BANNED DRUG IN INDIA

Soumyakanti Maity

Student

Bengal School Of Technology

   (A College Of Pharmacy)

INTRODUCTION

The drugs are strictly tested before being brought to market. These are first tested in animals and later in humans during clinical trials. The safety profiles of the drugs as well as the safety profiles are examined. Nevertheless, the drug has some adverse effects on the general public after drug use. This adverse effect is known as a system of regular monitoring after exposure to pharmacovigilance after exposure to the drug. If adverse effects are severe or the risks of drug use outweigh the benefits or if the drug is ineffective, the country may ban the drug or the drug company may voluntarily withdraw the drug. Some drugs may have adverse effects only when combined with the drug. In this case, only certain dose combinations are prohibited and not individual drugs. In India, the combination of multiple drugs, as well as certain quantities, is prohibited for production, marketing and distribution. In many other countries, most of the cheaper drugs that are banned, withdrawn or marketed under the ban continue to be sold in India. Pharmaceutical companies and gamers are playing with the lives of thousands of people who are unaware of the harmful effects of selling their drugs.

"There are over 60,000 brand formulations available in India. These preparations include single drug or fixed dose combination (FDC) all formulations are used to treat or prevent disease." The safety of combination drugs needs to be thoroughly evaluated, and there are considerations for drugs that are already in the market as a drug or an individual or a single drug entity. However, the safety profiles of the established drugs will change as they come together. Of the total drugs listed in the WHO's 14th list of essential drugs, 312, including a combination of 18 specific doses. However, many absurd combinations are popular and widely prescribed by physicians in our country.

Process of banning:

Executive committee examines harmful effects of the drug
⇩
The results are reported to the drugs technical advisory board

⇩
The government issues the ban order

⇩
DCGI notifies all state drug authorities
⇩
Authorities are instructed to carry out inspections

LIST OF DRUGS BANNED IN INDIA:

    A.   Single drug preparations (or combinations of ):

Ø  Amidopyrine

Ø  Phenacetin

Ø  Nialamide

Ø  Methaqualone

Ø  Methapyriline (and it’s salt)

Ø  Practolol

Ø  Penicillin skin/eye ointment

Ø  Tetracycline/Oxytetracyline/Demeclocycline liquid oral preparations.

Ø  Chloral hydrate

Ø  Fenfluramine

Ø  Dexfenfluramine

Ø  Terfenadine

Ø  Astemizole

Ø  Phenformin

Ø  Rofecoxib

Ø  Valdecoxib

Ø  Rosiglitazone

Ø  Nimesulide formulations in children below the age of 12 years.

Ø  Cisapride

Ø  Rimonabant

Ø  Phenyl Propanolamine

 A.   Fixed dose combination with any other drug:

Ø      Corticosteroids with any other drug for internal use.

Ø      Chloramphenicol with any other drug for internal use.

Ø      Sodium bromide/chloral hydrate with other drugs.

Ø     Ergot with any drug except preparations containing ergotamine, caffeine, analgesics, antihistamines for treatment of migraine.

Ø     Anabolic steroids with other drugs.

Ø     Metoclopramide with other drugs (except with aspirin/paracetamol).

Ø     Pectin and/or kaolin with any drug which is systematically absorbed

from G.I. tract, except for combination of pectin and/or kaolin with drugs not systematically absorbed.

Ø     Hydroxyquinolines with any other drug except in preparations for external use.

Ø     Oxyphenbutazone or phenylbutazone with any other drug.

Ø     Dextropropoxyphene with any other drug except antispasmodics and/or NSAIDs.

Ø     Analgin (metamizol) with any other drug.

Fixed dose drug combinations of:

Ø     Penicillin’s with Sulphonamides

Ø     Tetracycline with Vitamin C

Ø     Ant tubercular drugs with Vitamins (except Isoniazid with Pyridoxine HCl).

Ø     Vitamins with Analgesics/Anti-inflammatory drugs.

Ø     Vitamins with Tranquillizers.

Ø     Atropine and Analgesic-antipyretics.

Ø     Yohimbine and Strychnine with Testosterone and Vitamins.

Ø     Strychnine and Caffeine in tonics.

Ø     Iron with Strychnine, Arsenic and Yohimbine.

Ø     Antihistaminic with Antidiarrheal.

