OF NOTIFIED CEILING PRICES OF SCHEDULED DRUGS

Transcription

1 ISO 9001 : 2008 Certified Affordable Medicine for All COMPENDIUM OF NOTIFIED CEILING PRICES OF SCHEDULED DRUGS (AS ON 31ST JANUARY, 2015) National Pharmaceutical Pricing Authority Department of Pharmaceuticals Ministry of Chemicals and Fertilizers Government of India

2 National Pharmaceutical Pricing Authority 3 rd Floor, YMCA Cultural Centre 1 Jai Singh Road New Delhi Injeti Srinivas, IAS Chairman 11 February 2015 PREFACE The National Pharmaceutical Pricing Authority (NPPA) is mandated with the task of implementing the Drugs (Prices Control) Order (DPCO) 2013, which aims at making available all essential and lifesaving medicines to all at affordable prices through the instrumentality of price control. Drug price control is not something peculiar to India, but one that is prevalent in most countries, including many developed countries, though the methodology of price control may differ from one country to another. 2. Unlike the DPCO 1995, which adopted a cost-based approach for price fixation in respect of scheduled drugs, the DPCO 2013 adopts a market-based approach for price fixation. Second, the National List of Essential Medicines (NLEM) 2011 is adopted as the primary basis for determining essentiality, and is accordingly incorporated in the First Schedule to the DPCO 2013, which constitutes the list of scheduled medicines for the purpose of price control. Third, the price control is applied to specific formulations with reference to the medicine (active pharmaceutical ingredient), route of administration/ dosage form and strength as contained in the First Schedule. 3. Under the market-based approach, the ceiling price of a scheduled drug is determined by first working out the simple average of price to retailer (PTR) in respect of all branded-generic and generic versions of that particular drug formulation having a market share of 1 percent and above, and then adding a notional retailer margin of 16 percent to it. The maximum retail price (MRP) for that particular drug formulation must not exceed the notified ceiling price plus applicable local taxes.

3 National Pharmaceutical Pricing Authority 3 rd Floor, YMCA Cultural Centre 1 Jai Singh Road New Delhi All the existing manufacturers (including importers and marketers) of a scheduled formulation, selling branded or generic or both versions of that formulation at a price higher than the ceiling price plus local applicable taxes are required to reduce it to at least that level. At the same time, all existing manufacturers (including importers and marketers) of that formulation who are selling it below that price are required to maintain their existing MRP. Implementation of the price notification is to be communicated, in Form-V to the DPCO 2013, to all dealers, State Drug Controllers and NPPA immediately. Also the current price list of scheduled drugs has to be displayed by every dealer and retailer. 5. The ceiling price fixed for each scheduled formulation becomes operative and legally enforceable from the date on which the price is notified in the Gazette of India Extraordinary. In other words, the medicine cannot be sold at an MRP exceeding the ceiling price plus applicable local taxes from the date of price notification. However, for stock manufactured or available in the market prior to publication of the ceiling price, a grace period of 45 days is available to facilitate recall and/ or reprinting of the revised MRP on the label of the medicine in accordance with the notified ceiling price. But under no circumstances does it allow sale of a medicine at the pre-revised price even during the 45-day grace period, as the same stock keeping unit (SKU) of a particular medicine should not be offered to the consumer at a price exceeding the price specified in the current price list or the price indicated on the label of the medicine pack, whichever is less. Similarly, all batches manufactured after the price notification must necessarily conform to the notified ceiling price. 6. The notified ceiling price with respect to each scheduled formulation is valid for a period of five years from the date of original price notification, but subject to annual revision to be notified by NPPA on the first day of April every year as per the annual wholesale price index (WPI) with respect to the previous calendar year. The revision may mean increase or decrease in ceiling price depending upon whether the WPI is positive or negative. The manufacturers (including importers and marketers) are free to avail themselves of the annual revision in case of increase, without obtaining prior approval of the Government, but they are required to exercise their decision in this regard within 15 days of such revision and report to the NPPA in Form-II to DPCO 2013 failing which it shall be construed that the company has opted for nonrevision of MRP. However, they shall be bound to decrease their MRP correspondingly in case of decrease in the ceiling price due to negative WPI.

4 National Pharmaceutical Pricing Authority 3 rd Floor, YMCA Cultural Centre 1 Jai Singh Road New Delhi Non-compliance with the notified ceiling price or, in other words, the MRP breaching ceiling price plus applicable local taxes would be tantamount to overcharging the consumer, which is liable to be recovered along with interest thereon from the date of overcharging. The excess collection on account of overcharging along with interest is recoverable as arrears to land revenue under the Public Demand Recovery Act. 8. Further, non-compliance of price notification issued by NPPA, depending upon the gravity of the offence, could also attract prosecution under the Essential Commodities Act (ECA), Section 7 of the ECA 1955 provides for imprisonment for a term which shall not be less than 3 months, but which may extend to seven years and shall also be liable for fine. Section 9 of the ECA, 1955 makes false statements/ information also punishable with imprisonment for a term which may extend to five years or with fine or with both. Under section 10 of the ECA, 1955, offences committed by companies are punishable, and shall apply to every person who, at the time the contravention was committed, was in charge of, and was responsible to, the company for conduct of the business of the company as well as the company, shall be deemed to be guilty of the contravention and shall be liable to be proceeded against and punished accordingly. Every offence committed under the Essential Commodities Act, 1955 is a cognizable offence. 9. Implementation of the DPCO 2013 is the joint responsibility NPPA and State Drug Controllers. Accordingly, most State Governments have duly empowered Drug Inspectors under paragraph 30 (1) of DPCO 2013, which allows any Gazetted Officer of the Central Government or of a State Government, as the case may be, to exercise the power of entry, search and seizure to ensure that the provisions of the DPCO have been complied with. 10. At present the DPCO 2013 contains 680 scheduled drug formulations spread across 27 therapeutic groups, which effectively comes to 628 scheduled drug formulations if we net those appearing in more than one therapeutic group. As on date, the NPPA has fixed and notified the ceiling prices with respect to 509 scheduled formulations, apart from notification of annual WPI-linked revision whenever due. With regard to the remaining 119 scheduled drug formulations, 17, which are common to both DPCO 1995 and DPCO 2013, are not yet due for revision. With respect to the residual 102 scheduled drug formulations, the NPPA has not been able to fix the ceiling prices due to non-availability of corresponding market-based PTR data, efforts for which are continuously on, and those ceiling prices shall be notified as soon as the said data is available.

