News Update

WTO Meet in Buenos Aires - India hopeful of support on food security issueOver 15 mn girls aged between 15 to 19 experienced forced sex: UNICEFCentre to take a view on blending of methanol in petrol soon: GadkariCBDT issues refunds worth over Rs one lakh crore by Nov-endDRI nabs 3 persons with demonetised notes worth Rs 49 CroreIndia's fish production goes up to 11.4 mn tonneIncome tax collections reach Rs 4.8 lakh crore, 49% of target, by Nov-endUN observes International Anti-Corruption Day on Dec 9India needs to build institutional arbitration mechanism to woo investment: CJIGujarat Polls - 68% voting recorded in first phase, says Dy ECExport of software & ITes Services - UK alone accounts for total exports to Europe: RBICBEC Board approves song 'GST ka Swagatam' composed by JC Hemant Kumar TantiaGovt notifies IBBI Grievance & Complaint Handling Regulations, 2017 (See 'tiolcorplaws.com')EU, Japan finalise legal text to create largest free trade zoneJNPT logs 5.7% growth in container handlingEPF Scheme has now presence in 461 districts: GangwarGovt decides to take over Unitech Management; NCLT clears move to appoint 10 New DirectorsUK, EU thrash out scheme for BrexitSmart reuse and wastewater projects - 33 cities issue tendersTDS - Premium paid by tourist operator, seperately to RMCs for purchase of foreign currency, cannot be treated as commission payment requiring TDS deduction u/s 194H: ITATCX - 'Acetyl Salicylic Acid Tablets IP 50 MG (ASA)' is not a brand name but generic name, therefore, it does not fall under the definition of P & P medicament: CESTATCustoms - CBEC further eases guidelines for taking surety or securityGSTR 6: GSTN activates functionality for ISD ReturnE-Courts Project milestones reviewed; E-Filing facility for district courts launchedGST - Law Review Committee to examine recommendations of Advisory Group on Law ReviewStates, UTs pass Resolution for Future Roadmap to reform Power SectorCBDT suspends DCIT for allegedly harassing taxpayerCBDT Chairman not happy with 'Run Rate'CBDT extends due date for linking Aadhaar with PAN to March 31, 2018Govt to link about 140 services to Aadhaar; Deadline for linking to be extended to March 31, 2017CBEC notifies new Customs exchange ratesGSTN activates functionality to Revise TRAN-1Pre-Budget Meet - Industry seeks MAT exemption on write-back of notional income from IBC Plan
Untitled Document

Ministry of Chemicals and Fertilizers
(Department of Pharmaceuticals)

Dated: May 15, 2013

ORDER

S.O. 1221(E).- In exercise of the powers conferred by section 3 of the Essential Commodities Act, 1955, (10 of 1955), and supersession of the Drug (Prices Control) Order, 1995, except as respect to  things  done  or  omitted  to  be  done  before  such  supersession,  the  Central Government hereby makes the following Order, namely:-

1. Short title and commencement.-

(1) This Order may be called the Drugs (Prices Control) Order, 2013.

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

2. Definitions.-

(1) In this Order, unless the context otherwise requires,-

(a) “Act” means the Essential Commodity Act, 1955 (10 of 1955);

(b) "active pharmaceutical ingredients or bulk drug" means any pharmaceutical, chemical, biological or plant product including its salts, esters, isomers, analogues and derivatives, conforming to standards specified in the Drugs and Cosmetics Act, 1940 (23 of 1940) and which is used as such or as an ingredient in any formulation;

(c) “brand” means a name, term, design, symbol, trademark or any other feature that identifies one seller’s drug as distinct from those of other sellers;

(d) "ceiling price" means a price fixed by the Government for Scheduled formulations in accordance with the provisions of this Order;

(e) "dealer" means a person carrying on the business of purchase or sale of drugs, whether as a wholesaler or retailer and includes his agent;

(f) "distributor" means a person engaged in the work of distribution of drugs and includes an agent or a stockist  for stocking drugs for sale to a dealer;

(g) “existing manufacturer” means manufacturer existing on the date of publication of this order in the Official Gazette.

(h) "Form" means a form specified in the Second Schedule;

(i) "formulation" means a medicine processed out of or containing one or more drugs with or without use of any pharmaceutical aids, for internal or external use for or in the diagnosis, treatment, mitigation or prevention of disease and, but shall not include-

(i)   any medicine included in any bonafide Ayurvedic (including Sidha) or Unani (Tibb) systems of medicines;

(ii)  any medicine included in the Homeopathic system of medicine; and

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

(j) “generic version of a medicine” means a formulation sold in pharmacopeial name or the name of the active pharmaceutical ingredient contained in the formulation, without any brand name;

(k) "Government" means the Central Government;

(l) "import" with its grammatical variations and cognate expressions means bringing a drug into India from a place outside India for its sale;

(m) “local taxes” means any tax or levy (except excise or import duty included in retail price) paid or payable to the Government or the State Government or any local body under any law for the time being in force by the manufacturer or his agent or dealer;

(n) "manufacturer" for the purpose of this Order means any person who manufactures, imports and markets drugs for distribution or sale in the country;

(o) “market share” means the ratio of domestic sales value (on the basis of moving annual turnover) of a brand or a generic version of a medicine and the sum of total domestic sales value of the all brands and generic versions of that medicine sold in the domestic market having same strength and dosage form;

(p) “margin to retailer” for the purposes of this Order shall mean a percentage of price to retailer;

(q) “market based data” means the data of sales related to a drug collected or obtained by the Government as deemed fit, from time to time;

(r) “maximum retail price” means the ceiling price or the retail price plus local taxes and duties as applicable, at which the drug shall be sold to the ultimate consumer and where such price is mentioned on the pack;

(s) “moving annual turnover” in a particular month means cumulative sales value for twelve months in domestic market, where the sales value of that month is added and the corresponding sales of the same month in the previous year are subtracted;

(t) “National List of Essential Medicines” means National List of Essential Medicines, 2011 published by the Ministry of Health and Family Welfare as updated or revised from time to time and included in the first schedule of this order by the Government through a notification in the Official Gazette;

(u) “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 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 National List of Essential Medicines.

(v) "non-scheduled formulation" means a formulation, the dosage and strengths of which are not specified in the First Schedule;

(w) “pharmacoeconomics”  means a scientific discipline that compares the  therapeutic value of one pharmaceutical drug or drug therapy to another;

(x) "price list" means a price list referred to  in paragraphs 24 and 25 and  includes a supplementary price list;

(y) “price to retailer” means the price of a drug at which it is sold to a retailer which includes duties and does not include local taxes;

(z) "retail price" means the price fixed by the Government for a new drug under paragraph 5;

(za)  "retailer" means a dealer carrying on the retail business of sale of drugs to customers;

(zb)  “scheduled  formulation"  means  any  formulation,  included  in  the  First  Schedule whether referred to by generic versions or brand name;

(zc)  "schedule" means a Schedule appended to this Order;

(zd)  "wholesaler" means a dealer or his agent or a stockist engaged in the sale of drugs to a retailer, hospital, dispensary, medical, educational or research institution or any other agency;

(ze) “wholesale price index” means annual wholesale price index of all commodities as announced by the Department of Industrial Policy and Promotion, Government of India, from time to time.

(2) All other words and expressions used herein and not defined but defined in the Act or the Drugs and Cosmetics Act, 1940 (23 of 1940) shall have the meanings respectively assigned to them in the said Acts.

3. Directions  to  manufacturers  of  active  pharmaceutical  ingredients  or  bulk  drugs  or formulations.-

The Government may,-

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

(ii)  for  the  purpose  of  giving  any  direction  under  sub-paragraph  (i),  call  for  such information from manufacturers of active pharmaceutical ingredients or bulk drugs or formulations, as it may consider necessary and such manufacturer shall furnish the required information within such time the Government may fix.

4. Calculation of ceiling price of a scheduled formulation.-

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

Step1.  First the Average Price to Retailer of the scheduled formulation i.e. P(s) shall be calculated as below:

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 having market share more than or equal to one percent of total market turnover on the basis of moving annual turnover for that medicine.)

Step2.  Thereafter,  the  ceiling  price  of  the  scheduled  formulation  i.e.  P(c)  shall  be calculated as below:

P(c) = P(s).(1+M/100), where

P(s) = Average Price to Retailer for the same strength and dosage of the medicine as calculated in step1 above.

M = % Margin to retailer and its value =16

(2) The ceiling price calculated as per sub-paragraph (1) and notified by the Government shall be applicable to scheduled imported formulations also.

5. Calculation of retail price of a new drug for existing manufacturers of scheduled formulations.-

(1)  The  retail price  of  the  new  drug  available  in  domestic  market  shall  be calculated as provided in sub-paragraph (1) of paragraph 4.

(2)  (i)   the price to retailer of a new drug, not available in domestic market, shall be fixed by the Government on the principles of “Pharmacoeconomics” of the new drug, on the recommendation of a Standing Committee of Experts formed under paragraph 15.

(ii) the retail price of such new drug shall be fixed by adding sixteen percent margin to retailer on the price to retailer as fixed in item (i):

6. Ceiling price of a scheduled formulation in case of no reduction in price due to absence of competition.-

(1) where the average price to retailer of a scheduled formulation, arrived at as per the formula specified in sub-paragraph (1) of paragraph 4, has the effect of,-

(a)  no reduction in average price to retailer with respect to the prices to retailer of the schedule formulation; and

(b) there are less than five manufacturers for that formulation having one percent or more market share, the ceiling price shall be calculated as under:-

(i) in  the  event  of  other  strengths  or  dosage  forms  of  the  same  scheduled formulation is   available in the list of scheduled formulation, the average price to retailer shall be calculated  as under:

Step1: First the Average Price to Retailer of such scheduled formulation i.e. P(s) shall be calculated as under:

P(s) = Pm{1-(Pi1+Pi2+…)/(N*100)} Where,

Pm = Price to Retailer of highest priced scheduled formulation under consideration.