Ø     More than one Antihistamine in the same preparation.

Ø     Sedatives/Hypnotics/Anxiolytics with Analgesic-antipyretics.

Ø  H2 receptor antagonists with Antacids (except those combinations approved by Drugs Controller, India).

Ø     Anthelmintic (except Piperazine) with a Cathartic/Purgative.

Ø     Salbutamol (or any other bronchodilator) with centrally acting Antitussive and/or an Antihistamine.

Ø     Centrally acting Antitussives with Antihistamines having atropine like activity in expectorants.

Ø     Centrally acting Antitussive and/or Antihistamine in preparations for cough associated with asthma.

Ø     Laxative and/or antispasmodic drugs in enzyme preparations.

Ø     Glycerophosphates and/or other phosphates and/or CNS stimulant in liquid oral tonics.

Ø     Estrogenic and Progestin (other than oral contraceptives) containing per tablet Estrogen more than 50 ug ethinylestradiol (or equivalent) and progestin more than 3 mg of norethisterone acetate (or equivalent) and, all fixed dose combination injectable preparations containing synthetic estrogen and progesterone.

Ø     Ethambutol with Isoniazid, except in the following daily doses:
Isoniazid 200 mg + Ethambutol 600 mg or
Isoniaizd 300 mg + Ethambutol 800 mg

Ø    Pyrazinamide with other antitubercular drugs, except that which provide the following daily doses.

Ø    Essential oils with Alcohol having percentage higher than 20% proof (except preparations given in the I.P.).

Ø     Liquid oral tonic preparations containing alcohol more than 20% proof.

List of Drugs Prohibited for Manufacture and Sale through Gazette Notifications under Section 26a of Drugs & Cosmetics act 1940 by the Ministry of Health and Family Welfare Drugs Prohibited from the date of Notification:

Ø     Amidopyrine.

Ø     Fixed dose combinations of vitamins with anti–inflammatory agents and tranquilizers.

Ø     Fixed dose combinations of Atropine in Analgesics and Antipyretics.

Ø     Fixed dose combinations of Strychnine and Caffeine in tonics.

Ø     Fixed dose combinations of Yohimbine and Strychnine with Testosterone and Vitamins.

Ø     Fixed dose combinations of Iron with Strychnine, Arsenic and Yohimbine.

Ø     Fixed dose combinations of Sodium Bromide/chloral hydrate with other drugs.

Ø     Phenacetin.

Ø     Fixed dose combinations of antihistaminic with anti-diarrhoeal.

Ø     Fixed dose combination of Sedatives/ hypnotics/anxiolytics with analgesics-antipyretics.

Ø     Fixed dose combination of Rifampicin, isoniazid and Pyrazinamide, except those which provide daily adult dose given below:

Drugs	Minimum	Maximum
Rifampicin	450 mg	600 mg
Isoniazid	300 mg	400 mg
Pyrazinamide	1000mg	1500 mg

Drugs Prohibited for Manufacture, Sale and Distribution from Subsequent Date:

Drugs Formulation	Effective date	Notification
1. Cosmetics Licensed as toothpaste/tooth powder containing tobacco.	With immediate effect	GSR 444(E) dt.30.4.92
2.Parenteal Preparations fixed dose combination of streptomycin with Penicillin	Jan 1,1998	GSR 93(E) dt.25.2.97
3.Fixed dose combination of Vitamin B1, Vitamin B6 and Vitamin B12 for human use	Jan 1,2001	GSR 702(E) dt.14.10.99
4.Fixed dose combination of          haemoglobin in any form              (natural or synthetic).	Sep 1,2000	GSR 814(E) dt.16.12.99
5. Fixed dose combination of Pancreatin or Pancrelipase containing amylase, protease and lipase with any other enzyme.	Sept. 1,2000	GSR 814(E) dt.16.12.99
6. Fixed dose combination of Nitrofurantoin and trimethoprim.	Jan 1,2002	GSR 170(E) dt.12.3.01
7. Fixed dose combination of Phenobarbitone with any anti-asthmatic drugs.	Jan 1,2002	GRS 170(E) dt.12.3.01
8.Fixed dose combination of Phenobarbitone with Hyoscin and/or Hyoscyamine	Jan 1,2002	GSR 170(E) dt.12.3.01
9.Fixed dose combination of Phenobarbitone with Ergotamine and/or Belladona	Jan 1,2002	GSR 170(E) dt.12.3.01
10. Fixed dose combination of Haloperidol with any anti-cholinergic agent including Propantheline Bromide.	Jan 1,2002	GSR 170(E) dt.12.3.01
11. Fixed dose combination of Nalidixic Acid with any anti-amoebic including Metronidazole.	Jan 1,2002	GSR 170(E) dt.12.3.01
12. Fixed dose combination of Loperamide Hydrochloride with Furazolidone	Jan 1,2002	GSR 170(E) dt.12.3.01
13. Fixed dose combination of Cyproheptadine with Lysine or Peptone.	Jan 1,2003	GSR 170(E) dt.12.3.01
14.Astemizole	Apr.1,2003	GSR 191(E) dt.5.3.03
15.Terfinadine	Apr.1,2003	GSR 191(E) dt.5.3.03
17.Rafecoxib	Dec 13,2004	GSR 810(E) dt.01/10/03

