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REGISTERED NO. D. (D.)-72

The Gazette of India

EXTRAORDINARY

PART II—Section 3—Sub-section (ii)

PUBLISHED BY AUTHORITY

No. 148] NEW DELHI, SATURDAY, MARCH 31, 1979/CHAITRA 10. 1901

Separate paging is given to this Part in order that it may be filed as a separate compilation..

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MINISTRY OF PETROLEUM CHEMICALS AND FERTILIZERS (Department of Chemicals and Fertilizers) ORDER New Delhi, the 31st March, 1979

S.O. 190(E).—In exercise of the r>owers conferred by Section 3 of the Essential Commodities Act, 1955 (10 of 1955), the Central Government hereby makes the following Order, namely :—

1, Short title, extent and commencement—(l)This Order may be called the Drugs (Prices Control) Order, 1979.

(2) It extends to the whole of India.

(3) It shall come into force on the date of its publication in the Official Gazette.

2. Definitions—In this Order, unless the context other- wise requires —

(a) "bulk, drug" means any substance including pharma- ceutical, chemical, biological or plant product or medicinal gas conforming to pharmacopoeia! or other standards accepted under the Drugs and Cos- metics Act. 1940 (23 of 1940), which is used as such, or as an ingredient in any formulations;

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(b) "dealer" means a person carrying on the business of purchase or sale of drugs, whether as a whole- saler or retailer and whether or not in conjunction with any other business and includes an aeent of a dealer ;

(c) "distributor" means a distributor of drugs or his agent or a stockist appointed by a manufacturer or an importer for stocking his drugs for resale to a dealer ;

(d) "drug" includes :^

(i) a medicine for internal or external use of human beings or animals and all substances intended to be used for, or in, the diagnosis treatment, miti- gation or prevention of disease in human beings or animals ;

(ii) such substances, intended to affect the structure or any function of the human or animal body or Intended to be used for the destruction of vermin or insects which cause disease in human beings or animals, as may be specified from time to time by the Government by notification in the Official Gazette ; and

(iii) bulk, drugs and formulations ;

(e) "Form" means a Form specified in the Fourth Schedule ;

(f) "formulation" means a medicine processed out of, or containing one or more bulk drugs or drugs, with or without the use of any pharmaceutical aids for Jn'emal or external use for, or in the diagnosis, treatment, mitigation or prevention of disease in human beings or animals, but shall not include :—

(i) any bona fide Ayurvedic (including Sidha) or Unani (Tibb) systems of medicine ;

(il) any medicine included in the Homoeopathic sys- tem of medicine ;

(iii) any substance to which the provisions of the Drugs and Cosmetics Act, 1940 (23 of 1940) do not apply ;

(g) "free reserve" means a reserve created by appro- priation of profits, but does not include reserves provided for contingent liability, disputed claims, goodwill, revaluation and other similar reserves ;

(h) "Government" means the Central Government ;

(i) "import", with its grammatical variation and cog- nate expressions, means bringing into India from a place outside India; and "importer", in relation to any goods at any time between their importation and consumption, includes any owner or any person holding himself out to be the importer ;

(]) "leader price" means a price fixed by the Govern- ment for formulations specified in Category I, Catc gory II or Category ITI of the Third Schedule, in accordance with the provisions of paragraphs 10 and 11 keeping in view the cost or efficiency, or both, of major manufacturers of such formulations;

(k) "manufacture", in relation to any drug, includes any process or part of a process for making, alter- ing, finishing, packing, labelling, breaking-up or otherwise treating or adapting any drug with a view to its sale ;ind distribution but does not include the compounding or dispensing of any drug or the packing of any drug in the ordinary course of retail business, and "to manufacture" shall be cons- tuted accordingly ;

(1) "manufacturer" means any person who manufactures a drug ;

(m) "net-worth" means the share capital of a company plus free reserve, if any ;

(n) "new bulk drug" means a bulk drug manufactured, wjthin the country, for the first time after the commencement of this Order ;

(o) "pooled price", in relation to a bulk drug, means

the price fixed under paragraph 7 ;

(p) "pre-tax return" means profits before Payment or income-tax and surtax and includes such other ex- penses as do not form part of the cost of formula- tion ;

(q) "price list" means a price list referred to in this Order and include a supplementary price list ;

(r) "retail price" means the retail price of a drug arrived at or fixed in accordance with the provisions of this Order and includes a leader price ;

(s) -'retailer" means a dealer carrying on the retail

business ot sale of drugs to customers ;

(t) "retention price", in relation to a bulk drug, means the price fixed under paragraphs 4 and 7 for indivi- dual manufacturers, or importers, or distributors, of such bulk drugs ;

(u) "sales turn-over" means the product ot units of formulations sold by a manufacturer or an importer, as the case may be, in an accounting year multi- plied by retail price inclusive of sales tax, if any, paid on direct sales by the manuafcturer or importer but does not include excise duty and local taxes, if any ;

(v) "Schedule" means a Schedule appended to this

Order ;

(w) "wholesaler" means a wholesaler of drugs or his agent, or a stockist appointed by a manufacturer or an importer for the sale of his drugs to a re- tailer.

3. Power to fix the maximum sale price of indigenously manufactured bu k drugs specified in First Schedule or Second Schedule.—(1) The Govemmen* may, with a view to regu- lating the equitable distribution of an indigenously manu- factured bulk drug specified in the First Schedule or the Second Schedule and making it available at a fair price and subject to the provisions contained in sub-paragraph (2) and after making such inquiry as it deems fit, fix. from time to time, by notification in the Official Gazette, the maximum price at which such bulk drug shall be sold.

(2) While fixing the price of a bulk drug under sub- paragraph ( I ), the Government may take into account the average cost of production of such bulk drug manuafctured by an efficient manufacturer and allow a reasonable return on net-worth.

Explanation.—In this sub-paragraph, the expression "efficient

manufacturer" means a manufacturer :—

(b) Where the price of a MUK orug nas mn "wu. """vr* by the Government, the manufacturer shall, within fourteen days of the commencement of the Produc- tion of such bulk drug, make an application to the Government in Form I and intimate Government the price at which he intends to sell the bulk drug and the Government may, after making such inquiry as it deems fit, by order, fix a provisional price at which such bulk drug shall be sold.

(.c) The manufacturer referred to jn this sub-paragraph shall, within six months of the commencement of such production, make a further application to the Government in Form 1 and the Government may, after making such inquiry as it deems fit, by noti- fication in the Official Gazette, fix the price of such bulk drug.

4. Power to fix retention price and common sale price.— Notwiths'anding anything contained in paragraph 3, the Government may, if it considers necessary or expedient so to do for increasing the production of an indigenously manu- factured bulk drug specified in the First Schedule or the Second Schedule, by order, fix :—

(a) a retention price of such bulk drag ;

(b) a common sale price for such bulk drug, taking intc account the weighted average of the retention prict fixed under clause (a).

5. Power to fix maximum sale price of new bulk drug.— (a) Every manufacturer of new bulk drug shall, withy fourteen days of the commencement of production of sucl new bulk drug, make an application to the Government ii Form 1, and the Government may, after making such in quiry as it deems fit, decide to include such new bulk druj in this Order and by order, fix a provisional price at whicl such new bulk drug shall be sold.

