NOTIFICATIONS ISSUED IN PUBLIC-INTEREST (UPTO 10/2/2011) BY CENTRAL GOVERNMENT TO REGULATE, RESTRICT OR PROHIBIT MANUFACTURE, SALE OR DISTRIBUTION OF DRUGS UNDER SECTION 26-A OF DRUGS & COSMETICS ACT, 1940 THROUGH GAZETTE OF INDIA NOTIFICATIONS ISSUED FROM TIME TO TIME BY MINISTRY OF HEALTH & FAMILY WELFARE; NEW DELHI:

• Amidopyrine.
• Fixed dose combinations of Vitamins with Anti-inflammatory Agents and Tranquillisers.
• Fixed dose combinations of Atropine in Analgesics and Antipyretics.
• Fixed dose combinations of Strychnine and Caffeine in tonics.
• Fixed dose combinations of Yohimbine and Strychnine with Testosterone and Vitamins.
• Fixed dose combinations of Iron with Strychnine, Arsenic and Yohimbine.
• Fixed dose combinations of Sodium Bromide / Chloral Hydrate with other drugs.
• Phenacetin.
• Fixed dose combinations of Antihistaminic with Anti-diarrhoeals.
• Fixed dose combinations of Penicillin with Sulphonamides.
• Fixed dose combinations of Vitamins with Analgesics.
• Fixed dose combinations of Tetracycline with Vitamin C.
• Fixed dose combinations of Hydroxyquinoline group of drugs with any other drug except for preparations meant for external use.
• Fixed dose combinations of Corticosteroid with any other drug for internal use except for preparations meant for metered dose inhalers and dry power inhalers.
• Fixed dose combinations of Chloramphenicol with any other drug for internal use.
• Fixed dose combinations of crude Ergot preparations except those containing Ergotamine, Caffeine, Analgesics, Antihistamines for the treatment of migraine, headaches.
• Fixed dose combinations of Vitamins with Anti TB drugs except combination of Isoniazide with Pyridoxine Hydrochloride (Vitamin B6).
• Penicillin Skin / Eye Ointment.
• Tetracycline Liquid Oral preparations.
• Nialamide.
• Practolol.
• Methapyrilene, its salts.
• Methaqualone.
• Oxytetracycline Liquid Oral preparations.
• Demeclocycline Liquid Oral preparations.
• Combination of Anabolic Steroids with other drugs.
• Fixed dose combination of Oestrogen and Progestin (other than oral contraceptive) containing per tablet estrogen content of more than 50 mcg (equivalent to Ethinyl Estradiol) and Progestin content of more than 3 mg (equivalent to Norethisterone Acetate) and all fixed dose combination injectable preparations containing synthetic Oestrogen and Progesterone.
• Fixed dose combination of Sedatives / Hypnotics / Anxiolytics with Analgesics - Antipyretics.
• Fixed dose combination of Rifampicin, Isoniazid and Pyrazinamide, except those which provide daily adult dose given below:

• Fixed dose combination of Histamine H2-receptor antagonists with antacids except for those combinations approved by Drugs Controller, India.
• The patent and proprietary medicines of fixed dose combinations of essential oils with alcohol having percentage higher than 20% proof except preparations given in the Indian Pharmacopoeia.
• All Pharmaceutical preparations containing Chloroform exceeding 0.5% w/w or v/v whichever is appropriate.
• Fixed dose combination of Ethambutol with INH other than the following:

• Fixed dose combination containing more than one Antihistamine.
• Fixed dose combination of Anthelmintic with Cathartic / Purgative except for Piperazine.
• Fixed dose combination of Salbutamol or any other drug having primarily bronchodilatory activity with centrally acting anti-tussive and / or antihistamine.
• Fixed dose combination of Laxatives and / or Anti-spasmodic drugs in Enzyme preparations.
• Fixed dose combination of Metoclopramide with other drugs except combination of metoclopramide with Aspirin / Paracetamol.
• Fixed dose combination of centrally acting, Antitussive with Antihistamine, having high Atropine like activity in expectorants.
• Preparations claiming to combat cough associated with asthma containing centrally acting Antitussive and / or an Antihistamine.
• Liquid oral tonic preparations containing Glycerophosphates and / or other Phosphates and / or central nervous system stimulant and such preparations containing alcohol more than 20% proof.
• Fixed dose combination containing Pectin and / or Kaolin with any drug which is systemically absorbed from GI tract except for combinations of Pectin and / or Kaolin with drugs not systemically absorbed.
• Chloral Hydrate as a drug.
• Dover’s Powder I.P.
• Dover’s Powder Tablets I.P.
• Antidiarrhoeal formulations containing Kaolin or Pectin or Attapulgite or Activated Charcoal.
• Antidiarrhoeal formulations containing Phthalyl Sulphathiazole or Sulphaguanidine or Succinyl Sulphathiazole.
• Antidiarrhoeal formulations containing Neomycin or Streptomycin or Dihydrostreptomycin including their respective salts or esters.
• Liquid Oral Antidiarrhoeals or any other dosage form for Paediatric use containing Diphenoxylate or Loperamide or Atropine or Belladonna including their salts or esters or metabolites Hyoscyamine or their extracts or their alkaloids.
• Liquid Oral Antidiarrhoeals or any other dosage form for Paediatric use containing Halogenated Hydroxyquinolines.
• Fixed dose combination of Antidiarrhoeals with electrolytes.
• Patent and Proprietary Oral Rehydration Salts other than those conforming to the following parameters:-

