Against the backdrop of over 15 raids conducted till date on the illegal sale of habit forming drugs like cough syrups containing codeine phosphate, Maharashtra Food and Drug Administration (FDA) has alerted pharma companies like Pfizer, Cipla and Lupin to keep a tab on the distribution channels to address its illegal sale to drug addicts.
Cipla and Lupin has, however, stopped producing codeine containing brands like Rexcof and R-coff respectively following its irrational use, according to an FDA official.
According to official sources, Maharashtra FDA has asked the concerned companies to plug the loopholes in the distribution channel as codeine phosphate containing syrups have been sold in a clandestine manner involving smaller drug dealers.
Joint investigations done with the help of police have however failed to reveal the source and mastermind of these drug dealers because they are scattered across Madhya Pradesh and Gujarat from where these drugs are sourced out and distributed in Maharashtra through illegal distribution channels. These drugs are manufactured by around 20 companies in Himachal Pradesh, Dehradun and Jammu and Kashmir.
Says Sanjay Patil, joint commissioner, Maharashtra FDA, "Based on the raids conducted by Maharashtra FDA, we have seized 20 to 50 bottles on each raid and found that there are serious lacunae in the distribution channels of the respective companies. We have therefore alerted them on this aspect to fix it as soon as possible. "
Maharashtra FDA has in total detected 25 cases of illegal sale of codeine containing cough syrups by unauthorised persons to drug addicts without a prescription. As per official reports, FDA has been monitoring rampant misuse and abuse of cough syrup brands over the past one and a half years. It has also been observed that stockists have been found violating the conditions of licence.
FDA officials maintain that FDA has been successful in curbing such illegal activities. Action has been taken against the offenders as per Rule 65 of the Drugs and Cosmetics Rules in contravention to the conditions of licence. It has also been observed that cough syrups have been sold in the absence of pharmacist in certain cases. Informs a senior FDA official, "As per Rule 66 of Drugs and Cosmetics Rules, the licencing authority has the discretion to suspend or cancel licence of the holder for non-compliance."
The regulations of narcotics drugs are more severe than that for psychotropic substances under the Narcotics and Psychotropic Substances Act. The Central government vide notification no. S.O. 826 (E) dated 14.11.1985 has declared the list of narcotic drugs and preparations to be considered to be manufactured drugs. At Sr. No. 35 codeine is stated. This entry has exemption for preparations compounded with one or more other ingredients and containing not more than 100 mg of the drug per dosage unit and with a concentration of not more than 2.5 per cent in undivided preparation. Besides this, it also stipulates as being established in therapeutic practice as another criteria for its exemption as manufactured narcotic drug.
Hence, these preparations are also as per Rule 97(c) not to be labeled with suffix NRx (narcotic drugs) but rather to be labeled as Rx (Schedule H) as per Rule 96(b) of Drugs and Cosmetics Act, 1940 and Rules thereunder.
According to the Maharashtra FDA report on 'abuse of codeine containing cough syrups', it has been observed that figures of some of the leading brands are not proportional to the population figures and varies from state to state.