(2) (a) In every case where a provisional price has beej fixed for a new bulk drug, every manufacturer o such new bulk drug shall on completion of si months of production of such new bulk drug, mak a further application to the Government in Forr

(b) On receipt of an application under clause (a), tfc

Government may. after making such inquiry as deems fit, by notification in the Official Gazette, fix the price of such bulk drug.

(c) The price fixed under clause (b) shall be the maxi- mum selling price of such new bulk drug and no person (including a person manufacturing such bulk drug thereafter) shall sell such new bulk drug at a pnce exceeding the price so notified.

". Power to fix the maximum sale price of imported bulk

^⁸Jpe^Sedt.% Pmt or S e c o nd ScheduIe-lO) Every

;, ^K Schedule shall, within fourteen days of the import of

der?t;on)Se-G°V e r n f f l e D t,m a.y' after teKm into consfl Keo npri^orsuc?S.f u r n i s l l ed ta Form ²> * ord"-

sTWch⁶ bulkCMSUC? * * . * "• ^JoienS.'rtSi fixed

⁸ St a p n ce e ^ d f as

sale o f ^ f r t *^ retenfl^J"*" a."<* Pooled price for the Schatab. frX™!? ^i speclfifd m F'r e' Schedule or Second 8 E°?uK maliui^uTe8 Spedfi/d in t he F i r st Schedule or ( a> ™Tim pTj??J⁰T 'ndiv"dnal manufacturers, im-

(2) Where a manufacturer of formulations utilises in his formulations any bulk dn>g, either from his own pro- duction or procured by him from any other source, the price of such bulk drug being lower lhan the price allowed to him in the price of his formulations, the Government may require such manufacturer—

(a) to deposit into the Drug Prices Equalisation Account referred to in paragraph 17 the excess amount to be determined by the Government; or

(b) to sell the formulations at such prices as may be

fixed by the Government.

8. Prices of bulk drugs produced through indigenous research and development.—(1) With a view to providing encouragement to the manufacturers of new bulk drugs, produced through original research and developmental efforts in the country and have not been produced elsewhere, the provisions of this Order shall not apply to such bulk drugs tor a period of five years from the date of commencement of production of such new bulk drugs :

Provided that every manufacturer of such new bulk drug shall, within fourteen days of the commencement of pro- duction of such new bulk drug, make an application to the Government in Form 1 with a certificate from the Depart- ment of Science and Technology authenticating hh claim of having produced it as an entirely new bulk drug und also furnish to the Government the name of the said new bulk drug, the price at which it may be margeted by him or used by him for captive consumption and such other additional information as may be required by the Government.

Provided further that the price furnished to the Govern- ment in respect of the said new bulk drug shall not be in- creased without the prior approval of the Government.

(2) After the expiry of the period of five years referred to in sub-paragraph (I), the provisions of this Order shall apply to the new bulk drug referred to in that sub-para- graph..

9. Power to direct manufacturers of bulk drugs to sell bulk drugs to manufacturers of formulations.—(1) The Government may, from time to time, by general or special order, direct any manufacturer of any bulk drug to sell such bulk drujj to such manufacturers of formulations as may be specified in such order :

Provided that while making any such order, the Govern- ment sh;ill have regard to all or any of the following factors, namely :

)(a) the requirements for captive consumption of such

manufacturer ;

(b the requirements of other manufacturers of formu-

lations ;

(c) the planned growth of the pharmaceutical industrv in conformitj with the policy of the Government from time to time.

(2) For the purpose of making any order under sub- paragraph (1), the Government may call for such informa- tion from manufacturers, importers or distributors, of bulk, drugs as It may consider necessary and such manufacturers importers or distributors shall be bound to furnish such in- formation within such time us mav be specified by the Government.

10. Calculation of retail price of formulations —The retail price of a formulation shall be calculated in accordance with the following formula, namely .-

R.P. - (M.C. +C.C.+P. M. +P.C.) x

1 + I + E . D.

[ MU-¹

100 J

Where

"R. P." means retail pric".

"MCT means material cost and includes the cost of drugs and other pharmaceutical aids used including overage^ if any, and process loss thereon in accordance with

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as may be specified by the Government from time to time by notification in the Official Gazette in this, behalf.

"C.C." means conversion cost worked out in accordance with such norms as may be specified by the Government from time to time by notification in the Official Gazette in this behalf.

"P.M." means the cost of packing material including process loss thereon worked out in accordance with such norms as may be specified by the Government from time to time by notification in the Official Gazette in this behalf.

"P.O." means packing charges worked out in accordance with such norms as may be specified by the Government from time to time by noiification in the Official Gazette in this behalf.

"M.U." means mark-up referred to in paragraph 11,

"E.IV means excise duly :

Provided that in the case of an imported formulation the Winded cost shall form the basis for fixing its price along with such margin as the Government may allow from time to time.

Provided further that where an imported formulation is re- packed, its landed cost plus the cost of packing materials and packing charges as worked out in accordance with such norms as may be specified by the Government from time to time, by notification in the Official Gazette, shall from the basis for fixing its price.

Explanation.—For the purposes of this paragiaph, '"l.uided cost" shall mean tlua cost of import of drug inclusive of cus- toms duty and clearing charges.

11. Mark-up.—Mark-up referred to in paragraph 10 Includes the distribution cost, outward freight, promotional expenses, manufacturer's margin and the trade commission and shall not exceed—

(a) forty per cent in the case of formulations specified

In Category I of the Third Schedule ;

(b) lilty-five pei cent in the case of formulations speci-

fied in Category IF of the said Schedule :

(C) one hundred per cent in the case of tormiilatioti')

specified in Category HI of the said Schedule.

12. Power of Government to fix leader prices of formula- tions specified in Categories 1 and II of the Third Schedule— (1) The Government may, from lime to time, by notifica- tion in the Official Gazette, fix the leader price of a formula- tion specified in Category 1 or Category II of the Third Schedule and such leader price shall operate as the celling sale price for every manufacturer of such formulations.

(2) Notwithstanding anything contained hi sub-paragraph (1) where the selling price of a formulation of a iikinuiac- turer on the date of commencement of this Order is> less than the leader price fixed under sub-paragraph (1), such manutacturer shall not except with the prior approval of the Government increase the selling price of his formulation.

(3) The Government may of its own motion or on appli- cation made to it in this behalf by a manufacturer in Form 3 or Form 4 as the case may be, after calling for such in- formation as it may consider necessaiy, by order, fix a re- vised leader price for a formulation.

13. Power of Government to fix retail price of formula- tions specified in Category III of Third Schedule.—(I) The Government may, from time to time, by order, fix the re- tail price of a formulation specified in Category 111 of the Third Schedule in accordance with the provisions of para- graphs 10 and II.

(2) Where the Government fixes or tevises Lhe price o[ any bulk drug under the provisions of this order and a manu- facturer utilises such bulk drug in his formulations specified In Category III of the Third Schedule he shall, within thirty days of such fixation or revision, make an application to the Government in Form 3 or Form 4, as the case may be and Government may, if it considers necessary, fix or revise the price of such formulation.