Pi    =   % reduction in Average Price to Retailer of other strengths and dosage forms (calculated as in step1 of sub-paragraph (1) of paragraph 4) in the list of schedule formulations w.r.t the highest priced formulation taken for calculating the average price to retailer of such strengths and dosage forms.

N = Number of such other strengths or dosage forms or both in the list of schedule formulations

Step2. Thereafter, the ceiling price of the scheduled formulation i.e. P(c) shall be calculated as under:

P(c) = P(s).(1+M/100), where

P(s)  =  Average  Price  to  Retailer  of  the  scheduled  formulation  as calculated in step1 hereinabove and

M  =  % Margin to retailer and its value=16

(ii) in the event of other strengths or dosage forms of the scheduled formulation is not available in the schedule but there are other scheduled formulations in same sub- therapeutic category as that of the scheduled formulation, then the Ceiling Price shall be calculated as under:

Step1: First the Average Price to Retailer of such scheduled formulation i.e. P(s) shall be calculated as under:

P(s) = Pm{1-(Pi1+Pi2+…)/(N*100)}, Where,

Pm =  Price of highest priced formulation taken for calculating the average price to retailer of the formulation under consideration..

Pi   =  %  reduction in Average Price to Retailer of   other   schedule formulations (calculated as in step1 of sub-paragraph (1) of paragraph 4) in same sub-therapeutic category as that of the scheduled formulation under consideration w.r.t the highest priced formulation taken for calculating the average price to retailer.

N = Number of such other schedule formulations in same sub-therapeutic category as that of the scheduled formulation under consideration.

Step2. Thereafter, the ceiling price of the scheduled formulation i.e. P(c) shall be calculated as under:

P(c) = P(s)*(1+M/100), where

P(s)  =  Average  Price  to  Retailer  of  the  scheduled  formulation  as calculated in step1 above and

M  =  % Margin to retailer and its value=16

Explanation.- where the scheduled formulation under consideration is coming under more than one sub-therapeutic category, the Average Price to Retailer of the scheduled formulation shall be calculated after taking into consideration the percentage reduction in Average Price to Retailer of other schedule formulations under all such sub-therapeutic categories and the lowest average price to retailer shall be taken for calculating the ceiling price of the scheduled formulation under consideration;

(iii) in case the other strengths or dosage forms of the scheduled formulation are not available in the schedule and there is no sub therapeutic category of the scheduled under consideration, the ceiling price shall be calculated as under:

Step1: First the Average Price to Retailer of such scheduled formulation i.e. P(s) shall be calculated as under:

P(s) = Pm{1-(Pi1+Pi2+…)/(N*100)} Where,

Pm =  Price of highest priced formulation taken for calculating the average price to retailer of the formulation under consideration.

Pi   =   %  reduction  in  Average   Price   to   Retailer   of   other   schedule formulations (calculated as in step1 sub-paragraph (1) of paragraph 4) in same therapeutic category as that of the scheduled formulation under consideration w.r.t the highest priced formulation taken for calculating the average price to retailer.

N = Number of such other schedule formulations in same therapeutic category as that of the scheduled formulation under consideration.

Step2. Thereafter, the ceiling price of the scheduled formulation i.e. P(c) shall be calculated as under:

P(c) = P(s).(1+M/100), where

P(s) = Average Price to Retailer of the scheduled formulation as calculated in step1 above and

M  = % Margin to retailer and its value=16

Explanation.- where the scheduled formulation under consideration is coming under more than one therapeutic category, the Average Price to Retailer of the scheduled formulation shall be calculated after taking into consideration the percentage reduction in Average Price to Retailer of other schedule formulations under all such therapeutic categories and the lowest average price to retailer shall be taken for calculating the ceiling price of the scheduled formulation under consideration.

(2)  Notwithstanding anything contained in this paragraph, where the price has been fixed and notified by the Government under the Drugs (Prices Control) Order, 1995 the provisions of sub- paragraph (1) shall not apply.

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

8. Maximum retail price.-

(1) The maximum retail price of scheduled formulations shall be fixed by the manufacturers on the basis of ceiling price notified by the Government plus local taxes wherever applicable, as under:

Maximum Retail Price = Ceiling price + Local Taxes as applicable

(2) The maximum retail price of a new drug shall be fixed by the manufacturers on the basis of retail price determined by the Government plus local taxes wherever applicable, as under:

Maximum Retail Price = Retail Price + Local Taxes as applicable

9. Reference data and source of market based data.-

(1) Initially, the source of market based data shall be the data available with the pharmaceuticals market data specializing company - IMS Health (IMS) and if the Government deems necessary, it may validate such data by appropriate survey or evaluation.

(2)  The  Government  may  in  the  due  course  of  time  come  out  with  other  appropriate mechanism of collecting or obtaining the market based data related to drugs and the decision of Government with respect to collection or obtaining of data shall be final.

(3) The market based data, for fixing the ceiling price of scheduled formulations for the first time after the notification of this order, shall be the data of May, 2012.

(4) The market based data for fixing the retail price of new drugs available in the market, shall be the data available for the month ending immediately before six months of receipt of application for fixing the price of the new drug.

(5) The market based data for fixing the ceiling price of a scheduled formulation due to a revision in the first schedule shall be the data available for the month ending immediately before six month of notification of revision in the first schedule.

(6) Notwithstanding anything contained in this order, the reference date for the formulations which are part of the Drugs (Prices Control) Order, 1995 shall be as per the provisions of paragraph 10 of this Order.

10. Pricing of the formulations covered under Drugs (Prices Control) Order, 1995.-

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

(2) The prices of scheduled formulations, which are also specified in the First Schedule to the Drugs (Prices Control) Order, 1995, fixed and notified under the provisions of Drugs (Prices Control) Order,1995 after 31st  May,2012, shall remain effective for one year from the date of notification of such prices under Drugs (Prices Control) Order,1995 and immediately thereafter the  manufacturers  may  revise  the  prices  as  per  the  annual  wholesale  price  index  for  the previous calendar year announced by Department of Industrial Promotion and Policy and on the 1st April of succeeding financial year, the formula as in sub-paragraph (1) of paragraph 4 of this Order shall be applied for fixing the ceiling prices of such schedule formulations.

(3) The prices of scheduled formulations, which are specified in the Drugs (Prices Control) Order, 1995 but not specified in the First Schedule of this order, fixed and notified under the provisions of the said order, up to 31st May,2012, shall remain effective for further one year i.e. up to the 30thMay’2013 and thereafter prices of such formulations shall be regulated as in case of other non-scheduled formulations as stated in paragraph 20 of this Order.

(4) The prices of scheduled formulations, which are specified in the Drugs (Prices Control) Order, 1995 but not specified in the First Schedule of this order, fixed and notified under the provisions of the said order, after 31st  May,2012, shall remain effective for one year from the date of notification of such prices  and thereafter prices of such formulations shall be regulated as in case of other non-scheduled formulations as stated in paragraph 20 of this Order.

11. Ceiling price or retail price of a pack.-

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

(2) In the event of the unit of the dosage for a scheduled formulation not available in the first schedule, the lowest pack size for that category of medicine, as specified in the Drugs and Cosmetics Act, 1940 (23 of 1940) and the rules thereunder, shall be taken as unit dosage for calculating the ceiling price or retail price  as the case may be, for that scheduled formulation and  this  shall  be  applicable  while  calculating  the  per  unit  price  of  even  non-scheduled medicines for arriving at the retail price in case of paragraph 5.

12. Price of formulations (branded or generic version) listed in the National List of Essential Medicines, launched by a manufacturer.-

(1) A manufacturer, launching a scheduled formulation, shall be free to fix the price of the scheduled formulation equal to or below the ceiling price fixed for that schedule formulation by the Government.

(2) Where  an  existing  brand  is  re-launched  by  another  manufacturer  the  provisions  of paragraph 13 shall be applicable.

13. Price of scheduled formulations for the existing manufacturers.-

(1) All the existing manufactures of scheduled formulations, selling the branded or generic  or both the versions of scheduled formulations at a price higher than the ceiling price (plus local taxes as applicable) so fixed and notified by the Government, shall revise the prices of all such formulations downward not exceeding the ceiling price (plus local taxes as applicable):

Provided, that in case of scheduled formulations produced or available in the market before the date of notification of ceiling price, the manufacturers shall ensure within a period of forty-five days of the date of such notification that the maximum retail price of such scheduled formulation does not exceed the ceiling price (plus local taxes as applicable).

(2) All the existing manufactures of scheduled formulations, selling the branded or generic or both the versions of scheduled formulations at a price lower than the ceiling price (plus local taxes  as  applicable)  so fixed  and notified  by  the  Government  shall  maintain  their existing maximum retail price.

(3) Annual increase in maximum retail price may be carried out as per the increase in the wholesale price index with respect to previous year as per the provision of sub-paragraphs (2) and (3) of paragraph 16.

Provided that in case of decline in wholesale price index, a corresponding reduction in the prices shall be made as per the provision of sub-paragraph (4) of paragraph 16.

14. Fixation of ceiling price of scheduled formulations.-

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

(2) Where any manufacturer sells a scheduled formulation at a price higher than the ceiling price (plus local taxes as applicable) fixed and notified by the Government, such manufacturers shall be liable to deposit the overcharged amount along with interest thereon from the date of such overcharging.