REASON FOR BAN:

Generic name	Use	Reason for ban	Brand names(s)
1. Analgin	Pain-killer	Bone-marrow depression	Novalgin, Baralgan
2. Cisapride	Acidity, constipation	Irregular heart beat	Ciza, Syspride
3. Droperidol	Anti-depressant	Irregular heart beat	Droperol
4. Furazolidone	Anti-diarrhoeal	Cancer	Furoxone, Lomofen*
5. Nimesulide	Pain-killer, fever	Liver failure	Nise, Nimulid
6. Nitrofurazone	Anti-bacterial cream	Cancer	Furacin, Emfurazone,
7. Phenolphthalein	Laxative	Cancer	Jetomisol-P
8.Phenylpropanolamine	Cold & cough	Stroke	D'Cold*, Vicks Action 500*
9. Oxyphenbutazone	NSAID	Bone marrow depression	Sioril
10. Piperazine	Anti-worms	Nerve damage	Piperazine, Helmazan*
11. Quiniodochlor	Anti-diarrhoeal	Damage to sight	Enteroquinol

REGULATIONS & GUIDELINES:

Process of banning drug in India is done by DTAB (Drug technical advisory board) which is the final authority on imposing a ban. Drug controller general of India notifies all state drug authorities and manufacturer about ban on the drug.

At IPA we understand the problems faced by pharma professionals in accessing requisite information in order to comply with the regulatory requirements at home and in the regulated foreign markets. We’ve tried to simplify things for you by assembling the important Indian and international guidelines and regulations in this section.

Indian Regulations & Guidelines:

