Is cough syrup a narcotics drugs

Is cough syrup a narcotics drugs

This is very debatable issues that cough syrup those contain codeine as one of the ingredients, come under Narcotics drugs or not.

What is Codeine?

Codeine is a narcotic pain-reliever and cough suppressant similar to morphine and hydrocodone. Moreover, a small amount of codeine is converted to morphine in the body. The precise mechanism of action of codeine is not known; however, like morphine, codeine binds to receptors in the brain (opioid receptors) that are important for transmitting the sensation of pain throughout the body and brain. Codeine increases tolerance to pain, decreasing discomfort, but the pain still is apparent to the patient. In addition to reducing pain, codeine also causes sedation drowsiness and depresses breathing. Codeine frequently is combined with acetaminophen (Tylenol) or aspirin for more effective pain relief. The FDA approved codeine in 1950.

Use of Codeine in Cough Syrup –

There are a number of Cough preparations like Corex of M/s Prizer Limited, Mumbai, Phensedyl of M/s. Nicholas Piramal India Limited Mumbai, Codokuff of M/s. German Remedies, Codeine Linctus of M/s. Zydus Alidac, Rexcof, etc. moving in interstate commerce. These preparations contain among other drugs Codeine Phosphate 10mg as one of the ingredients. By virtue of the fact that these preparations contain Codeine and its salts they do not fall under the provisions of NDPS Act and Rules of 1985 but they fall under Schedule H of the Drugs & Cosmetics Rules and are governed by the said rules. Though stocking and sale of these drugs do not attract the provisions of NDPS act and Rules 1985, however, these formulations are prescriptions drugs and are to be dispensed on the prescription of a registered Medical Practitioners only.

Further, under notification number S.O.826 (E) dated 14th Nov 1985 under the Narcotic Drugs and Psychotropic Substances Act and Rules 1985 certain preparations are exempted as manufactured drugs provided the preparations contain the Narcotic drug to the extent permitted. In respect of Codeine under entry no.35 it is stated that Codeine and Ethyl Morphine and their salts including Dionine all dilutions and preparations are considered to be manufactured drugs except those which are compounded with one or more other ingredients and containing not more than 100 milligrams of the drug per dosages unit and with a concentration of not more than 2.5 percent in undivided preparations and which have been established in therapeutic practice.”

For Example, if considered cumulatively in context of Phensedyl Cough Syrup containing codeine, it transpires that Phensedyl is a Schedule H drug, because Schedule H includes “codeine” as one of the ingredients. Such Schedule H drug (such as Phensedyl Syrup) can be manufactured, distributed, sold, stocked or exhibited, etc. only under a license issued for that purpose under Section 18(c). Section 18-B of the D & C Act provides for maintenance of records and furnishing of information by the licensee and the same is required to be furnished to any officer or authority under the D & C Act( Drugs & Cosmetics Act ) if such information is required.

Phensedyl contains Codeine, a Narcotic Substance, however, within the prescribed limits, as per the condition of the license granted to the manufacturer. The notification issued under Section 2 (xi)(b) of the N.D.P.S Act, dated 14.11.1985 itself permits the use of Codeine in the manufacture of the drug, however up to 100mg per dosage unit. Each bottle of Phensedyl contains Codeine Phosphate in the proportion of 9.5 mg. per 5 ml., i.e. per dosage unit, which is permissible in view of the exception contained at Serial No. 3.5 of the aforesaid notification. Further, the Codeine Phosphate concentration comes to 1.9 percent, in undivided preparation as per the report of the Forensic Science Laboratory. It has not been disputed at the bar that the drug Phensedyl has been established in therapeutic practice for the treatment of dry cough. Therefore, the preparation in question falls within the ambit of the exception as contained in the item at Serial No. 35 of the Notification.

Considering various aspects of this in the context of NDPS. Act and D & C Act, a considered opinion that Phensedyl Cough Syrup would not constitute a Narcotic Drug because it is not Codeine (a narcotic drug). Codeine is only one of the ingredients, which is required for therapeutic purposes. Codeine contained in Phensedyl syrup is within the prescribed limits and percentage, as prescribed under Central Government Notification issued under the NDPS Act.

It cannot be disputed that Phensedyl is a Schedule H drug, under the D & C Act. Conditions under the D & C Act are required to be complied with by the licensed stockist. For contravention of the said provisions, surely provisions of NDPS Act cannot be invoked to conclude that the recovered article has become a Narcotic Drug. It would be an offense punishable under the D & C Act, under the relevant provisions which are extracted above.





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