Health Ministry notified on implementation of Schedule H1 drugs in D&C rules | No more OTC selling of antibiotics

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The Drugs and Cosmetics Rules, 1945 (D&C rules) were amended vide Drugs and Cosmetics (Fourth Amendment) Rules, 2013 published under Gazette notification G.S.R. 588(E) dated 30.08.2013 regarding the inclusion of Schedule H1 under the D&C rules containing certain antibiotics, anti-TB drugs and habit forming drugs. The notification states that these rules will come into force after six months of their publication in the official Gazette i.e. from 1st March, 2014

Various representations were received from the Drug Manufacturers Associations and Individual manufacturers that the chemists may not be able to sell the drugs covered under the Schedule H1 which are not labeled as per provisions of the amended rules even though these drugs at the time of their manufacture were labeled in accordance to the rules applicable to them.

Ministry of Health and Family Welfare considered all representations and it has been decided that the drugs included in the Schedule H1 manufactured upto 28th February, 2014 without the labeling requirements specified in the said notification but labeled as per provisions applicable for them at the time of their manufacture, may continue to be sold even beyond 1st March, 2014.

The notification specifies, “The Chemist, while selling Schedule H1 drug, would, however, be required to comply with the requirements for the sale of drugs covered under the said notification in respect of requirements of sale of these drugs against the prescription of an RMP and maintenance of sale records as specified therein.”

As per Gazetted notification G.S.R. 588(E), followings are the drugs included in schedule H1 drugs: (46 drugs)

Alprazolam, Balofloxacin, Buprenorphine, Capreomycin, Cefdinir,
Cefditoren, Cefepime, Cefetamet, Cefixime, Cefoperazone, Cefotaxime,
Cefpirome, Cefpodoxime, Ceftazidime, Ceftibuten, Ceftizoxime,
Ceftriaxone, Chlordiazepoxide, Clofazimine, Codeine, Cycloserine,
Diazepam, Diphenoxylate, Donpenem, Ertapenem, Ethambutol Hydrochloride,
Ethionamide, Feropenem, Gemifloxacin, Imipenem,
lsoniazid, Levofloxacin, Meropenem, Midazolam, Moxifloxacin,
Nitrazepam, Pentazocine, Prulifloxacin, Pyrazinamide, Rifabutin,
Rifampicin, Sodium Para-aminosalicylate, Sparfloxacin, Thiacetazone,
Tramadol, Zolpidem


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