(3) The retail price of a formulation once fixed by the Government under sub-paragraph i\) shall not be increased by any mnnufnctiirei except with the prior approval of the Government.

(4) Any manufacturer, who desires revision of the retail price of a formulation fixed under sub-paragraph (1), shall make an application to the Government in Form 3 or Form 4, as the case may be, and the Government may, after call- ing for such information as it may consider necessary, by order, fix a revised price for such formulation.

(5) Notwithstanding anything contained in the foregoing sub-paragraphs, the retail price of a formulation, specified in Category 11 of the Third Schedule, of a manufacturer shall, until the retail price thereof is fixed under the provisions of this Order, be the price which prevailed immediately before the commencement of this Order and the manufac- turer of such formulation shall not sell such formulation at a price exceeding the price which prevailed as aforesaid.

(6) (a) Without prejudice to the provisions of the pre- ceding sub-paragraphs the Government may, if it considers necessary or expedient so to do, by notification in the official Gazette, fix a leader price for any formulations specified in Category III of the Third Schedule and any manufacturer of such formulation may sell such formulation at a price not exceeding the price so notified and intimate the Govern- ment accordingly.

(b) The provisions of sub-Paragraph (2) shall not apply

to such manufacturer

14. General provisions regarding prices of formulations .— (1) No Manufacturer or importer shall market a new formu- lation or a new pack, or a new dojage form of his existing formulation specified in Categoiy I or Category II or Cate- gory HI of the Third Schedule without obtaining the prior aproval of its price from the Government,

(2) No person shall sell or dispose of Hny imported for- mulations specified in Category I or Category II or Category 111 of the Third Schedule without obtaining the prior appro- val of its price from the Government.

(3) Any manufacturer or importer, who desires to obtain the approval of the Government in respect of the price for any formulations referred to in sub-paragraph (1) or Sub- Paragraph (2), shall make an application to the Govern- ment in Form 3 or Form 4, as the case may be, and the Government may, within a period of four months of the re- ceipt of an application accord its approval, subject to such modifications, as it may consider necessary :

Provided thnt where approval is not accorded with the said period of four months, the manufacturer or importer, as the case may be, may market the new formulation or new pack or new dosage form referred to in sub-paragraph (i) ut the price declared by him in his application, isfiue the price list forthwith and intimate ttje Government accordingly.

Provided further that the Government may, if it consi- ders necessary, by order, revise the price so declared by the manufacturer or importer, as the case may be, and upon such region, the manufacturer or importer shall not sell such for- mulation at a price exceeding the price so revised.

15. Power to revise prices of formulations .—Notwithstan-

ding anything contained in this Order :—

(a) The Government may, after obtaining such infor- mation as it may consider necessary from a manu- facturer or an importer, fix or revise the retail price of one or more formulations marketed by such manufacturer or importer, including a formulation not (specified in any of the categories of the Third Schedule, in such manner as the pre-tax return on the sales turnover of such manufacturer or importer does not exceed the maximum pre-tax return specified in the Fifth Schedule ;

(b) the Govurnmcnl may, if it considers necessary so to do in public interest, by order, revise the retail price of any formulation specified in any of the categories of the Third Schedulc.

16. Fixation of price under certain circumstnnces .—Where any manufacturer, importer, or distributor of any bulk drug or formulation fails to furnish information at required under this order within the time specified therein, the Government may, on the basis of such information as may be available with it, by order, fix a price in respect of such bulk drug or formulation, aa the case may be.

17, Drug Prices Equalisation Account .—(1) The Govern- ment shall maintain an Account to be knnwn as the Drugs Prices Equalisation Account to which shall be credited—

(a) by the manufacturer, importer or distributor, us

the case may be- -

(i) the amout determined under sub-paragraph (2)

of paragraph 7;

(ii) the excess of the common selling price or, _ as

the case may be, pouled price over his retention price ; and

(bj such other sums of money as the Central Govern- ment may, after due appropriation made by Parlia- ment by law in this behalf, grant from time to time.

(2) The amount credited under sub-paragraph (1) shall

be spent only :—

(a) for paying to the manufacturer, importer or dis- tributor, as the case may be, the short-fall between his retention price and the common selling price or, as the case may be, the pooled price for the purpose of increasing the production, or securing the equitable distribution and availability at fair prices, of drugs ;

(b) for expenses incurred by the Government in dis-

charging the functions under this paragraph.

(3) Every manufacturer, impor'er or distributor may, if he has any claim under clause (a) of sub-paragraph (2), make an application to the Government and the Government may, in settling the claim, require the manufacturer, importer or distributor, as the case may be, to furnish such details as may be specified by it in this behalf.

(4) The Government shall maintain account of all moneys credited to. and expended from out of, the Drug Prices Equalisation Account and such other reports and return? as it may consider necessary relating to I he said account.

18. Certain provisions of this Order to apply to formula- lions not included in Category I, Category II or Category HI of Third Schedule,—The provision of (his Order, other than those contained in paragraphs 10 to 14 (both inclusive), shall apply to any formulation not specified in Category I, Category II or Category III of the Third Schedule.

19. Furnishing of piice list by manufacturer or Importer lo dealers.—(1) Evejy manufacturer or importer of a for- mulation Intended for the sale shall furnish to the dealers, State Drug Controllers and the Government, a price list showing the price at which the formulation is sold to a retailer (in- clusive of excise duty) and the retail price of such formulation and ihe list shall be furnished to the dealers, in Form 3, not later than thirty days from the commencement of this Order :—

Provided that where a manufacturer or an importer fur- nishes such a price list, it shall not be obligatory for such manufacturer or importer to furnish a fresh price list at the time of every subsequent sale to the dealer unless there is any chance by way of addition, deletion or alteration in that list. In which case a supplementary price list including such additions, delctioas or alterations shall be furnished.

(2) Every manufacturer or importer shall give effect to the change in prices as approved by the Government from time to time, within fifteen days from the receipt by such manufacturer or Importer of the communication jn this behalf from the Government.

20 Retail price to be displayed on label of container.— F.very manufacturer, importer or distributor of a formulation intended for sale shall display in indelible print mark on the label of the container of the formulation or the minimum pack thereof offered for retail sale, the maximum retail price of that formulation wilh the words "'retail price not to exceed preceding it, and "local taxes extra" succeeding it.

21. Control of sale prices of formulations specified in Third Schedule.—No retailer shall sell any formulation speci- fied in any of the categories in the Third Schedule to any person at a price exceeding the price specified in the current price list or the price indicated on the label of the container or pack thereof, whichever is less, plus the local taxes, if any, payable.

Explanation.—For the purposes of this paragraph, "local taxes include sales tax and octroi actually paid by the re- tailer under any law in forc" in a particular area.

22. Sale of spljt quantities of formulations.—No dealer shall sell loose quantity of any formulation drawn from a bottle pack of such formulation at a price which exceeds the pro-rata price of the formulation plus 5 per cent thereof :

Provided that nothing in this behalf shall apply to any

formulation compounded at the premises of the dealer.

