Drug bans All talk, no walk

Even as drugs banned worldwide continue

to be sold in India, the regulator is dragging its feet on effecting forceful bans

India has banned several controversial drugs, including antibiotic Gaifloxacin, pain-killer for children Nimesulide, anti-stomach acid reflux medicine Cisapride, a component of popular cough syrups phenylpropanolamine (PPA) and anti-obesity drug Sibutramine, in the past couple of years.

However, most of these drugs had been available in Indian markets for years and even decades after being banned in developed countries like Britain, the US, Canada, Sweden, Denmark, Australia, New Zealand and Japan.

?Banning globally prohibited drugs in India does not require expertise, but commitment to public good. No drug can be imported, manufactured or sold in India without permission from the Drugs Controller General India (DCGI), which is expected to protect people from harmful drugs as part of its statutory duty. Unfortunately, when it comes to banning harmful drugs, the DCGI keeps on dragging its feet,? says Chandra M Gulati, one of India?s top experts in drug regulation, also the editor of Monthly Index of Medical Specialities (MIMS), a well-known medical journal.

There are numerous other cases where medicines banned in developed countries continue to be prescribed and sold in India since rules to check and remove drugs that produce harmful side effects are not available. While some industry players claim there should not be a blanket ban in India for drugs banned abroad, doctors argue against this statement.

?When new drugs are to be introduced in the country, the regulator picks studies on the safety and efficacy of that drug done abroad and uses the same to allow that drug to be sold in India, then why can?t the same logic be applied for bans?? asks Dr Gopal Dabade, a Karnataka-based ENT surgeon and co-convener, All India Drug Action Network (AIDAN), an NGO.

Three drugs?pefloxacin (antibacterial), lomefloxacin (antibiotic) and sparfloxacin (antibiotic)?which are currently sold in India, were either never marketed by countries with well-developed regulatory systems like the US, Canada, Britain and Australia, or were discontinued later due to adverse drug reactions, said the 59th report of the parliamentary standing committee on health and family welfare, probing the issue of irregular approval of drugs in India.

?Anti-diabetic agent phenformin was banned abroad in the 1970s due to unacceptable side effects and introduction of safer medicines, but continued to be sold in India till 2003, which is for over 30 years, and was banned only when the Delhi High Court raised the issue,? said the report.

The panel also noted that Analgin, a pain killer, continues to be sold in India after being banned in the US in 1977 and later in other countries like Sweden, Australia, New Zealand, Syria, Nigeria, Philippines and even Nepal for triggering a sharp fall in white blood cells.

Analgin was also banned for use in animals in 1995 in the US. ?Analgin crosses the placenta and should not be used during pregnancy. Similarly, women who are breastfeeding must not use the drug. How many people know this?? said the ministerial panel. India is yet to seriously consider the issue of withdrawing Analgin.

Another controversial drug, Buclizine, used for appetite stimulation in children, was approved in 2006 without clinical trials and without consulting experts. However, the same drug has not been approved in the US, UK, Canada and Australia for such indications.

The health ministry is now contemplating forming an adverse drug reaction monitoring system that would enable regulators find side effects of various existing medicines. ?Based on the data compiled for contra-indications and adverse drug reactions (ADRs), existing medicines can be banned or put with label changes and warning inserts,? said sources.

The ministry?s thinking is in line with the 12th Plan, which states that ?pharmaco-vigilance, post-marketing surveillance, adverse drug response monitoring, quality control, testing, re-evaluation of registered products would be accorded priority under drug regulation?.

However, medical practitioners say determination of side effects of marketed medicines is an extremely complicated exercise that requires infrastructure, appropriate result-oriented methodology and expertise.

?While every country would like to monitor ADRs, presently, only a few have the competence, capacity and infrastructure required to do so. There is no alternative but to depend on ADRs found abroad,? says Gulati.

The parliamentary panel had recommended that ?the most effective system is to control post-marketing phase IV studies on a very large number of patients. In the past decade, all the major adverse effects that led to banning of drugs were identified in large-scale phase IV trials. The ministry may wish to consider the possibility of using this format in the country.?

The health ministry also plans to link medicine ban in India to regulatory decisions on those drugs in major developed economies. In the action taken note submitted by the MoHFW to the parliamentary committee on December 28, 2012, it was stated (Para 1.19) that: ?It has since been decided that whenever a drug is banned due to adverse drug reactions in countries with well-developed and efficient regulatory system viz the US, UK, EU, Australia, Japan and Canada, the manufacture, import and marketing of such drugs would be immediately put under suspension till the safety of the drug is examined and established in the country.?

?Yet not a single drug has been banned as of date even after four months have passed,? says Gulati.

However, some sections of the industry and medical practitioners say extensive and detailed examination of adverse effects of globally banned drugs on Indian people is necessary before they can be qualified as not suitable in the country. ?These are time-consuming efforts and considering that the drug regulator has limited manpower and resources, this may take some more time,? say industry players.

While the health ministry?s intentions may be noble, it would be hard to put such a structure together immediately, considering that the Central Drug Standards Control Organization (CDSCO) does not have accurate and updated information on drugs marketed in the country.

In its action taken report, the health ministry informed the parliamentary panel that data regarding 85,000 brands of drug formulations approved by various state licensing authorities had been uploaded on the CDSCO website. However, when the panel evaluated the data, it could locate only 65,500-odd formulations on the site, of which several were banned drugs and several others were drugs that had been discontinued.

Lurking Danger

Below are some drugs banned in India and developed countries, and yet available in India

In India

(mostly between 2010-11):

* Rosiglitazone (anti-diabetic)

* Sibutramine (anti-obesity)

* Nimesulide (pain killer; for pediatric use)

* Gaifloxacin (antibiotic)

* Cisapride (treat acid reflux)

Source: Industry, Central Drugs Standard Control Organization (CDSCO)

In developed countries

(but mostly available in India):