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Ketamine manufacturing not allowed in state: FDA

PANAJI: The food and drugs administration on Wednesday said that no licence has been issued to any individual or  company for manufacturing  ketamine in the state.

A senior official of the department clarified that the FDA has no jurisdiction vis-à-vis an industrial unit at the Pissurlem industrial estate where the banned ketamine was unearthed in large quantity by the directorate of revenue intelligence last week.

“Only when ketamine is in pure form and sold at pharmacies  as a medicinal drug then the FDA comes into picture. If anybody deals with raw ketamine in an unlicensed premise illegally then it is the duty of the enforcement agencies to crack down on such activities…  It doesn’t fall under our preview,” the official explained.

The official said that there are 362 wholesalers  in the state  registered with the FDA  for  supplying  medicines.  Out of the 362 wholesalers,   only three  wholesalers currently deal in ketamine.

“Ketamine is an anaesthetic medication. It is imported from outside the state by the wholesalers  to supply the same to hospitals and  pharmacies attached to them. Ketamine is supplied only on written requirements from the doctors,” the official said adding that the retailers have refrained from storing ketamine due to the strict compliance procedures of the FDA. The FDA mandatorily seeks the quarterly report from these wholesalers  about the purchase, sale and the quantity of ketamine available with them in the stock.

The official informed that alprazolam drug is also sold under different brand names by pharmacists for the treatment of  panic disorders and anxiety. However, the pharmacists have to mandatorily sell this drug on the prescription of the doctors.

The FDA has formed a vigilance team which conducts surprise inspection, even on Sundays, to keep a tab on violations of the norms.

“in the recent past  we have not found any violation as far as the  purchase and sale of ketamine and alprazolam are concerned.  It was in the year 2004 when these particular drugs were sold illegally by a few pharmacies, and  we had prosecuted them as per the Drug and Cosmetic Act,” the official said.

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