CDSCO	Central Drugs Standard Control Organization (CDSCO), Ministry of Health & Family Welfare, Government of India provides general information about drug regulatory requirements in India.
NPPA	Drugs (Price Control) Order 1995and other orders enforced by National Pharmaceutical Pricing Authority (NPPA), Government of India. View the list of drugs under price control here.....
D & C Act, 1940	The Drugs & Cosmetics Act, 1940 regulates the import, manufacture, distribution and sale of drugs in India.
Schedule M	Schedule M of the D&C Act specifies the general and specific requirements for factory premises and materials, plant and equipment and minimum recommended areas for basic installation for certain categories of drugs.
Schedule T	Schedule T of the D&C Act prescribes GMP specifications for manufacture of Ayurvedic, Siddha and Unani medicines.
Schedule Y	The clinical trials legislative requirements are guided by specifications of Schedule Y of The D&C Act.
GCP guidelines	The Ministry of Health, along with Drugs Controller General of India (DCGI) and Indian Council for Medical Research (ICMR) has come out with draft guidelines for research in human subjects. These GCP guidelines are essentially based on Declaration of Helsinki, WHO guidelines and ICH requirements for good clinical practice.
The Pharmacy Act,1948	The Pharmacy Act, 1948is meant to regulate the profession of Pharmacy in India.
Links to important international guidelines and regulatory bodies:
WHO (Medicines)	WHO guidelines on medicines policy, intellectual property rights, financing & supply management, quality & safety, selection & rational use of medicines, technical co-operation and traditional medicines.
WHO sites	WHO guidelines on all areas relevant to health of people all over.
ICH	International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH)guidelines defining quality, safety, efficacy & related aspects for developing and registering new medicinal products in Europe, Japan and the United States
OECD	Organization for Economic Collaboration and Development including 30 member countries covers economic and social issues in areas of health care.
EMEA	European Medicines Agency (EMEA),a decentralized body of the European Union headquartered in London, prescribes guidelines for inspections and general reporting and all aspects of human & veterinary medicines in the European Union.
US FDA	Regulations, guidelines, notifications, news and communications from US Food and Drug Administration.
TGA	Specifications regulating medicines, medical devices, blood, tissues & chemicals, issued by Therapeutic Goods Administration, the Australian regulatory body.
South Africa	The department of Health, South Africa.
WTO	News, resources, documents and publications of the World Trade Organization (WTO), the global international organization dealing with the rules of trade between nations.
Codex Alimentarius	Collection of international food standards and guidelines for processed, semi–processed and raw foods, adopted by the Codex Alimentarius Commission under the Joint FAO / WHO Food Standards Programme.
MHRA	News, warnings, information and publications of Medicines and Healthcare products Regulatory Agency (MHRA), responsible for ensuring efficacy and safety of medicines and medical devices in the UK.
	Advisories, warnings, recalls, reports, publications, activities, legislations and guidelines from Health Canada, the Federal Department responsible for health related issues in Canada.
Thai FDA	Thai Food and Drug Administration laws and regulations with respect to drugs, food, cosmetics and narcotics.
HSA, Singapore	Health Sciences Authority (HSA), the regulatory body of Singapore.
DOH, Philippines	The Department of Health, Philippines.
Medsafe,  New Zealand	Medsafe, New Zealand Medicines and Medical Devices Safety Authority.
NPCB, Malaysia	Regulatory information, news and publications of National Pharmaceutical Control Bureau, Malaysia.
DGMP, Belgium	Guidelines and useful information to ensure safety, efficacy and quality of medicines, issued by Directorate-General Medicinal Products, Belgium.
BfArM, Germany	Licensing and registration guidelines for medicinal products laid down by Federal Institute for Drugs and Medical Devices, Germany
Swiss Medic	Swiss regulatory agency for therapeutic products.
MPA, Sweden	Regulatory and surveillance guidelines issued by Medical Products Agency, Sew

 

 

 

Popular drug ranitidine recalled after carcinogenic qualities confirmed:

The drug has been found to have levels of a carcinogen above what the US FDA prescribes 
United States (US) pharma major, Sandoz Inc issued a ‘voluntary recall’ of popular drug ranitidine on September 23, 2019, after confirmation that it had a carcinogenic substance in it. 
“Sandoz Inc is voluntarily recalling all quantities and lots within expiry, of Ranitidine Hydrochloride capsules in the US to the consumer level because of confirmed contamination with N-Nitrosodimethylamine (NDMA) above levels established by the Food and Drug Administration (FDA) in batches of Sandoz Ranitidine Hydrochloride capsules,” the voluntary recall notice read. 
Sandoz has withdrawn 14 batches of the drugs which it manufactured in 2017 and 2018 and which were set to expire in 2020 and 2021. 

According to the FDA, NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.
“Sandoz will be notifying its distributors and customers via overnight mail and via the Sandoz website, and will arrange for return of all recalled products,” the notice said.
“Wholesalers (direct customers) will be asked to immediately stop distribution and return any stock to Sandoz, and contact the retail pharmacies in their group to do the same. Pharmacies will be asked to immediately stop dispensing Sandoz Ranitidine Hydrochloride capsules and return remaining stock to Sandoz by contacting Stericycle to request a recall packet,” it added.
Ranitidine is a prescription drug but is also sold over the counter (OTC). As an OTC drug, it is used to decrease the volume of acid produced in the stomach. It is also used to prevent and relieve heartburn associated with acid ingestion and sour stomach.
As a prescription drug, it has multiple uses, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease or GERD.
On September 13, the US FDA had first said it was looking into possible contamination of ranitidine with NDMA. On September 23, the federal agency issued another alert, stating it was testing ranitidine products from multiple manufacturers.
It said although NDMA might cause harm in large amounts, the levels the FDA was finding in ranitidine from preliminary tests, barely exceeded amounts one might expect to find in common foods.
“The FDA is evaluating whether the low levels of NDMA in ranitidine pose a risk to patients. FDA will post that information when it is available,” the statement said.  
It also clarified that it was not calling for individuals to stop taking ranitidine at this time; however, patients taking prescription ranitidine who wish to discontinue use should talk to their health care professional about other treatment options.
“People taking OTC ranitidine could consider using other OTC medicines approved for their condition. There are multiple drugs on the market that are approved for the same or similar uses as ranitidine,” the FDA alert said. 

