(Published in Part II, Section 3, Sub-section (ii) of the Gazette of India, Extraordinary)

Government of India

Ministry of Chemicals and Fertilizers

National Pharmaceutical Pricing Authority

New Delhi, the 24^th September, 2009

ORDER

S.O. 2458(E)- In exercise of the powers, conferred by sub-paragraphs (1) and (2) of paragraph 9 and paragraph 11 of the Drugs (Prices Control) Order, 1995, read with No. S.O. 637 (E) dated the 4^thSeptember, 1997 issued by the Government of India in the Ministry of Chemicals and Fertilizers and in supersession of the Order of the Government of India in the Ministry of Chemicals and Fertilizers, (National Pharmaceutical Pricing Authority) No. S.O. 1665(E), dated 27^th September, 2007, in so far as it relates to formulation packs mentioned in the table below, except in respect of things done or omitted to be done before such supersession, the National Pharmaceutical Pricing Authority, hereby fixes the prices as specified in column (5) of the table below as ceiling prices exclusive of excise duty and local tax, if any, and in column (6) of the table below as Equivalent MRP inclusive of excise duty and education cess, sales tax/VAT of each of the Scheduled formulations specified in the corresponding entry in column (2) of the said Table with the strength and pack size specified respectively in the corresponding entries in columns (3) and (4) thereof:

Table

Sl. No.	Name of the Formulation	Strength	Pack Size	Ceiling Price (Rs.)	Equivalent MRP*(inclusive of all taxes)(Rs.)
(1)	(2)	(3)	(4)	(5)	(6)
--	--	Each coated tab contains	--	--	--
1	Multivitamins and    Mineral Tablets	Vitamin A Acetate-5000iu    Vitamin D3 -400iu Vitamin E -15iu / mg,   Thiamine Mononitrate-10mg     Riboflavine-10mg, Pyridoxine HCl-2mg  Cyanocobalamine-7.5mcg, Niacinamide-50mg   Calcium Panthothenate-10mg, Ascorbic Acid-75mg     Heavy Magnesium Oxide-30mg,  Maganese Sulphate Monohydrate-2.8mg   Copper Sulphate-2.0mg,  Zinc Sulphate Monohydrate-63mg    Selenium Di-oxide-70mcg	10’s  Strip/Blister	7.62	8.15
--	--	Each hard/soft gelatin capsules contains	--	--	--
2	Multivitamins and Mineral Capsules	Vitamin A Acetate-5000iu    Vitamin B1  Mononitrate-10mg   Vitamin B2 (Riboflavine) -10mg,    Vitamin B6 (Pyriboxine HCl) -2mg,    Vitamin B12 (Cyanocobalamine) -7.5mcg,    Vitamin C-75mg, Vitamin D3 -400iu  Vitamin E Acetate-15 i.u / mg    Calcium Pantothenate-10mg,   Folic Acid-1mg, Niacinamide-50mg, Biotin D-150mcg, Zinc Sulphate monohydrate – 63mg  Potassium Iodide eq. to Iodine-150mcg,   Magnesium Oxide heavy -30mg, Copper Sulphate – 2mg,    Chromium picolinate eq. to Chromium-25mcg   Selenium Dioxide Monohydrate eq. to Selenium-70mcg  Sodium Molybdate Dihyderate eq. to Molybdenum-25mcg   Colloidal Silicon Dioxide eq. to Silicon-1mg   Sodium Borate eq. to Boron-150mcg  Magnase Sulphate – 2.8mg	10’s    Strip/Blister	8.80	9.41

*Subject to actual payment of Government levies/taxes, as applicable.

Note :

(a)        For all the other Vitamin formulations having composition within the prescribed range in Schedule-V under Drugs and Cosmetics Act, 1940.  The Following adjustment shall be made by a manufacturer to work out the ceiling price (column no.5) for a product under the said order for formulation(s) in column No.2, when there is a change in the composition and the following factors (which are inclusive of admissible MAPE) shall be added/subtracted as -the case may be to the notified ceiling price given in column No.5 of the table on the following basis.

