New Delhi: Pharmaceutical formulations such as codeine-based cough syrups like Phensedyl and Corex and tramadol preparations such as Spasmoproxyvon Plus had been seized by NCB from smugglers along the India-Bangladesh border. In order to stop the abuse of the drugs, the Narcotics Control Bureau (NCB) has asked the Drug Controller General of India (DCGI) to reduce the availability of codeine-based cough syrups and tramadol preparations as they are being used as narcotic drugs.
According to the NCB, these formulations are being abused due to their wide availability which must be substantially reduced in order to identify their movement in the market. And suggested that these pharmaceutical preparations should be sold state wise according to specific batch/lot sizes and this information should be printed on their labels taking a cue from the way alcoholic beverages such as beer are sold.
LiveMint reports that in a letter written to the apex drug controller, the NCB stated “It has been seen that pharmaceutical preparations including codeine-based cough syrups, tramadol preparations, etc., are being abused and the same are being seized by various drug law enforcement agencies. During the investigation of the cases, the point of diversion could not be established as the lot size of drugs is big and same lot size is distributed to many stockists/distributors in different states. It is suggested that the batch/lot size of these formulations must be reduced substantially in order to identify the exact points of diversions from authorized channels for unauthorized abuse. Additionally, the diversion points will be effectively blocked and easily identifiable.”
The issue has been already addressed to industry groups by the drug controller. The industry groups include Indian Drug Manufacturers’ Association (IDMA), the Federation of Pharma Entrepreneurs, the Federation of Indian Chambers of Commerce and Industry, the Confederation of Indian Industry, the Indian Pharmaceutical Association. The drug controller has suggested that payment be made through cheques only for buying these formulations
The final decisions regarding the issue will be taken after the issue is deliberated at the Drugs Consultative Committee (DCC) meeting which is going to held on 18 September.
A senior official in DCGI office said, “the suggestions by the NCB which wants tighter controls so that it is not misused and the industry lobby will be deliberated in DCC.”
Pfizer Inc, Abbott India Ltd, Cipla Ltd, Zydus Cadila, Aurobindo Pharma Ltd and Sun Pharmaceutical Industries Ltd are the major pharmaceutical firms making formulations based on codeine.
“Pfizer is supportive of measures that can curtail any nonprescription use of codeine based formulations. Towards this we are in active dialogue with the authorities to enable regulatory provisions that can help curtail such use and at the same time ensure that patients continue to receive the benefits of codeine based formulations as the treatment for their respiratory condition through genuine prescriptions,” said Pfizer.