The Tamil Nadu Drugs Control Department (TN DCD) has started inspections and surprise raids in the premises of wholesalers all over the state against distribution of multi-dose vials of diclofenac, a non-steroidal anti-inflammatory drug (NSAID) which, in multi-doses, is not permitted for human use.
The medicine is permitted for human use only in single dose vials. Multi dose vials of this drug were previously used for veterinary use, but use of diclofenac for animal use was banned by the government in the year 2008.
According to sources from the directorate of drugs control in Chennai, the law enforcement officials in Madurai and in Chennai have detected large stocks of multi-dose vials of diclofenac and confiscated more than 2,000 packs. Sources said the dose-controlled vials of this medicine are manufactured and distributed in Tamil Nadu by some companies of north India. The wholesalers in Tamil Nadu are purchasing these vials along with other drugs and supplying them to private hospitals and pharmacies.
While briefing about the seizure, M Abdul Khader, the director of the drugs control administration, said, “Diclofenac in multi dose vials is not permitted for human use, but single dose vials are permitted, and that too only one prick from one vial. The multi-dose vials are used by private hospitals for several injections to different patients on various occasions. More than one prick from a vial is not permitted. Knowingly or unknowingly, the wholesalers are distributing large quantities of dose-controlled vials of diclofenac to various clinics and hospitals”.
The director said several companies in north India and many wholesalers in the state are under scanner and raids are continuing. He said the regulatory officials in Madurai and in Chennai have seized more than 2,000 vials of these restricted quantity vials from wholesalers godowns. Each seized vial consists of 30 ml.
Following the seizure, the department has started legal actions against the offenders and started filing cases. According to the director, the department has already initiated cases against four companies operating in other states and seven wholesalers doing business in Madurai and in Chennai.
As per Schedule P(1) of the D&C Rules the pack size and label of the vial should be in single dose. But the labels of the seized items are in multi-doses. So, penal action may be taken against the companies and the wholesalers as per Section 27(d) of the D&C Act, said K Sivabalan, joint director at the drugs control directorate.
He said the offenders are liable to get 1 year to 2 years imprisonment and a fine of Rs. 20,000.