15. Fixation of retail price of a new drug for existing manufacturers of scheduled formulations.-

(1) The Government shall form a Standing Committee of such Experts, as it may deem fit, within sixty days of notification of this order with a view to recommend the retail prices of new drugs on the principles of “Pharmacoeconomics”.

(2)  Where  an  existing  manufacturer  of  a  drug  with  dosages  and  strengths  as  specified  in National List of Essential Medicines launches a new drug, such existing manufacturers shall apply for prior price approval of such new drug from the Government in Form-I specified under Schedule-II of this Order.

(3)  On  receipt  of  the  application  under  sub-paragraph  (2),  in  the  event  of  the  new  drug available in domestic market, the Government shall fix the retail price of the new drug in accordance with the provision of sub-paragraph(1) of paragraph 5 and in the event of the new drug not available in domestic market, the Government shall forward the same to the Standing Committee of Experts who shall examine the application on the principles of “Pharmacoeconomics” and make recommendations of retail price of the new drug to the Government within thirty days of the receipt of application.

(4) The Government shall, on receipt of recommendation under sub-paragraph (3), within thirty days, fix the retail price of such new drug and such price shall be applicable to such applicant of such new drug.

(5) Where existing manufacturer of scheduled formulation fails to apply for prior approval of the  price  of  the  new  drug  in  Form-I,  such  manufacturer  shall  be  liable  to  deposit  the overcharged amount over and above such price fixed and notified by the Government, if any, along with interest thereon from the date of launch of the new drug, in addition to the penalty.

(6) No existing manufacturer of a scheduled formulation shall sell such a new drug at a price higher than the retail price (plus local taxes as applicable) fixed by the Government for such new drug and in case such a manufacturer is found to sell such a new drug at a price higher than  the  retail  price  (plus  local  taxes  as  applicable)  fixed  by  the  Government,  such manufacturer of the new drug shall be liable to deposit the overcharged amount along with interest from the date of overcharge, in addition to the penalty.

16.  Revision of ceiling price of scheduled formulations.-

(1) The Government shall revise the ceiling prices of scheduled formulations as per the annual wholesale price index (WPI) for preceding calendar year on or before 1st April of every year and notify the same on the 1st day of April every year.

(2) The manufacturers may increase the maximum retail price (MRP) of scheduled formulations once in a year, in the month of April, on the basis of the wholesale price index with respect to previous  calendar  year  and  no  prior  approval  of  the  Government  in  this  regard  shall  be required.

(3) Information about the revision, if carried out, shall be forwarded to the Government in either electronic or physical form in Form-II within a period of fifteen days of such revision and non-submission of information under this sub-paragraph shall be construed as non revision of maximum retail price (MRP) and the concerned manufacturer shall be liable to deposit the amount  charged  over  and  above  the  pre-revised  maximum  retail  price  (MRP),  alongwith interest thereon from the date of overcharging.

(4) In case of decline in wholesale price index, there shall be a corresponding reduction in the maximum  retail  price  and  in  case  of  scheduled  formulations  produced  or  available  in  the market before the date of notification of revised ceiling price, the manufacturers shall ensure within a period of forty-five days of the date of such notification that the maximum retail price (MRP) of such scheduled formulation does not exceed the revised ceiling price (plus local taxes as applicable) and information about the revision shall be sent to the Government in either electronic or physical form in Form-II within a period of fifteen days of such revision.

(5) Non-submission  of  information under  the sub-paragraph  (4) shall be construed  as non reduction in maximum retail price (MRP) and the concerned manufacturer shall be liable to deposit the amount charged over and above the maximum retail price revised based on decline in wholesale price index, alongwith interest thereon as overcharged amount from the date of overcharging.

17. Amendment of the list of scheduled formulation.-

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

(2) The medicines omitted from the first schedule shall fall under the category of non-scheduled formulations.

18. Revision of ceiling price on the basis of moving annual turnover (MAT).-

The revision of ceiling prices on the basis of moving annual turnover value shall be carried out,-

(i) as and when the National List of Essential Medicines is revised by the Ministry of Health and Family Welfare or five years from the date of fixing the ceiling price under this Order whichever is earlier;

(ii) when the number of manufacturers of a scheduled formulation, having price of a scheduled formulation more than or equal to seventy five percent of the ceiling price fixed and notified by the Government, has decreased by twenty five percent or more than the number of manufacturers as existing on the reference date;

(iii) when the number of manufacturers of a scheduled formulation, having prices of their scheduled formulation equal to or lower than twenty five percent of the ceiling price fixed by the Government, has increased by twenty five percent or more than the number of manufacturers as existing on the reference date.

Explanation.- For the purpose of items (ii) and (iii) the “reference date” shall be for first revision of ceiling price May, 2012 and for second or subsequent revision the date of previous revision of the ceiling price.

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

20. Monitoring the prices of non-scheduled formulations.-

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

(2) The manufacturer shall be liable to deposit the overcharged amount along with interest thereon from the date of increase in price in addition to the penalty.

21. Monitoring the availability of scheduled formulations.-

(1) The Government shall monitor the production and availability of scheduled formulations and the active pharmaceutical ingredients contained in the scheduled formulation and the manufacturer of scheduled formulations and the active pharmaceutical ingredients contained in the scheduled formulation shall furnish the information as stated in Form-III of schedule-II of this Order quarterly.

(2) Any manufacturer of scheduled formulation, intending to discontinue any scheduled formulation from the market shall issue a public notice and also intimate the Government in Form-IV of schedule-II of this order in this regard at least six month prior to the intended date of discontinuation and the Government may, in public interest, direct the manufacturer of the scheduled formulation to continue with required level of production or import for a period not exceeding one year, from the intended date of such discontinuation within a period of sixty days of receipt of such intimation.

22. Recovery of dues accrued under the Drugs (Prices Control) Order, 1979 and to deposit the same into the Drugs Prices Equalisation Account.-

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

(2) The existing amount, if any, in the Drugs Prices Equalisation Account on or before the date of commencement of this Order, and the amount deposited under sub-paragraph (1) shall be utilised for;-

(a) paying to the manufacturer, importer or distributor, as the case may be, the shortfall 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) meeting the expenses incurred by the Government in discharging the functions under this paragraph; and

(c) promoting higher education and research in Pharmaceutical Sciences and Technology and for the purposes incidental thereto.

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

24. Carrying into effect the price fixed or revised by the Government, its display and proof thereof.-

(1) For all the scheduled formulations having maximum retail price (MRP) higher than ceiling price (plus local taxes as applicable), the manufactures shall revise the maximum retail price (MRP) not exceeding the ceiling price (plus local taxes as applicable):

Provided that in case of scheduled formulations produced or available in the market before the date of notification of ceiling price, the manufacturers shall ensure within a period of forty-five days  of  the date  of  the  notification  that  the  maximum  retail  price  of  such  scheduled formulation does not exceed the ceiling price (plus local taxes as applicable).

(2) Every manufacturer of a schedule formulation intended for sale shall display in indelible print mark, on the label of container of the formulation and the minimum pack thereof offered for retail sale, the maximum retail price of that formulation based on the ceiling price notified in the Official Gazette or ordered by the Government in this behalf with the words "Maximum Retail Price" preceding it and the words 'inclusive of all taxes' succeeding it.

(3) Every manufacturer shall issue a price list and supplementary price list, if required, in Form V to the dealers, State Drugs Controllers and the Government indicating reference to such price fixation or revision as covered by the order or Gazette notification issued by the Government, from time to time.

(4) Every retailer and dealer shall display the price list and the supplementary price list, if any, as furnished by the manufacturer, on a conspicuous part of the premises where he carries on business in a manner so as to be easily accessible to any person wishing to consult the same.

25. Display of prices of non-scheduled formulations and price list thereof.-

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

(2) Every manufacturer shall issue a price list and supplementary price list, if required, of the non-Scheduled formulations in Form-V to the dealers, State Drugs Controllers and the Government indicating changes, from time to time.

(3) Every retailer and dealer shall display the price list and the supplementary price list, if any, as furnished by the manufacturer or importer, on a conspicuous part of the premises where he carries on business in a manner so as to be easily accessible to any person wishing to consult the same.

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

27. Sale of split quantities of formulations.- No dealer shall sell loose quantity of any formulation at a price which exceeds the pro-rata price of the formulation.

28. Manufacturer, distributor or dealer not to refuse sale of drug.- Subject to the provisions of the Drug and Cosmetics Act, 1940 (23 of 1940) and the rules made thereunder, -

(a) no manufacturer or distributor shall withhold from sale or refuse to sell to a dealer any drug without good and sufficient reasons;

(b) no dealer shall withhold from sale or refuse to sell any drug available with him to a customer intending to purchase such drug.

29. Maintenance of records and production thereof for inspection.- Every manufacturer shall maintain records relating to the sales of individual active pharmaceutical ingredients or bulk drugs manufactured or imported and marketed by him, as the case may be, and the sales of formulations units and packs and also such other records as may be directed from time to time by the Government and the Government shall have the power to call for any record and to inspect such records at the premises of the manufacturer.

30. Power of entry, search and seizure.-

(1) Any Gazetted Officer of the Central Government or of a State Government, as the case may be, authorised by a general or special order by the Central Government or by the State Government, as the case may be, in this behalf may, with a view to securing compliance with this Order or to satisfy himself that the provision of this Order have been complied with-

(a) enter and search any place;

(b) seize any drug, alongwith the containers, packages or coverings in which the drug is found, in respect of which he suspects that any provision of this Order has been, is being, or is about to be contravened, and thereafter take all measures necessary for securing production of the drug, containers, packages or coverings, 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 purchase 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 provisions of Code of Criminal Procedure, 1973 (2 of 1974), relating to search and seizure shall, so far as may be, apply to searches and seizures under this Order.