5 National Pharmaceutical Pricing Authority 3 rd Floor, YMCA Cultural Centre 1 Jai Singh Road New Delhi The Compendium of Notified Ceiling Prices of Scheduled Drugs 2015 has been brought out with the objective of disseminating information related to notified ceiling prices in respect of scheduled drugs, to all stakeholders, particularly consumers and consumer welfare organisations/ NGOs; manufacturers, including importers and marketers of pharmaceuticals products; stockist/ distributors, dealers and retailers; doctors and public health experts; and enforcement functionaries. Apart from serving as a compendium of notified ceiling prices, it is also expected to help in propagating the NLEM, which is basically aimed at promoting scientific and rational use of medicines that is both clinically-effective and cost-effective. 12. I sincerely hope that all stakeholders will find this compendium extremely useful as a ready reckoner. The enforcement functionaries may find this compendium useful in carrying out monitoring and enforcement activities with regard to price compliance under DPCO The NPPA has provided on its website an online facility to lodge complaints related to price and availability of pharmaceuticals, which may be used by consumers, NGOs and enforcement functionaries to report cases of overcharging or non-availability of medicines, if any. A soft copy of the compendium is also placed on the NPPA website along with copies of related Gazette of India Extraordinary price notifications in PDF format. Although every effort has been made to maintain accuracy in the compendium, the NPPA shall not be responsible for any error or mistake that may have inadvertently crept into the compendium. The reader is, therefore, advised to refer to the relevant official Gazette notification before taking any action on the basis of this compendium. (Injeti Srinivas)

6 DISCLAIMER The information contained herein is not a substitute to ceiling prices notified in the Gazette of India Extraordinary. For the official version, please refer to the relevant Gazette Notification issued in this regard, which may be accessed from the NPPA website at

7 SCHEDULE-I [Refer Paragraph 2(t), 2(zb)] of DPCO, 2013 NATIONAL LIST OF ESSENTIAL MEDICINES 2011 SECTION : 1 - ANESTHESIA 1.1 General Anesthetics and Oxygen Sl. No. Medicines Route of Strengths Unit Ceiling Price S.O. Date of (i) Ether Inhalation (ii) Halothane with vaporizer Inhalation 1ml (E) ml (E) (iii) Isoflurane Inhalation 1ml E) ml (E) (iv) Ketamine Hydrochloride Injection 10mg/ml 1ml (E) (v) Injection 50mg/ml 1ml (E) ml (E) (vi) Nitrous Oxide Inhalation Cubic Meter (E) Cubic Meter (E) (vii) Oxygen Inhalation Cubic Meter (E) Cubic Meter (E) (viii) Thiopentone Sodium Injection 0.5 gm powder Each Pack (E) Each Pack (E) Injection 1 gm powder 1 gm (E) gm (E) Added Medicines (x) Sevoflurane Inhalation 1 ml (E) ml (E) (xi) Propofol Injection 1% oil Each Pack (E) suspension 1ml 2535(E) ml (E) ml (E) Local Anesthetics (i) Bupivacaine Hydrochloride Injection 0.25% 1 ml (E) ml (E) (ii) Bupivacaine Hydrochloride Injection 0.5% 1 ml (E) ml (E)

8 (iii) Bupivacaine Hydrochloride Injection 0.5% to be mixed 1 ml (E) with 7.5% 1 ml (E) glucose solution (iv) Lignocaine Hydrochloride Topical Forms 2-5% 1 ml / gm (E) ml / gm (E) Injection 1-2% Each Pack (E) Each Pack (E) ml (E) ml (E) Spinal 5% +7.5% Glucose (v) Lignocaine Hydrochloride Injection 1%+ Each Pack (E) Adrenaline 1:200,000 Each Pack (E) (vi) Lignocaine Hydrochloride Injection 2%+ 1 ml (E) Adrenaline 1:200,000 1 ml (E) ml (E) Added Medicines (vii) EMLA cream Cream 1 gm (E) gm (E) Preoperative Medication and Sedation for Short Term Procedures (i) Atropine Sulphate Injection 0.6 mg/ml 1 ml (E) ml (E) (ii) Diazepam Tablets 5 mg 1 Tablet (E) Tablet (E) Diazepam Injection 5 mg / ml 1 ml (E) ml (E) Diazepam Syrup 2mg/5ml Diazepam Suppository 5 mg 1 Suppository (E) (iii) Midazolam Injection 1 mg / ml 1ml (E) ml (E) mg / ml 1ml (E) ml (E) (iv) Morphine Sulphate Injection 10 mg / ml 1ml (E) ml (E)