For each 10 Tablet/Capsules in Strip/Blister

1. For each 500 unit or part thereof of Vitamin A (as Acetate dry powder) Rs.0.0319 shall be added / subtracted.
2. For each 100 unit or part thereof of Vitamin D3 Rs.0.0077 shall be added / subtracted.
3. For each 5 mg or part thereof of Niacinamide Rs.0.0569 shall be added / subtracted.
4. For each 5 mg or part thereof of Cal. Pantothenate Rs.0.0674 shall be added / subtracted.
5. For each 5 mg or part thereof of D Pethenol Rs.0.0437 shall be added / subtracted.
6. For each 0.05 mg (50mcg) or part thereof of Folic Acid Rs.0.0017 shall be added / subtracted.
7. For each 1 mcg or part thereof of Vitamin B12 Rs.0.0046 shall be added / subtracted.
8. For each 1 mg or part thereof of Vitamin B1 Rs.0.0168 shall be added / subtracted.
9. For each 1 mg or part thereof of Vitamin B2 Rs.0.0404 shall be added / subtracted.
10. For each 0.5 mg or part thereof of Vitamin B6 Rs.0.0091 shall be added / subtracted.
11. For each 10 mg or part thereof of Vitamin C Rs.0.1214 shall be added / subtracted.
12. For each 5 mg or part thereof of Vitamin E Rs.0.1252 shall be added / subtracted.
13. For each 10 mg or part thereof of Zinc mineral elements Rs.0.0422 shall be added / subtracted.
14. For each 0.05 mg (50mcg) or part thereof of Vitamin H (D-Biotin) Rs.0.0382 shall be added / subtracted.
15. For each 50 mcg or part thereof of element of Iodine Rs.0.0027 shall be added / subtracted.
16. For each 1 mg or part thereof of elements, of Iron Rs.0.0049 shall be added / subtracted.
17. For each 5 mg or part thereof of mineral elements, of Magnesium Rs.0.0219 shall be added / subtracted.
18. For each 1 mg or part thereof of mineral elements of Manganese, Rs.0.0052 shall be added / subtracted.
19. For each 1 mg or part thereof of mineral elements of Copper Rs.0.0108 shall be added / subtracted.
20. For each 10 mg or part thereof of mineral elements of Calcium Rs.0.0228 shall be added / subtracted.
21. For each 10 mg or part thereof of mineral elements of Phosphorous Rs.0.0152 shall be added / subtracted.
22. For each 10 mg or part thereof of mineral elements of Potassium Rs.0.0128 hall be added / subtracted.
23. For each 10 mg or part thereof of mineral elements of Chloride Rs.0.0141 shall be added / subtracted.
24. For each 10 mcg or part thereof of mineral elements of Chromium Rs.0.0012 shall be added / subtracted.
25. For each 10 mcg or part thereof of mineral elements of Molybdenium Rs.0.0007 shall be added / subtracted.
26. For each 10 mcg or part thereof of mineral elements of Selenium Rs.0.0086 shall be added / subtracted.
27. For each 5 mcg or part thereof of mineral elements of Nickel Rs.0.0003 shall be added / subtracted.
28. For each 10 mcg or part thereof of mineral elements of Tin Rs.0.0004 shall be added / subtracted.
29. For each 1 mg or part thereof of mineral elements of Sillicon Rs.0.0148 shall be added / subtracted.
30. For each 10 mcg or part thereof of mineral elements of Vanadium Rs.0.0021 shall be added / subtracted.
31. For each 100 mcg or part thereof of mineral elements of Boron Rs.0.0016 shall be added / subtracted.
32. For each 10 Million spores or part thereof of Lactic Acid Bacillus Rs.0.017 shall be added / subtracted.
33. For each 10 mcg or part thereof of Vitamin K Rs.0.0024 shall be added / subtracted.
34. For each 1mg or part thereof of L-Carnitine Tartrate Rs.0.03046 shall be added / subtracted.
35. For each 5 mg or part thereof of Glycin Rs. 0.03429 shall be added / subtracted.
36. For each 5 mcg or part thereof of Lutien Rs. 0.00076 shall be added / subtracted.
37. For each 5 mcg or part thereof of Mecobalamin/Methylcobalamine Rs. 0.02041 shall be added / subtracted.
38. For each 5mcg or part thereof of Lycopene Rs. 0.00076 shall be added / subtracted.
39. For each 1mg or part thereof of L-Arginine Rs. 0.02481 shall be added / subtracted.
40. For each 1mg or part thereof of L-Histidine Rs. 0.05338 shall be added / subtracted.
41. For each 1mg or part thereof of L-Isoleucine Rs. 0.05892 shall be added / subtracted.
42. For each 1mg or part thereof of L-Lysine Rs. 0.00710 shall be added / subtracted.
43. For each 1mg or part thereof of DL-Methionine Rs. 0.03215 shall be added / subtracted.
44. For each 1mg or part thereof of L-Phenyl alanine Rs. 0.01897 shall be added / subtracted.
45. For each 1mg or part thereof of L-Threonine Rs. 0.00339 shall be added / subtracted.
46. For each 1mg or part thereof of L-Tryptophan Rs. 0.13026 shall be added / subtracted.
47. For each 1mg or part thereof of L-Valine Rs. 0.03234 shall be added / subtracted.
48. For each 1mg or part thereof of Alpha Lipoic Acid Rs. 0.03321 shall be added / subtracted.
49. For each 5mg or part thereof of Sodium Feredetate Rs. 0.04217 shall be added / subtracted.
50. For each 5mg or part thereof of Beta Carotene Rs. 0.76184 shall be added / subtracted.
51. For each 10mg or part thereof of Fish Lipid Oil Rs. 0.04922 shall be added / subtracted.
52. For each 1mg or part thereof of Inositol Rs. 0.02825 shall be added / subtracted.
53. For each 1mg or part thereof of Rutin (vitamin P) Rs. 0.02723 shall be added / subtracted.
54. For each 1mg or part thereof of L-Leucine Rs. 0.03564 shall be added / subtracted.
55. For each 1mg or part thereof of L-Glutamic Acid Rs. 0.03228 shall be added / subtracted.
56. For each 1mg or part thereof of L-Glutathione Rs. 0.39035 shall be added / subtracted.

