The recent admission by the US FDA that the US has a large number of unapproved drugs circulating in the market, is shocking. Many of these products are also advertised in widely circulated medical journals. The unapproved products are being prescribed by physicians as they are not able to recognize the products lacking required FDA approval. The Acting FDA Commissioner, Dr Andrew von Eschenbach says, "Right now, many unapproved drugs represent a public health threat as consumers wrongly assume that these widely marketed drugs are approved and have been found to be safe and effective by the FDA". The issue has come to the notice of FDA with the finding of use of carbinoxamine-containing products in children under the age of 2. FDA then discovered that numerous unapproved products containing carbinoxamine labelled for use in children as young as one month of age are in the market. The US FDA drug approval system is widely recognized for bringing safe and effective new drugs into the market. It is surprising, therefore, that many older or existing drugs are in market without required FDA approval. It is a pity that this is happening in a year in which FDA celebrates 100 years of protecting the public health. This is a serious drug safety issue which needs to be addressed most urgently by the government of the world's largest pharmaceuticals market. The Marketed Unapproved Drugs - Compliance Policy Guide, issued by the FDA on June 8, is one step to contain this problem. It outlines a prioritized, risk-based enforcement approach encouraging companies manufacturing drugs without FDA approval to comply with the approval process and ensure safety and efficacy of their products. This guidance articulates FDA's expectation that manufacturers of products requiring FDA approval submit applications to FDA to show that their products are safe and effective. The guidance discusses the approach the FDA will use to bring such drugs into the approval process. That much is fair.
The practice of marketing drugs without the approval is a much more serious issue in India and no concerted approach is forthcoming from the central government to address this issue. As the central drug authority, DCGI is not in charge of issuing drug manufacturing licences, there is no compiled record of the unapproved drugs in the Indian market. As manufacturing and trading licences are issued by drug control authorities in various states with no coordination between themselves, unapproved drugs mainly in the form of irrational and harmful combinations are only multiplying in the Indian market. Thus fixed dose combinations with no therapeutic rationale like ciprofloxacin with tinidazole, amlodipine with lozarten and nifedipine with atenolol, etc are just a few instances. Nimesulide, an unsafe drug, unapproved by 168 countries including the US, is freely marketed in India. Same is the case with phenylpropanolamine (PPA), a drug banned in the US and unapproved in most European countries. The drug is being widely used for several cough and cold preparations in the country. Efforts by the office of the DCGI in the past to bring some control on these harmful products have not yielded any results with no cooperation from the state drug authorities. Another issue of concern is the extremely slow process of withdrawal of banned drugs from the market. Rofecoxib was banned in India in mid 2005 following Merck's decision to withdraw the molecule from world markets. But most of Indian rofecoxib brands remained in the market until early 2006. Similarly Crocin quik of GSK, unapproved by Gujarat FDCA, is sold in rest of the country. The Union health ministry has to take up this matter with utmost seriousness and strengthen country's regulatory machinery to remove these unsafe drugs from the pharmaceutical market.