The Drugs Control Administration in Andhra Pradesh has registered a case under Section 18 (c) of Drugs and Cosmetics Act, 1940, against the Secunderabad-based Shruthi Bulk Drugs Pvt Ltd for purchasing, selling and exporting 3300 kg of Ketamine Hydrochloride US P along with other drugs without possessing valid drug licenses.
According to R P Meena, director general, Drugs and Copy Rights, government of Andhra Pradesh, the cost of 3300 kg Ketamine Hydrochloride USP in the country, as per the bill value, is Rs 2.5 crore. But the company sold it for Rs 5.3 crore and in international market it would cost around Rs 33 crore. Even though the trading agency was raided by the regulating agencies, no seizure was made, but certain documents pertaining to exports have been seized.
Investigation so far revealed that the trading agency was purchasing and selling drugs like Ketamine Hcl USP, Pantoprazole Pellets, Omperazole Pellets, Erythromycin Stearate B.P, Norfloxacin USP, Mebendazole USP, Chlorphenaramine Maleate BP, Cefadroxil Monohydrate BP, Ampicillin Trihydrate BP, Cephalexin Monohydrate BP, Metronidazole, Cefuroxime Axetil, Loratidine and Tinidazole BP for the past three years.
While speaking to Pharmabiz, Meena said the firm was also engaged in exporting the drugs to various countries without having drug licences in Hyderabad. The company was exporting Ketamine to some Asian countries including Malaysia for the last few years. Ketamine hydrochloride is a controlled substance for export under Narcotics and Psychotropic Substances, Act 1985, he said.
According to information received, the director general said, Shruthi Bulk Drugs Pvt Ltd sold or exported the Drug Ketamine Hydrochloride USP to two different firms in Malaysia and the further investigations are on to check whether the agencies in Malaysia are genuine or not. The department has sought the help of several investigating agencies outside India to enquire how long this illegal trade was going on.
The drug Ketamine Hydrochloride USP is used medicinally both in humans and animals as Anaesthetic, and also used extensively for cases of trauma and surgeries.
Drug inspector, K Raja Bhanu working with the vigilance wing in the drugs control department said the managing director of the company is one Prakash. P Kadakia against whom the case was registered. The investigation pertains to the purchase and sale of drugs including Ketamine without possessing valid drug licenses under D&C Act, 1940 and it will extent to the dealing of the firm with respect to the firms or manufacturers who were involved in selling of the drugs to the firm, he said.