The National Pharmaceutical Pricing Authority (NPPA) has identified certain anomalies and discrepancies in specification or description in the drugs already included in National List of Essential Medicines, 2011 (NLEM) with reference to drugs specified in Indian Pharmacopoeia, National Formulary of India and market data.

The national drug price regulator now proposes rectification in respect of drug formulations already included in NLEM 2011 to comply with the specifications in Indian Pharmacopoeia, National Formulary of India and market data.

According to senior officials, the NPPA had undertaken a detailed study of the drugs already included in the NLEM with a view to ensuring that all life saving and essential drugs of mass consumption are included in the NLEM for safeguarding the public interest in consonance with the directions received from the Department of Pharmaceuticals, vide letter no. 31026/24/2010-PI.I dated 07.08.2014.

Accordingly, the NPPA had carried out consultations with civil society stakeholders, public health experts, state drugs controllers, pharma industry associations and trade associations. In the first part of the study, certain anomalies/discrepancies in specification/description in the NLEM 2011 has been identified with reference to drugs specified in Indian Pharmacopoeia, National Formulary of India and market data which requires rectification.

Officials said that the proposed rectification is considered necessary to comply with the objective of ensuring that all life saving and essential drugs of mass consumption are included in the NLEM for safeguarding the public interest, in respect of drug formulations already included in NLEM 2011.

The NPPA has invited comments from all the stakeholders and industry associations on the NPPA proposal within a period of three weeks.

