Maharashtra Food and Drug Administration (FDA) has in total detected 25 cases of illegal sale of Codeine containing cough syrups by unauthorised persons to drug addicts without a prescription. According to a senior FDA official, all the offenders have been arrested and police investigations are going on in these cases.
As per official reports, FDA has been monitoring rampant misuse and abuse of cough syrup brands like Rexcof from Cipla and Corex manufactured by Pfizer over the past few months. 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 will be 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 licence 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 like Corex manufactured by Pfizer are not proportional to the population figures and varies from state to state.
FDA has recommended to the Central Government certain stringent measures to curb widespread misuse of such cough syrups. It has suggested that there should be drastic reduction in quota of narcotic drugs granted to the manufacturers. Policy of granting quota has to be reviewed. It should be based on the actual requirement rather than sales figures submitted by the firm. Codeine phosphate syrups should be included under Schedule X of Drugs and Cosmetics Act, 1940 which requires that copy of a prescription to be preserved by the chemist.