Ranitidine is safe:

In a controversial debate over the commonly used heartburn drug Ranitidine, Steroids pharmaceutical science today said the drug is safe. The company said that the results of tests provided by the US Food and Drug Authority (FDA) showed that ranitidine tablets of steroids were within the “acceptable limit” for the presence of 300 mg of potential cancer-causing substances.

Following this report, the company is likely to restart the sale of drugs. The statement said, "The Company intends to provide additional updates in the coming days, including possible reassessments.

The Bengaluru-based company last month halted the production and sale of drugs after it was exposed to cancer-related impurity called N-nitrosodimethylanine (NDMA).

U.S. and E.U. regulators say they are investigating the discovery of carcinogen NDMA through branded and generic Xantac. The U.S. drug regulator lowered the risk of contamination and said its tests showed it did not cause carcinogen.

Janet Woodcock, director of the FDA's Centre for Drug Evaluation and Research, said in a statement that the sale of the Zantac brand - the levels of potential carcinogen N-nitrosodimethylamine (NDMA) found on ranitidine are similar to your level if you eat simple foods like grilled or smoked meat. Would expect

Why Nimesulide is banned?

The continuing use of nimesulide for Indian children is shocking. Numerous studies have established the life threatening hepatotoxic effects of nimesulide. Nimesulide is not used in the United States, and many European countries have also banned the drug because of its unacceptable rate of serious adverse reactions.
Although some studies have indicated that nimesulide may be chosen for osteoarthritis in selected patients with associated gastric problems, other non-steroidal anti-inflammatory drugs such as acetaminophen (paracetamol) are far better choices as antipyretics or analgesics, especially for children. No rationale exists for selecting nimesulide as the first drug of choice for fever or pain. Published studies from India indicate rampant abuse of nimesulide.⁵ At least 12 paediatric preparations of nimesulide are available in India, which affirms the widespread use of the drug in children.

Hardly any dependable post-marketing surveillance for adverse drug reactions is undertaken in India. Moreover, unlike in the West, Indian doctors are not under any real supervision and therefore do not necessarily keep up with the rapidly changing information about adverse effects. Patients receiving nimesulide should be closely monitored for evolving hepatic failure. Indian patients may not follow necessary guidelines, for simple economic reasons. Even if the Indian drug control agencies are reluctant to impose a total ban on nimesulide, they should immediately forbid its use for treatment of fever or pain.
A plethora of scientific data show that nimesulide should not be used as the primary mode of treatment as an antipyretic or analgesic, especially in children, for whom much better and safer choices are available. It will be unfortunate if the Indian government waits for another “committee” report before stopping the use of nimesulide, even for the treatment of pain or fever, and lets more innocent patients suffer needlessly.

Why Cisapride is banned?

Cisapride is a gastroprokinetic agent, a drug that increases motility in the upper gastrointestinal tract. It acts directly as a serotonin 5-HT₄ receptor agonist and indirectly as a Para sympathomimetic. Stimulation of the serotonin receptors increases acetylcholine release in the enteric nervous system. It has been sold under the trade names Prepulsid (Janssen-Ortho) and Propulsid (in the United States). It was discovered by Janssen Pharmaceutica in 1980. In many countries, it has been either withdrawn from the market or had its indications limited due to incidences of serious cardiac side-effects.
The commercial preparations of this drug are the racemic mixture of both enantiomers of the compound. The positive enantiomer itself has the major pharmacologic effects and does not induce many of the detrimental side-effects of the mixture.

Medical use of Cisapride:

Cisapride has been used for the treatment of gastroesophageal reflux disease (GERD). There is no evidence it is effective for this use in children. It also increases gastric emptying in people with diabetic gastroparesis. Evidence for its use in constipation is not clear.
In many countries, it has been either withdrawn or had its indications limited because of reports of the side-effect long QT syndrome, which may cause arrhythmias. The U.S. Food and Drug Administration (FDA) issued a warning letter to doctors and cisapride was voluntarily removed from the U.S. market on July 14, 2000. Its use in Europe has also been limited. It was banned in India and in the Philippines in 2011.