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

Provided that pending a decision by the Government on the application submitted under the above paragraph, no manufacturer shall sell a scheduled formulation or a new drug, as the case may be, at a price exceeding the ceiling price or retail price, as the case may be, fixed by the Government of which a review has been applied for.

32. Non-application of the provisions of this order in certain cases.-

The provisions of this order shall not apply to,-

(i) a manufacturer producing a new drug patented under the Indian Patent Act, 1970 (39 of 1970) (product patent) and not produced elsewhere, if developed through indigenous Research and Development, for a period of five years from the date of commencement of its commercial production in the country.

(ii) a manufacturer  producing a new drug in the country by a new process developed through indigenous Research and Development and patented under the Indian Patent Act, 1970 (39 of 1970) (process patent) for a period of five years from the date of the commencement of its commercial production in the country.

(iii) a manufacturer producing a new drug involving a new delivery system developed through indigenous Research and Development for a period of five years from the date of its market approval in India:

Provided that the provision of this paragraph shall apply only when a document showing approval of such new drugs from Drugs Controller General (India) is produced before the Government.

Explanation.- Notwithstanding anything contained in this Order, for the purpose of this paragraph “new drug” shall have the same meaning as is assigned to under rule 122E of the Drugs and Cosmetics Rules, 1945;

File No.31011/17/2012-PI-II

Shambhu Kallolikar)
Joint Secretary to the Government of India

Schedule-I
(See Paragraphs-2(t),2(zb))Symbols P, S and T appearing in NLEM 2011 denote essentiality at Primary, Secondary and Tertiary levels respectively.

NATIONAL LIST OF ESSENTIAL MEDICINES 2011

Section: 1 – Anesthesia

1.1 General Anesthetics and Oxygen

Medicines Category Route of Administration Strengths
Ether S, T Inhalation --
Halothane with vaporizer S, T Inhalation  
Isoflurane S, T Inhalation  
Ketamine Hydrochloride P, S, T Injection 10 mg / ml, 50 mg / ml
Nitrous Oxide P, S, T Inhalation  
Oxygen P, S, T Inhalation  
Thiopentone Sodium S, T Injection 0.5 g, 1 g powder

Added Medicines

Sevoflurane T Inhalation  
Propofol P,S,T Injection 1% oil suspension

1.2 Local Anesthetics

Medicines Category Route of Administration/ Dosage Form Strengths
Bupivacaine Hydrochloride S, T Injection 0.25%, 0.5%, 0.5% to be mixed with 7.5% glucose solution
Lignocaine Hydrochloride P, S, T Topical Forms, Injection, Spinal 2-5%, 1-2%, 5% +7.5% Glucose
Lignocaine Hydrochloride + Adrenaline P, S, T Injection 1%, 2%  + Adrenaline1:200,0 00

Added Medicines

EMLA cream T Cream  

1.3 Preoperative Medication and Sedation for Short Term Procedures

Medicines Category Route of Administration/ Dosage Form Strengths
Atropine Sulphate P, S, T Injection 0.6 mg / ml
Diazepam P,S,T S, T Tablets Injection, Syrup, Suppository 5 mg 5 mg / ml 2mg/5ml 5 mg
Midazolam P, S, T Injection 1 mg / ml 5 mg / ml
Morphine Sulphate S, T Injection 10 mg / ml
Promethazine P, S, T Syrup 5 mg / 5 ml

Section: 2 - Analgesics , Antipyretics, Nonsteroidal Anti-inflammatory Medicines,  Medicines  used  to  treat Gout and Disease Modifying Agents used in Rheumatoid Disorders

2.1: Non-Opioid Analgesics, Antipyretics and Nonsteroidal Anti-inflammatory Medicines

Medicines Category Route of Administration/ Dosage Form Strengths
Acetyl Salicylic Acid P, S, T Tablets 325, 350 mg
Diclofenac T Tablets 50 mg
T Injection 25 mg / ml
Ibuprofen P, S, T Tablets Syrup 200 mg, 400 mg 100mg/5ml
Paracetamol P, S, T Injection 150 mg / ml
P, S, T Syrup 125 mg / 5ml
P, S, T Tablets 500 mg
P, S, T Suppository 80 mg, 170 mg

2.2 Opioid Analgesics

Medicines Category Route of Administration/ Dosage Form Strengths
Morphine Sulphate S, T Injection 10 mg / ml
Tablets 10 mg

Added medicines

Tramadol S,T Injection Cap 50 mg/ml 50 mg,100 mg
Fentanyl S,T Injection 50ug/ml   2ml ampoule

2.3 Medicines used to treat Gout

Allopurinol S, T Tablets 100 mg
Colchicine S, T Tablets 0.5 mg

2.4 Disease modifying agents used in Rheumatoid disorders

Azathioprine S, T Tablets 50 mg
Methotrexate S,T Tablets 5mg, 7.5mg, 10mg
Sulfasalazine S, T Tablets 500 mg

Added medicines

Hydroxychloroquine phosphate S,T Tablets 200 mg
Leflunomide S,T Tablets 10mg, 20 mg tab

Section: 3 – Antiallergics and Medicines used in Anaphylaxis

Medicines Category Route of Administration/ Dosage Form Strengths
Adrenaline Bitartrate P, S, T Injection 1 mg / ml
Chlorpheniramine Maleate P, S, T Tablets 4 mg
Dexchlorpheniramine Maleate P, S, T Syrup 0.5 mg / 5 ml
Dexamethasone P, S, T Tablets 0.5 mg
    Injection 4 mg / ml
Hydrocortisone Sodium Succinate P, S, T Injection 100 mg
Pheniramine Maleate P, S, T Injection 22.75 mg / ml
Prednisolone P, S, T Tablets 5 mg, 10 mg, 20 mg
Promethazine P, S, T Tablets 10 mg, 25 mg
    Syrup 5 mg / 5 ml

Added Medicines

Cetrizine P,S,T Tablets Syrup 10mg 5 mg/ml

Section: 4 - Antidotes and Other Substances used in Poisonings

4.1: Nonspecific

Medicines Category Route of Administration/ Dosage Form Strengths
Activated Charcoal P,S,T Oral  

4.2: Specific

Medicines Category Route of Administration/ Dosage Form Strengths
Atropine Sulphate P,S,T Injection 1 mg/ml
Specific Antisnake venom P,S,T Injection Polyvalent Solution/ Lyophilyzed Polyvalent Serum  
Calcium gluconate P,S,T Injection 100mg/ml
Desferrioxamine mesylate S, T Injection 500mg
Methylthioninium chloride (Methylene blue) S, T Injection 10 mg / ml
Penicillamine S, T Tablets or Capsules 250 mg
Dimercaprol S, T Injection in oil 50 mg / ml
Flumazenil T Injection 0.1 mg / ml
Sodium Nitrite S, T Injection 30 mg / ml
Sodium Thiosulphate S, T Injection 250 mg/ ml
Naloxone P,S,T Injection 0.4mg/ml
Pralidoxime Chloride(2- PAM) P,S,T Injection 25 mg/ml

Added medicines:

N-acetylcysteine P,S,T Injection 200 mg/ml(5 ml)

Section: 5 – Anticonvulsants/ Antiepileptics

Medicines Category Route of Administration/ Dosage Form Strengths
Carbamazepine P, S, T Tablets Syrup 100mg 200mg 100 mg/5ml
Diazepam P,S,T Injection 5 mg  / ml
Magnesium sulphate S,T Injection 500 mg /ml
Phenobarbitone P,S,T ST P,S,T Tablets Injection Syrup 30 mg, 60 mg 200 mg/ml 20 mg/5ml
Phenytoin Sodium P,S,T Capsules or TabletsSyrup Injection 50 mg, 100mg 25mg/ml 50 mg/ml
Sodium Valproate P,S,T Tablets Syrup 200 mg, 500mg 200 mg/5ml
T Injection 100 mg/ml

Added Medicines

Lorazepam T Injection 2mg/ml

Section: 6 – Anti-infective Medicines

6.1 Anthelminthics

6.1.1 Intestinal Anthelminthics

Medicines Category Route of Administration/ Dosage Form Strengths
Albendazole P,S,T TabletsSuspension 400 mg 200 mg/ 5 ml
Added Medicines
Piperazine P,S,T Tablets Solution 4.5 gm 750mg/5ml

6.1.2 Antifilarials

Medicines Category Route of Administration/ Dosage Form Strengths
Diethylcarbamazine citrate P,S,T Tablets 50 mg

6.1.3 Antischistosomals and Antitrematode Medicines

Medicines Category Route of Administration/ Dosage Form Strengths
Praziquantel S, T Tablets 600 mg

6.2 Antibacterials

6.2.1 Beta lactam medicines

Medicines Category Route of Administration/ Dosage Form Strengths
Amoxicillin S,T Powder for suspension Capsules 125 mg / 5 ml 250 mg, 500 mg
Ampicillin P,S,T Capsules Powder for suspension Injection 250 mg, 500 mg 125 mg / 5 ml 500 mg
Benzathine Benzylpenicillin P,S,T Injection 6 lacs, 12 lacs units
Cefotaxime S, T Injection 125 mg, 250 mg 500 mg
Ceftazidime S, T Injection 250mg, 1g
Ceftriaxone S, T Injection 250 mg, 1 g
Cephalexin P,S,T Syrup Capsules 125 mg / 5 ml 250 mg, 500 mg
Cloxacillin P,S,T Capsules Injection Liquid 250 mg, 500 mg 250 mg 125mg/ 5 ml
Added Medicines
Amoxicillin+Clavulinic acid T Tablets Powder for suspension Injection 625 mg 228.5mg/5ml 600mg, 1.2gm
Cefixime T Tablet 100, 200mg