23. Manufacturer, distributor and dealer not to refuse sale of drug-—Subject to (he provisions of the Drugs and Cosme- tics Act, 1940 (23 of 1940) :—

(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 and drug available with him to a customer wanting to purchase such drug,

24. Price to the wholesaler and retailer.—(1) No manu- facturer, importer or distributor shall sell a formulation to a wholesaler unless otherwise permitted under the provisions of this Order or any other order made thereunder, at a price higher than :—

(a) the retail price minus 14 per cent thereof, in the

case of ethical drugs, and

(b) the retail prjee minus 12 per cent thereof, in the

case of non-ethical drugs,

(2) No manufacturer, importer, distributor or wholesaler shall sell a formulationtoa retailer unless otherwise permit- ted under the provisions of this Order or any order made thereunder, at a price higher than ;—

(a) the retail price minus 12 per cent thereof, in the

case of ethical drugs, and

(b) the retail price minus 10 per cent thereof, in the

case of non-ethical drugs.

Explanation.—For the purposes of this paragraph, —

(i) "ethical drugs" shall include all drugs specified in Schedule C, entries Nos. 1, 2, 3, 7, 8 and 9 of Schedule C ( l ), Schedule H, Schedule G, Schedule H and Schedule I, appended to the Drugs and Cosmetjcs Rules, 1945. made under the Drugs and Cosmetics Actr 1940 (23 of 1940) ; and

(ii) "non-ethical drugs" shall mean all drugs other than

ethical drugs.

t

351

(2) Every manufacturer shall, wjthin six months of the close of the accounting year, submit to the Government in- formation for that year in Form 6.

(3) Fvery dealer or manufacturer shall maintain the wish memo ur credit memo, boots of account and records of purchase and sale of drugs and shall mate available the said records for inspection by the Government.

26. Power of entry, search and seizure.'—(I) Any gazetted officer of the Central Government or of a State Govern- ment authorised by a general or special order by the Central Government or, as the case may be, the State Government in this behalf may, with a view to securing compliance with this Order or to satisfy himself that the provisions of this Order have been complied with—•

(a) enter and search any place ;

(b) seize any drug, along with 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 secur- ing production of the drug, containers, packages or coverings, so seized, in a court of law and for their safe custody pending such production ;

(c) seize any document, such as, cash memo or credit memo books, books of account and records of pur- chase and sale of the drugs in respect of which he suspects that any provision of this Order has been, is being, or is about to be contravened,

(2) The provision of section 100 of the Code of Criminal Procedure, 1973 (2 of 1974), relating to search and seizure Nhall, so far as may be, apply to searches and seizures under this Order,

27. Power to review,—Any person aggrieved by any notifi- cation or order under paragraphs 3, 4, 5, 6, 7, 9, 12, 13, 14, 15 or 16 may apply to the Government for a review of the notification or order within fifteen days of the date of publication of the notification in the Official Gazette, or, as the case may be, the receipt of the order by him, and the Government may make such order on the application as it may consider necessary.

28. Power to issue directions.—The Government may, from time to time, issue such directions, consistent with the provi- sions of this Order to any manufacturers or Importer, us may be necessary to cany out the provisions of this Order and such manufacturer or importer shall comply with such direc- tions.

29. Penalties.—Any contravention of any of the provisions of this Order shall be punishable in accordance with the pro- vision;, of the Essential Commodities Act, 1955 (10 of 1955).

30. Interpretation.—If any question arises as to the placing of o formulation in any of the categories of the Third Sche- dule, such question shall be decided by the Government.

31 Power to exempt.—(1) The Government may, having regard to the factors mentioned in sub-paragraph (2) and subject to such conditions, if any, as it may specify, by Order in the Official Gazette, exempt any drug manufacturing unit or a class of such units from the operation of all or any of the provisions of this Order and may, as often as may be, revoke or modify such Order,

c r n m e n' ™y- by :i general or special order,

and ' J ^ ^ t o n d f ag anything contained in sub-paragraphs (1) fix ;?V,w- G o v fix, in public interest, the price to the wholesaler or retailer in respect of any formulation the price of which hns been fixed or revised under this Older

™?tFn,?!!iflnenrnCC °f r e c?r ds a nd Pr o d u c t' °n thereof for ins- £ ™ v ~? E v"y manufacturer stall maintain in such form os may he specified by the Government, recordsrelatineto

A sf '" f" ™ yer of individual bulk manufacturedI bv him tuL .1 t r o v er of formulations packwfoe, and also such other records as may be directed- from time to time by (2) While granting exemption under sub-paragrupb (1), the Government shall have regard to all or any of the following factors relating to the drug manufacturing unit or a class of such units, namely :—

(a) number of workers employed ; (b) amount of capital invested; (c) range and type of products manufactured ; (d) sales turnover,

recon!s

s h a 11 be o p en

^ S T G S ^S

f or • • " * £ "" 32, Delegation of powers.—The Government may, by noti- fication in the Official Gazette, direct that all or any of Ihc powers conferred upon it by this Order, other than those

contained in pragraphs 27y 28, 30 and 31 shall, subjcc* to such icstrictions, exceptions and conditions; if any, as may be specified, in Ihc direction, be exercisable also by—

(a) such officer or authority subordinate to the Ont:;il

Government; or

Ib) such Stnte Government or such officer ui :uithoriiy

subordinate lo the. State Government.

14. Frusemide 15. Oxytetracycltae 16. Primaquin 17. Glyceryl Trinitrate 18. Quinine 19. Pyrolfdlne Methyl Tetracycline 20. Demcthyl Chlorotetracycline

in m;o be specified in the direction

THE SECOND SCHEDULE

[See Paragraph 3, 4, 6(1), 7(1)]

" 33. Repeal,—As from the commencement of this Order, the Drufis /(Prices Control) Order, 1970, shall cease to operate ovtpt as respects things clone or omitted to be dure before such cesser.

List of Bulk Drugs (including salts, esters and derivatives, TFany) used in Category III formulations appearing In Third

Schedule

[No. 5(3)/7K-Drug. II] M. S. PANDIT, Dy. Secy.

I. Anaestnatlcs, General and Local ;

THE FIRST SCHEDULE

[See Paragraph 3, 4, 6(1) 7 (1)]

BULK DRUGS

List of Bulk Drugs (Including salts, derivatives and esters, if any) used in Cat. I & II formulations appearing in Third Schedule

I. Bulk Drugs used In Category I bormulatlons

1. Benzocaine 2. Chloroform 3. Cocaine 4. Ether 5. Ethyl Chloride 6. Halothane 7. Trichloroethylene 8. Procaine 9. Xylocaine (Lignocaine)

SI. No. Name of the Bulk Drug

10. Marcaine 11. Thiopcntone Sodium 12. Ketamine

II. AnalagMlcs and Antipyretics :

1. Insulin 2. lodo-Chlorohydroxyquinoline 3. Isonlcotinlc Acid Hydrazidc 4. PAS Acid 5. PAS Sodium 6. Potassium Penicillin G. 7. Sodium Penicillin G. 8. Procaine Penicillin 9. Penicillin Potassium V

(Phonoxy Methyl Penicillin)