Why, ban drug are available?

India has become a dumping ground for banned drugs. The prohibited drug manufacturing business is booming and because there are more customers and all illegality is properly obeyed. The irony is that very few people know about the banned drugs and consume them unknowingly, causing them much harm in themselves. The issue is serious and we must not delay in warning messages to criminals and innocent people.
As a big-time business venture and a short-term entrepreneur, drugs are on the rise. There are certain provisions for proper checks and control of counterfeit drugs in Indian markets. What’s worse is the little sense of buyers and the slapdash attitude. Even at this time, a large population accepts drugs and drugs without a doctor's instructions, which can in fact be a very wrong decision and dangerous.
Thanks to the "non-existent" adverse drug response system in India, analogue, cisapride, nimsulide and piperazine are among the best-selling drugs in the world, due to severe side effects. According to a report by the World Health Organization, the single cause of adverse drug reactions has not yet been found in any country. The business of producing these discarded drugs in India is evolving. The most common ones are Nice (Dr.Reddys), Nimulid (Panacea Biotech) which has been cancelled for liver damage, while Vix Action 500 from Procter & Gumball's stable has been cancelled to increase the likelihood of brain bleeding. Anti-depressant drug drugprol (Troyer Sponsored) was terminated for irregular heart rate in patients. Anti-diarrheal drug furoxone (from Glaxo's house) was withdrawn from the market after reports of cancer in some patients who were given the drug. Eleven drugs - banned, withdrawn or marketed in North America, Europe, and many Asian countries - continue to be sold in India, including eleven drugs - cisapride, furzolidone, nimsulide and phenylpropanamine.
India's contribution to the worldwide collection of data on the side effects of different drugs is dismal. Countries like Ireland, Switzerland and Italy with a population of about 4 million, 33 million and 57 million, respectively had submitted 25, 33 and 225 adverse drug reaction on nimesulide. However, India, with over 1 billion population did not report any. Another drug Sildenafil (erectile dysfunction drug) had 18 adverse drug reactions reported from Australia but none from India. According to a health ministry source, monitoring of adverse drug reaction is not followed in the curriculum for medical students in India and majority of doctors do not maintain records on patients.

New Delhi: A report by a parliamentary committee has shown that the drug industry regulator, the Drug Controller General of India (DCGI), has been approving, on average, one new drug a month without conducting mandatory clinical trials or seeking expert medical opinion—findings that expose the deep flaws prevalent in India’s drug approval process.
The committee found that an “overwhelming” majority of the drugs were being approved on the basis of personal prescriptions and without any scientific evidence. The report concludes that “there is adequate documentary evidence to show that (expert) opinions are written by the invisible hands of drug manufacturers and experts merely oblige by putting their signatures”.
Of the 42 drugs scrutinized, 11 were approved without phase-III clinical trials for safety and efficacy being conducted.
According to the committee’s findings, CDSCO approved 33 new drugs (including Cipla Ltd.’s colistimethate and pirfenidone, Novartis Pharmaceutical’s aliskiren and GlaxoSmithKline’s ambrisentan) between January 2008 and October 2010 without conducting clinical trials and 25 drugs without seeking the opinion of medically-qualified experts.
It also found that four drugs (Novartis’s everolimus, UCB Biosciences Inc.’s buclizine, Eli Lilly and Co.’s pemetrixid, and a fixed-dose combination of Thelon Pharmaceuticals’ pregabalin) were approved by “non-medical staff of CDSCO” without the mandatory clinical trials or opinion of medical experts and that 13 drugs were actually banned in developed countries.

REASONS OF AVAILABILITY OF BANNED DRUGS IN INDIA:

Ø  A lengthy legal procedure to ban any drug in India which is banned in developed countries gives long time to manufacturers to manufacture these banned drugs in India. Commercial interests of pharmaceutical companies, corruption, lack of transparency and accountability is the major reason for such delay in 28 banning procedure.

Ø  Regulatory bodies lack enforcement power.

Ø  Due to the poverty line in India these drugs are easily marketed at low costs.

Ø  Many private practitioners and physicians are unaware about the ban.

