Emedinews Edit: GATIFLOXACIN banned but not the eye drops

Gatifloxacin formulation for systemic use in human by any route including oral and injectable was prohibited for manufacture and distribution in the country by Ministry of Health, Government of India on 16.03.2011.

After the ban, the Drug Controller Department approved an eye formulation of gatifloxacin which caused confusion amongst the medical professionals.

Drug Controller of India issued a clarification dated 03.06.2011 with gatifloxacin ophthalmic formulations like eye drops and ointment which are topical formulations and are not for systemic use are not banned.

Schedule HX is not patient–friendly

The recent move on the part of the Union Health Ministry to amend the Drugs and Cosmetic Rules 1945 through Schedule HX is creating a stir among chemists and pharmacists, who are opposed to it. Even for the medical profession, this amendment is not patient–friendly.

Under the Schedule HX, the drugs for TB (Rifampicin, Isoniazid and Pyrazinamide), Ciprofloxacin and Norfloxacin (for Diarrhea) and Framycetin (for burns) would no longer be as easily available as they are today.

The Schedule HX has Part A and Part B. And, according to it, 16 antibiotics in Part A would be sold directly by drug manufacturers to the tertiary care hospitals, and 74 drugs in Part B can be sold by the chemist only on the prescription of Registered Medical Practitioners in duplicate. The extra copy of the prescription would be kept with the chemist for a further 2 years.

The schedule talks about the need to have tertiary hospitals, registered medical practitioners and prescriptions in duplicate for the drugs in Schedule HX.

There are no tertiary hospitals in the rural areas.

Newer antibiotics are very costly and if they can only be prescribed in a tertiary care hospital, will people be able to afford these hospitals?

ICU care in a tertiary hospital may cost 30-50,000 per day.

Today many chemists offer hefty discounts on branded drugs as they play with margins of up to 40%. No tertiary care hospital will pass on this discount to the patient.

A patient may have to be given antibiotic for weeks and most of this period may be ambulatory at home through a private nurse. Will the prescription be allowed from a tertiary care hospital pharmacy as an outpatient?

Patients requiring these drugs invariably will be required to be transferred to a tertiary care hospital for the treatment. This may not be in the interest of the patient and the treating doctor.

Banned drugs still available: whom to blame?

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.