6.2.2 Other antibacterials

Medicines Category Route of Administration/ Dosage Form Strengths
Amikacin S, T Injection 250 mg / 2 ml
Azithromycin S,T Tablets Suspension Injection 100, 250,500mg 100mg/5ml 500mg
Ciprofloxacin Hydrochloride P,S,T Injection Tablets 200 mg /100 ml 250 mg, 500 mg
Co-Trimoxazole (Trimethoprim + Sulphamethoxazole) P,S,T Tablets Suspension 80 + 400 mg 160+800 mg 40 + 200 mg / 5 ml
Doxycycline P,S,T Tablets 100 mg
Erythromycin Estolate P,S,T Syrup Tablets 125 mg / 5 ml 250 mg, 500 mg
Gentamicin P,S,T Injection 10 mg/ml, 40 mg/ml
Metronidazole P,S,T Tablet Injection Syrup 200mg,400 mg 500mg/100 ml 100mg/5ml
Nitrofurantoin P,S,T Tablets 100 mg
Sulphadiazine S, T Tablets 500 mg
Vancomycin Hydrochloride T Injection 500 mg, 1 g

6.2.3 Antileprosy medicines

Medicines Category Route of Administration/ Dosage Form Strengths
Clofazimine P,S, T Capsules 50 mg, 100 mg
Dapsone P,S, T Tablets 50 mg, 100mg
Rifampicin P,S, T Capsules or Tablets 150 mg, 300 mg

6.2.4 Antituberculosis medicines

Medicines Category Route of Administration/ Dosage Form Strengths
Ethambutol P,S,T Tablets 200 mg, 400 mg, 600 mg, 800 mg
Isoniazid P,S,T Tablets Syrup 50 mg, 100 mg, 300 mg 100 mg/5ml
Ofloxacin S, T Tablets 100 mg, 200 mg
    Syrup 50 mg / 5 ml
Pyrazinamide P,S,T Tablets 500 mg, 750 mg, 1000 mg, 1500 mg
Rifampicin P,S,T Capsules/Tablets Syrup 50 mg, 150 mg, 300 mg,450 mg 100 mg / 5 ml
Streptomycin Sulphate P,S,T Injection 0.75 g, 1 g

6.3 Antifungal medicines

Medicines Category Route of Administration/ Dosage Form Strengths
Amphotericin B S, T Injection 50 mg
Clotrimazole P,S,T Pessaries Gel 100 mg, 200 mg, 2%
Fluconazole S, T Capsules or Tablets 50 mg, 100 mg, 150 mg, 200 mg
Griseofulvin P,S,T Capsules or Tablets 125 mg, 250 mg
Nystatin P,S,T Tablets Pessaries 500,000 IU 100,000 IU

6.4 Antiviral medicines

6.4.1 Antiherpes medicines

Medicines Category Route of Administration/ Dosage Form Strengths
Acyclovir S, T Tablets Injection Suspension 200 mg, 400 mg 250 mg, 500 mg 400 mg / 5 ml

6.4.2 Antiretroviral medicines

6.4.2.1 Nucleoside reverse transcriptase inhibitors

Medicines Category Route of Administration/ Dosage Form Strengths
Didanosine S, T Tablets 250 mg, 400 mg
Lamivudine S, T Tablets 150 mg
Lamivudine + Nevirapine + Stavudine S, T Tablets 150 mg + 200 mg+ 30 mg
Lamivudine + Zidovudine S, T Tablets 150 mg + 300 mg
Stavudine S, T Capsules 15 mg, 30 mg, 40 mg
Zidovudine S, T Tablets 100 mg, 300 mg
ADDED MEDICINES
Stavudine+ Lamivudine S,T Tablets 30mg+ 150mg
Zidovudine+ Lamivudine+ Nevirapine S,T Tablets 300mg+ 150mg+ 200mg

6.4.2.2 Non-nucleoside reverse transcriptase inhibitors

Medicines Category Route of Administration/ Dosage Form Strengths
Efavirenz S, T Capsules 200 mg, 600 mg
Nevirapine S, T Capsules Suspension 200 mg 50 mg / 5 ml

6.4.2.3 Protease inhibitors

Medicines Category Route of Administration/ Dosage Form Strengths
Indinavir S, T Capsules 200 mg, 400 mg
Nelfinavir S, T Capsules 250 mg
Ritonavir S, T CapsulesSyrup 100 mg, 400 mg / 5ml
Saquinavir S, T Capsules 200 mg

6.5 Antiprotozoal Medicines

6.5.1 Antiamoebic and Antigiardiasis medicines

Medicines Category Route of Administration/ Dosage Form Strengths
Diloxanide Furoate P,S,T Tablets 500 mg
Metronidazole P,S,T Tablets Injection 200 mg, 400 mg 500 mg /100 ml
6.5.2 Antileishmaniasis medicines
Medicines Category Route of Administration/ Dosage Form Strengths
Amphotericin B S, T Injection 50 mg
Pentamidine Isothionate S, T Injection 200 mg
Sodium Stibogluconate S, T Injection 100 mg / ml
6.5.3 Antimalarial Medicines
6.5.3.1 For curative treatment
Medicines Category Route of Administration/ Dosage Form Strengths
Artesunate (To be used only in combination with Sulfadoxine +Pyrimethamine) P,S,T Tablets 50 mg
Chloroquine phosphate P,S,T Tablets Injection Syrup 150 mg base40 mg /  ml 50 mg / 5 ml
Primaquine P,S,T Tablets 2.5 mg, 7.5 mg
Pyrimethamine P,S,T Tablets 25 mg
Quinine sulphate P,S,T ST Tablets Injection 300 mg 300 mg / ml
Sulfadoxine + Pyrimethamine P,S,T Tablets 500 mg + 25 mg
Medicines added
Clindamycin S,T Tablet 150, 300mg
6.5.3.2 For prophylaxis
Medicines Category Route of Administration/ Dosage Form Strengths
Medicines added
Mefloquine S,T Tablet 250 mg base
6.5.4 Antipneumocystosis and Antitoxoplasmosis medicines
Medicines Category Route of Administration/ Dosage Form Strengths
Co-Trimoxazole (Trimethoprim + Sulphamethoxazole) P,S,T Tablets Suspension 80 + 400 mg 160+800 mg 40 + 200 mg / 5 ml
Pentamidine Isothionate S, T Injection 200 mg

Section: 7 –Antimigraine medicines
7.1: For treatment of acute attack
Medicines Category Route of Administration/ Dosage Form Strengths
Acetyl Salicylic Acid P,S,T Tablets 300 - 350 mg
Dihydroergotamine S, T Tablets 1 mg
Paracetamol P,S,T Tablets 500 mg
7.2: For Prophylaxis
Medicines Category Route of Administration/ Dosage Form Strengths
Propranolol hydrochloride P,S,T Tablets 10 mg, 40 mg

Section: 8 – Antineoplastic, immunosuppressives and medicines used in palliative care
8.1: Immunosuppressive medicines
Medicines Category Route of Administration/ Dosage Form Strengths
Azathioprine T Tablets 50 mg
Cyclosporine T Capsules 10 mg, 25 mg, 50 mg, 100 mg
    Concentrate for Injection 100 mg/ml
8.2: Cytotoxic medicines
Medicines Category Route of Administration/ Dosage Form Strengths
Actinomycin D T Injection 0.5 mg
Alpha Interferon T Injection 3 million IU
Bleomycin T Injection 15 mg
Busulphan T Tablets 2 mg
Cisplatin T Injection 10 mg / vial 50 mg / vial
Cyclophosphamide T Tablets Injection 50 mg, 200 mg 500 mg
Cytosine arabinoside T Injection 100 mg/vial 500 mg/vial 1000 mg/vial
Danazol T Capsules 50 mg, 100 mg
Doxorubicin T Injection 10 mg, 50 mg
Etoposide T Capsules Injection 100 mg 100 mg/ 5 ml vial
Flutamide T Tablet 250 mg
5-Fluorouracil T Injection 250 mg / 5 ml
Folinic Acid T Injection 3 mg / ml
Gemcitabine hydrochloride T Injection 200 mg 1 gm
L- Asparaginase T Injection 5000 KU.
Melphalan T Tablet 2 mg, 5 mg
Mercaptopurine T Tablet Injection 50 mg 100 mg / ml
Methotrexate T Tablet Injection 2.5 mg 50 mg / ml
Mitomycin-C T Injection 10 mg
Paclitaxel T Injection 30 mg / 5 ml
Procarbazine T Capsules 50 mg
Vinblastine sulphate T Injection 10 mg
Vincristine T Injection 1 mg / ml

Added medicines

Carboplatin T Injection 150 mg, 450 mg vial
Dacarbazine T Injection 500 mg
Daunorubicin T Injection 20 mg vial
Ifosfamide T Injection 1 gm/2ml vial
Mesna T Injection 200 mg
Oxaliplatin T Injection 50 mg vial
Imatinib T Tablets 100 mg, 400 mg
Chlorambucil T Tablets 2 mg

8.3: Hormones and antihormones

Medicines Category Route of Administration/ Dosage Form Strengths
Prednisolone S, T Tablets 5 mg
Injection 20 mg, 25 mg (as sodium phosphate or succinate)
Raloxifene T Tablets 60 mg
Tamoxifen Citrate T Tablets 10 mg, 20 mg

8.4: Medicines used in palliative care

Medicines Category Route of Administration/ Dosage Form Strengths
Morphine Sulphate T Tablets 10 mg
Ondansetron S, T Tablets 4 mg, 8 mg
Injection 2 mg/ml
Syrup 2 mg/5 ml

