Last week Pharmabiz reported about a series of raids conducted by the office of DCGI on pharmacy outlets in Delhi and Rajasthan for selling two of the banned drugs namely gatifloxacin and tegaserod. The officials stated to have seized huge stocks of the brands of these companies namely Lupin, Dr Reddy's, Sun Pharma, Cipla, Hetero Drugs, Torrent Pharma, Aristo Pharma, Intas and others. The inspectors of the Central Drug Standard Control Organization have conducted 135 raids in over 90 pharmacies in Delhi and Rajasthan. DCGI had banned gatifloxacin, an antibiotic and tegaserod, a chronic constipation drug for their adverse effects on last March 16. The order required the drug companies to withdraw their brands from the market with immediate effect. The decision to recall these drugs from the markets was on the basis of recommendations of the Drugs Technical Advisory Board. It is indeed surprising that these banned products continued to be sold in retail outlets even after three months of their ban. It is possible that the sales were taking place without the knowledge of the companies as most of the makers of these drugs are large and reputed companies. However, the manufacturers cannot pretend to be ignorant about such illegal sales of their products in the trade channels. Most of them have the monitoring system to track the sales of their products throughout the country.
Now, prior to the ban order of gatifloxacin and tegaserod in last March, DCGI had also banned drugs like nimesulide, cisapride, phenylpropanolamine and human placenta extracts for their adverse effects. These drugs have also been in the market for last many years and belonged again to large companies. The manufacturers, shortly after the ban, moved Madras High Court against the order and got an interim stay of the DCGI order and the case is pending in the court. CIPI, representing small drug units has, however, withdrawn its case against the ban from the Madras HC a few days ago. All these drugs have been already banned in developed nations, like the US, UK, Canada, Sweden, Denmark, Australia, New Zealand and Japan several years ago. What is being noticed in India for some time now is growing resistance from pharmaceutical companies to any withdrawal order from the regulatory authorities even if the drug is highly unsafe. One has to accept the fact that no drug is absolutely safe and all have side effects. Safety only means that the benefits of the drug outweigh the risks. Drug authorities worldwide grant marketing approval for drugs only after consideration of this principle of cost benefit. Continuation of marketing drugs with serious ADRs could be highly dangerous to the millions of patients who are taking them. Therefore, both the industry and trade have to cooperate with the regulatory authorities in withdrawing potentially harmful drugs from the market in public interest. And when the country’s most authoritative body recommends a ban on the basis of safety parameters, no pharmaceutical company has the moral ground to challenge such an action.
