Codeine and its preparations, including salts, are manufactured drugs under the NDPS Act, except when compounded with other ingredients and not exceeding specified limits, and when not used in therapeutic practice.

Joymalya Bagchi, J.

Petitioner is a clearing and forwarding agent of M/s. Abott Healthcare Pvt. Ltd. and has valid licence to deal with various drugs including phensedyl cough syrup.

2. By a notification dated 10th March, 2016 the Central Government banned combinations of 344 fixed dose combination including combination of phensedyl cough syrup. Such notification according to the petitioner is the subject matter of challenge in Delhi and other High Courts. I am further informed that before the Delhi High Court the Union of India informed the said Court that instructions had been issued to the State authorities not to implement the said notification. Such information was also uploaded on the website of Drug Controller General of India.

3. Under such circumstances, the petitioner has sought a declaration that phensedyl cough syrup cannot be treated as a `narcotic drugs' or `psychotropic substance' or a `manufactured drugs' under the Narcotic Drugs and Psychotropic Substances Act, 1985. Reliance is placed in that regard to Item No.35 of 159 the notification being SO 826(E) dated 14.11.1985 issued by the Central Government as follows:

"S.O. 826 (E), dated 14th November, 1985 - In exercise of the powers conferred by sub-clause (b) of clause (xi) of Section 2 of the Narcotic Drugs and Psychotropic Substances Act, 1985 (61 of 1985), the Central Government hereby declares the following narcotics substance and preparation to the manufactured drugs, namely:

......................

(35) Methyl morphine (commonly known as `Codeine') and Ethyl morphine and their salts (including Dionine), all dilutions and preparations except those which are compounded with one or more other ingredients and containing not more than 100 milligrams of the drug per dosage unit and with a concentration not more than 2.5 per cent in undivided preparations and which have been established in therapeutic practice."

4. Reliance has also been placed on the order dated 26th October, 2005, issued by the Drugs Controller General of India which reads as follows:

"As you are aware there are number of Cough preparations like Corex of M/s. Pfizer Limited, Mumbai, Phensedyl of M/s. Nicholas Piramal India Limited, Mumbai, Codokuff of M/s. German Remedies, Codeine Linctus of M/s. Zydus Alidac etc. moving in inter state 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 it 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 Rule 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 Practioners only. Further you may be already aware that 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 per cent in undivided preparations and which have been established in therapeutic practice.

The above brought to your notice for information and necessary action."

5. Similar clarification dated March, 2009, was issued by Drug Controller General of India which reads as follows:-

Subject:- Request for clarification of drug substance Cough Linctus containing Codeine Phosphate - Regarding

Sir,

Please refer to your letter no nil dat