New Delhi, 21 March 2014: The Union health ministry has allowed the chemists to
sell
antibiotics listed under the Schedule H1, but manufactured before
February 28, without the new labelling requirements even as the
notification regarding the antibiotics has come into effect from March
1.
However, the chemists have been asked to follow other
instructions for the sale of these antibiotics with regard to
prescription and maintenance of
sale records as per the amended rule under the Schedule H1, according to the official sources.
The relaxation was given following the representations by the
trade bodies citing difficulties in relabelling of the products
manufactured earlier. The Government had notified the amendment to
include Schedule H1 under the Drugs and
Cosmetics Rules 1945 on August 30, 2013, containing certain antibiotics, anti-TB drugs and
habit forming drugs. The notification has come into effect from March 1, 2014, after the stipulated time of six months.
“The representations were received from the drug manufacturers
associations as well as individual manufacturers that the chemists may
not be able to sell the drugs covered under the Schedule HI which are
not labelled as per the provisions of the amended rules even though
these drugs at the time of their manufacture were labelled in accordance
with the rules applicable to them,” said a notice from the Drug
Controller General of India (DCGI).
“The representations have been considered by the Ministry of
Health and Family
Welfare and it has been decided that the drugs included in the Schedule
H1 manufactured upto February 28, 2014 without the labelling
requirements specified in the notification but labelled as per
provisions applicable for them at the time of their manufacture, may
continue to be sold beyond March 1, 2014. The chemist, while selling the
drugs included in Schedule H1 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 sales records as specified
therein,” the notice said.
After dilly-dallying on the issue of antibiotics policy for long,
the Government had amended the Drugs and Cosmetics Rules to insert
Schedule H1 category to regulate the use of antibiotics in the country,
but placing 46 antibiotics under category instead of original proposal
to include 91 drugs.
The government made it
compulsory for these listed antibiotics to carry warning also. “If it contains a
drug substance
specified in Schedule H1, the drug formulation shall be labelled with
the symbol Rx which shall be in red and conspicuously displayed on the
left top corner of the label,” according to the official notification by
the health ministry.
Antibiotics falling under third and
fourth generation
and several habit forming drugs are in the list. Alprazolam,
Balofloxacin, Buprenorphine, Capreomycin, Cefdinir, Cefditoren,
Cefepime, Cefetamet, Cefixime, Cefoperozone, Cefotaxime, Cefpirome,
Cefpodoxime, Ceftazidime, Ceftibuten, Ceftizoxime, Ceftriaxone,
Chlordiazepoxide, Clofazimine, Codein, Cycloserine, Diazepam,
Diphenoxylate, Doripenem, Ertapenem, Ethambutol Hydrochloride,
Ethionamide, Feropenem, Gemifloxacin, Imipenem, Isoniazid, Levofloxacin,
Meropenem, Midazolam, Moxifloxacin, Nitrazepam, Pentazocine,
Prulifloxacin, Pyrazinamide, Rifabutin, Rifampicin, Sodium
Para-aminosalicylate, Sparfloxacin, Thiacetazone, Tramadol and Zolpidem
are the drugs included in the list.
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