules 125mg shall not be called a Scheduled Drug
18 Amoxicillin Capsules 250mg is covered under schedule: Scheduled Drugs3. If Dosage Form of a scheduled formulation is changed, it ceases to be a Scheduled Drugs e.g. ---Amoxicillin Capsules 250mg is covered under schedule:Amoxicillin Tablet 250mg shall not be called a Scheduled Drug
19 Amoxicillin Capsules 250mg is covered under schedule Scheduled Drugs4. If Dosage Form & Strength of a scheduled formulation are changed, it ceases to be a Scheduled Drugs e.g. ---Amoxicillin Capsules 250mg is covered under scheduleAmoxicillin Tablet 125mg shall not be called a Scheduled Drug
20 5. Scheduled Drug shall mean Formulation with Same strength and Same dosage form as in the schedule and nothing else.
22 Non - Scheduled Drugs1. What is not a Scheduled Drug is a NON- SCHEDULED DRUG2. Under para 2(v), “Non-Scheduled Formulation” means a formulation, containing the molecule, the dosage and strengths of which are not specified in the First Schedule; (Non-NLEM Drug / Formulation) For Example: Aceclofenac, Nimusulide, Sildenafil Citrate, Norfloxocin, Rabeprazole
24 New Drug / New Formulation Under para 2(u) of DPCO 2013, New Drug has been defined as under:“New Drug” for the purposes of this Order shall mean a formulation launched by an Existing manufacturer of a drug of specified dosages and strengths as listed in the National List of Essential Medicines (NLEM Formulation) by combining the drug with another drug either listed or not listed in the National List of Essential Medicines or a formulation launched by changing the strength or dosages or both of the same drug of specified dosages and strengths as listed in the NLEM List.
25 New Drug / New Formulation concept is applicable to “Existing Manufacturer” andNot to a “New Manufacturer”Concept is applicable at the launch of new drug andNot for existing formulations under production, even if covered under the definition of New Drug.
26 New DrugNew Drug / New Formulation, in simple words covers -a. NLEM Formulations with same specifieddosage and strength as combined with another NLEM Formulations with same specified dosage and strength.
28 New DrugExample 2: Omaprazole 20mg Tabletis Scheduled Drug Domperadone 10mg Tabletis Scheduled Drug Omaprazole 20mg + Domperadone 10mg Tablet is New Drug
29 New DrugExample 3: Cefixime 100mg Tabletis Scheduled Drug Ofloxacin 100mg Tabletis Scheduled DrugCefixime 100mg + Ofloxacin 100mg Tabletis New Drug
30 New DrugExample 4: Vitamin A 5000IU Capsuleis Scheduled Formulation.Vitamin D 0.25mg CapsuleVitamin A 5000IU + Vitamin D 0.25mg Capsuleis New Drug.
31 Non - NLEM Formulations New Drugb. NLEM Formulations with same specified dosage and strength as combined with anotherNon - NLEM Formulations
32 New DrugExample 1: Paracetamol 500mg Tabletis Scheduled Formulation Aceclofenac 100mg Tabletis Non - Scheduled Formulation Paracetamol 500mg + Aceclofenac 100mg Tablet is New Drug
33 New DrugExample 2: Diclofenac Sodium 50mg Tabletis a Scheduled FormulationSerratiopeptidase 10mg Tabletis Non-Scheduled DrugsDiclofenac Sodium 50mg + Serratiopeptidase 10mg Tablet is New Drug
34 New DrugExample 3: Clopidogrel 75 mg Tabletis a Scheduled Formulation Aspirin 75 mgis Non-Scheduled DrugsClopidogrel 75 mg + Aspirin 75 mg Tabletis New Drug
35 New Drugc. NLEM Formulations by changing its strength Example 1: Paracetamole 500mg Tablet is a Scheduled Drug Paracetamole 325mg Tablet is a New DrugExample 2: Clopidogrel 75 mg Tablet is a Scheduled Drug Clopidogrel 150 mg Tablet is a New Drug
36 New Drugd. NLEM Formulations by changing its dosage form --Example 1: Diclofenac 50mg Tablet is a Scheduled Drug. Diclofenac 50mg Ointment is a New Drug.Example 2: Clopidogrel 75 mg Tablet is a Scheduled Drug. Clopidogrel 75 mg Capsule is a New Drug.