Ø  Non –compliance by the patient by self prescribing the drugs for common ailments and disorders. The patient has a mindset that he gets well fast with the drug he takes like Nimesulide, Rofecoxib, Phenylpropanolamine for common ailments such as cold, cough, head ache, etc and they don't know about the side effects, whether these . 29,30 drugs are banned or not.

Ø  Because of self prescription, numbers of allergic and anaphylactic reactions are occurring frequently in India. This can be prevented by public awareness programmes regarding the status, use, and side effects of self prescription.

Ø  Non-availability of appropriate drugs and their high 28, 29 cost . 29,30

Ø  Prescribers lack of knowledge and experience

Ø  In some places such as Ludhiana, the department has no provision for notifying to hospital and doctors about the status of these banned drugs except through newspaper.

Ø  One of the reasons for the free availability of banned drugs in the market is this communication gap between the DCGI and state drug controllers.

Ø Drug Inspectors cannot reach out & inspect every pharmacist/wholesaler because Drug Inspectors are too few.

Reference:

1.        Shankar PK. A rational drug policy. Indian Journal of Medical Ethics.2004; Jan-Mar 12(1) [online]. Available from: URL: http://www.ijme.in/121di011.html [accessed 2007 Dec 10]

2.        Clay KD, Hanson JS, Pope SD et al. Brief Communication: Severe Hepatotoxicity of Telithromycin: Three Case Reports and Literature Review. Annals of Internal Medicine [cited 2006 March 21]. Available from: URL: http://www.annals.org/cgi/content/abstract/144/6/415 [accessed 2007 July 11]

3.        Parmar DM, Jadav SO. Should banned drugs be mentioned clearly?. Indian J Pharmacol 2006;38:438-438.

4.        Thawani V, Sharma S, Gharpure K. Pharmacovigilance: Is it possible if bannable medicines are available over the counter?. Indian J Pharmacol 2005; 37:191-191.

5.        Parmar DM, Jadav SO. Should banned drugs be mentioned clearly?. Indian J Pharmacol 2006;38:438-438.

6.        Shiva M, Rane W. Drugs of doubtful efficacy. In: Banned & bannable drugs- unbiased drug information essential drugs and rational drug policy. 5th edi. New Delhi (India): Voluntary Health Association of India (VHAI); 2004. p 134-7.

7.        ‘Use of Fixed Dose Combination (FDC) Drugs in India: Central Regulatory Approval and Sales of FDCs Containing Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), Metformin, or Psychotropic Drugs’, PLoS Medicine. doi: 10.1371/journal.pmed.1001826.

8.        ‘Residues of Diclofenac in Tissues of Vultures in India: A Post-ban Scenario’, Archives of Environmental Contamination and Toxicology. Springer US, 74(2), pp. 292–297. doi: 10.1007/s00244-017-0480-z.

9.        ‘Metamizole: A review profile of a well-known “forgotten” drug. Part I: Pharmaceutical and nonclinical profile’, Biotechnology and Biotechnological Equipment, 26(6), pp. 3329–3337. doi: 10.5504/bbEq.2012.0089.

10.    WorldHealthOrganization(2005)Thioridazinewithdrawnduetopoorbenefit/riskprofile.WHOPharmaceuticalsNewsletter2005,No01.http://apps.who.int/medicinedocs/en/d/Js8116e/1.7.html.

11.    GovernmentofIndiaMinistryofHealthandFamilyWelfare(2003)TheDrugsandCosmeticsActand Rules.http://www.emergogroup.com/sites/default/files/file/india-drugs-and-cosmetics-act-1940-actno-23.pdf.

12.    CentralDrugsStandardControlOrganization(2013)FixeddosecombinationsapprovedbyDCG(I) since1961tillDecember,2013.http://www.cdsco.nic.in/writereaddata/FDC_approved_dcgi%281% 29_2013.pdf.

13.    Shaji, J. and Lodha, S. (2010) ‘Regulatory status of banned drugs in India’, Indian Journal of Pharmaceutical Education and Research.

14.    Nikolova, I. et al. (2012) ‘Metamizole: A review profile of a well-known “forgotten” drug. Part I: Pharmaceutical and nonclinical profile’, Biotechnology and Biotechnological Equipment, 26(6), pp. 3329–3337. doi: 10.5504/bbEq.2012.0089.