Seizure of date expired drugs valued at Rs 5.5 crore by the Tamil Nadu police from the raids conducted in Chennai and some other parts of the state has shocked the state government and the patient community. Majority of the seized drugs stated to belong to a leading Bangalore based pharmaceutical company. The stock of date expired drugs was first located by the state drug control department at a Kodungaiyur dump yard of Chennai Municipality during its inspection drive. The Department later informed the police for further raids and seizure. Director of the state drug control department suspects that many more drug companies could be involved in recycling of expired drugs with the support of a powerful drug mafia. According to the TN police, stocks of expired drugs of the Bangalore based company was lifted by an unauthorized person and threw them at the dumping ground without the knowledge of the Municipal authorities. There is no convincing explanation available from the company as to how such huge stocks of expired drugs reached the dump yard. Information available so far in this case is adequate to assume that an organized racket in date expired drugs is thriving in Tamil Nadu and quite possibly in other states of the country. In fact, seizure of the date expired drugs suspected to belong to the Bangalore based company, has, to a great extend, changed the general impression that the source of spurious and substandard drugs is only small drug units.

Implications of the seizure of expired drugs in Chennai are rather scary to say the least. If the TN Drug Control Department and police are able to establish that the Bangalore company is directly involved in the racket, it would mean that other large pharma companies could also be involved in similar illicit activity. It is a fact that the competition in pharmaceutical products is intense today with large number of players entering into in each therapeutic segment. Unsold stocks of products in major therapeutic categories are thus unavoidable with the pharmaceutical trade. Pharmaceutical companies are expected to take back the stocks of expired drugs from the retailers and wholesalers regularly for destroying as there is no way to redeem the potency of the expired drugs. That would mean that pharma companies have to hold huge quantities of expired drugs at the end of two or three years of the expiry period. Now the question is whether the pharma companies are destroying the expired drugs regularly. The state drug control authorities have no clue on this. And there is no system of monitoring this activity as of now. If that is the case, there is every possibility of recycling of expired drugs and putting them back into the pharmaceutical trade. That is an extremely dangerous activity and DCGI has to find an effective regulatory solution immediately to stop it.