1. Amidopyrin 2. Baralgan Ketone 3. Codiene 4. Dextropropoxyphene 5. Fentanyl Citrate 6. Methyl Salicylate 7. Osadrine 8. Paracetamol 9. Pentazocaine

10. Phenacetein 11. Propoxy Phenazone 12. Phenylisopropylpyiazolone

10. Streptomycin Sulphate 11. Thiacetazone 12. Dapsonc 13. Aspirin 14. Pethldine 15. Bonzathine Penicillin

III. Antbelmlntki:

1. Bephenium hydroxy nephthoate 2. Dithiazamin Iodide 3. Pyrivinlum 4. Tetramlsol 5. Thiabendazole 6. Pyrantel

16. Calcium PAS 17. Pertussis Toxoid 18. Diptheria Toxoid 19. Tetanus Toxoid 20. Digoxin 21. Hydrochlorthiazidc 22. Di-Iodohydroxyquinoline 23. Morphine Sulphate

IV. Anrlameoblcs :

1. Broxyquinoline

II. Bulk Drugs used in Category II Formulations

2. Brobenzoxalidine 3. Bismuth Glycollylarsanilate 4. Dehydroemetine. 5. Diloxamide 6. Emetine 7. Furazolidone 8. Chlorophenoxamfde (Clefamlde) 9. Metronidazole

10. Phanquone

1. Amodiaquln 2. Chloramphenicol 3. Chloroquln 4. Prednisolone 5. Tetracycline 6. Tolbutamide 7. Sulphadlmidine 8. Diethylcarbamazine Citrate 9- Analgln

V. Anti-asthmatic and Enteric Antiseptics i

10. Phenobarbitone 11. Phthalyl Sulphathiazole \2. Calcium B. PAS 13. Ploerazine

1. Ephedrine 2. Pseudo-Ephedrine 3. Salbutamol

352/1 '

X. Antidiabetics :

4. Aminophylline 5. Theophylline 6. Papaverine 7. Ajmalicin

VI. Antibiotics :

1. Carbutamide 2. Chlorpropamide 3. Glybenclamide 4. Glipizide 5. Metformin 6. Phenformin

XI. Antibistaminics :

1. Antazoline 2. Bucilizine 3. Cyclizine 4. Carbinoxamine 5. Chlorocyclizine 6. Chlorpheniramine 7. Clemisole 8. Dimenhydrinate 9. Dimethindone

1. Amphotericin 2. Bacitracin 3. Carbenicillin 4. Cloxacillin 5. Cephalexin 7. Cephaloridine 6. Cycloserine 8. Doxycycline 9. Framycetin 10. Gentamycin 11. Gramicidin 12. Griseofulvin 13. Kanamycin 14. Lincomycin 15. Methicillin 16. Nystatin 17. Neomycin 18. Oxacillin 19. Oleandomycin 20. Paranmomycin 21. Polymixin 22. Rifampicin 23. Spiramycin 24. Viomycin 25. Lymecycline 26. Colistin 27. Tyrothricin 28. Ampicillin 29. Erythromycin

VII. Anti-Cancer Drugs :

10. Diphenhydramine 11. Diphenyl Pyraline 12. Diphenyl-Piperadine-Propane 13. Hydroxyzine 14. Mepyramine 15. Methdilazine 16. Methapyrilene 17. Meclozine 18. Pheniramine 19. Halopyramine 20. Promethazine 21. N-Phenyl-N-Benzyl-4-Amino-l-Methyl-Piperadine 22. Pyrolidylethyl Phenyl Benzyl-Amine 23. Isothiopendyl 24. Phenindamine 25. Triprolidine 26. Triplenamine 27. Thenalidine 28. Trimeprazine 29. Cyproheptadine 30. Dexachloropheniramine 31. Bamipiem (Soventol)

XII. Antileprotic Drugs :

Clofazimine

XIII. Antimalarial Drugs :

1. Mepacrine

2. Pyrimethamine

XIV. Antirheumatic :

1. L-Asparaginase 2. Busulphan 3. Chlorambudl 4. Cyclophosphamide 5. Cerubidin (Daunorubicin) 6. 5 FlurouracilJ 7. 6-Mercaptopurine 8. Thiotepa (NNN-Trienthylenethiophosphoramide) 9. Mitomycin 10. Adviamycin 11. Bleomycin 12. Azathioprime 13. Melphalan 14. Vinblastin 15. Vincrastine

1. Ibuprofen 2. Indomethacin 3. Oxy-Phenylbutazone

VIII. Anticoagulants :

4. Phenyl Butazone 5. Sodium Salicylate

XV. Antiseptics :

1. Warfarin 3—£—Acetonylbenzyl)-4-hydroxycoumarin). 2. Heparin 3. Ethyl Biscoumacetate. 4. Pheniyridione 5. Heparinoid substance isolated or derived from L\mg

Tissue.

IX. Anticovulsants :—

1. Chloroxylenols 2. Chlorocresols 3. Hexyl-Resorcinol 4. Greosote 5. Hydrogen Peroxide 6. Iodine 7. Cetrimide 8. Chlorhexidine

1. Ethosuximide 2. Diphenyl Hydantoin 3. Primidone

1387 GI78/44.

XVI. Antispasmodfcs i

1. Atropine Methylnitrate 2. Ethylmorphine 3. Belladonna Alkaloids 4. Hyoscine

6. Trlamberene 7. Mersalyl Add 8. Acetazolamlde 9. Ethoxzolamide 10. Chlorothiazide 11. Cyclopenthiazide 12. Hydroflumcthlazlde

XVII. Antttubercular :

13. Ethacrinic add.

XXI. Drugj used for Calcium therapy i

1. Ethambutol 2. Ethionamldc 3. Pyrasdnamide 4. Morphazlnamide 5. Prothionamlde

XVIII. Cardiovascular :

1. Calcium Oluconate 2. Caldum Levulinate 3. Caldum Lactate 4. Caldum Lactoblonate

(i) Antihypertenslve :

XXH. Haematlnlcs :

1. Ferrous Gluconate 2. Ferrous Fumerate 3. Forrous Sulphate 4. Iron-Dextran Complex 5. Liver Extract 6. Ferric Ammonium Citrate 7. Iron-Sorbitol Complex

1. Rauwelfia Alkaloids 2. Guancthidino Sulphate 3. Methyl Dopa 4. Pentolinlum Tartarate 5. Dihydroargocrystlne 6. Cloposamide 7. Clonidine 8. Dihydralazine

XXm. Oral Contraceptlyes i

(ii) Peripheral Vasodilators and Coronary Vasodilator t

1. Oestradlol 2. Lynestrenol 3. Ethlsterone 4. Mestranol 5. Nor-ethlsterone 6. Dimethisterone 7. Norgestrel 8. Megestrol 9. Ethynodiol

1. Histamine 2. Isoxsuprlne 3. Nylidrine 4. Penta Erythritol Tetranitrate 5. Prenylamlne 6. Sorblde Nitrate 7. Dlpyridamol 8. Amyl Nitrite 9. Mannltol Hexanitrate

10. Norothynodral.

(iii) Cardiac Glycosldes :

