Last month, Ranbaxy Pharmaceuticals announced a voluntary recall of 73 million tablets of its epilepsy and nerve pain drug, gabapentin, from the US market. The company had to withdraw the product as it was containing certain impurities beyond the permissible levels prescribed by the US FDA. This is the first time an Indian drug company has gone for such a massive recall of a drug from the US market on quality issues. Just two weeks ago, Merck initiated a recall of 11 lots of its Pedvaxhib vaccine and two lots of Comvax combination vaccine from the US market. Both the vaccines, used against infection among infants, are found to be contaminated by impurities on inspection by the company staff. Merck is already in serious financial trouble on account of its Vioxx withdrawal and payment liability of millions of dollars in compensation to patients who have been taking the drug. In yet another case, Roche was asked to stop production and marketing of Viracept, an anti HIV drug by the European Medicines Agency in last June after finding nelfinavir mesylate, the active ingredient in the product, was contaminated by ethanol, a chemical used for cleaning the process machinery. Such frequent recalls of drugs from the market indicate that all drug approvals even by the world's top regulatory agencies like the US FDA and EMA are not above board and needs constant monitoring and corrective action.
The initiative took by the Drug Controller General of India to weed out irrational and harmful drug combinations should be viewed in this context. Everyone knows that the 294 combination drugs were approved for marketing by the state drug authorities without the due process of clinical trials and other mandatory tests. The safety and efficacy of these combinations, numbering over 1000 products, are therefore to be doubted. It is wrong to argue that these products were in the market for many years and therefore they may be allowed to remain in the market. And the representatives of the drug industry in their meeting in last October at Chandigarh had also concurred with the DCGI that majority of the 294 of drug combinations are absurd and irrational and needed to be weeded out. Now, the only blame the industry can put on DCGI is that he was a bit harsh in handling the issue by not providing some more time to the industry to clear up the mess in the market. But that is no justification for the industry to paralyse the whole process of DCGI by moving court and getting stay orders. By doing this, industry is just trying to protect their own interest only at the cost of a lot of harm to millions of patients in the country. They are able to get away with this outrage only because the patient community in India is not organized as in developed countries. It is high time Indian pharmaceutical companies should have learnt to become patient caring rather than only physician centric in the domestic market.