Added Medicines

Filgrastim T Injection 1 ml vial
Allopurinol T Tablets 100 mg

Section: 9 –Antiparkinsonism medicines

Medicines Category Route of Administration/ Dosage Form Strengths
Bromocriptine Mesylate S, T Tablets 1.25 mg, 2.5 mg
Levodopa+ Carbidopa P,S,T Tablets 100 mg+10 mg 250 mg+25 mg 100 mg+25 mg
Trihexyphenidyl Hydrochloride P,S,T Tablets 2 mg

Section: 10 –Medicines affecting the blood

10.1: Antianaemia medicines

Medicines Category Route of Administration/ Dosage Form Strengths
Cyanocobalamin P, S,T Injection 1 mg/ml
Ferrous Sulphate/ Fumrate P,S,T Tablets Tablets equivalent to 60 mg elemental iron
Oral solution 25mg elemental iron (as sulphate)/ml
Folic Acid P,S,T Tablets 1 mg , 5mg
Iron Dextran S, T Injection 50 mg iron/ml
Pyridoxine P,S,T Tablets 10 mg

10.2: Medicines affecting coagulation

Medicines Category Route of Administration/ Dosage Form Strengths
Heparin Sodium S, T Injection 1000 IU/ml 5000 IU/ ml

Protamine Sulphate S, T Injection 10 mg/ml
Phytomenadione P, S, T Injection 10 mg/ml
Warfarin sodium S, T Tablets 5 mg

Added Medicines

Enoxaparin T Injection 40mg, 60mg

Section: 11 –Blood products and Plasma substitutes

11.1: Plasma Substitutes

Medicines Category Route of Administration/ Dosage Form Strengths
Dextran-40 P,S,T Injection 10%
Dextran-70 P,S,T Injection 6%
Fresh frozen plasma T Injection  
Hydroxyethyl Starch (Hetastarch) S, T Injection 6%
Polygeline S, T Injection 3.5%

11.2: Plasma fractions for specific use

Medicines Category Route of Administration/ Dosage Form Strengths
Albumin S, T Injection 5%, 20 %
Cryoprecipitate S, T Injection  
Factor VIII Concentrate S, T Injection Dried
Factor IX Complex (Coagulation Factors II,VII, IX, X) S, T Injection Dried
Platelet Rich Plasma S, T Injection  

Section: 12 –Cardiovascular medicines

12.1: Antianginal medicines

Medicines Category Route of Administration/ Dosage Form Strengths
Acetyl salicylic acid P,S,T Tablets 75mg, 100mg, 350 mg soluble/dispersible
Diltiazem S, T Tablets 30 mg, 60 mg
Glyceryl Trinitrate P,S,T Sublingual Tablets Injection 0.5 mg 5mg/ml
Isosorbide 5 Mononitrate/ Dinitrate P,S,T Tablets 10 mg, 20 mg
Metoprolol P,S,T Tablets Injection 25 mg, 50 mg 1mg/ml
Added Medicines
Clopidogrel T Tablets 75 mg

12.2: Antiarrhythmic medicines

Medicines Category Route of Administration/ Dosage Form Strengths
Adenosine S,T Injection 3 mg/ml
Amiodarone S, T Tablets Injection 100 mg, 200 mg 50 mg/ml (3 ml ampoule)
Diltiazem S, T Tablets 30 mg, 60 mg
T Injection 5 mg/ ml
Esmolol T Injection 10 mg / ml
Lignocaine Hydrochloride S, T Injection 1%, 2%
Procainamide Hydrochloride T Tablets Injection 250 mg 100mg/ml
Verapamil S, T Tablets Injection 40 mg, 80 mg 2.5mg/ml

12.3: Antihypertensive medicines

Medicines Category Route of Administration/ Dosage Form Strengths
Amlodipine P,S,T Tablets 2.5 mg, 5 mg
Atenolol P,S,T Tablets 50 mg, 100 mg
Enalapril Maleate P,S,T T Tablets Injection 2.5 mg, 5mg 1.25mg/ml
Losartan Potassium S, T Tablets 25 mg, 50 mg
Methyldopa P,S, T Tablets 250 mg
Nifedipine S, T Capsules Tablets Sustained release tablets or capsules 5 mg, 10mg 10mg, 20mg 10mg, 20mg
Sodium Nitroprusside T Injection 50 mg/ 5 ml

Added Medicines

Hydrochlorthiazide P,S,T Tablets 12.5, 25 mg

12.4: Medicines used in heart failure

Medicines Category Route of Administration/ Dosage Form Strengths
Digoxin S, T Tablets Injection Elixir 0.25 mg 0.25 mg/ml 0.05 mg/ml
Dobutamine S,  T Injection 50 mg / ml
Dopamine Hydrochloride S,T Injection 40 mg / ml

12.5: Antithrombotic medicines

Medicines Category Route of Administration/ Dosage Form Strengths
Acetyl salicylic acid P,S,T Tablets 75mg, 100mg, 350 mg soluble/dispersible
Heparin Sodium S, T Injection 1000 IU /ml 5000 IU/ml
Streptokinase S, T Injection 750,000 IU 15,00,000 IU
Urokinase T Injection 500,000 IU/ml 10,00,000 IU/ml
New Category - ADDED

12.6 Hypolipidemic Medicines

Atorvastatin P,S,T Tablets 5 mg, 10 mg

Section: 13 –Dermatological medicines (Topical)

13.1: Antifungal medicines

Medicines Category Route of Administration/ Dosage Form Strengths
Miconazole P,S,T Ointment or Cream 2%

13.2: Antiinfective medicines

Medicines Category Route of Administration/ Dosage Form Strengths
Acyclovir S, T Cream 5%
Framycetin Sulphate P,S,T Cream 0.5%
Methylrosaniliniu m Chloride (Gentian Violet) P,S,T Aqueous solution 0.5%
Neomycin + Bacitracin P,S,T Ointment 5 mg + 500 IU / g
Povidone Iodine P,S,T Solution or Ointment 5%
Silver Sulphadiazine P,S,T Cream 1%

13.3: Antiinflammatory and antipruritic medicines

Medicines Category Route of Administration/ Dosage Form Strengths
Betamethasone Dipropionate P,S,T Cream / Ointment 0.05%
Calamine P,S,T Lotion  

13.4: Astringent Medicines

Medicines Category Route of Administration/ Dosage Form Strengths
Zinc Oxide P,S,T Dusting Powder  

13.5: Medicines affecting skin differentiation and proliferation

Medicines Category Route of Administration/ Dosage Form Strengths
Coal Tar P,S,T Solution 5%
Dithranol T Ointment 0.1-2%
Glycerin P,S,T Solution  
Salicylic Acid P,S,T Solution 5%

13.6: Scabicides and Pediculicides

Medicines Category Route of Administration/ Dosage Form Strengths
Benzyl benzoate P,S,T Lotion 25 %

Added Medicines

Permethrin S,T Cream Lotion 5% 1%, 5%

Section: 14 –Diagnostic agents

14.1: Ophthalmic medicines

Medicines Category Route of Administration/ Dosage Form Strengths
Fluorescein S, T Eye drops 1%
Lignocaine S, T Eye Drops 4%
Tropicamide S, T Eye drops 1%

14.2: Radiocontrast media

Medicines Category Route of Administration/ Dosage Form Strengths
Barium Sulphate S, T Suspension 100% w/v, 250% w/v
Calcium Ipodate S, T Injection 3 g
Iopanoic Acid S, T Tablets 500 mg
Meglumine Iothalamate S, T Injection 60% w/v (iodine =280 mg / ml)
Meglumine Iotroxate S, T Solution 5-8 g iodine in 100-250 ml
Propyliodone S, T Oily, suspension 500-600 mg / ml
Sodium Iothalamate S, T Injection 70% w/v(Iodine =420 mg / ml)
Sodium Meglumine Diatrizoate S, T Injection 60% w/v(Iodine conc. =292 mg / ml), 76% w/v(Iodine conc. =370 mg / ml)

Section: 15 –Disinfectants and antiseptics

15.1: Antiseptics

Medicines Category Route of Administration/ Dosage Form Strengths
Acriflavin+Glycerin P, S, T Solution  
Benzoin Compound P, S, T Tincture  
Cetrimide P, S, T Solution 20% (conc. for dilution)
Chlorhexidine P, S, T Solution 5% (conc. for dilution)
Ethyl Alcohol 70% P, S, T Solution  
Gentian Violet P, S, T Paint 0.5%, 1%
Hydrogen Peroxide P, S, T Solution 6%
Povidone Iodine P, S, T Solution 5%, 10%

15.2: Disinfectants

Medicines Category Route of Administration/ Dosage Form Strengths
Bleaching Powder P, S, T Powder Contains not less than 30 % w/w of available chlorine (as per I.P)
Formaldehyde Solution P, S, T Solution Dilute 34 ml of formaldehyde solution with water to produce 100 ml (As per I.P)
Glutaraldehyde S,T Solution 2%
Potassium Permanganate P, S, T Crystals for solution  

Section: 16 –Diuretics

Medicines Category Route of Administration/ Dosage Form Strengths
Furosemide P,S,T Injection Tablets 10 mg/ ml 40mg
Hydrochlorothiazid e P,S,T Tablets 25 mg, 50 mg
Mannitol P,S,T Injection 10%, 20%
Spironolactone P,S,T Tablets 25 mg

Section: 17 – Gastrointestinal medicines

17.1: Antacids and other Antiulcer medicines

Medicines Category Route of Administration/ Dosage Form Strengths
Aluminium Hydroxide + Magnesium Hydroxide P,S,T Tablet Suspension  
Omeprazole P,S,T Capsules 10 mg, 20 mg, 40 mg
Ranitidine P,S,T Injection 25 mg / ml