XXIV. Opthalmolglcal Preparation! i

1. Digitoxin 2. Lanatosldes 3. OnabaJne

(iv) Others

1. Sulphacetamide 2. Boric Add 3. Atropine 4. Pilocarpine 5. Phenylophrine 6. Homatroplne 7. Physostigmine Salicylate

XXV. OiytodCi :

1. Ergot Alkaloids 2. Oxytocin

1. Nikethamide 2. Clofibrate 3. Xenthlnol Nicotinate 4. Carbacol (40) 5. Propranalol 6. Quinidine 7. Procainamlde 8. Methacholtae

XXVI. Plasma Expanders and Transfusion Solution :

XIX. Corticosterolds

1. Dextran 2. Polyvinyl Pyrrolldone 3. Dextrose Anhydrous 4. Sodium Chlorido 5. Sod. Lactate 6. Pot. Chloride

1. Dexamethasone 2. Betamethasone 3. Triamdnolone 4. Prednisone 5. Hydrocortisone 6. Cortisone 7. A.C.T.H. (Corticotropln)

XXVU. Sera and Vaccines :

XX. Diuretics :

1. Antirablc Vaccine 2. Yellow Fever Vaccine 3. Cholera Vaccine 4. Tetanus antitoxin 5. Diphtheria antitoxin 6. Gasgangrene antitoxin

1. BcnztbJarido 2. Bendrofluazide 3. Chlorthalidenc 4. Polythlazlde 5. Sph-anolactone

7. Antirabic Scrum 8. Antivenom Serum

9. B.C.G. Vaccine 10. Typhoid Vaccine 11. Polio myclitlcs Vaccine (oral) 12. TAB vaccine

KXVJII. Urinary :

1. Nitrofurantion. ?.. Nilidixic Acid. 3. Mcthannmine.

XXIX. Vitamins :

1. Vitamin — A.. 2. V'UmU-Bl. 3. Vitamin-B12. 4. Vitamin B'-i. 5. Vitamin Bl2 (Cyino anj Hvdroxy). 6. Vitimn C 7. Vitamin D3. 8. Vitamin K. 9. Vitamin P. 10. Vitamin H. 11. Niicin and NUcinamidc. 12. Panthcnols and Panto-then ate:-. 13. Folic Acid.

XXX. Antacids :

1. Aluminium Hydroxide. 2. Magnesium carbonate. 3. Magnesium Triplicate. 4. Mignesium Hydroxide. 5. Sodium Bicarbonate. 6. Calcium Carbonate.

XXXI. Antidlarrhoeals :

1. Diphenoxylate. 2. Sulphaguanidinc. 3. Kaolin. 4. Pectin.

XXXII. Antlgout drugs ::

1. Altopurinol.

2. Probenecid.

XXXHI. Disinfectants :

Cresols.

XXXIV. Antitussives and Expectorants :

1. Chlophodional. 2. Dextromethorphan. 3. Guiacol Glyceryl Ether. 4. Noscapine. 5. Oxeladine. 6. Piperazethate. 7. Pholcodeinc 8. Menthol.

XXXV. Dental products other than those containing local anaes-

thetics:

1. Sodium Fluoride. 2. Stannous Fluoride.

XXXVI- Dermatological preparations not containing antibiotics

sulphonamides and corttcosterotds:

1. Sulphur lublimed. 2. Mothoxsalen.

352/3

3. Ichlhammol. 4. Amrnoniated mercury.

5. Rcsorcinol. 6. Chrysavobin. 7. Dithranol. K. Salicylic acid. 9. BenTOic acid.

10. Zinc oxide. 11 - Benzyl benzoalc. 12. Gamma benzenchcx.'chloiide. 13. Calamine. 14. Chlorphencsin.

XXXVII. Parasympathomimetics:

1. Mcthacholine. 2. Carbachol, 3. Neosligmine. 4. Phy^ostigmirc. 5. Acetyl Chloline Chloride. 6. Pyridostigmine.

XXXVIII. Other Anti-lnfcctives

1. Trimcthopritn. 2. Sulphimlhoxazole. 3. Sulphamoxole, 4. Sulpliadimeihoxin. 5. Sulphtiphenozolc. 6. Sulphamethoxypyridazine. 7. Sulphasom'dine. 8. Sulphadiazine. 9. Sulphafurazolc.

10. Succinyl SulphatMazoIe. 11. Tolnaftate.

THE THIRD SCHEDULE

(See paragraphs2(j), II, 12,13, 14,15,18, 21 and 30)

LTST ov CATEGORY I, CATEGORY II AND CATEGORY

III FORMULATIONS

Catcgory-I Formulations

1. Aspirin Tablets. 2. Dlfioxin Tablets. 3. DDS Tablets. 4. DPT Vaccine-;. 5. Insulin Injection (all sorts) 6. Hydro-Chlorothiazide Tablets. 7. Todo-chloro-hydroxy-quinoline tablets and Di-iodo-hydro-

oxy-quinoline tablets.

8. INH tablets. 9. TNH plus Thiacetazonc tablets.

10. Morphine sulphate injection, 11. Penicillin injection including procaine Penicillin G and

Benzathlne Penicillin (all strengths)

12. PAS and its salts, granules and tablets. 13. Phenoxymethyl penicillin tablets. 14. Streptomycin injection all strengths plus combination with

penicillin.

15. Pcthidine Injection.

Category-II Formulations

1. Anaigin Tablets. 2. Amodiaquin Tablets.

3. Chloramphenicol oral preparations including chloramphcni- col paimiatc, suspension and Syrup and chloramphenicol Sodium Subcinateinjectable.

4. Chloramphenicol in combination with Streptomycin. 5. Chloroquin salts. 6. Primaquin Tablets. 7. Cnlcium Benzoyl PAS Tablets. 8. Diethyl carbamazsine citrate tablets. 9. Fursemide tablets, injection.

10. GlycarylTrinitrate tablets. 11. Phthalyl Sulphathiazole Tablets. 12. Prednisolone Tablets and injection. 13. Phenobarbitone Tablets. 14. Piperazine and its salts—tablets, syrup. 15. Sulphadimuiine labiets.

16. Tetracyclinos, capsules, tablets, syrup, injection, eye oirt- ment (including Oxy-Demelhyl-Chloro tird Pyi it-]u'

17. Tolbutamide tablets.

18. Tetanus Toxoid Injection.

19 Diphtheria tetanus toxoid injection.

20. Quinine Salts, tablets and injection.

Category-Hi Formulations

Formulations based on drugs falling under the following Categories excluding the formulations included in Categories I

and II:

1. Anaesthatics, General and Local. 2. Analagesics and Antipyretics. 3. Antheliminics 4. Antiamoebics. 5. Anti asthmotic drugs and Enteric Antiseptics. 6. Antibiotics including semisynthetlc antibiotics. 7. Anticancer Drugs, 8. Anticoagulants, 9. Anticonvulsants.

10. Antidiabatics. 11. Antihistaminics. 12. Antileprotic Drugs.

13. Antimalarial Drugs. 14. Antirhemotic and Antigout drugs. 15. Antiseptics, 16. Antispasmodics. 17. Antitubercular Drugs. 18. Cardiovascular Drugs. 19. Corticosteroids. 20. Diuretics, 21. Drugs used for Calcium therapy. 22. Haematinics. 23. Oral Contraceptives. 24. Opthalmological preparations 25. Oxytocics. 26. Plasma Expanders and Transfusion Solutions. 27. Sera and Vaccines. 28. Vitamins. 29. Urinary drugs. 30. Antacids. 31. Antidiarrhoeals, 32. Disinfectants.