9 (v) Promethazine Syrup 5 mg / 5 ml 1 ml (E) (E) ml (E) 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 (i) Acetyl Salicylic Acid Tablets 325mg 1 Tablet (E) Acetyl Salicylic Acid Tablets 350 mg (ii) Diclofenac Tablets 50 mg 1 Tablet (E) Tablet (E) (iii) Ibuprofen Tablets 200 mg Injection 25 mg / ml 1 ml (E) ml (E) ml (E) Tablets 400 mg Syrup 100mg/5ml 1 ml (E) ml (E) (iv) Paracetamol Injection 150 mg / ml 1ml (E) ml (E) ml (E) Syrup 125 mg / 5ml 1 ml (E) ml (E) ml (E) Tablets 500 mg 1 Tablet (E) Tablet (E) Suppository 80 mg 1 Suppository (E) Suppository (E) Suppository (E) Suppository 170 mg 1 Suppository (E) Suppository (E) Suppository (E) Opioid Analgesics (i) Morphine Sulphate Injection 10 mg / ml 1ml (E) ml (E)

10 Tablets 10 mg 1 Tablet (E) Tablet (E) (ii) Tramadol Injection 50 mg/ml 1 ml (E) ml (E) Capsule 50 mg 1 Capsule (E) Capsule (E) Capsule (E) Capsule 100 mg (iii) Fentanyl Injection 50µg/ml 1 ml (E) ml ampoule 1ml (E) Medicines used to treat Gout (i) Allopurinol Tablets 100 mg 1 Tablet (E) Tablet (E) (ii) Colchicine Tablets 0.5 mg 1 Tablet (E) Tablet (E) Disease modifying agents used in Rheumatoid disorders (i) Azathioprine Tablets 50 mg 1 Tablet (E) Tablet (E) (ii) Methotrexate Tablets 5mg 1 Tablet (E) Tablet (E) Tablets 7.5mg 1 Tablet (E) Tablet (E) Tablets 10mg 1 Tablet (E) Tablet (E) (iii) Sulfasalazine Tablets 500 mg 1 Tablet (E) Tablet (E) Added medicines (iv) Hydroxychloroquine Tablets 200 mg 1 Tablet (E) Phosphate 1 Tablet (E) (v) Leflunomide Tablets 10mg 1 Tablet (E) Tablet (E) Tablets 20 mg 1 Tablet (E) Tablet (E)

11 Section: 3 - Antiallergics and Medicines used in Anaphylaxis (i) Adrenaline Bitartrate Injection 1 mg / ml 1 ml (E) ml (E) (ii) Chlorpheniramine Maleate Tablets 4 mg 1 Tablet (E) Tablet (E) (iii) Dexchlorpheniramine Syrup 0.5mg /5ml 1 ml (E) Maleate 1 ml (E) (iv) Dexamethasone Tablets 0.5 mg 1 Tablet (E) Tablet (E) Injection 4 mg / ml 1 ml (E) ml (E) (v) Hydrocortisone Sodium Injection 100 mg Each Pack (E) Succinate Each Pack (E) (vi) Pheniramine Maleate Injection mg / ml 1 ml (E) (vii) Prednisolone Tablets 5 mg 1 Tablet (E) Tablet (E) Tablets 10 mg 1 Tablet (E) Tablet (E) Tablets 20 mg 1 Tablet (E) Tablet (E) (viii) Promethazine Tablets 10 mg 1 Tablet (E) Tablet (E) Tablets 25 mg 1 Tablet (E) Tablet (E) Added Medicines (ix) Cetrizine Tablets 10mg 1 Tablet (E) Tablet (E) Syrup 5 mg/ml 1 ml (E) ml (E) Section: 4 - Antidotes and Other Substances used in Poisonings (i) Activated Charcoal Oral : Nonspecific - 5 -

12 4.2: Specific (i) Atropine Sulphate Injection 1 mg/ml (ii) Specific Antisnake venom Injection -- Polyvalent Solution/ Lyophilyzed Polyvalent Serum (iii) Calcium Gluconate Injection 100mg/ml 10ml Ampoule (E) ml Ampoule (E) (iv) Desferrioxamine Mesylate Injection 500mg Each Pack (E) Each Pack (E) (v) Methylthioninium Chloride Injection 10 mg / ml (Methylene Blue) (vi) Penicillamine Tablets or Capsules250 mg 1 Capsule (E) Capsule (E) (vii) Dimercaprol Injection in oil 50 mg / ml (viii) Flumazenil Injection 0.1 mg / ml (ix) Sodium Nitrite Injection 30 mg / ml 1 ml (E) (x) Sodium Thiosulphate Injection 250 mg/ ml (xi) Naloxone Injection 0.4mg/ml 1 ml (E) ml (E) (xii) Pralidoxime Chloride Injection 25 mg/ml (2-PAM) Added medicines: (xiii) N-acetylcysteine Injection 200 mg/ml(5 ml) 1 ml (E) ml (E) Section: 5 - Anticonvulsants/ Antiepileptics (i) Carbamazepine Tablets 100mg 1 Tablet (E) Tablet (E) Tablets 200mg 1 Tablet (E) Tablet (E) Syrup 100 mg/5ml 1 ml (E) (ii) Diazepam Injection 5 mg/ml 1 ml (E) ml (E)

13 (iii) Magnesium sulphate Injection 500 mg /ml 1 ml (E) ml (E) (iv) Phenobarbitone Tablets 30 mg 1 Tablet (E) Tablet (E) Tablet (E) Tablets 60 mg 1 Tablet (E) Tablet (E) Tablet (E) Injection 200 mg/ml 1 ml (E) ml (E) Syrup 20 mg/5ml 1 ml (E) ml (E) (v) Phenytoin Sodium Capsules or 50 mg 1 Tablet (E) Tablets 1 Tablet (E) mg 1 Tablet (E) Tablet (E) Capsule (E) Capsule (E) Syrup 25mg/ml Injection 50 mg/ml 1 ml (E) ml (E) (vi) Sodium Valproate Tablets 200 mg 1 Tablet (E) Tablet E) Tablets 500mg 1 Tablet (E) Tablet (E) Syrup 200 mg/5ml 1 ml (E) ml (E) Injection 100 mg/ml 1 ml (E) ml (E) Added Medicines (vii) Lorazepam Injection 2mg/ml 1ml (E) ml (E)