(b)        The prices fixed are the maximum retail prices in column (6) (inclusive of excise duty and local taxes if any) for the specified pack and packs of similar strength, and companies cannot claim exemption on any ground therefrom, unless specifically permitted by the Government/National Pharmaceutical Pricing Authority(NPPA) through an order.

(c)        The companies / manufacturers may added taxes only if they have paid actually to the Government on the price mentioned in the column (5).  If there is any variation in the MRP (inclusive of the taxes), the same may be intimated to the NPPA in the Form-V of DPCO, 1995.

(d)        Pro-rata pricing for packs of same composition but of different sizes will be applicable vide S.O. No. 83(E) dated 27.1.1998 for tablet and capsule packed in strip/blister.

(e)        For different packing material used or, different drug delivery systems or any other special features/forms claimed, the ceiling prices, as specified in Column No. 5 above, shall be applicable unless the companies approaches the NPPA for specific price approvals for its formulations.

(f)         The prices fixed/notified hereinabove under the provisions of the DPCO, 1995 have to be mandatorily implemented by the manufacturing /marketing company notwithstanding its status of compliance of conditions for such formulation pack under the Drugs and Cosmetics Act, 1940.

(g)        The manufacturer and marketing company for the above said formulation shall be required to take the requisite prior approval from the competent Authority for any change in the composition of the above said formulation with written prior intimation to the NPPA.

(h)        The ceiling price arrived on the basis of above shall not exceed the MRP by multiplying the ceiling price by a factor of 1.0696 as per the existing rates of excise duty and VAT.

(i)         The MRP arrived as above shall be subject to payment of Government levies / taxes as applicable and necessary adjustment in the factor of 1.0696 shall necessarily be required to be made by the manufacturer/marketing company, whenever the existing rate of excise duty and/or VAT undergoes a change, subject to the condition that the excise duty and/or VAT so calculated shall in no case exceed the actual excise duty and/or VAT paid by the manufacturer/marketing company or as applicable as per the factor of 1.0696. The manufacturer/marketing company shall be specifically liable to ensure the compliance of this condition.

(j)       Any other formulation / composition not covered in the above table that has any one of the scheduled drugs in Column No. (3) as one of its ingredients, it shall be subject to the price ceiling at respective serial number of the table, as the case may be, unless the manufacturer has got hereafter specific price fixed by the NPPA for that formulation.

(k)        The manufacturer or marketing company not complying with the ceiling prices and conditions specified in notes hereinabove within 15 days from the date of above said notification, shall be liable to deposit overcharged amount along with the interest under the provisions of the DPCO, 1995 read with the Essential Commodities Act, 1955.

(l)         Consequent to the issue of ceiling price of the formulation pack(s) in this notification, the price order(s) issued prior to this date of notification stand automatically withdrawn.

PN/111/2009F

F. No. 8(20)/2009/D.P./NPPA-Div.-II

                                                                                                              (MANISH GOSWAMI)

                                                                                                                     Deputy Director

Last Page Updated: 03-06-2019