156 Drugs Banned In India List PDF Free Download

156 Drugs Banned In India List PDF Download Info

The Health Ministry Had Banned 156 Fdc Drugs Over Concerns Related To Safety. Among The Combinations Are Popular Antibiotics, Painkillers, And Multivitamins. The Ban Aims At Public Safety By Removing From Circulation Unsafe Drug Combinations.

156 Drugs Banned In India List PDF Free Download

The Health Ministry Has Banned 156 Fixed-dose Combination Drugs That Include The Most Consumed Antibiotics, Pain Relief Drugs, And Multivitamins. The Ministry Of Health Reported That The Date In A Gazette Dated 21st August Had Notified That Manufacturing, Advertisement, And Selling Of These Drugs Are Now Prohibited As They Pose Health Hazard.

It Has Cautioned Against The Fixed Combinations Treatment Of Fever And Hypertension, Antibiotics, Anti-allergic Drugs, Analgesics, And Antipyretics Other Than The Use Of Multivitamins.

FDC Drugs: What Are They?

Cocktails On A General Basis Refer To Those Drugs That Are Inclusive Of Two Or More Active Pharmaceutical Ingredients Combined At A Fixed Dose. Aceclofenac 50mg + Paracetamol 125mg Tablet Is Used Regularly As An Analgesic That The Union Health Ministry Has Declared Banned Through A Notification In The Official Gazette On The 12th Of This Month.

The Other Combination Products In The List Include Levocetirizine + Phenylephrine Hcl + Paracetamol, Mefenamic Acid + Paracetamol Injection, Cetirizine Hcl + Paracetamol + Phenylephrine Hcl, Paracetamol + Chlorpheniramine Maleate + Phenyl Propanolamine, And Camylofin Dihydrochloride 25 Mg + Paracetamol 300 Mg.

Caffeine Should Not Be Taken Together With Taurine, Tramadol, And Paracetamol.

Moreover, It Has Proscribed A Mix Of Paracetamol, Tramadol, Taurine, And Caffeine. This Prohibited Mixture Contains Within Its Structure An Opioid-based Analgesic, Tramadol.

It Added, “The Central Government Is Satisfied That The Safety Of The Patients Is Likely To Be Affected By The Said Fixed Dose Combination Drug While There Are Other Safe And Effective Alternatives Available.”. A Centre-appointed Expert Committee Gave The Opinion That These Fdcs, After Due Deliberation, Were Irrational. “The Fdc May Involve Risk To Human Beings,” It Said And Added, “Therefore, Under Section 26 A Of The Drugs And Cosmetics Act 1940, It Is Required To Ban The Manufacturing, Sale Or Distribution Of This Fdc In The Greater Public Interest.”

It Was Quoted That The Dtab Recommended: “The Central Government Is Satisfied That It Is Necessary And Expedient In Public Interest To Prohibit The Manufacture, Sale, And Distribution For Human Use Of The Said Drug In The Country”.

The Indian Government Has Banned 156 Fdc Drugs, Which Include Antibiotics, Analgesics, Multivitamins, The Cure For Fever, And Hypertension.

This Is A Giant Step Towards Safeguarding Public Health. It Has Been Considered To Be The Most Significant Blow Since 344 Kinds Of Such Drugs Were Scissored Out Of The Indian Markets In 2016. A Gazette Notification Of The Union Ministry Of Health And Family Welfare On Thursday Buzzed The Prohibition To Manufacture, Distribute, And Sell These Banned Fdcs.

A Panel Of Experts, Tasked With Evaluating A Total Of 324 Fdcs, Provided Recommendations That Collectively Concluded The Ban.

Effect In The Pharmaceutical Industry.

Such Routinely Used Restricted Combinations Include The Injection Combination Of Mefenamic Acid And Paracetamol, Used For Fever And Pain Management, And The Combination Of Omeprazole Magnesium With Dicyclomine Hcl To Relieve Stomach Discomfort. According To The Notification, This Restriction Is Going To Hit Sales Of Leading Drugmakers Like Sun Pharmaceuticals, Cipla, Dr. Reddy’s Laboratories, Torrent Pharmaceuticals, And Alkem Laboratories.

