In the wake of spread of seasonal communicable diseases, especially swine flu, in the country, the Tamil Nadu drugs control directorate has formed 50 special squads of drug inspectors to conduct investigations and surprise raids in retail pharmacies to check whether the retail shops are selling the Schedule X drug, oseltamivir, without prescription.
During the last three months, a total of 125 cases have been found out and investigations are going on. All the violators have been served show-cause notices from the directorate. As per penal section 27 (d) of the Drugs and Cosmetics Act, the punishment for such violation is a fine of Rs. 20,000 and an imprisonment of one year, sources informed Pharmabiz.
The regulators are mainly pursuing the sale of the drug, oseltamivir (Tamiflu), which is a Schedule X drug, and the retailers of the medicine require special licence to stock and sell it. Out of the 40,000 plus retail shops in Tamil Nadu, only 600 of them are licensed to sell oseltamivir. All over India, of the total 8 lakh drug retailers, 2,500 have been allowed to stock and sell it.
M Abdul Khadar, director of drugs control administration, said the formation of special squads has been made due to the spread of swine flu in the country, though the disease is under control in Tamil Nadu. The Squads will operate under respective ADCs who will report their findings to the directorate.
The retailers are given special licence 20 (F) to stock and sell Schedule X category drugs, the wholesalers get 20 (G) licence and the manufacturers require 25 (F) licence to manufacture the products.
The DC clarified that there was no licensed manufacturer in Tamil Nadu to produce oseltamivir drug, but the tablets, capsules and liquid forms of the drug are brought from other states by specially licensed distributors.
Oseltamivir drug cannot be sold without the prescription of doctors who will give two prescriptions, one of which should be kept by the chemists in their shops. They are also required to maintain a register of the sale for subsequent scrutiny by drug control officials. As per Section 65 (9) (a) of the drugs and cosmetics rules 1945, Schedule X drugs should be sold on prescriptions only.
Recently more than 600 cases of death were reported from various parts of the country due to the outbreak of swine flu. The drugs controller general of India (DCGI) soon informed all the chemists associations in the country to ensure the availability of the restricted drug, oseltamivir, and wanted all state drug controllers to issue special licence to chemists for stocking the drug in case of requirement.