14 Section: 6 - Anti-infective Medicines 6.1 Anthelminthics Intestinal Anthelminthics (i) Albendazole Tablets 400 mg 1 Tablet (E) Tablet (E) Tablet (E) Suspension 200 mg/ 5 ml 1 ml (E) ml (E) Added Medicines (ii) Piperazine Tablets 4.5 gm Solution 750mg/5ml 1 ml (E) ml (E) Antifilarials (i) Diethylcarbamazine citrate Tablets 50 mg 1 Tablet (E) Tablet (E) Antischistosomals and Antitrematode Medicines (i) Praziquantel Tablets 600 mg 1 Tablet (E) Tablet (E) Antibacterials Beta lactam medicines (i) Amoxicillin Powder for 125 mg / 5 ml 1 ml (E) suspension 1 ml (E) Capsules 250 mg 1 Capsule (E) Capsule (E) Capsules 500 mg 1 Capsule (E) Capsule (E) (ii) Ampicillin Capsules 250 mg 1 Capsule (E) Capsule (E) Capsules 500 mg 1 Capsule (E) Capsule (E) Powder for 125 mg / 5 ml 1 ml (E) suspension 1 ml (E)

15 Injection 500 mg Each Pack (E) Each Pack (E) (iii) Benzathine Benzylpenicillin Injection 6 lacs units 1 Injection (E) ml (E) Injection 12 lacs units 1 Injection (E) ml (E) (iv) Cefotaxime Injection 125 mg Each Pack (E) Injection 250 mg Each Pack (E) Injection 500 mg Each Pack (E) (v) Ceftazidime Injection 250mg Each Pack (E) Each Pack (E) Injection 1gm Each Pack (E) Each Pack (E) (vi) Ceftriaxone Injection 250mg Each Pack (E) Each Pack (E) Injection 1gm Each Pack (E) Each Pack (E) (vii) Cephalexin Syrup 125 mg / 5 ml 1 ml (E) ml (E) Capsules 250 mg 1 Capsule (E) Capsule (E) Capsules 500 mg 1 Capsule (E) Capsule (E) (viii) Cloxacillin Capsules 250 mg 1 Capsule (E) Capsules 500 mg 1 Capsule (E) Injection 250 mg Each Pack (E) Liquid 125mg/ 5 ml Added Medicines (ix) Amoxicillin+Clavulinic acid Tablets 625 mg 1 Tablet (E) Tablet (E) Powder for 228.5mg/5ml 1 ml (E) suspension 1 gm (E)

16 Injection 600mg Each pack (E) Each pack (E) Injection 1.2gm Each pack (E) Each pack (E) (x) Cefixime Tablet 100 mg 1 Tablet (E) Tablet (E) Tablet 200mg 1 Tablet (E) Tablet (E) Other antibacterials (i) Amikacin Injection 250 mg / 2 ml 1 ml (E) ml (E) (ii) Azithromycin Tablets 100mg 1 Tablet (E) Tablet (E) Tablets 250mg 1 Tablet (E) Tablet (E) Tablets 500mg 1 Tablet (E) Tablet (E) Tablet (E) Suspension 100mg/5ml 1 ml (E) ml (E) Injection 500mg Each Pack (E) Each Pack ` 1156(E) (iii) Ciprofloxacin Hydrochloride Injection 200 mg /100 ml 1 ml (E) ml (E) S.O. No. 1784(E) dt withdraw with immediate effect 1823(E) ml (E) Tablets 250 mg 1 Tablet (E) Tablets 500 mg 1 Tablet (E) (iv) Co-Trimoxazole Tablets mg 1 Tablet (E) (Trimethoprim + Sulphamethoxazole) Tablets mg 1 Tablet (E) Tablet (E) Tablet (E) Suspension mg/5 ml 1 ml (E) ml (E)

17 (v) Doxycycline Tablets 100 mg 1 Tablet (E) Tablet (E) (vi) Erythromycin Estolate Syrup 125 mg / 5 ml Tablets Tablets 250 mg 500 mg (v) Gentamicin Injection 10 mg/ml (vi) Metronidazole Tablet 200mg Injection 40 mg/ml 1 ml (E) ml (E) Tablet Injection 400mg 500mg/100ml Syrup 100mg/5ml 1 ml (E) ml (E) (vii) Nitrofurantoin Tablets 100 mg 1 Tablet (E) Tablet (E) (viii) Sulphadiazine Tablets 500 mg 1 Tablet (E) (ix) Vancomycin Hydrochloride Injection 500 mg Each Pack (E) Each Pack (E) Injection 1 gm Each Pack (E) Each Pack (E) Antileprosy medicines (i) Clofazimine Capsules 50 mg 1 Capsule (E) Capsule (E) Capsules 100 mg 1 Capsule (E) Capsule (E) (ii) Dapsone Tablets 50 mg 1 Tablet (E) Tablet (E) Tablets 100mg 1 Tablet (E) Tablet (E) (iii) Rifampicin Capsules or Tablets150 mg 1 Tablet (E) Capsules or Tablets300 mg 1 Tablet (E)

