The recent unearthing of expired drugs scam by the Tamil Nadu Drug Control Department and the state police brought to light some of the gray areas of the Drugs & Cosmetics Act. The Act is rather silent on handling of expired drugs of pharmaceutical companies. Every pharma company will have a build up of stocks of expired products as the potency of most of the drugs does not normally last more than two or three years. The pharma companies are believed to be collecting the expired drugs from the trade channels and destroy them regularly. It is more of a voluntary act by the pharma companies. And there is no monitoring of the destruction of goods of the companies by the state drug authorities. Expired drugs used to be an insignificant quantity for most companies decades ago. Today the situation has changed dramatically. Even reputed and large pharma companies have huge quantities of date expired drugs because of the intense competition in every therapeutic segment. The seizure of Rs 5.5 crore worth of expired drugs belonging to one company by the TN state authorities from a dump yard is a testimony to this hard reality. Even for a large pharma company this is not a small loss which can be written off. If one company can have expired drugs of this magnitude, total value of expired drugs belonging to the industry could be quite sizeable.

It is almost impossible to get a reliable estimate of the value of expired drugs for a particular a period from the industry for obvious reasons. In a situation like this, it is quite possible that some pharma companies get tempted to enter into unethical means to cut their losses. And there are people and agents readily available to make this task easy for the pharma companies. The TN police has seized stocks of expired cough syrups and tablets belonging to other reputed companies also last month. What TN drug authorities and police are trying to find out from the probe is the modus operandi of this dangerous activity. The state authorities have reason to doubt that some companies may be directly involved in recycling of expired drugs with the help of anti social elements. These leads from the investigation indicate to the fact that recycling of expired drugs is a nationwide racket. What is discovered in Chennai and other parts of TN is only a tip of an iceberg. A thorough investigation into recycling of expired drugs is, therefore, called for to find out who all are involved and the extend of their involvement. The office of the DCGI has to look at this whole scandal with due seriousness. First of all, the D&C Act needs to have adequate provisions pertaining to collection and destruction of the expired drugs. These provisions should also insist on maintaining of records of collection and destruction of such stocks.