Some of the NPPA proposals are Propofol injection 1% oil suspension (Strength:‘10mg per ml or 1% w/v'); paracetamol syrup 125 mg /5ml (Strength:‘as per I.P.’Dosage: ‘oral liquids’); tramadol capsule 50mg, 100mg (Dosage:‘ tablet/capsule’); sodium valproate syrup 200 mg/5ml (Dosage:‘oral liquids’); sodium valproate injection 100mg/ml (Strength:‘20mg/ml’); amoxicillin powder for suspension 125mg/5ml (Dosage:‘oral suspension/dry syrup’); ampicillin powder for suspension 125mg/5ml (Dosage:‘oral suspension/dry syrup’); cephalexin syrup 125mg/5ml (Dosage:‘oral suspension/dry syrup’); cloxacillin liquid 125mg/5ml (Dosage:‘oral suspension/dry syrup’);  erythromycin estolate syrup 125 mg/5 ml (Medicine: ‘Erythromycin’ Dosage: ‘oral liquid’); erythromycin estolate tablets 250 mg, 500 mg (Medicine:‘Erythromycin’); metronidazole syrup 100mg/5ml (Strength:‘as per I.P.’Dosage:‘oral liquids’); clotrimazole gel 2% (Strength:‘as per I.P.’Dosage:‘topical preparation’); didanosine tablets 250 mg, 400 mg (Dosage:‘tablet/capsule’); zidovudine tablet 100mg, 300mg (Dosage:‘tablet/capsule’); efavirenz capsules 200 mg,600mg (Dosage:‘tablet/capsule’); nevirapine capsules 200 mg (Dosage:‘tablet/capsule’); nelfinavir capsules 250 mg (Dosage:‘tablet/capsule’); ritonavir capsules 100 mg, (Dosage:‘tablet/capsule’); chloroquine phosphate syrup 50 mg/5 ml (Medicine: ‘chloroquine’ Dosage:‘oral liquid’); clindamycin tablet 150, 300mg (Dosage:‘capsule’ Strength: ‘150mg, 300mg’); danazol capsules 50 mg, 100 mg (Dosage: ‘capsule/tablet’); gemcitabine hydrochloride injection 200 mg, 1gm (Medicine: ‘gemcitabine’); imatinib tablet 100mg, 400mg (Dosage: ‘capsule/tablet’); ferrous sulphate/fumrate tablets equivalent to 60 mg elemental iron (Strength: ‘200mg’ or tablets equivalent to 60 mg/65mg elemental iron);  povidone iodine solution or ointment 5% (Dosage:‘topical preparation’); permethrin lotion 1%, 5% (Dosage:‘topical preparation’); benzoin compound tincture (Strength:‘as per IP’);  aluminium hydroxide +magnesium hydroxide tablet (Medicine : ‘antacid tablets of aluminium +magnesium + methicon salt/MPS salts’ (Strength : ‘need not to mention’); aluminium hydroxide + magnesium hydroxide suspension (Medicine:‘antacid oral syrup/suspension of aluminium + magnesium + methicon salt/MPS salts’ (Strength :‘need not to mention’); miconazole drops 1% (Dosage: ‘drops not available’); miconazole ointment or cream 2% (Dosage: ‘topical preparation’ Strength : 2% w/w); acetazolamide tablets 250 mg (Dosage:‘tablet/capsule’); misoprostol tablets 100ug (Strength :‘200mcg’); potassium chloride injection 11.2% Sol. (Strength:’11.2% w/v’); multivitamins (As per Schedule V of Drugs and Cosmetics Rules) tablets (Dosage:‘tablet/ capsule’); bupivacaine hydrochloride injection 0.25%, 0.5%, 0.5% to be mixed with 7.5% glucose solution (Strength:‘as per IP’); paracetamol injection 150mg/ml (Strength:‘125mg/ml’); lignocaine hydrochloride injection 1-2%,  (Strength:‘1% wiv, 2% wiv’); lignocaine hydrochloride topical forms, 2 - 5 % (Dosage: ‘topical preparation’Strength :2%, 5%); lignocaine hydrochloride+ adrenaline injection 1%, 2% +adrenaline1:200,000 (Strength:‘as per IP’); fentanyl injection 50ug/ml 2ml ampoule (Strength :‘50mg/ml); hydroxychloroquine phosphate tablets 200 mg (Medicine:‘hydroxychloroquine sulphate’); leflunomide tablets 10mg, 20mg tab (Strength:‘10mg, 20mg’); activated charcoal oral (Dosage:‘tablet’); specific antisnake venom injection polyvalent, solution/lyophilyzed, polyvalent serum (Dosage: ‘categorised separately); pralidoxime chloride(2-PAM) injection 25 mg/ml (Medicine:‘pralidoxime chloride’); N-acetylcysteine injection 200mg/ml(5ml) (Strength:‘200mg/ml’);  sodium valproate injection 100 mg/ml (Strength:‘20mg/ml’); piperazine tablet 4.5gm (Strength :‘500mg/Tab’);  amoxicillin+clavulinic acid tablets 625mg (Strength:‘(500mg + 125mg)’); amoxicillin+clavulinic acid powder for suspension 228.5mg/5ml (Dosage:‘oral suspension’ Strength:‘(200mg + 28.5mg)/5ml’); amikacin injection 250 mg/2ml (Strength: ‘250mg/ml’); ciprofloxacin hydrochloride injection 200 mg /100 ml (Medicine:‘ciprofloxin’ Strength : ‘2mg/ml’); metronidazole injection 500mg/100ml (Strength:‘5mg/ml’); amphotericin B injection 50 mg (Strength:‘50mg/ml’); chloroquine phosphate tablets 150 mg base (Medicine : ‘chloroquine’ Strength :‘250mg’); quinine sulphate injection 300 mg / ml (Medicine :‘quinine dihydrochloride’); cyclosporine concentrate for injection 100 mg/ml (Dosage:‘injection’); doxorubicin injection 10 mg, 50mg (Strength:‘2mg/ml’); etoposide injection 100 mg/ 5ml vial (Strength:‘20mg/ml’); filgrastim injection 1 ml vial (Strength :‘300mcg’); ferrous sulphate/fumrate oral solution 25mg elemental iron (as sulphate)/ml (Dosage:‘oral liquid’ Strength: ‘combination with other drug’); sodium nitroprusside injection 50 mg/ 5 ml (Strength : ‘50mg /ml’); acyclovir cream 5% (Dosage: ‘tropical preparation’ Strength :‘5% w/w’); framycetin sulphate cream 0.50% (Dosage:‘tropical preparation’ Strength :‘1% w/w’); methylrosanilinium chloride (gentian violet) aqueous solution 0.50% (Strength:‘5% w/w’); silver sulphadiazine cream 1% (Dosage:‘tropical preparation’ Strength:‘1% w/w’); betamethasone dipropionate cream/ointment 0.05% (Dosage:‘tropical preparation’ Strength:‘0.05% w/w’); calamine lotion (Strength: ‘as per I.P.’); gentian violet paint 0.5%, (Strength:‘5% w/v’); ondansetron syrup 2 mg/ml (Dosage:‘oral liquid’ Strength: ‘2mg / 5ml’); ondansetron injection 2mg/ml (Strength:‘as per I.P.’); ispaghula granules (Dosage:‘powder/ granules’); chloramphenicol drops/ointment 0.4%, 1% (Strength:‘ear drops – 0.4%w/v, 0.5%w/v eye drop – 0.5%w/v ointment – 1%w/w’); ciprofloxacin hydrochloride drops/ointment 0.30% (Medicine ‘ciprofloxacin’ Strength : ‘0.3%w/w’); gentamicin drops 0.30% (Strength: ‘0.3%w/v’); sulphacetamide sodium drops 10%,20% (Strength: ‘10%w/v, 20% w/v’); prednisolone acetate drops 0.10% (Strength :‘1%w/v’); prednisolone sodium phosphate drops 1% (Strength :‘1%w/v’); betaxolol hydrochloride drops 0.25%,0.5% (Strength :‘0.25%w/v,0.5%w/v’); timolol maleate drops 0.25%, 0.5%, (Strength:‘0.25%w/v,0.5%w/v’); homatropine drops 2% (Strength:‘2%w/v’); intraperitoneal dialysis solution 4Of approximate composition (Strength : ‘As per available details’); thiopentone sodium injection 0.5 g, 1 g powder (Strength:‘0.5 g, 1 g’); enalapril maleate injection 1.25mg/ml (Medicine ‘enalaprilat’).