A Study on Banned Drugs in India: A Review

 

Manohar D. Kengar*, Ganesh B. Vambhurkar Asha M. Jagtap, Akshata S. Gavade, Manojkumar M. Nitalikar

Rajarambapu College of Pharmacy, Kasegaon, Dist–Sangli, Maharashtra, India–415404.

 

ABSTRACT:

The numbers of single drugs as well as fixed dose combinations drugs are banned in other countries but they have manufacturing, marketing and distribution in India. Over the counter availability of banned drugs sufficient adverse drug reactions data about these drugs have not been reported. The adverse effect of drugs is detected by regular monitoring after the drug released called pharmacovigilance. The Indian regulatory authority monitoring the new drug in market before pre-clinical study and permit to sold in market. The banned dugs prescribed over the counter the responsible as unawareness of physicians and patients, poverty, self-medication, carelessness of regulatory authorities, non availability of appropriate drugs, high cost, and communication. The Government of India is in the process of developing a regulatory regime designed to ensure the quality, safety and performance of medical devices.

 

 

 

INTRODUCTION:

The drugs are chemical or synthetic substance which used for diagnosis, treatment, mitigation and prevention of a disease, disorder and otherwise enhance physical or mental well-being.

 

Every type of new drugs precise introduced in to the market before testing and getting under approval by NDA and FDA. The drugs are introduced into the market after pre-clinical and clinical trials studies. Preclinical studies are carried out in more than two species of experimental animals ^[1].

 

 

 

A clinical trial are conducted in number human volunteers for confirmation of useful properties of new drug, and any new drugs in clinical trial it follows under the guidelines of ICH and GCP. The drug efficacy as well as safety profile are tested and the adverse effect of drugs are detected by regular monitoring after the drug released called pharmacovigilance. Adverse drug reactions (ADRs) are undesirable effects of medications that lead to large-scale morbidity and mortality in developed countries ^[2][3][4]. A drug is banned more risk are immediately banned by the regulatory authorities by knee jerk response so as to ensure the safety of population^[5]. It identifies unidentified ADRs, risk factors for the occurrence of ADRs, drug safety issues and risk benefit comparisons among medications belonging to different therapeutic classes ^[6][7]. Studies led to more controversies regarding its association with agranulocytosis and it was again 6withdrawn from the market in 1999^[8]. In India over the counter availability of banned drugs sufficient adverse drug reactions data about these drugs have not been reported.

Reason for Banning a Drug:

Drugs undergo rigorous or clinical trial testing before they are introduced into the market. The drug efficacy as well as safety profiles are tested. The adverse effect of drugs is detected by regular monitoring after the drug released called pharmacovigilance. Adverse drug reactions are officially described as ‘A response to a drug which is noxious and unintended, and which occurs at dose normally used for prophylaxis, diagnosis or therapy of disease or for modification of physiological function ^[9]. In India the highest authority is Drug controller General of India which extends the approval of any drug or banned drug.

 

Why India Still Selling Banned Drugs:

Some drugs are still available in India because gap between Drug Controller General India and State Drug Controllers as well as unawareness of physicians and patients, poverty, self medication, carelessness of regulatory authorities, non availability of appropriate drugs, high cost, and communication . The irony is that very few people know about the banned drugs and consume them unaware, causing a lot of damage of themselves. The issue is severe and we must not delay in spreading the warning message to the offenders and innocent people ^[10]. One fact the many banned drug available over the counter with changed formulation but same brand name. The drugs are available without prescription so the general population is ignorant about the serious side effects. India has serious issues with use, availability and distribution of banned drugs ^[11].

 

Most of the Drugs Banned In Other Countries But Available In India:

There are some examples of medicines, which are banned in other many countries but still available and sold in India. 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 29,30drugs are banned ^[12][13]. The most responsible Indian regulatory authorities sold banned drugs in India. It depends unawareness of physicians and patients, poverty, self-medication, carelessness of regulatory authorities, non availability of appropriate drugs, high cost, and communication. The latest reports suggest that India is one of the few countries that report large amount various banned drug to different part of world ^[14]. The list of banned drugs sold in India ^[15][16].

 

Table 1: Status of the banned drugs available in India

Sr.No	Banned drugs	Available in India
1.	Oxyphenbutazon	Available
2.	Phenformin	Available
3.	Rofecoxib	Available
4.	Nimesulide	Available
5.	Phenyl propanamine	Available
6.	Metamizole	Available
7.	Cisapride	Available
8.	Furazolidone	Available
9.	Piperazine	Available
10.	Pergolide	Available
11.	Droperido	Available
12.	Quiniodochlo	Available
13.	Cerivastanin	Available
14.	Analgin	Available
15.	Bepride	Available
16.	Cisronm	Available
17.	Cefaclor	Available

 

The Annual Sale of Banned Drug in India^[17][18]

The government has banned drug as many as 1,670 drug brands, estimated total annual sales of Rs 3,728 crore (Rs 37.28 billion), an analysis by IMS Health shows. the 344 fixed drug combinations which were banned by the government last week, triggering protests and legal action by pharma industry. The various Indian pharma companies manufactured banned drugs.