18 6.2.4 Antituberculosis medicines (i) Ethambutol Tablets 200 mg 1 Tablet (E) Tablet (E) (ii) Isoniazid Tablets 50 mg Tablets 400 mg 1 Tablet (E) Tablet (E) Tablets 600 mg 1 Tablet (E) Tablet (E) Tablets 800 mg 1 Tablet (E) Tablet (E) Tablets 100 mg 1 Tablet (E) Tablet (E) Tablets 300 mg 1 Tablet (E) Tablet (E) Syrup 100 mg/5ml 1 ml (E) ml (E) (iii) Ofloxacin Tablets 100 mg 1 Tablet (E) Tablet (E) Tablets 200 mg 1 Tablet (E) Tablet (E) Syrup 50 mg / 5 ml 1 ml (E) ml (E) (iv) Pyrazinamide Tablets 500 mg 1 Tablet (E) Tablet (E) (v) Rifampicin Capsules/Tablets 50 mg Tablets 750 mg 1 Tablet (E) Tablet (E) Tablets 1000 mg 1 Tablet (E) Tablet (E) Tablets 1500 mg 1 Tablet (E) Tablet (E) Capsules/Tablets 150 mg 1 Tablet (E) Capsules/Tablets 300 mg 1 Tablet (E) Capsules/Tablets 450 mg 1 Tablet (E)

19 Syrup 100 mg / 5 ml (vi) Streptomycin Sulphate Injection 0.75 gm Each Pack (E) Each Pack (E) gm Each Pack (E) Each Pack (E) Antifungal medicines (i) Amphotericin B Injection 50 mg Each Pack (E) Each Pack (E) (ii) Clotrimazole Pessaries 100 mg 1 Pessaries (E) Pessaries (E) Pessaries (E) Pessaries 200 mg 1 Pessaries (E) Pessaries (E) Pessaries (E) Gel 2% 1 gm (E) gm (E) (iii) Fluconazole Capsules or 50 mg 1 Capsule (E) Tablets 1 Capsule (E) Tablet (E) Tablet (E) Capsules or 100 mg 1 Capsule (E) Tablets 1 Capsule (E) Tablet (E) Tablet (E) Capsules or 150 mg 1 Capsule (E) Tablets 1 Capsule (E) Tablet (E) Capsules or 200 mg 1 Capsule (E) Tablets 1 Capsule (E) Tablet (E) Tablet (E) (iv) Griseofulvin Capsules or 125 mg 1 Tablet (E) Tablets Capsules or 250 mg 1 Tablet (E) Tablets 1 Tablet (E)

20 (v) Nystatin Tablets 500,000 IU Pessaries 100,000 IU 6.4 Antiviral medicines Antiherpes medicines (i) Acyclovir Tablets 200 mg 1 Tablet (E) Tablet (E) Tablets 400 mg 1 Tablet (E) Tablet (E) Injection 250 mg Each Pack (E) Each Pack (E) Injection 500 mg Each Pack (E) Each Pack (E) Suspension 400 mg / 5 ml 1 ml (E) ml (E) Antiretroviral medicines Nucleoside reverse transcriptase inhibitors (i) Didanosine Tablets 250 mg 1 Tablet (E) Tablet (E) Tablets 400 mg 1 Tablet (E) (ii) Lamivudine Tablets 150 mg 1 Tablet (E) Tablet (E) (iii) Lamivudine + Nevirapine Tablets 150 mg+200 mg 1 Tablet (E) Stavudine + 30 mg 1 Tablet (E) (iv) Lamivudine + Zidovudine Tablets 150 mg+300 mg 1 Tablet (E) Tablet (E) (v) Stavudine Capsules 15 mg (vi) Zidovudine Tablets 100 mg Capsules 30 mg 1 Capsule (E) Capsule (E) Capsules 40 mg 1 Capsule (E) Capsule (E) Tablets 300 mg 1 Tablet (E) Tablet (E)

21 ADDED MEDICINES (vii) Stavudine+Lamivudine Tablets 30mg+150mg 1 Tablet (E) Tablet (E) (viii) Zidovudine+Lamivudine+ Tablets 300mg+150mg+ 1 Tablet (E) Nevirapine 200mg 1 Tablet (E) Non-nucleoside reverse transcriptase inhibitors (i) Efavirenz Capsules 200 mg 1 Capsule (E) Capsule (E) (ii) Nevirapine Capsules 200 mg Capsules 600 mg 1 Capsule (E) Suspension 50 mg / 5 ml 1 ml (E) ml (E) Protease inhibitors (i) Indinavir Capsules 200 mg (ii) Nelfinavir Capsules 250 mg Capsules 400 mg 1 Capsule (E) Capsule (E) (iii) Ritonavir Capsules 100 mg 1 Capsule (E) Capsule (E) Syrup 400 mg / 5ml (iv) Saquinavir Capsules 200 mg 6.5 Antiprotozoal Medicines Antiamoebic and Antigiardiasis medicines (i) Diloxanide Furoate Tablets 500 mg 1 Tablet (E) Tablet (E) (ii) Metronidazole Tablets 200 mg Tablets Injection 400 mg 500 mg /100 ml

22 6.5.2 Antileishmaniasis medicines (i) Amphotericin B Injection 50 mg Each Pack (E) Each Pack (E) (ii) Pentamidine Isothionate Injection 200 mg (iii) Sodium Stibogluconate Injection 100 mg / ml 1 ml (E) ml (E) Antimalarial Medicines For curative treatment (i) Artesunate (To be used Tablets 50 mg 1 Tablet (E) only in combination with 1 Tablet (E) Sulfadoxine + Pyrimethamine) (ii) Chloroquine phosphate Tablets 150 mg base Injection Syrup 40 mg / ml 50 mg / 5 ml (iii) Primaquine Tablets 2.5 mg 1 Tablet (E) Tablet (E) Tablets 7.5 mg 1 Tablet (E) Tablet (E) (iv) Pyrimethamine Tablets 25 mg 1 Tablet (E) (v) Quinine sulphate Tablets 300 mg 1 Tablet (E) Tablet (E) Injection 300 mg / ml 1ml (E) ml (E) (vi) Sulfadoxine + Tablets 500 mg+ 1 Tablet (E) Pyrimethamine 25 mg 1 Tablet (E) Medicines added (vii) Clindamycin Tablet 150mg Tablet 300mg 1 Tablet (E) Tablet (E)

