In a setback for pharmaceutical companies, the Narcotics Control Bureau (NCB) has asked the Drug Controller General of India (DCGI) to “substantially reduce” the availability of codeine-based cough syrups and tramadol preparations (which provide pain relief for post-surgery pain and cancer treatment), saying they are being used as narcotic drugs.
The NCB had earlier this year seized pharmaceutical formulations such as codeine-based cough syrups like Phensedyl and Corex and tramadol preparations such as Spasmoproxyvon Plus from smugglers along the India-Bangladesh border.
The NCB says these formulations, which are widely available, are being abused and their availability must be substantially reduced in order to identify their movement in the market. Taking a cue from the way alcoholic beverages such as beer are sold, NCB suggests that these pharmaceutical preparations be sold “state wise” according to specific batch/lot sizes and that this information should be printed on their labels, according to a letter written by NCB to the drug regulator in July.
“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 authorised channels for unauthorised abuse. Additionally the diversion points will be effectively blocked and easily identifiable,” said the letter, a copy of which has been reviewed by Mint.
The NCB had raised concerns over the issue of abuse of pharmaceutical preparations in a review meeting with the minister of state for home in the first half of the year. The Border Security Force too had recently seized bottles of Phensedyl near the India-Bangladesh border. The bottles were to be smuggled into Bangladesh, where these cough syrups are banned and selling them is punishable.
The drug controller has already taken up the matter with industry groups, including the 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, suggesting cheques be made the only payment option for buying these formulations.
The final decisions will be taken after the issue is deliberated at the Drugs Consultative Committee (DCC) meeting slated for 18 September. Chaired by the DCGI, the DCC is attended by all the state drug controllers.
“The suggestions by the NCB which wants tighter controls so that it is not misused and the industry lobby will be deliberated in DCC,” said a senior official in DCGI office requesting anonymity.
The major pharmaceutical firms making formulations based on codeine, an opioid, are Pfizer Inc. which sells cough syrup Corex, Abbott India Ltd, whose Phensedyl commands around a third of India’s cough syrup market, and Cipla Ltd. Preparations based on tramadol, also an opioid, are made by Zydus Cadila, Aurobindo Pharma Ltd and Sun Pharmaceutical Industries Ltd, among others.
This is not the first time that codeine-based formulations have come under the scanner. In March 2016 the health ministry’s list of around 350 fixed dose combination (FDC) drugs that were banned included those based on codeine, used in popular cough syrups. The government had decided to prohibit the sale of these medicines as they were found to be irrational and without any therapeutic use.
A Pfizer spokesperson said, “Pfizer is supportive of measures that can curtail any non-prescription 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 treatment for their respiratory condition through genuine prescriptions.”
Sun Pharma’s spokesperson declined to comment, while the others did not respond to emails seeking comments.