(a) Patent and Proprietary Oral Rehydration Salts on reconstitution to one litre shall contain:-

• Sodium- 50 to 90 millimoles.
• Total osmolarity- 240-290 millimoles.
• Dextrose: Sodium molar ratio - Not less than 1:1 and not more than 3:1.
  
  (b) Patent and Proprietary cereal based Oral Rehydration Salts on reconstitution to one litre shall contain:-

• Sodium- 50 to 90 millimoles.
• Total osmolarity- Not more than 290 millimoles.
• Precooked rice- Equivalent to not less than 50 gms and not more than 80 gms as total replacement of Dextrose
  
  (c) Patent and Proprietary Oral Rehydration Salts (ORS) may contain aminoacids in addition to Oral Rehydration Salts conforming to the parameters specified above and labelled with the indication for “Adult Choleratic Diarrhoea only.”
  
  (d) Patent and Proprietary Oral Rehydration Salts shall not contain Mono or Polysaccharides or saccharine sweetening agent.

   

  • Fixed dose combination of Oxyphenbutazone or Phenylbutazone with any other drug.
  • Fixed dose combination of Analgin with any other drug.
  • Fixed dose combination of Dextropropoxyphene with any other drug other than Anti-spasmodics and / or non-steriodal Anti-inflammatory drugs (NSAIDS).
  • Fixed dose combination of a drug, standards of which are prescribed in the Second Schedule to the said Act with an Ayurvedic, Siddha or Unani drug.
  • Mepacrine Hydrochloride (Quinacrine and its salts) in any dosage form for use for female sterilization or contraception.
  • Fenfluramine and Dexfenfluramine.
  • Fixed dose combination of Diazepam and Diphenhydramine Hydrochloride.
  • Parenteral preparations containing fixed dose combination of Streptomycin with Pencillins.
  • Fixed dose combination of Vitamin B1, Vitamin B6 and Vitamin B12 for human use.
  • Fixed dose combination of Haemoglobin in any form (natural or synthetic).
  • Fixed dose combination of Pancreatin or Pancrelipase containing Amylase, Protease and Lipase with any other Enzyme.
  • Fixed dose combination of Nitrofurantoin and Trimethoprim.
  • Fixed dose combination of Phenobarbitone with any Anti-asthmatic drugs.
  • Fixed dose combination of Phenobarbitone with Hyoscin and / or Hyoscyamine.
  • Fixed dose combination of Phenobarbitone with Ergotamine and / or Belladona.
  • Fixed dose combination of Haloperidol with any Anti-cholinergic agent including Propantheline Bromide.
  • Fixed dose combination of Nalidixic Acid with any Anti-amoebics including Metronidazole.
  • Fixed dose combination of Loperamide Hydrochloride with Furazolidone.
  • Fixed dose combination of Cyproheptadine with Lysine or Peptone.
  • Astemizole for human use.
  • Terfinadine for human use.
  • Formulations Containing Phenformin for human use.
  • Rofecoxib and its formulations for human use.
  • Valdecoxib and its formulation for human use.
  • Diclofenac and its formulations for animal use.
  • Rimonabant.
  • Rosiglitazone and its formulations for human use.
  • Nimesulide formulations for human use in children below 12 years of age.
  • Cisapride and its formulations for human use.
  • Phenylpropanolamine and formulations for human use.
  • Human Placentral Extract and formulations for human use.
  • Sibutramine and its formulations for human use.
  • R-sibutramine and its formulations for human use.
  • Letrozole for induction of ovulation in anovulation infertility.

NOTIFICATIONS ISSUED IN PUBLIC-INTEREST (UPTO 10/2/2011) BY CENTRAL GOVERNMENT TO REGULATE, RESTRICT OR PROHIBIT MANUFACTURE, SALE OR DISTRIBUTION OF COSMETICS UNDER SECTION 26-A OF DRUGS & COSMETICS ACT, 1940 THROUGH GAZETTE OF INDIA NOTIFICATIONS ISSUED FROM TIME TO TIME BY MINISTRY OF HEALTH & FAMILY WELFARE; NEW DELHI:

• All Cosmetics Licensed as toothpastes / tooth powders containing tobacco.