Added Medicines

Pantoprazole T Injection 40 mg
Famotidine P,S,T Tablets 20 mg

17.2: Antiemetics

Medicines Category Route of Administration/ Dosage Form Strengths
Domperidone P,S,T Tablets Syrup 10 mg 1 mg / ml
Metoclopramide P,S,T Tablets Syrup Injection 10 mg 5 mg  / 5 ml 5 mg / ml
Promethazine P,S,T Tablets Elixir or Syrup Injection 10 mg, 25 mg 5 mg  / 5 ml 25 mg / ml

Added Medicines

Ondansetron S,T Tablet Syrup Injection 4mg, 8 mg 2 mg/ml 2mg/ml

17.3: Antiinflammatory Medicines

Medicines Category Route of Administration/ Dosage Form Strengths
Added Medicines
5-Amino salicylic Acid (5-ASA) S,T Tablets 400mg

17.4: Antispasmodic medicines

Medicines Category Route of Administration/ Dosage Form Strengths
Dicyclomine Hydrochloride P,S,T Tablets Injection 10 mg 10 mg / ml
Hyoscine Butyl Bromide P,S,T Tablets Injection 10 mg 20 mg / ml

17.5: Laxatives

Medicines Category Route of Administration/ Dosage Form Strengths
Bisacodyl P,S,T Tablets, Suppository 5 mg
Ispaghula P,S,T Granules  

17.6: Medicines used in diarrhorea

17.6.1 Oral dehydration salts

Medicines Category Route of Administration/ Dosage Form Strengths
Oral Rehydration Salts P,S,T Powder for solution Glucose: 13.5 g/L Sodium chloride: 2.6 g/L Potassium chloride: 1.5 g/L Trisodium citrate dihydrate+: 2.9 g/L Powder for dilution in 200ml; 500 ml; 1000ml. (As per I.P)

17.6.2 Antidiarrhoeal medicines

Medicines Category Route of Administration/ Dosage Form Strengths
Medicines added
Zinc Sulfate P,S,T Syrup 20 mg/5ml

Section: 18 –Hormones, other endocrine medicines and contraceptives

18.1: Adrenal hormones and synthetic substitutes

Medicines Category Route of Administration/ Dosage Form Strengths
Dexamethasone S,T Tablets Injection 0.5mg 4mg/ml
Hydrocortisone Sodium Succinate P, S,T Injection 100 mg / ml
Methyl Prednisolone S,T Injection 40 mg/ ml
Prednisolone P, S,T Tablets 5mg, 10mg, 20mg

18.2: Androgens

Medicines Category Route of Administration/ Dosage Form Strengths
Testosterone P,S,T Capsules Injection 40mg(as undecanoate) 25mg/ml(as propionate)

18.3: Contraceptives

18.3.1: Hormonal Contraceptives

Medicines Category Route of Administration/ Dosage Form Strengths
Ethinylestradiol + Levonorgesterol P,S,T Tablets 0.03 mg +0.15 mg
Ethinylestradiol + Norethisterone P,S,T Tablets 0.035 mg +1.0 mg
Hormone Releasing IUD T Levonorgesterol Releasing IUD

18.3.2: Intrauterine devices

Medicines Category Route of Administration/ Dosage Form Strengths
IUD containing Copper P,S,T    

18.3.3: Barrier Methods

Medicines Category Route of Administration/ Dosage Form Strengths
Condoms P,S,T    

18.4: Estrogens

Medicines Category Route of Administration/ Dosage Form Strengths
Ethinylestradiol P,S,T Tablets 0.01mg 0.05mg

18.5: Medicines used in Diabetes mellitus

18.5.1: Insulins and other Antidiabetic agents

Medicines Category Route of Administration/ Dosage Form Strengths
Glibenclamide P,S,T Tablets 2.5 mg, 5mg
Insulin Injection (Soluble) P,S,T Injection 40 IU / ml
Intermediate Acting(Lente/NPH Insulin) P,S,T Injection 40 IU / ml
Metformin P,S,T Tablets 500mg

Added medicines

Premix Insulin 30:70 injection P,S,T Injection 40IU/ml

18.5.2 Medicines used to treat hypoglycemia

Medicines Category Route of Administration/ Dosage Form Strengths
Glucagon T Injection 1mg/ml
    Added medicines  
25% Dextrose P,S,T Injection 100 ml

18.6 Ovulation Inducers

Medicines Category Route of Administration/ Dosage Form Strengths
Clomiphene citrate T Tablets 50mg, 100mg

18.7 Progestogens

Medicines Category Route of Administration/ Dosage Form Strengths
Medroxy Progesterone Acetate P,S,T Tablets 5mg, 10mg
Norethisterone P,S,T Tablets 5mg
18.8 Thyroid and antithyroid medicines
Medicines Category Route of Administration / Dosage Form Strengths
Carbimazole P,S,T Tablets 5mg, 10mg
Levothyroxine P,S,T Tablets 50μg, 100 μg
Iodine S,T Solution 8 mg / 5 ml

Section: 19 Immunologicals

19.1: Diagnostic agents
Drugs Category Route of Administration/ Dosage Form Strengths
Tuberculin, Purified Protein derivative P,S,T Injection 1 TU, 5 TU
19.2: Sera and immunoglobins
Drugs Category Route of Administration/ Dosage Form Strengths
Anti-D immunoglobin (human) S, T Injection 300 μg
Polyvalent Antisnake Venom P,S,T Injection 10 ml
Antitetanus Human immunoglobin P,S,T Injection 250 IU, 500 IU
Diphtheria Antitoxin  S, T  Injection   10,000 IU
Rabies immunoglobin  P,S,T    Injection   150 IU / ml
                                                                                                         

19.3: Vaccines

19.3.1: For Universal Immunisation

Drugs Category Route of Administration/ Dosage Strengths
    Form  
B.C.G Vaccine P,S,T Injection  
D.P.T Vaccine P,S,T Injection  
Hepatitis B Vaccine P,S,T    Injection  
Measles Vaccine  P,S,T Injection  
Injection Oral Poliomyelitis vaccine (LA)  P,S,T Solution  

19.3.2: For Specific Group of Individuals

Drugs Category Route of Administration/ Dosage Strengths
    Form  
Rabies Vaccine P,S,T Injection  
Tetanus Toxoid P,S,T Injection  

Section: 20 – Muscle Relaxants (Peripherally acting) and Cholinesterase Inhibitors

Drugs  Category Route of Administration/ Dosage Form Strengths
Atracurium besylate  S, T  Injection    10 mg / ml 55
Neostigmine S,T Tablets, Injection 15 mg, 0.5mg/ml
Pyridostigmine S, T Tablets, Injection 60 mg, 1mg/ml
Succinyl choline chloride S,T Injection 50 mg/ml

Added drugs

Vecuronium P,S,T Injection 2 mg/ml

Section: 21 – Ophthalmological Preparations

21.1: Anti-infective agents
Medicines Category Route of Administration/ Dosage Form Strengths
Chloramph enicol P,S,T Drops/Ointment 0.4%, 1%
Ciprofloxa cin Hydrochlor ide P,S,T Drops/Ointment 0.3%
Gentamici n P,S,T Drops 0.3%
Miconazol e P,S,T Drops 1%
Povidone Iodine S,T Drops 0.6%
Sulphacet amide Sodium P,S,T Drops 10%,20%
21.2: Antiinflammaory agents
Medicines Category Route of Administration/ Dosage Form Strengths
Prednisolone Acetate P,S,T Drops 0.1%
Prednisolo ne Sodium Phosphate P,S,T Drops 1%
21.3: Local Anaesthetics
Medicines Category Route of Administration/ Dosage Form Strengths
Tetracaine Hydrochlor ide P,S,T Drops 0.5%
21.4: Miotics and Antiglucoma medicines
Medicines Category Route of Administration/ Dosage Form Strengths
Acetazola mide S,T Tablets 250 mg
Betaxolol Hydrochlor ide T Drops 0.25%, 0.5%
Pilocarpin e S,T Drops 2%, 4%
Timolol Maleate P, S, T Drops 0.25%, 0.5%,
21.5: Mydriatics
Medicines Category Route of Administration/ Dosage Form Strengths
Atropine Sulphate P,S,T Drops/Ointment 1%
Homatropi ne P,S,T Drops 2%
Phenyleph rine P,S,T Drops 5%

21.6: Ophthalmic Surgical Aids
Medicines Category Route of Administration/ Dosage Form Strengths
Methyl Cellulose T Injection 2%

Section: 22 – Oxytocics and Antioxytocics

22.1: Oxytocics
Medicines Category Route of Administration/ Dosage Form Strengths
Methyl Ergometrine P,S,T Tablets Injection 0.125mg 0.2mg/ml
Mifepristone T Tablets 200mg
Oxytocin S,T Injection 5 IU/ ml, 10IU/ml

Added medicines
Misoprostol T Tablets 100ug

22.2: Antioxytocics

Medicines Category Route of Administration/ Dosage Form Strengths
Terbutaline Sulphate S,T Tablets Injection 2.5 mg 0.5 mg/ml
Added Medicines
Nifedipine S,T Tablets 10 mg