 

Table 2: Affected companies, banned drugs and annual sale.

company	Banned product	Annual sales
Pfizer	Corex and Corex-DX	Rs 423 crore (Rs 4.23 billion)
Macleods Pharma's	skin cream Panderm+	Rs 228.2 crore (Rs 2.28 billion)
Abbott's	cough syrups-Phensedyl, Tixylix and Tossex	Rs 290 crore (Rs 2.9 billion)
Lupin’s	Gluconorm -PG,	Rs 46.5 crore (Rs 465 million),
	Glimepiride+Pioglitazone+Metformin.	Rs 525 crore
	Chlopheniramine Maleate+Codeine	Rs 700 crore (Rs 7 billion)
GlaxoSmithKline	Crocin Cold and Flu, Piriton-CS, Dilo-DX and Piriton	Rs 58 crore (Rs 580 million).

 

CONCLUSION:

The drugs are chemical or synthetic substance which used for diagnosis, treatment, mitigation and prevention of a disease, disorder and otherwise enhance physical or mental well-being. Before egrouse test passing in manufacturing development then after a series of quality control process only a drug can be released into market. The importance manufacturers and their local regulatory agencies cannot be over emphasized information about banned drug, which importance of pharmacists, other health-care professionals, physicians and patients to continue to report serious suspected adverse drug reactions known. A note of caution on these drugs could help patients in deciding whether they want to take the drug. The marketing monitoring screening carefully reduces number of problems useful drugs in developed as ADR’s in banned drug and subsequent licensing. To stop the use of banned drugs, what is needed is the cumulative effort by doctors, pharmacists, researchers and manufactures along with the involvement of strict and vigilant regulatory authorities.

ACKNOWLEDGEMENT:

Authors are highly Acknowledge the help of teaching staff of Rajarambapu College of Pharmacy, Kasegaon. For providing necessary information required for research work. Also we are highly Acknowledge the help and guidance of Dr M. M. Nitalikar.

 

REFERANCE:

1.       Thorat SB, Banarjee SK, Gaikwad DD, Jadhav SL and Thorat RM. Clinical trial: A review. International Journal of Pharmaceutical Sciences Review and Research, 2010; 1 (2):101-106.

2.       Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: A meta-analysis of prospective studies. JAMA. 1998; 279:1200–5.

3.        World Health Organization. Geneva, Switzerland: WHO; 2002. [Last accessed on 2012 Oct 31]. Safety of Medicines. A guide to detecting and reporting adverse drug reactions. Available from: http://www.whqlibdoc.who.int/hq/2002/WHO_EDM_QSM_2002; 2.

4.       Moore N, Lecointre D, Noblet C, Mabille M. Frequency and cost of serious adverse drug reactions in a department of general medicine. Br J Clin Pharmacol. 1998; 45:301–8.

5.       Mudur G. Indian regulators are accused of laxity in not banning drugs. British Medical Journal, 2004; 329(7471): 878.

6.       Rawlins MD. Spontaneous reporting of adverse drug reactions. Br J Clin Pharmacol. 1988; 26:1–5.

7.       Dukes MN. The importance of adverse reactions in drug regulation. Drug Saf. 1990; 5:3–6.

8.       Oricha BS, Muhammad BY. Dipyrone (Novalgin, Metamizole): Banned and Unbanned: The dilemma of commonly prescribed and over the counter analgesic. Annals of African Medicine 2003; 2 (2): 101-2.

9.       The importance of pharmacovigilance safety monitoring of medicinal products. World Health Organization 1969.

10.     Monthly index of medical specialities 5 apr 2008.

11.     Drugs Banned in other Countries But Available in India. [Last accessed on 2012 Oct 31]. Available from: http://www.medindia.net/patients/patientinfo/drugs-bannedin-other-countries-but-available-inindia.htm.

12.     Tiwary P., Rajshree. Role of medicine information in promoting rational drug use, Pharma Times. 2006; 38 (7): 20.

13.     Drug and Cosmetics Act. Available from:URL:http://www.drugscontrol.org/ban_drugs.htm.

14.     Mnjari Gupta, Anil Ghom, FM Debta, Sunil Vyas, Abhijeet Deoghare, Prshant Gupta, Shantala Gupta, a review article on Banned drugs: Still available in india; Journal of Indian academy of oral medicine and radiology, July-September 2011; 23 (3):S380-381.

15.     Jessy Shaji and Shital Lodha, Regulatory Status of Banned Drugs in India; Indian J.Pharm. Educ. Res. 44(1), Jan-Mar, 2010.

16.     R. Soni, V. Singh, G. K. Sharma, N. Dashora and A. Dashora, awareness about banned drugs: a review; advance research in pharmaceutical and biological, 2015; Vol 5 (II).

17.     Roge AB, Tarte PS, Kumare MM, Shendarkar GR, Vadvalkar SM. Forced Degradation Study: An Important Tool in Drug Development. Asian J. Research Chem. 2014; 7(1): 99-102.

18.     E. Gopinath, Bhadauria RS, Jain A. Pharmaceutical Product Recall: An Overview for Handling and Decision Making. Research J. Pharm. and Tech. 2011; 4 (9): 1333-1339.

 

 

 

 

 

Accepted on 19.10.2018            © A&V Publications All right reserved