23 For prophylaxis Medicines added (i) Mefloquine Tablet 250 mg base 1 Tablet (E) Tablet (E) Antipneumocystosis and Antitoxoplasmosis medicines (i) Co-Trimoxazole Tablets mg 1 Tablet (E) (Trimethoprim + Sulphamethoxazole) Tablets mg 1 Tablet (E) Tablet (E) Suspension mg/5 ml 1 ml (E) ml (E) (ii) Pentamidine Isothionate Injection 200 mg Section: 7 -Antimigraine medicines 7.1: For treatment of acute attack (i) Acetyl Salicylic Acid Tablets mg (ii) Dihydroergotamine Tablets 1 mg 1 Tablet (E) Tablet (E) (iii) Paracetamol Tablets 500 mg 1 Tablet (E) Tablet (E) : For Prophylaxis (i) Propranolol Hydrochloride Tablets 10 mg 1 Tablet (E) Tablet (E) mg 1Tablet (E) Tablet (E)

24 Section: 8 - Antineoplastic, immunosuppressives and medicines used in palliative care 8.1: Immunosuppressive medicines (i) Azathioprine Tablets 50 mg 1 Tablet (E) Tablet (E) (ii) Cyclosporine Capsules 10 mg Capsules 25 mg 1 Capsule (E) Capsule (E) Capsules 50 mg 1 Capsule (E) Capsule (E) Capsules 100 mg 1 Capsule (E) Capsule (E) Concentrate for 100 mg/ml 1 ml (E) Injection 1 ml (E) : Cytotoxic medicines (i) Actinomycin D Injection 0.5 mg 1 Injection (E) (ii) Alpha Interferon Injection 3 million IU Each Pack (E) Each Pack (E) (iii) Bleomycin Injection 15 mg 1 ml (E) ml (E) (iv) Busulphan Tablets 2 mg 1 Tablet (E) Tablet (E) (v) Cisplatin Injection 10 mg / vial Each Pack (E) Each Pack (E) Injection 50 mg / vial Each Pack (E) Each Pack (E) (vi) Cyclophosphamide Tablets 50 mg 1 Tablet (E) Tablet (E) Tablets 200 mg Injection 500 mg 1 Injectable (E) Injectable (E) (vii) Cytosine arabinoside Injection 100 mg/vial Each Pack (E) Each Pack (E)

25 Injection 500 mg/vial Each Pack (E) Each Pack (E) Injection 1000 mg/vial Each Pack (E) Each Pack (E) (viii) Danazol Capsules 50 mg 1 Capsule (E) Capsule (E) Capsules 100 mg 1 Capsule (E) Capsule (E) (ix) Doxorubicin Injection 10 mg Each Pack (E) Each Pack (E) mg Each Pack (E) Each Pack (E) (x) Etoposide Capsules 100 mg 1 Capsule (E) Capsule (E) Injection 100mg/5ml vial Each Pack (E) Each Pack (E) (xi) Flutamide Tablet 250 mg 1 Tablet (E) Tablet (E) (xii) 5-Fluorouracil Injection 250 mg / 5 ml 1 ml (E) ml (E) (xiii) Folinic Acid Injection 3 mg / ml (xiv) Gemcitabine hydrochloride Injection 200 mg Each Pack (E) Each Pack (E) Injection 1 gm Each Pack (E) Each Pack (E) (xv) L- Asparaginase Injection 5000 KU. Each Pack (E) Each Pack (E) (xvi) Melphalan Tablet 2 mg 1 Tablet (E) Tablet (E) (xvii) Mercaptopurine Tablet 50 mg Tablet 5 mg 1 Tablet (E) Tablet (E) Injection 100 mg / ml (xviii) Methotrexate Tablet 2.5 mg 1 Tablet (E) Tablet (E)

26 Injection 50 mg / ml 1 ml (E) ml (E) (xix) Mitomycin-C Injection 10 mg Each Pack (E) Each Pack (E) (xx) Paclitaxel Injection 30 mg / 5 ml Each Pack (E) Each Pack (E) (xxi) Procarbazine Capsules 50 mg 1 Capsule (E) Capsule (E) (xxii) Vinblastine Sulphate Injection 10 mg Each Pack (E) Each Pack (E) (xxiii) Vincristine Injection 1 mg / ml Each Pack (E) Each Pack (E) Added medicines (xxiv) Carboplatin Injection 150 mg vial Each Pack (E) Each Pack (E) Injection 450 mg vial Each Pack (E) Each Pack (E) (xv) Dacarbazine Injection 500 mg Each Pack (E) Each Pack (E) (xvi) Daunorubicin Injection 20 mg vial Each Pack (E) Each Pack (E) (xvii) Ifosfamide Injection 1 gm/2ml vial Each Pack (E) Corrigendum reg. Ifofsamide 430(E) Injection,1gm/2ml vial Each Pack (E) (xviii) Mesna Injection 200 mg 1 ml (E) ml (E) (xix) Oxaliplatin Injection 50 mg vial 1 Injectable (E) Injectable (E) (xx) Imatinib Tablets 100 mg 1 Tablet (E) Tablet (E) Tablets 400 mg 1 Tablet (E) Tablet (E) (xxi) Chlorambucil Tablets 2 mg 1 Tablet (E) Tablet (E)