37 New Druge. NLEM Formulations by changing its strength and dosage formExample 1: Diclofenac 50mg Tablet is a Scheduled Drug.Diclofenac 30mg Ointment is a New Drug.(Strength and Dosage Form Both Changed)
38 New DrugExample 2: Tramadol 50 mg / ml Injection is a Scheduled Drug.Tramadol 37.5 mg tablets is a New Drug (Strength and Dosage Form Both Changed) However if New Drug using NDDS and has approval from DCGI then DPCO is not applicable for 5 years.
39 New DrugExample 3: Metformin Tab 500mg is a Schedule Drug Metformin Tab 500mg SR is a New Drugand will be exempted under DPCO for 5 yrs after DCGI approval.
40 New DrugExample 4:Tramadol SR or ER TabParacetamol SR or ER TabAre not covered under DPCO
42 Not a New DrugExample 1: Paracetamole 500mg is Scheduled Drug Aceclofenac 100mg is not Scheduled Drug Paracetamole 325mg + Aceclofenac 100mg is not Scheduled Drug and is not aNew Drug under DPCO for price approval
43 Not a New DrugExample 2: Paracetamole 500mg is Scheduled Drug Nimusulide 100mg is not Scheduled Drug Paracetamole 325mg + Nimusulide 100mg is not Scheduled Drug and is not a New Drugunder DPCO for price approval
44 DEFINITION OF MANUFACTURER & EXISTING MANUFACTURER
45 WHO IS EXISTING MANUFACTURER? Under Para 2 (g) of DPCO 2013, “Existing Manufacturer” means Manufacturer Existing on the Date of Publication of DPCO 2013 in the official gazette.
46 ManufacturerUnder para 2(o) Drug Price Control order 2013 Manufacturer has been defined as under: “Manufacturer” for the purpose of this order means any person who manufactures, imports and markets drugs for distribution or sale in the country.
47 ManufacturerFor the purpose of DPCO, following persons shall be manufacturers in India:i) A manufacturer, who himself markets drugs for distribution or saleii) An Importer, who markets drugs for distribution or saleiii) A marketer who markets drugs for distribution or sale after getting drugs mfd. By a contract manufacture.
48 ManufacturerA Contract Manufacturer who is not a marketer, is not manufacturer under DPCO 2013.
50 1. PRICE TO RETAILERPrice to Retailer mean price of a drug at which it is sold to a retailer which includes duties and does not include local taxes.Price to Retailer is retail price fixed by Govt. As divided by 1.16 or say % of Retail Price.
51 2. CEILING PRICECeiling Price means price fixed by Govt.Under DPCO.Ceiling Price shall include Retailers Markup / profit margin of 16% over purchase price of retailer
52 3. MAXIMUM RETAIL PRICEMaximum Retail Price means ceiling price or retail price + local taxes & duties as applicable at which drug shall be sold to the ultimate consumer and where such price is mentioned on the pack.
54 CALCULATION OF PRICEDiscussion of DPCO Price Fixation was confined to NLEM Formulations with specified dosage and specified strength only.Now a parallel DPCO has been created to cover new drugs, for taking price approval in case of new launch by an existing manufacturer.
55 Calculation of Ceiling Price of a Scheduled Formulation a. Average Price to Retailer P(s)(Sum of prices to retailer of all the brands and generic versions of the medicine having market share more than or equal to one percent of the total market turnover on the basis of moving annual turnover of that medicine) / (Total number of such brands and generic versions of the medicine)
56 For working out the average price, all marketed brands of a company having market share more than 1% taken considered together – Alembic case
57 Calculation of Ceiling Price of a Scheduled Formulation b. It must be noted that Govt. has not taken Retail Price Base, but has taken Price to Retailer Base, which would mean that average MRP would come down.c. Retailers would get a markup of 16% on their purchase price and they will not get % on Retail Price.
58 Calculation of Ceiling Price of a Scheduled Imported Formulation Ceiling Prices are calculated and notified by Govt. as per formula above shall also be applicable to Scheduled Imported Formulations
59 Calculation of retail price of a new drug for existing manufacturers of scheduled formulations:- If such new drug is available in domestic market, the retail price shall be calculated in the same manner i.e. as per Scheduled Formulations.
60 Calculation of retail price of a new drug for existing manufacturers of scheduled formulations:- If such new drugs are not available in domestic market, the price to retailer shall be fixed based on principals of Pharmacoeconomics by Govt. on the recommendation of standing committee of experts. 16% margin of retailer shall be added thereon for the purpose of fixing retail price.