33. Antitussives and Expectorants.

34. Dental products other than those containing local anaes-

thetics.

35. Dermatological preparations not containing antibiotics

sulphonamides and Corticosteroids.

36. Otic preparations not beased on antibiotics.

37. Parflsympathomimetics.

38. Other Anti-lnfectives

THE FOURTH SCHEDULE

FORMS

Form-] (To be submitted in duplicate)

(See paragraphs 2(c), 3(4), 5 and 8(1),

Form of application for fixation or revision of prices of

bulk drugs.

•J. Name of the Bulk Drug:

2. Name of the Manufacturer:

3. Address of the Registered/Head Office of the Manufacturer.

4. Address of the Factory: (a) Industrial Licence/SSI

Registration No.

5. Licensed capacity (b) Date of Issue of the Licenc e/

Date of Registration. (c) Production capacity:

Licensed: Tonnes/Kgs/ Litres/etc.

6. Installed capacity: (a) No. of shifts; One/Two/

Three

(b) No. of operating days per

year.

(c) Masc production per shift:

Tonnes/Kgs/Litres/etc.

(d) Date of commissioning. (e) Installed capacities per

annum.

7. Date of commencement of commercial production:

8. Actual production achieved during the last accounting year (preferably month-wise) and also monthly production during the current year; Tonnes/Kgs./Litres/etc.

9. Brief note on the manufacturing process adopted by you indicating all stages including recovery of bye-products, if any, solvents etc, and state-wise overall yields for each drug.

10. Average hourly rate of production for each of the bulk drug since commencement of commercial production.

11. Maximum hourly rate of production achievable.

12. Estimated production of the bulk drug during the next

throe years.

13. If the production is proposed to be captively consumed for manufacture of the formulation, please furnish the quantity to be so consumed out of the production given against SI. No. 8. and SI. No. 12.

14. Capital employed for the manufacture of the bulk drug(s):

(a) Net fixed assets (after depreciation) (b) Working Capital (c) Total

(In the case of multi-purpose plant the capital employed as above and the share to be allocated to the bulk drug/intermediate under consideration to be given).

15. Please state how the above capital employed is financed by

net worth and borrowings.

16. Please state the average rate of interest paid by you on your

borrowings, supported by figures.

17. Please furnish latest c.i.f. price of the bulk drug if the same had been imported or is being imported by you or by any other agency known to you.

18. Please furnish the cost of production of the bulk drug as per Proforma (attached) duly certified by a Practising Cost/ Chartered Accountant.

Notes : (1) Any hold up affecting production to be shown clearly

against Serial No. 8.

(2) In case the same plant facilities arc used for production

of moro than one product the information as per Serial No. 6 may be given produetwise.

(3) Please furnish a copy each of audited Balance Sheet and Profit and Loss Account for the last three years.

PROFORMA

(See Horn 18)

I. Name of the Bulk Drug

II. (a) Production in Tonnes/Kg*/Litres/etc.

(b) Salos in Tonncs/Kgs./Litres etc. (c) Despatches in Tonnes/Kgs./Litres/etc,

HI. Period for which the cost data is given :

Unit Actual

Per Unit Particulars Norms of

Rate Amouni t of produc-

tion

Qty. Cost

Rs.

Consu- mption during the period

consumption as per Project report of know-how or sup- pliers' gua- ranteed norms or the norms developed by you as standards

1. Raw materials : (a) Imported

1. 2.

3.

(b) Indigenous

1. 2. 3.

Total raw material cost Less Recoveries of Solvents Net Raw material cost

2. Utilities

(a) Power (b) Water (c) Fuel Oil (d) other services (to be specified)

3. Conversion cost

(a) Salaries and Wages (b) Operating supplies or consumable stores. (c) Repairs and Maintenance (d) Other factory overheads (e) Administration overheads. (f) Depreciation

4. Total cost of production

5. Interest on Borrowings

6. Minimum Bonus

Total

7. Packing :

(a) Materials (b) Other expenses

8. Selling Expenses 9. Transport Charges

352/5

10. Transit Insurance Charges

11. Total cost of sales

12. Profit margin (Basis of calculations to be given)

13. Selling Price (11 + 12)

14. Existing price or National price or Declared price

Notes

(i) Items of expenses, to be excluded from costs :

(a) Bonus in excess of statutory minimum

(b) Bad Debts & Provisions,

(c) Donnlions and charities

(d) Loss/Gain on sale of assets

(o) Brokerage and commission

(f) Expenses not recognised by Income-Tax authorities

(salary/prvquiMtics, advertisements etc.)

(g) Adjustments relating to previous years.

(ii) In the cose of imported raw materials please furnish separately the c.i.f. price, duty of cuiioms and other charges totalling to the landed cost adopted against SI. No. l(a).

(iii) Cost of intermediate!, manufactured for captive use should be on llie basis of factory cost of production inclusive of administration overheads and shown separately against SI. No. 1 (b). A separate cost-sheet in the same proForma may please be appended.

(iv) Cost of generated utilities like power, steam, etc. should be separately given furnishing the details of purchased utilities consumed, rate and cost with other expenses incurred on generation, wilh ref. to SI. 2.

(v) Details in i\sspsct of factory overheads, administration overheads and selling expense;, should be furnished, against SI. No. 3 (d) (c) and SI. No. 8

(vi) The basis of depreciation adopted in your financial accounts may please be given, against SI- No. 3 (f)

(vii) Please indicate whether the existing price is notional,

dclcared or approved against SI. No.. 14.

TO BE CERTIFIED BY COST ACCOUNTANT/

CHARTERED ACCOUNTANT.

FORM 2

(To be submitted in Duplicate by the importers of drugs appearing in Ihe First and Second Schedules for each imported consignment).

[Sec Paragraph 2(e) and 6]

1. Name of the Company

2. Address ol Registered/Head Office/Factory, if any :

3. Rcfcrcnoo to permission given by competent authority for

import of the bulk drugs.

4. Name of the drug-

5. Specification of the drug

6. Country from which imported

7. Quantity imported Tonnes/Kgs/Littres/etc.

. C .I f. value in foreign currency

Per unit

Rs.

Total Rs.

(a) c.l.f. value actually paid in Rs. (Not to include bank commission, interest, etc.)

fb) Duty of customs actually paid

Clearing charges actually

(o)

(d) (O

9. Type of formulation

Plain Tablets/coated tablets/soft/hard/printed/capKules/wi- thout/with/sealing band/Saterilo/Non-Sterile/Liquids/pow- der/Ointment/Cream/etc.

10. Typo of Packing

Aluminium/Paper/Cellophane/Strips/Vials/Ampoulcs/bott- les/tins/Jars/With/Without/dropper/Cutting blades/catch cover/eta.

11. Size of Packs

IO's/100's/etc./l m|/2 ml/10 ml/etc./5 gms/10 gms/etc.

