Updated Banned Drugs List
Updated Banned Drugs List
Updated Banned Drugs List
16. Fixed dose combinations of Vitamins with Anti TB drugs GSR NO.
Except combination of Isoniazid with Pyridoxine Hydrochloride 578 (E) Dated
23.07.1983
(Vitamin B6).
17. Penicillin skin/eye Ointment. GSR NO.
578 (E) Dated
23.07.1983
18. Tetracycline Liquid Oral preparations. GSR NO.
578 (E) Dated
23.07.1983
19. Nialamide. GSR NO.
578 (E) Dated
23.07.1983
20. Practolol. GSR NO.
578 (E) Dated
23.07.1983
21. Methapyrilene, its salts. GSR NO.
578(E)Dated2
3.07.1983
22. Methaqualone. GSR NO.
49 (E)
Dated
31.01.1984
23. Oxytetracycline Liquid Oral preparations. GSR NO.
322 (E)
Dated
03.05.1984
24. Demeclocycline Liquid Oral preparations. GSR NO.
322 (E)
Dated
03.05.1984
25. Combination of anabolic Steroids with other drugs. GSR NO.
863 (E) Dated
22.11.1985
26. Fixed dose combination of Oestrogen and Progestin (other than Substituted
oral contraceptive) containing per tablet Estrogen content of vide GSRNO.
743 (E)
more than 50mcg (equivalent to Ethinyl Estradiol) and content of Dated
more than 3 mg (equivalent to Norethisterone 10.08.1989
Acetate) and all fixed dose combination injectable preparations
containing synthetic Oestrogen and Progesterone.
27. Fixed dose combination of Sedatives/hypnotics/anxiolytics GSR NO.
with analgesics-antipyretics. 999(E)Dated26.
12.1990
28. Fixed dose combination of Rifampicin, isoniazid and Substituted
Pyrazinamide, except those which Provide daily adult dose vide GSR
NO.100(E)
given below: Dated
11.02.2003
Drugs Minimum Maximum
Rifampicin 450mg 600mg
Isoniazid 300mg 400mg
Pyrazinamide 1000mg 1500mg
29. Fixed dose combination of Histamine H-2 receptor antagonists GSR NO.
with antacids except for those combinations approved by 999 (E)
Dated
Drugs Controller, India. 26.12.1990
30. The patent and proprietary medicines of fixed dose GSR NO.
combinations of essential oils with alcohol having percentage 999 (E)
Dated
higher than 20% proof except preparations given in the Indian 26.12.1990
Pharmacopoeia.
84. Human Placental Extract and its formulations for human use Substituted
except its vide GSR NO.
418 (E)Dated
1. Topical application for wound healing, and 30.05.2011
2. Injection for pelvic inflammatory disease.
85. Sibutramine and its formulations for human use. GSR NO.
82(E) Dated
10.02.2011
86. R-Sibutramine and its formulations for human use. GSR NO.
82(E) Dated
10.02.2011
87. “Gatifloxacin formulation for systemic use in human by any GSR NO.
route including oral and injectable”. 218(E) Dated
16.03.2011
88. Tegaserod and its formulations GSR NO.
218(E) Dated
16.03.2011
89. Letrozole for induction of ovulation in anovulatory infertility. GSR NO.
752(E) Dated
12.10.2011
90. Serodiagnostic test kits for diagnosis of tuberculosis GSR 432 (E)
Dated
07.06.2012 &
GSR 433 (E)
Dated
07.06.2012
91. Dextropropoxyphene and formulations containing G.S.R.332 (E)
Dextropropoxyphene for human use dated
2# 23.5.2013
518. Substituted
Fixed dose combinations of Corticosteroids with any other vide GSR
drug [excluding Fixed Dose Combination of Tamsulosin HCl NO. 255(E)
Dated
0.4mg (as film coated modified release tablet) + Deflazacort 07.04.2021
30mg in hard gelatin capsule] for internal use except for
preparations meant for meter dose inhalers and dry powder
inhalers.
(a) The manufacturer shall indicate in a conspicuous manner on the package-inserts and
promotional literature of the dextropropoxyphene and its formulations: -
“Use of drug for cancer pain only”, and
“Daily administered dose shall not exceed 300mg. per day”.
(b) The container of the medicine containing dextropropoxyphene shall be labeled with
the following words: -
Use of drug for cancer pain only”, and
“Daily administered dose shall not exceed 300 mg per day”
(c) The manufacturer shall advise the registered medical practitioners to administer
or prescribe the said drug and its formulations for use in patients with cancer pain
only.
3#
As per Hon'ble Supreme Court order dated 15.12.2017, the list of 15 FDCs were claimed
prior to 1988. The matter is still under examination in consultation with Expert
Committee.
4#
As per Hon'ble Supreme Court order dated 14.02.2019, the list of 04 FDCs were claimed
prior to 1988. The matter is still under examination in consultation with Expert
Committee.
5#
The Notification of S.O. No. 705 (E) dated 10.03.2016 [S.O. No. 4379 (E) dated 07.09.2018]
was quashed by Hon’ble Delhi High Court vide its order dated 13.03.2019. The CDSCO has
filed an appeal against the order dated 13.03.2019 and the matter is sub judice.
The Notification of S.O. No. 760 (E) dated 10.03.2016 [S.O. No. 4429 (E) dated 07.09.2018]
was quashed by Hon’ble Delhi High Court vide its order dated 18.02.2019 The CDSCO has
filed an appeal against the order dated 18.02.2019 and the matter is sub judice.
The Notification of S.O. No. 806 (E) dated 10.03.2016 [S.O. No. 4471 (E) dated 07.09.2018]
& S.O. No. 807 (E) dated 10.03.2016 [S.O. No. 4472 (E) dated 07.09.2018] were quashed
by Hon’ble Delhi High Court vide its order dated 13.02.2019. The CDSCO has filed an
appeal against the order dated 13.03.2019 and the matter is sub judice.
The Notification of S.O. No. 814 (E) dated 10.03.2016 [S.O. No. 4479 (E) dated 07.09.2018]
was quashed by Hon’ble Delhi High Court vide its order dated 22.02.2019. The CDSCO has
filed an appeal against the order dated 22.02.2019 and the matter is sub judice.
The Notification of S.O. No. 1855 (E) dated 08.06.2017 [S.O. No. 4706 (E) dated
07.09.2018] pertaining to FDC of S(+) Etodolac + Paracetamol was quashed by Hon’ble
Delhi High Court vide its order dated 22.01.2020.
Note: The above list of prohibited Drugs is prepared as per the records available with this
office. If discrepancy is observed, the same may be brought to the notice of this office along
with documentary evidence for necessary action.