After the government made acquiring Ketamine drug difficult as it may be misused, the state regulatory body Food and Drug Administration (FDA) has instructed close to 5,000 chemists in the city to return the stocked drug in case they don’t have permission to stock or sale the drug under the revised rules.
In November, the Central Government had revised the rules to bring Ketamine under the stringent Schedule X drugs instead of its previous listing as a Schedule H drug.
Ketamine is an anaesthetic drug, a painkiller and a bronchodilator, which opens up the airway of a patient. However, it has a wide scope for misuse as it leads to hallucination and is often used by people as a recreational drug.
“Under Schedule H, Ketamine could earlier be sold by a registered medical practitioner. However, under Schedule X, the rules for acquiring Ketamine have been strengthened,” said a FDA drug inspector.
The sale of Ketamine requires a double prescription from a clinician. “One of the prescriptions is retained by the patient while the second copy has to be kept with the chemist. The chemist has to maintain records of sale and purchase of the drug for at least two years,” the drug inspector added.
Drug inspectors have been instructed to inspect chemist shops in Mumbai by Joint Commissioner (drugs), Mumbai, SP Patil. “Those who don’t hold the licenses 20F and 20G under the Drugs and Cosmetics Act to stock Ketamine have been instructed to return back branded and generic stock to the pharmaceutical manufacturer,” said another FDA inspector. Any chemist selling the drug without proper licenses will be booked under the Act and may be imprisoned for anything between three to five years.
In Maharashtra, over 27 manufacturers produce fifty formulations of Ketamine injections.
“Chemists and stockists have been provided with a detailed list of 50 ketamine-based drugs. They have also been asked to return stocks if they don’t have relevant licences, or apply for new licences,” said Om Sadhwani, joint commissioner, law, FDA, adding, “Ketamine should be stocked under strict vigilance under lock-and-key arrangement.”
FDA inspectors also observed that those chemists attached to hospitals stock Ketamine, while others who did not have requisite licenses to stock Schedule X drugs have surrendered stock.
“Sale of Ketamine is not profitable for many chemists. They are not keen to apply for new licence to procure the drug under Schedule X. We are maintaining strict vigilance to prevent misuse of the drug, so chemists are returning stock in a smooth manner,” said a senior FDA official.