Banning or restricting the use of unsafe drugs is becoming increasingly slow in India often requiring court intervention. Such laxity or hesitation on the part of the office of the Central Drug Standards Control Organisation is quite disturbing and calls for some serious introspection. One such case, in this regard, is that of astemizole and terfinadine, two anti-allergic drugs. CDSCO had taken a decision on October 29, 2002 to ban the use of these two drugs, but gave time up to August 2003 for the companies to stop their manufacture and sale in the country. There was no need for the office of the DCGI to grant almost 10 months to withdraw these products from the market after finding them unsafe for use. It is, therefore, not surprising that an NGO had to file a PIL in the Delhi High Court against the continued marketing of these drugs in the country. The Court promptly directed the CDSCO to file a reply on the order prohibiting the drugs from August 2003. The Delhi HC has rightly taken the stand that if the government is satisfied of prohibiting the marketing and use of a particular drug, then that should be done with immediate effect. DCGI office, subsequent to the Court order, reviewed the whole matter and amended the order and now made the ban effective from April 1,2003.
Another case is that of nimesulide, a widely prescribed drug with huge sales. The drug is not in use in the US and several European countries for some years as it is considered unsafe particularly for children. After a number of media reports in recent months, there has been a lot of pressure on the government to ban the use of nimesulide in India too. But the DCGI has chosen to allow continued marketing of the drug although some of the pharma companies have voluntarily withdrawn their pediatric dosage forms from the market. DCGI decision to allow marketing is on the basis of a report submitted by Indian Academy of Pediatricians about the drug safety. A section of pediatricians have, however, questioned the veracity of this report submitted to the DCGI. Be that as it may, DCGI decision allowing the continued marketing of nimesulide has been challenged by another NGO in the Delhi High Court. The Court has directed DTAB to review the safety profile of the drug and file a report by May 26. Meanwhile, MIMS has published a list of 11 globally banned drugs prepared by WHO. Most of these drugs are still being marketed in India. The government's stand is that there is "no system of global banning of a drug" as these drugs are still available in India and "many" other countries. But the fact is that a majority of the developed countries, constituting almost 80 percent of the world pharmaceutical market, do not allow the marketing of these 11 unsafe drugs. Should not the Indian regulatory bodies take note of such a hard reality and act. The issue of unsafe drugs floating in the market place has also been brought to the notice of the DCGI by Ahmedabad-based CERC several times in the past. Now, CERC is planning to move Court against DCGI's inaction. All these are indications of a build up of public outcry against ineffectiveness of the drug regulatory system in the country. It would be, therefore, prudent on the part of the Union health ministry to wake up and address such serious issues without any further delay.