27 8.3: Hormones and antihormones (i) Prednisolone Tablets 5 mg 1 Tablet (E) Tablet (E) Injection 20 mg (as 1 ml (E) sodium phosphate or succinate) Injection 25 mg (as sodium phosphate or succinate) (ii) Raloxifene Tablets 60 mg 1 Tablet (E) Tablet (E) (iii) Tamoxifen Citrate Tablets 10 mg 1 Tablet (E) Tablet (E) Tablets 20 mg 1 Tablet (E) Tablet (E) : Medicines used in palliative care (i) Morphine Sulphate Tablets 10 mg 1 Tablet (E) Tablet (E) (ii) Ondansetron Tablets 4 mg 1 Tablet (E) Tablet (E) Tablets 8 mg 1 Tablet (E) Tablet (E) Injection 2 mg/ml 1 ml (E) ml (E) Syrup 2 mg/5 ml 1 ml (E) ml (E) Added Medicines (iii) Filgrastim Injection 1 ml vial (iv) Allopurinol Tablets 100 mg 1 Tablet (E) Tablet (E)

28 Section: 9 -Antiparkinsonism medicines (i) Bromocriptine Mesylate Tablets 1.25 mg 1 Tablet (E) Tablet (E) Tablets 2.5 mg 1 Tablet (E) Tablet (E) (ii) Levodopa+ Carbidopa Tablets 100 mg+10 mg 1 Tablet (E) Tablet (E) Tablets 250 mg+25 mg 1 Tablet (E) Tablet (E) Tablets 100 mg+25 mg 1 Tablet (E) Tablet (E) (iii) Trihexyphenidyl Tablets 2 mg 1 Tablet (E) Hydrochloride 1 Tablet (E) Section: 10 -Medicines affecting the blood 10.1: Antianaemia medicines (i) Cyanocobalamin Injection 1 mg/ml (ii) Ferrous Sulphate/ Fumrate Tablets Tablets equivalent to 60 mg elemental iron Oral solution 25mg elemental iron (as sulphate)/ml (iii) Folic Acid Tablets 1 mg 1 Tablet (E) Tablet (E) Tablets 5mg 1 Tablet (E) Tablet (E) Tablet (E) (iv) Iron Dextran Injection 50mg iron/ml 1 ml (E) ml (E) (v) Pyridoxine Tablets 10 mg 1 Tablet (E)

29 10.2: Medicines affecting coagulation (i) Heparin Sodium Injection 1000 IU/ml 1 ml (E) ml (E) Injection 5000 IU/ ml 1 ml (E) ml (E) ml (E) (ii) Protamine Sulphate Injection 10 mg/ml 1 ml (E) ml (E) (iii) Phytomenadione Injection 10 mg/ml 1 ml (E) ml (E) (iv) Warfarin sodium Tablets 5 mg 1 Tablet (E) Tablet (E) Added Medicines (v) Enoxaparin Injection 40mg Each Pack (E) Each Pack (E) Injection 60mg Each Pack (E) Each Pack (E) Section: 11 -Blood products and Plasma substitutes 11.1: Plasma Substitutes (i) Dextran-40 Injection 10% 1 ml (E) ml (E) (ii) Dextran-70 Injection 6% (iii) Fresh frozen plasma Injection (iv) Hydroxyethyl Starch Injection 6% 1 ml (E) (Hetastarch) 1 ml (E) (v) Polygeline Injection 3.5% 1 ml (E) : Plasma fractions for specific use (i) Albumin Injection 5% Injection 20% 1 ml (E) ml (E)

30 (ii) Cryoprecipitate Injection -- (iii) Factor VIII Concentrate Injection Dried Each Pack (E) Each Pack (E) (iv) Factor IX Complex Injection Dried (Coagulation Factors II,VII, IX, X) (v) Platelet Rich Plasma Injection -- Section: 12 -Cardiovascular medicines 12.1: Antianginal medicines (i) Acetyl salicylic acid Tablets 75mg soluble/ 1 Tablet (E) dispersible 1 Tablet (E) mg soluble/ 1 Tablet (E) dispersible 350mg soluble/ 1 Tablet (E) dispersible (ii) Diltiazem Tablets 30 mg 1 Tablet (E) Tablet (E) Tablets 60 mg 1 Tablet (E) Tablet (E) (iii) Glyceryl Trinitrate Sublingual Tablets 0.5 mg 1 Tablet (E) Tablet (E) Injection 5mg/ml 1ml (E) ml (E) (iv) Isosorbide 5 Mononitrate/ Tablets 10 mg 1 Tablet (E) Tablet (E) Tablets 20 mg 1 Tablet (E) Tablet (E) Isosorbide Dinitrate Tablets 10 mg 1 Tablet (E) Tablet (E) Tablets 20 mg 1 Tablet (E) (v) Metoprolol Tablets 25 mg 1 Tablet (E) Tablet (E) Tablet (E)

31 Added Medicines Tablets 50 mg 1 Tablet (E) Tablet (E) Tablet (E) Injection 1mg/ml 1 ml (E) ml (E) (vi) Clopidogrel Tablets 75 mg 1 Tablet (E) Tablet (E) : Antiarrhythmic medicines (i) Adenosine Injection 3 mg/ml 1 ml (E) ml (E) (ii) Amiodarone Tablets 100 mg 1 Tablet (E) Tablet (E) Tablets 200 mg 1 Tablet (E) Tablet (E) Injection 50mg/ml (3ml 1 ml (E) ampoule) 1 ml (E) (iii) Diltiazem Tablets 30 mg 1 Tablet (E) Tablet (E) Tablets 60 mg 1 Tablet (E) Tablet (E) Injection 5 mg/ ml 1 ml (E) ml (E) (iv) Esmolol Injection 10 mg / ml 1 ml (E) ml (E) (v) LignocaineHydrochloride Injection 1% Each Pack (E) Each Pack (E) (vi) Procainamide Hydrochloride Tablets 250 mg Injection 2% 1 ml (E) ml (E) Injection 100mg/ml (vii) Verapamil Tablets 40 mg 1 Tablet (E) Tablets 80 mg 1 Tablet (E) Injection 2.5mg/ml 1 ml (E)