61 Calculation of Ceiling price of a scheduled formulation in case of no reduction in price due to absence of competitionCeiling Prices in such case shall be fixed as per para 6 of the order
62 Calculation of ceiling price by existing manufacturer selling the products at a price lower than the ceiling price + taxesUnder rule 13(2) such manufacturers shall maintain their existing maximum retail price
63 Calculation of Ceiling Price of Drugs Covered Under DPCO 1995 Formulations covered in Schedule –I of DPCO 2013 and also under DPCO 1995, prices of which were fixed up to ; such prices shall be applicable up to Thereafter i.e. from such prices will be increased in tandem with whole sale price Index of previous calendar year i.e
64 Calculation of Ceiling Price of Drugs Covered Under DPCO 1995 Formulations covered in Schedule –I of DPCO 2013 and also under DPCO 1995, prices of which were fixed after ; such prices shall remain applicable for 1 year from the date of such notification(s). Thereafter these prices will be increased from respective dates in tandem with whole sale price Index of previous calendar year.
65 Calculation of Ceiling Price of Drugs Covered Under DPCO 1995 Formulations not covered in Schedule –I of DPCO 2013, but covered under DPCO 1995, prices of which were fixed up to ; such prices shall remain applicable up to Thereafter i.e. from ; such formulations will because Non-Schedule Drugs and prices can be increased by 10%.
66 Calculation of Ceiling Price of Drugs Covered Under DPCO 1995 Formulations not covered in Schedule –I of DPCO 2013, but covered under DPCO 1995, prices of which were fixed after ; such prices shall remain applicable for 1 year from the date of such notification; and thereafter such formulations will become NSD and prices can be increased by 10% from the respective dates.
68 1. Calculation of Retail Price of a Pack (Rule 11) Average Price to retailer shall be calculated on the dosage bases i.e. per tablet, per capsule, per injection or per ml in volume as listed in first schedule.2. Therefore, bigger the pack, more will be the gain.
69 3. Who has to maintain records for inspection under DPCO Manufacturer – YESRetailers / Wholesalers - NO
70 4. Power of Search & Seizer Powers to be sparing usedBut any place; by any authorised personHow much overcharging is possible for formulations produced before New Price notificationsTo the extent seized and not what was produced
71 5. Govt. Power under DPCOPower given to Gazetted Officers of Central & State Government to enter and seize drugs.Overcharging + Interest + Penalties provided. Earlier penalties were not there.Controlled price will be revised every five years or when NLEM is updated or revised or when there is a significant change in market structure.
72 6. Power of drug inspectors If Drugs Inspectors are given power as Gazetted officers under DPCO –Concerned D.I. can inspect the records of manufacturer and not of Retailer
73 7. Quantum of current overcharging Presently overcharging + Interest + Penalty are recoverableFrom ManufacturerOnly on stocks held and sold by manufacturer only
74 Applicability of New Drug price approval is for Existing Manufacturer only. There is no applicability of price approval of ‘New Drug’ by new manufacturer.
75 9. DPCO going beyond its scope It is observed that under Section 12.3 Anti-hypertensive Medicines against Atnelol 50mg tablet is only specified but in the Schedule 1 under DPCO, 2013 both 50mg and 100mg tablets are specified. 100mg tablet as such be omitted from Schedule 1 of DPCO, 2013 as there was no mandate to include it.There may be other such examples; which requires further examination.
76 New DrugVide S.O 2534 (E)Fixed the price of Cefexime Ofloxacin Tablet Rs 5.73 per tabWhile combination is not a Scheduled Drug. Ceiling Price Fixed for Cefexime 100 mg is Rs.7.69 per tab and Ofloxacin 100 mg is Rs. 3.30
78 PRICE REVISIONSi) In case of Scheduled Drugs and New Drugs – Increase or Decrease is allowed as per whole sale price index of previous calendar year and such increase shall be applicable from 1st April each year. Govt. will issue such ceiling price also.
79 PRICE REVISIONSii) In case of Non-Scheduled drugs – upto 10% increase every 12 calendar months is allowed. iii) In case of Scheduled Drugs so being sold by existing manufacturers at a price lower than the ceiling price fixed, increase in the existing price shall be allowed annually as per whole sale price index.
81 FORM-IApplication for Fixation / Revision of a New Drug para 2(u), 5,7,8,9,15FORM-IISubmission of Revised Prices for Scheduled Formulations (Para16)FORM-IIIQuarterly Return for production import & sale of NLEM Drugs para 21(1)FORM-IVApplication for Discontinuation / Import of Scheduled Formulations para 21 (2)FORM-VPerforma for Price List (para 2(x), 24, 25, 26)