some drugs are mentioned in slides are banned in india but available in market

1. MAYUR N.GHOTKAR
RAJARAMBAPU COLLEGE OF
PHARMACY, KASEGAON.
AVAILABILITY OF BANNED
DRUGS IN INDIA

2. INTRODUCTION:-
* Adverse drug reactions, or ADRs, are officially described as: A
response to a drug which is noxious and unintended, and which occurs
at doses normally used for the prophylaxis, diagnosis or therapy of
disease, or for the modification of physiological function.
* Pharmacovigilance is the Pharmacological science relating to the
detection, assessment, understanding and prevention of adverse effects,
particularly long term and short term side effects of medicines.

3. Generally speaking, Pharmacovigilance is the science of collecting,
monitoring, researching, assessing and evaluating information from healthcare
providers and patients on the adverse effects of medications, biological
products, herbalism and traditional medicines with a view to:
@ Identifying new information about hazards associated with medicines
@ Preventing harm to patients.
This in turn will help in finding the usefulness of the currently available drugs
guiding decisions pertaining to a drug’s fate in the market.

4. Reason for banning the drugs
 The adverse effects of medications / Hazardous side
effects of drugs

5. Authority In India For Approval/Ban
The Drug.
 If the drug is found to be very safe and efficacious, DCGI is the
highest authority in India to extend the approval of such drug.
 On the other hand, if through Pharmacovigilance adverse events
are found to be critical, DCGI takes the action to ban such drug in
India.

6. Why banned drug in many countries still
available in India:-
 Many of them are over the counter drugs (brands) are available
with changed formulation but same brand name.
 They are available without prescription so the general
population is ignorant about the serious side effects.
 The manufacturers take the aid of pending court cases and
continue distribution until decision is made.

7. * The answer to such unethical distribution and availability of banned drug
may lie in the insufficient data about ADR and its reporting.
* Many studies about pharmacovigilance and ADR reporting have shown very
poor ADR reporting in India due to lack of knowledge and practice
* Things get further complicated due to issues such as self medication, since it
is not monitored by physicians, and patients miss the important step of getting
warned about the side effects of the drug and the subsequent ADR reporting if
any, is unavailable.

8. * There is lack of awareness about the safety issues associated with
medications or about the discontinued nature of medications and the
consequences upon their consumption in India.
* The Cost of drug act as key determinant of sale of banned drugs.

9. Killer drugs still available in Indian market but
banned in other countries:

10. Revital
 Composition :- Multivitamin
 USE:- As multivitamin supplement
 Manufactured by :- Ranbaxy India
 Reason For Ban :- It was banned in USA , UK and
Germany due to its serious side effects like
Eg. Convulsions, Dizziness, Fast heartbeat, High blood
pressure, Irritability, Weakness, Constipation, Swelling
of feet.

11. Corex
 Composition :- Chlorpheniramine + Phenylpropanalamine
+ Paracetamol
 USE:- To relive symptoms of sinus pressure, runny nose,
itching of the throat.
 Manufactured by :- Pfizer
 Reason For Ban :- It cause short term memory loss,
sleeplessness, tremors , spasms, due to high sugar content
unsuitable for diabetic patients

12. Vicks action-500
 Composition:- Paracetamol, Diphenhydramine,
Phenylephrine, Caffeine.
 Use:- Used in treatment of Headache, Common
cold, Nasal congestion.
 Manufactured by:- P & G (Procter & Gamble)
 Reason for Ban:- It is declared not good for health it
can create Asthma and TB.

13. Liv- 52
 It is an Ayurvedic preparation
 Use :- As Hepatoprotective , Immunomodulater
 Manufactured by :- Himalaya
 Reason For Ban :-

14. Combiflam
 Composition- Ibuprofen + Paracetamol
 Use: – As Painkiller
 Manufactured by:- Aventis
 Reason For Ban:- Rash, Bloody and Cloudy Urination,
Fatigue, Gastric ulcer, Severe Heartburn, Abnormal Blood
Count.

15. Nise
 Composition: - Nimesulide + Dichlofenac
 Use :- Painkiller, Anti- inflammatory
 Manufactured by: - Dr. Reddy’s
 Reason for Ban:- Serious liver damage

16. Evion - E
 Composition:- Vitamin- E
 Use:- Vitamin – E deficiency
 Manufactured by:- Merck Consumer Healthcare Ltd.
 Reason For Ban:- Chance of developing Prostate
cancer, High dose causes rash, headache, bleeding,
blurred vision, stomach cramps, Diarrhea.

17. References
 http://cdsco.nic.in/html/G.S.R%20910E.pdf
 http://cdsco.nic.in/GSR_82_E.pdf
 http://cdsco.nic.in/GSR_218%28E%29.pdf
 http://www.medindia.net/news/Import-and-
Manufacture-of-Rosiglitazone-Banned-75107-1.htm
 http://indiatoday.intoday.in/site/story/government-
bansnimesulide/1/129859.html

18. Thank you !!!