32 12.3: Antihypertensive medicines (i) Amlodipine Tablets 2.5 mg 1 Tablet (E) Tablet (E) Tablet (E) Tablets 5 mg 1 Tablet (E) Tablet (E) Tablet (E) (ii) Atenolol Tablets 50 mg 1 Tablet (E) Tablet (E) Tablets 100 mg 1 Tablet (E) Tablet (E) (iii) Enalapril Maleate Tablets 2.5 mg 1 Tablet (E) Tablet (E) Tablets 5 mg 1 Tablet (E) Tablet (E) Injection 1.25mg/ml Each Pack (E) (iv) Losartan Potassium Tablets 25 mg 1 Tablet (E) Tablet (E) Tablets 50 mg 1 Tablet (E) Tablet (E) (v) Methyldopa Tablets 250 mg 1 Tablet (E) (vi) Nifedipine Capsules 5 mg 1 Capsule (E) Capsule (E) Capsules 10mg 1 Capsule (E) Capsule (E) Tablets 10mg 1 Tablet (E) Tablet (E) Tablets 20mg 1 Tablet (E) Tablet (E) Sustained Release 10mg 1 Capsule (E) Tablets or Capsules 1 Capsule (E) Sustained Release 10mg 1 Tablet (E) Tablets or Capsules 1 Tablet (E) Sustained Release 20mg 1 Capsule (E) Tablets or Capsules 1 Capsule (E)

33 Sustained Release 20mg 1 Tablet (E) Tablets or Capsules 1 Tablet (E) (v) Sodium Nitroprusside Injection 50 mg/ 5 ml Each Pack (E) Each Pack (E) Added Medicines (vi) Hydrochlorthiazide Tablets 12.5mg 1 Tablet (E) Tablet (E) Tablets 25 mg 1 Tablet (E) Tablet (E) : Medicines used in heart failure (i) Digoxin Tablets 0.25 mg 1 Tablet (E) Tablet (E) Injection 0.25 mg/ml 1 ml (E) ml (E) ml (E) Elixir 0.05 mg/ml (ii) Dobutamine Injection 50 mg / ml (iii) Dopamine Hydrochloride Injection 40 mg / ml Each Pack (E) ml 2536(E) ml (E) : Antithrombotic medicines (i) Acetyl salicylic acid Tablets 75mg soluble/ 1 Tablet (E) dispersible 1 Tablet (E) mg soluble/ 1 Tablet (E) dispersible 350mg soluble/ 1 Tablet (E) dispersible (ii) Heparin Sodium Injection 1000 IU /ml 1 ml (E) ml (E) Injection 5000 IU/ml 1 ml (E) ml (E) ml (E) (iii) Streptokinase Injection 750,000 IU Each Pack (E) Each Pack (E)

34 Injection 15,00,000 IU Each Pack (E) Each Pack (E) (iii) Urokinase Injection 500,000IU/ml Each Pack (E) Each Pack (E) Each Pack (E) Injection 10,00,000IU/ml New Category - ADDED 12.6 Hypolipidemic Medicines (i) Atorvastatin Tablets 5 mg 1 Tablet (E) Tablet (E) Tablets 10 mg 1 Tablet (E) Tablet (E) Tablet (E) Section: 13 -Dermatological medicines (Topical) 13.1: Antifungal medicines (i) Miconazole Ointment or 2% 1gm (E) gm (E) Cream 2% 1gm (E) gm (E) : Antiinfective medicines (i) Acyclovir Cream 5% 1 gm (E) gm (E) (ii) Framycetin Sulphate Cream 0.5% 1gm (E) (iii) Methylrosanilinium Aqueous solution 0.5% Chloride (Gentian Violet) (iv) Neomycin + Ointment 5 mg+ 1 gm (E) Bacitracin 500 IU/gm (v) Povidone Iodine Solution or 5% 1 ml (E) ml (E) Ointment 5% 1gm (E) gm (E) (vi) Silver Sulphadiazine Cream 1% 1 Gm (E)

35 13.3: Antiinflammatory and antipruritic medicines (i) Betamethasone Cream/Ointment 0.05% 1 gm (E) Dipropionate 1 gm (E) (ii) Calamine Lotion -- 1 ml/gm (E) ml / gm (E) ml / gm (E) (i) Zinc Oxide Dusting Powder : Astringent Medicines 13.5: Medicines affecting skin differentiation and proliferation (i) Coal Tar Solution 5% (ii) Dithranol Ointment 0.1-2% (iii) Glycerin Solution -- 1ml (E) ml (E) (iv) Salicylic Acid Solution 5% 13.6: Scabicides and Pediculicides (i) Benzyl Benzoate Lotion 25% 1ml (E) ml (E) Added Medicines (ii) Permethrin Cream 5% 1 gm (E) gm (E) (i) Fluorescein Eye drops 1% (ii) Lignocaine Eye Drops 4% Lotion 1% 1 ml (E) ml (E) Lotion 5% 1 ml (E) ml (E) Section: 14 -Diagnostic agents 14.1: Ophthalmic medicines (iii) Tropicamide Eye drops 1% 1 ml (E) ml (E)