AKUMS DRUGS & PHARMACEUTICALS LTD.

1. AKUMS DRUGS & PHARMACEUTICALS LTD. D. C . JAIN dcj@akums.net 9811056056

2. WHAT IS COVERED UNDERDPCO - 2013

3. Covered under DPCO 1. SCHEDULED DRUGS : Strength & Dosage Forms of 348 drugs in Schedule 1 Those selling at higher MRP shall bring down their MRP as notified by NPPA. Those selling at lower MRP shall not increase their MRP as per notified price; but will Continue to sell at their existing price.

4. Covered under DPCO 2. 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 DPCO 4. Monitoring of MRP of NON – SCHEDULED DRUGS (only 10% price increase per Annum allowed) 5. Control over BULK DRUGS MANUFACTURER For 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. Covered under DPCO 7. Control over FORMULATION MANUFACTURER Directing not to stop manufacturing or reduce manufacturing of required quantities of formulation covered under NLEM.

7. Covered under DPCO 8. Pricing of formulations covered under DPCO 1995 - shall remain valid upto 31.05.2013 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 DPCO 10. 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.

9. WHAT IS NOT COVERED UNDER DPCO - 2013

10. NOT Covered under DPCO 1. 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 DPCO 6. 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 DPCO 9. 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 DPCO 11. All innovations in dosage as SR, ER, etc., unless already specified in Schedule; a separate manufacturing licence has been granted as such.

14. WHAT IS SCHEDULED DRUG / FORMULATIONS

15. Scheduled Drugs “Scheduled Drug/Formulation” consisting of 348 drugs / 652 formulations Under 27 therapeutics mentioned in First Schedule appended to DPCO 2013 With same strength and With same dosage forms, Whether referred to by generic version or By brand name.

16. Scheduled Drugs As per NPPA clarification Paracetamol Syrup and Paracetamol Suspension are same DOSGAE FORMS And therefore same ceiling price is applicable

17. Scheduled Drugs 2. If Strength of a scheduled formulation is changed, it ceases to be a Scheduled drugs e.g. – Amoxicillincapsules 250mg and 500mg are covered under schedule: Amoxicillincapsules 125mgshall not be called a Scheduled Drug

18. Scheduled Drugs 3. If Dosage Form of a scheduled formulation is changed, it ceases to be a Scheduled Drugs e.g. --- AmoxicillinCapsules 250mg is covered under schedule: AmoxicillinTablet 250mg shall not be called a Scheduled Drug

19. Scheduled Drugs 4. If Dosage Form & Strength of a scheduled formulation are changed, it ceases to be a Scheduled Drugs e.g. --- AmoxicillinCapsules 250mg is covered under schedule AmoxicillinTablet 125mg shall not be called a Scheduled Drug

20. Scheduled Drugs 5. Scheduled Drug shall mean Formulation with Same strength and Same dosage form as in the schedule and nothing else.

21. WHAT IS NON-SCHEDULED DRUG / FORMULATIONS

22. Non - Scheduled Drugs 1. What is not a Scheduled Drug is a NON- SCHEDULED DRUG 2. 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

23. WHAT IS NEW DRUG

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” and Not to a “New Manufacturer” Concept is applicable at the launch of new drug and Not for existing formulations under production, even if covered under the definition of New Drug.

26. New Drug New Drug / New Formulation, in simple words covers - a. NLEM Formulations with same specified dosage and strength as combined with another NLEM Formulations with same specified dosage and strength.

27. New Drug Example 1: Paracetamol 500mg Tablet is Scheduled Formulation Diclofenac 50mg Tablet is Scheduled FormulationParacetamol 500mg + Diclofenac 50mg Tablet is New Drug/Formulation

28. New Drug Example 2: Omaprazole 20mg Tablet is Scheduled DrugDomperadone 10mg Tablet is Scheduled DrugOmaprazole 20mg + Domperadone 10mg Tablet is New Drug

29. New Drug Example 3: Cefixime 100mg Tablet is Scheduled DrugOfloxacin 100mg Tablet is Scheduled Drug Cefixime 100mg + Ofloxacin 100mg Tablet is New Drug

30. New Drug Example 4: Vitamin A 5000IU Capsule is Scheduled Formulation. Vitamin D 0.25mg Capsule is Scheduled Formulation. Vitamin A 5000IU + Vitamin D 0.25mg Capsule is New Drug.

31. New Drug b. NLEM Formulations with same specified dosage and strength as combined with another Non - NLEM Formulations

32. New Drug Example 1: Paracetamol 500mg Tablet is Scheduled FormulationAceclofenac 100mg Tablet is Non - Scheduled FormulationParacetamol 500mg + Aceclofenac 100mg Tablet is New Drug

33. New Drug Example 2: Diclofenac Sodium 50mg Tablet is a Scheduled Formulation Serratiopeptidase 10mg Tablet is Non-Scheduled Drugs Diclofenac Sodium 50mg + Serratiopeptidase 10mg Tablet is New Drug

34. New Drug Example 3: Clopidogrel 75 mg Tablet is a Scheduled FormulationAspirin75 mg is Non-Scheduled Drugs Clopidogrel 75 mg + Aspirin 75 mg Tablet is New Drug

35. New Drug c. NLEM Formulations by changing its strength Example 1:Paracetamole 500mg Tablet is a Scheduled DrugParacetamole 325mg Tablet is a New Drug Example 2: Clopidogrel 75 mg Tablet is a Scheduled DrugClopidogrel 150 mg Tablet is a New Drug

36. New Drug d. 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 Drug e. NLEM Formulations by changing its strength and dosage form Example 1:Diclofenac 50mg Tablet is a Scheduled Drug. Diclofenac 30mg Ointment is a New Drug. (Strength and Dosage Form Both Changed)

38. New Drug Example 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 Drug Example 3:Metformin Tab 500mg is a Schedule DrugMetformin Tab 500mg SR is a New Drug and will be exempted under DPCO for 5 yrs after DCGI approval.

40. New Drug Example 4: Tramadol SR or ER Tab Paracetamol SR or ER Tab Are not covered under DPCO

41. WHAT IS NOT A NEW DRUG

42. Not a New Drug Example 1:Paracetamole 500mg is Scheduled DrugAceclofenac 100mg is not Scheduled DrugParacetamole 325mg + Aceclofenac 100mg is not Scheduled Drug and is not a New Drug under DPCO for price approval

43. Not a New Drug Example 2:Paracetamole 500mg is Scheduled DrugNimusulide 100mg is not Scheduled DrugParacetamole 325mg + Nimusulide 100mg is not Scheduled Drug and is not a New Drug under 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. Manufacturer Under 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. Manufacturer For the purpose of DPCO, following persons shall be manufacturers in India: i) A manufacturer, who himself markets drugs for distribution or sale ii) An Importer, who markets drugs for distribution or sale iii) A marketer who markets drugs for distribution or sale after getting drugs mfd. By a contract manufacture.

48. Manufacturer A Contract Manufacturer who is not a marketer, is not manufacturer under DPCO 2013.

49. PRICES DEFINED

50. 1. PRICE TO RETAILER Price 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 86.2069% of Retail Price.