12. No. of Packs sold during the last accounting year

„___

incurred with details —— L;inded cost (a + b fc) •——• Innoitors margin-in case of those who import for sales only — •——

Prop.wort Selling Price/Notlo-

(f>

ml Price " —

„.

Existing Selling Priuc/Ncitio-

NUTE : The figures given here to be certified by a paractising

Cost Accountant/Chartered Accountant.

FORM 3

[Paragraph 2(c), 12, 13 and (14)]

(Form of application for manufactures seeking approval or

revision of prfoo of formulations to be submitted in seven

copios)

1. Namo of tho Manufacturer

2. Address of Reigistered/Head Office

3. Address of the Facotry

4. Name of the Formulation

5. Categoty of formulation and therapeutic group to which it belongs as per Third Schedule of Drugs (Price Control) Order, 1979.

6. Composition as approved by Drug Control Authorities.

7. Industrial Licence/Small Scnle Industrial Unit Registration

No, and Date

8. Drug Control Authorities Permission No. and Date

Name of materials

Unit

i.

"si. Nc

Previous Rate/ unit, if

any (Date) Rs.

3

2

13. Value of sales effected durig the last recounting ycrr cxilu- ding duty of excise and its percentpgc to tolrl spies of for- mulations excluding duty of excise (12 pnd 13 above appli- cable in case of revision application only),

14. Broak-up of Retail Price : Existing Now

(If any) claimed Rs/Pack Rs./Pack approved on ——)

(a) Material Cost [M. C. as per

S. No. 15(d)]

(b) Conversion Cost (C C. as

per norms)

(c) Pecking Material Costs (P. M.)

(As per S. No. 16 as per norms)

(d) Packing charges (P. U.) (as

per norms) •

(e) Ex-factory cost (a to d) (f) Mark-up (M. U,— % on

(e) above

(g) Excise Duty (h) Retail Price (R.P.) (e+f+g)

15. Material Cost:

(a) Batch Size:

Nos./Litres/Kgs/ctc.

(b) No. ofpacks actually obtained from the batch size as in

(a) above.

(c) No¹ of Packs that can be thooretical ly obtainedLfrom the

batch size as in (a) above,

(d) Materials' Cost for the batch site as in (a) above;—

Cost for the batch (5x8)

Over age, if any

Totp.l Qty. required

Current Rate/unit

Theoretical Qty. , required per batch

(Date)

Rs.

8

9

7

6

4 5

352/7

16. Packing Materials Coat:

Batch Size

. Packs of

Tpbs/

gms/etc. each

Name of packing Materials

Unit

Rater per Unit Rs.

SI. No

Quantity required per batch Nos./Kgs./

Present (date)

Value of packing materials per batch Rs.

Previous (date)

etc.

1

2

5

6

7

4

1. 2. 3.

etc.

Total

Add : Process loss as per norms

⁰/ of above

Total packing material cost

Packing Material cost per pack Total packing Material cost

No. of Packs as per batch size.

Note;—The figures in this form to be certified by a practising Cost Accountant Chartered Accountant.

FORM 4

(To be submitted in seven copies)

(Paragraphs 2(e), 12, 13 and 14)

Form of application to be submitted for price approval of formulation imported in finished form.

1. Name of the Company 2. Address of the Registered/Head Office/Factory, if any 3. Reference to Permssion, if any, given by drug control authorities

for import of the item.

4. Name of the imported formulation. 5. Type of formulation : Capsule/Tablets/etc.

6. Composition of the Formulation 7. Type'of Packs:

Strip/vial/Ampoule/eto.

8. Pack size:

10's/etc/lOml/etc. 5 gms./eto.

9. Country from which imported and Date of Import

10. Quantity/No, of Packs imported

Per pack Rs,

Total Rs.

11. C.I.F.value in Foreign Currency

(Not to include bank commission, Interest, etc.)

12. C.I.F. value in Rs- actually paid

(Not to include bank commission, interest, etc.)

13. Duty ofcustoms, if any, actually paid 14. Clearing Charges (with details) actually incurred

Applicable in case of re-packing

15. Landed Cost (12+13 + 14)' "| 16. Packing Material, ifany as per forms < 17. Packing Charges, if any, as per forms J 18. Landedcost(Inoludingre-packingcost,ifany (15tol7) 19. Mark-up claimed % of S- No. 18 20. Duty ofexoise, if any

21. Retail Price claimed (18 to 20)

22. (a) Existing Retail price, if any

(b) No. of Packs sold duringthelast accounting year, if any. (c) Value of sales excluding duty of excise effected during the

last accounting year, if any.

Note : Figures given here to be certified by a practising Cost Accountant/Chartered Accountant.

FORM 5

(See paragraphs 2 (e) und (19)

(Torm of Price List)

Nim: of the formulation and its

Specification of the pack

Duty of excise

form

s. No.

Rato

0/

Amount Rs.

/o

Type (strip/ bottle/etc.)

Price to the retailer (inclusive of excise duty)

Composi- tion (main ingredients to bo given)

Size 10/100/ etc/1 ml/ etc/1 gm/

Rs.

Retail Price (inclusive of excise duty) Rs.

otc.

¹

4

⁵

6

7

⁸

9

R s- RS.

35279

5. Turnover of Formulations:—

Pack Size No. of packs Sales Value Name

i.

si. Nc

excluding duty of excise

Rs.

Own Formulations:

A.

(i) Category I:

1. 2. 3. etc (ii) Category II:

1. 2. 3. etc. (iii) Category III:

1. 2. 3. etc. (iv) Others 1. 2. 3. etc.

B. , Sub-Total( )

Purchased Formulations: (a) Imported:

(1) Category I:

1. 2. 3. etc.

(11) Category H:

1. 2, 3. etc.

(ill) Category m :

1. 2. 3. etc. (iv) Others 1. 2. 3. etc.

Sub-Total (Ba)

(b) Indigenous :

(Category-wise as indicated above). Sub total (Bb)

C Export Sales

Total (A+B+C)

6. Allocation of sales and expenses as shown in the audited Profit and Loss Account:-

(In Rupees)

Particulars

Allocation to

SI. No.

Formulations

Basis of

alloca-

tion

Other activities (if any)

Bulk

Drugs

Total as

per audi-

ted Profit

and Loss

Account

Imported Export

Own manufac-

Sub- total (5 to 8)

ture

Indige- nous purcha- sed

1

2

9

10

3 4

6 7

8

5

11

A. 1.

Income

Sales Income (excluding duty

of excise and other taxes)

1387 GI/78—5

4 5 6 7 S 9 10 11 1 2

2. Cash subsidy (if any) 3. Other Income

Total (1 to 3)

B. Expenses

4. Raw materials consumed 5, Packing materials consumed 6. Powers and Fuel 7. Salaries and Wages 8. Stores and Spares 9. Repairs and Maintenance

10. Insurance 11. Depreciation 12. Royalty 13. Interest 14. Head Office Expenses 15. Doaler's Commission an

Discount

16. Research and Development

expenses

17. Other Expenses Total (4 to 17)

C. Profit before tax

(A-B)

D. Profit before tax as a %ng

sales turnoter C