This Includes A Total Of 156 Fixed Dosage Combination (Fdc) Drugs To Include Antibiotics, Multivitamins, And Analgesics. The Gazette Notification Dated August 21 Says The Health Ministry Has Prohibited Their Manufacture, Marketing, And Distribution In The Country And Declared Them Unsafe.

It Added That Restricted Fdcs Include, Among Others, Antibiotics, Anti-allergic Drugs, Analgesics, Multivitamins, And Combination Doses For Fever And Hypertension.

The Recommendations Were Based On The Advice Received From Dtab And A Specialized Panel Set Up At The Federal Level.

“.the Central Government Is Satisfied That There Are Safer Alternatives To The Said Drug And That Using The Drug Fixed Dose Combination (Hereinafter To Be Referred To As Fdc) Of Amylase + Protease + Glucoamylase + Pectinase + Alpha Galactosidase + Lactase + Beta- Gluconase + Cellulase + Lipase + Bromelain + Xylanase + Hemicellulase + Malt Diastase + Invertase + Papain Is Likely To Involve Risk To Human Beings.” The Statement Went On To Say That The Matter Had Been Reviewed By An Expert Committee, Constituted By The Central Government, Which “Observed That The Said Expert Committee Had Held This Fdc As Irrational.”

The Drug Technical Advisory Board On The Above Fdc That Has Been Looked Into Found That “There Is No Therapeutic Justification For The Ingredients Included In This Fdc.” The Said Fdc Can Be Dangerous To Humans.

Therefore, Manufacture For Sale, Or For Distribution, Of The Said Fdc Needs To Be Prohibited In A Larger Public Interest Under Section 26 A Of The Drugs And Cosmetics Act, 1940. As Discussed Above, It Would Not Be Acceptable To Put Such Implementation Regarding Regulations Or Limits While Allowing Its Usage In Patients.

Therefore, Recommended For Prohibition Only Under Section 26a. Some Of The Principal Fdc Drugs Include A Dicyclomine Hcl And Omeprazole Magnesium That Reduce Abdominal Distress, And An Injection Of Mefenamic Acid Along With Paracetamol For Reduction Of Pain And Swelling Across A Series Of Disorders.

Fdcs ; Other Examples Are Ursodeoxycholic Acid With Metformin Hcl In Management Of Fatty Liver In Diabetics And Povidone Iodine With Metronidazole And Aloe In The Prevention And Cure Of Skin Infections. ‘the Dtab Did Not Find The Claims Of These Combination Medicines Right And Took The Decision Considering That The Harm To The Patient Is More Than The Benefit’, Said The Gazette Notice Of The Decision.

‘”Therefore, Under Section 26a Of The Drugs And Cosmetics Act 1940, It Is Necessary To Prohibit The Manufacture, Sale Or Distribution Of This Fdc In The Larger Public Interest,” It Said.’. The Banned List Of 156 Substances Includes Paracetamol And Mucus-dissolving Syrups And Popular Mixtures Of Antihistamines And Nasal Decongestants. Combinations Of Antibiotics, Iodine Solutions, And Acne Creams Also Figure In The List. 

Some Of The Banned Combinations Include A Migraine Treatment And An Antiemetic, The Combination Of The Supplements Menthol With Aloe Vera; Silver Sulfadiazine For Burns, Along With An Antiseptic, Aloe Extract, And A Vitamin. An Indian Express Story Wrote That This Was The Biggest Crackdown On Fdcs Ever Since The Government Banned 344 Drugs In 2016, Which The Pharma Manufacturers Had Then Challenged.

Following The Court Directive, The Government Again Sent The Matter To The Drugs Technical Advisory Board, Which Too Came To Hold That 328 Were “Irrational” And Should Be Banned. Acting On This Recommendation Of The Drugs Technical Advisory Board, The Government, In 2018, Banned All 328 Combinations. Fifteen Fdcs Manufactured Before 1988 Were Claimed To Be Exempt From The Ban.

On This, Sudarshan Jain, Secretary General Of The Indian Pharmaceutical Alliance, Reacted To Financial Express.com By Saying, “Fdc Is Something That Kokate And Nilima Kshirsagar Committees Have Recommended Be Discussed For Quite Some Time. “All Things Considered, And This Is The Right Step In The Interest Of The Patients”.