Yesterday I was called by AajTak News to comment on the continuing availability of three banned drugs Gatifloxacin, Tegaserod and Rosiglitazone in the markets in India.
The response of the chemist to this issue was that once a drug has been banned it’s the duty of the pharmaceutical company to immediately recall its stocks. If they do not do so and the doctors keep on prescribing the said drug then how could they not dispense it.
When we talked to many doctors they said they have no means to know when a drug has been banned or a new drug is introduced in the market. The pharma representatives come and inform whenever a new drug
has been introduced but not when a drug is banned.
The banned drug list on the website of DCI has not updated since 2008. New drugs introduced list is updated only twice a year. Banned drugs circulars are only for a brief period. If a drug is banned, it becomes the duty of the DCI to inform all registered doctors within a week. MCI and the State Medical Councils have the list, then what is the difficulty in communication.
Gatifloxacin was banned in March 2011. As per the circular, Gatifloxacin ban was for manufacture, sale and distribution of Gatifloxacin formulation for systemic use in human by any route including oral and injectable.
Its surprising that after Gatifloxacin was banned its ophthalmic formulation was approved. As per the DCI site, on 19.5.11, Gatifloxacin 0.3% + Loteprednol Etabonate 0.5% + Benzalkonium Chloride 0.01% w/v Ophthalmic suspension was approved for post operative steroid repulsive inflammatory ocular conditions when ocular bacterial infections or a risk of bacterial infection exists. Such discrepancy is sufficient to confuse the treating doctors.
Following are the drugs that have been recently banned.
1. Gatifloxacin, Tegaserod were withdrawn from the market on 16th March 2011.
2. Rosiglitazone, the diabetic drug was banned on October 7 2010 with immediate effect.
3. Following drugs were banned on 10th Feb 2011
a. Nimesulide formulations for human use in children below 12 years of age
b. Cisapride and its formulations for human use.
c. Phenylpropanolamine and its formulations for human use.
d. Human placental extract and its formulations for human use.
e. Sibutramine and its formulations for human use.
f. R-Sibutramine and its formulations for human use.
When ever a drug is banned its the duty of the state drug controller to ensure that the ban is immediately effective and the formulations called from the market on top priority. The chemists and druggists are directed to stop the sale of these drugs and return the unused stocks to the manufacturers.
Issues
1. The DCI site is http://www.cdsco.nic.in/
2. The section Drugs Banned in India http://cdsco.nic.in/html/Drugsbanned.html mentions since 2003 only about the following drugs
i. Fixed-dose combination of Cyproheptadine with Lysine or Peptone banned on Jan 1, 2003 GSR 170(E) dated dt.12.3.01
ii. Astemizole banned on Apr.1, 2003 vide GSR 191(E) dt.5.3.03
iii. Terfinadine banned on Apr.1, 2003 vide GSR 191(E) dt.5.3.03
iv. Phenformin banned on Oct.1, 2003 vide GSR 780(E) dt.1.10.03
v. Rofecoxib banned on Dec 13, 2004 vide GSR 810(E) dt. 13.12.04
vi. Valdecoxib and its formulations banned on July 25, 2005 vide GSR 510(E) dt. 25.07.05
vii.Diclofenac and its formulations for animal use banned on July 4, 2008 vide GSR 499(E) dt.4.07.08
No drug has been added to the list after 2008. The list needs to be updates every week if not every day. If a drug is banned and is still available, the license of the pharma company should be cancelled.
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