Betamethasone P,S,T Injection 4 mg/ml
Section: 23 – Peritoneal Dialysis Solution
Medicines Category Route of Administration/ Dosage Form Strengths
Intraperitoneal Dialysis Solution T   4Of approximate composition
Section: 24 – Psychotherapeutic Medicines
24.1: Medicines used in Psychotic Disorders
Medicines Category Route of Administration/ Dosage Form Strengths
Chlorpromazine hydrochloride P,S,T Tablets Syrup Injection 25 mg, 50mg, 100mg 25mg/5ml 25mg/ml
Haloperidol S, T Injection 5mg/ml
Added medicines
Olanzapine T Tablets 5mg,10mg
24.2: Medicines used in mood disorders
24.2.1: Medicines used in Depressive disorders
Medicines Category Route of Administration/ Dosage Form Strengths
Amitriptyline P,S,T Tablets 25 mg
Fluoxetine hydrochloride P,S,T Capsules 20 mg
Imipramine P,S,T Tablets 25 mg, 75 mg
24.2.2: Medicines used in Bipolar disorders
Medicines Category Route of Administration/ Dosage Form Strengths
Lithium Carbonate T Tablets 300 mg

Added Medicines

Sodium   Valproate     P,S,T Tablets 200 mg,   500mg

24.3: Medicines used for Generalized Anxiety and Sleep Disorders

Medicines Category Route of Administration/ Dosage Form Strengths
Alprazolam P,S,T Tablets 0.25 mg,   0.5 mg
Diazepam P,S,T Tablets 2 mg,   5mg

24.4: Medicines used for obsessive compulsive disorders and panic attacks

Medicines   Category Route of Administration/ Dosage Form Strengths
Added Medicines
Fluoxetine hydrochloride   P,S,T Capsules   20 mg

Section: 25 – Medicines acting on the respiratory tract

25.1: Antiasthmatic medicines

Medicines   Category   Route of Administration/ Dosage Form   Strengths
Beclomethasone Dipropionate P,S,T Inhalation 50 µg,   250µg/dose
Hydrocortisone sodium succinate P,S,T Injection 100 mg,   200mg,   400 mg
Salbutamol sulphate P,S,T Tablets Syrup Inhalation 2mg, 4mg   2mg/5ml   100µg/dose
Added Medicines      

Ipratropium bromide P,S,T Inhalation 20µg/metere d dose
25.2: Antitussives
Medicines Category Route of Administration/ Dosage Form Strengths
Codeine phosphate S,T Tablets Syrup 10mg 15mg/ 5ml
Dextromethorphan P,S,T Tablets 30mg

Section: 26 – Solutions correcting water, electrolyte and acid-base disturbances

26.1: Oral
Medicines Category Route of Administration/ Dosage Form Strengths
Oral Rehydration Salts P, S, T Powder for Solution As per IP

26.2: Parenteral

Medicines Category Route of Administration/ Dosage Form Strengths
Glucose P, S, T Injection 5% isotonic, 10%, 15%.
Glucose with sodium chloride P, S, T Injection 5% + 0.9%
Normal Saline P, S, T Injection 0.9%
N/2 Saline S, T Injection  
N/5 Saline S, T Injection  
Potassium Chloride P, S, T Injection 11.2% Sol.
Ringer Lactate P, S, T Injection As per IP
Sodium P, S, T Injection As per IP

26.3: Miscellaneous

Medicines Category Route of Administration/ Dosage Form Strengths
Water for Injection P, S, T Injection 2 ml, 5 ml, 10 ml

Section: 27 – Vitamins and Minerals

Medicines Category Route of Administration/ Dosage Form Strengths
Ascorbic Acid P,S,T Tablets 100 mg, 500 mg
Calcium carbonate P,S,T Tablets 250 mg, 500 mg
Multivitamins (As per Schedule V of Drugs and Cosmetics Rules) P,S,T Tablets  
Nicotinamide P,S,T Tablets 50 mg
Pyridoxine P,S,T Tablets 25 mg
Riboflavin P,S,T Tablets 5 mg
Thiamine P,S,T Tablets 100 mg
Vitamin A P,S,T Tablets Capsules 5000 IU, 50000 IU, 100000 IU,
Injection 50000 IU/ml
Vitamin D (Ergocalciferol) P,S,T Capsules 0.25 mg, 1 mg

Added Medicines

Calcium gluconate P,S,T Injection 100mg/ml in 10 ml ampoule

SCHEDULE-II FORM - I

PROFORMA FOR APPLICATION FOR PRICE FIXATION / REVISION OF A NEW DRUG FORMULATION RELATED TO NLEM FORMULATION
(See paragraphs 2(u),5,7,8,9,15)

1. Name of the formulation:

2. Name and address of the manufacturer/importer:

3. Name of the Marketing Company, if any:

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

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

6. Date of commencement of production / import:

7. Type of formulation (Tablets/ Capsules/ Syrup/ Injection/ Ointment/ Powder etc.):

8. Size of packs (10’s/ 100’s/ 1 ml/ 2 ml/ 10 ml/ 5 gms/ 10 gms etc.)

9. Therapeutic category/ use of the formulation.

10. The Retail Price  claimed for approval

11. Reason for submission of application for price fixation / revision.

12. Any other information relevant to product and its process of manufacturing/ packaging/ distribution.

The information furnished above is correct and true to the best of my knowledge and belief.

Place:

Date:

Authorised Signatory:

Name:

Designation:

SCHEDULE-II

FORM - II

PROFORMA FOR SUBMISSION OF REVISED-PRICES FOR SCHEDULED FORMULATIONS
(See paragraph 16)

1. Name and address of the manufacturer / importer / distributor.

2. Name and address of the marketing company, if any.

Sl. No. Name of  the Product (Formulation  and  its    dosage forms) Composition of scheduled formulation/ new drug Pack Size WPI change w.r.t preceeding Year Price to retailer (incl. of D.) (Rs.) Maximum Retail Price (incl. of E.D.&Taxes) (Rs.) Ceiling Price(Notified) (Rs.) Effective Batch No. and date
Pre-Revised Revised Pre-Revised Revised
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)
  Scheduled Formulations                
  Own Manufactured Formulations                
  Purchased/Imported Formulations                

Notes:-  In case of purchased formulation, name of the manufacturer shall be indicated.

The information furnished above is correct and true to the best of my knowledge and belief.

Place:

Date:

Authorised Signatory:

Name:

Designation:

FORM – III

PROFORMA FOR QUARTERLY RETURN IN RESPECT OF PRODUCTION/IMPORT AND SALE OF NLEM DRUGS
(See paragraphs 21(1))

1. Name and address of the manufacturer/importer:

2. Name and address of marketing company, if any:

3. Details of production/import and sale for the Quarter of a Year:    …………………

TABLE-A

Name of the Scheduled Formulation Composition /Strength Dosage Form Unit(No/ kg/Ltr) Production/Import Level Domestic Sale
Previous Year Current Year Previous Year Current Year
1st Quarter 2nd Quarter 3rd Quarter 4th Quarter 1st Quarter 2nd Quarter 3rd Quarter 4th Quarter
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) (12) (13) (14)
                           

Name of the Scheduled Formulation Composition /Strength Dosage Form Unit(No/ kg/Ltr) Production/Import Level Domestic Sale
Previous Year Current Year Previous Year Current Year
1st Quarter 2nd Quarter 3rd Quarter 4th Quarter 1st Quarter 2nd Quarter 3rd Quarter 4th Quarter
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) (12) (13) (14)
                           

TABLE-B

Name of the Bulk Drug/API used in Scheduled Formulation Unit (Kg/ Ltr) Installed Capacity Production/Import Level Domestic Sale
Previous Year Current Year Previous Year Current Year
1st Quarter 2nd Quarter 3rd Quarter 4th Quarter 1st Quarter 2nd Quarter 3rd Quarter 4th Quarter
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) (12) (13)
                         

Constraints, if any:

Note:-

(1) Production outsourced / carried out on job work basis should also be included.

The information furnished above is correct and true to the best of my knowledge and belief.

Place:

Date:

Authorised Signatory:

Name:

Designation:

SCHEDULE-II FORM - IV

PROFORMA FOR SUBMISSION OF THE DETAILS IN RESPECT OF DISCONTINUATION OF THE PRODUCTION AND/ OR IMPORT OF SCHEDULED FORMULATION
(See paragraphs 21(2))

1.  Name of the formulation:

2.  Name and address of the manufacturer/importer :

3.  Name of the Marketing Company, if any:

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

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

6.  Celling Price and date of notification:

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

8.  Therapeutic category as per NLEM:

9.  Date of commencement of production / import

10. Proposed date of discontinuation:

11. Reasons for discontinuation of production / import:

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

13. Year-wise sale during the last 5 years including current year

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

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

Place:

Date:

Authorised Signatory:

Name:

Designation:

SCHEDULE-II

FORM - V

PROFORMA FOR PRICE LIST
(See paragraphs 2(x),24,25,26)

1. Name and address of the manufacturer / importer / distributor.

2. Name and address of the marketing company, if any.

TABLE-A

Sl. No. Name of the Product (Formulation and its dosage forms) Composition   approved   by Drug Control Authorities Pack Size Price to retailer (incl. of E.D.) (Rs.) Maximum Retail Price (incl. of E.D.&Taxes) (Rs.)
(1) (2) (3) (4) (5) (6)
  Scheduled Formulations  
  Own Manufactured Formulations        
  Purchased/Imported Formulations        

TABLE-B

Sl. No. Name  of  the  Product  (Formulation  and  its dosage forms) Composition    approved    by Drug Control Authorities Pack Size Price to retailer (incl. of E.D.) (Rs.) Maximum Retail Price (incl. of E.D.&Taxes) (Rs.)
(1) (2) (3) (4) (5) (6)
  Non-Scheduled Formulations  
  Own Manufactured Formulations        
  Purchased/Imported Formulations        

Notes:-  In case of purchased formulation, name of the manufacturer shall be indicated.

The information furnished above is correct and true to the best of my knowledge and belief.

Place:

Date:

Authorised Signatory:

Name:

Designation:

Shemaleup.net x-comics.org vr-porn360.net