Maharashtra Food and Drug Administration (FDA) has detected over 20 cases of illegal sale of Codeine containing cough syrups to drug addicts in huge quantities without a prescription and without issuing a sales bill. Official reports indicate that there has been rampant misuse and abuse of cough syrup brands like Rexcof from Cipla and Corex manufactured by Pfizer over the past few months as chemists and stockists have violated the conditions of licence.
The state regulator is in the process of taking action 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 chemists have sold the cough syrups in the absence of pharmacist in certain cases. Informs a senior FDA official, "As per Rule 66 of Drugs and Cosmetics Rules, the authority has the discretion to suspend or cancel licence for professional misconduct by the licence holder."
Pinpointing on the rampant misuse of Narcotic and Psychotropic substances, a senior FDA official says, "Since these products are covered under Schedule H of the Drugs and Cosmetics Act 1940 and Rules thereunder, except the 15 covered under Schedule X, the effective monitoring of these products is tedious and time consuming. This has led to more manufacturers marketing their products containing narcotic drugs and psychotropic substances resulting in more availability of the products and hence of more misuse and abuse."
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 and which has been established in therapeutic practice are not to be considered 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. Some companies are offering huge trade margins to retail chemists for the cough syrups. Huge trade margin allures chemists to sell large quantity of such drugs without prescription and in contravention to the conditions of licenses issued under the provisions of law.
FDA has recommended 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. Manufacturing companies should be discouraged from offering huge trade margins and unethical practice of promotions. 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.