|
DCGI directs state drug controllers & industry associations to urgently address non-compliance to Schedule H, H1 and X
|
|
Shardul Nautiyal, Mumbai
February 22 , 2019
|
|
|
In its ongoing crackdown on illegal sale of narcotic drugs, the Drug
Controller General of India (DCGI) has directed all the state drug
controllers and the industry to urgently address non-compliance to
Schedule H, H1 and X and plug the loopholes in the drug supply chain
system.
In a letter addressed to the state drug controllers and
industry associations, DCGI has stated that concerns have been raised
regarding illegal sale of prescription medicines in a clandestine
manner. Representations have been received in the context of sale of
psychiatric medicines without prescription also.
This letter is a
wake up call for the drug regulatory mechanism across the country as
the central drug regulator has been getting reports of rampant misuse of
certain habit forming drugs and illegal sale of psychiatric medicines
without prescription over the past few months.
Taking cognizance
of the scenario, Gujarat Food and Drug Control Administration (FDCA)
recently canceled 27 drug retail licenses and suspended 35 drug retail
licenses for illegal sale of codeine containing cough syrup without
prescription and purchase bill
It seized 40,352 codeine phosphate
containing cough syrup bottles of 100 ml each worth Rs. 46 lakh from a
firm based in Ahmedabad.
Following its irrational use, some
companies have, however, stopped producing codeine phosphate containing
brands. This has led to circulation of spurious brands in the market,
according to an official.
However, unscrupulous drug dealers
posing as authorised stockists have found their way in violating the
conditions of license as stipulated in Rule 65 of the Drugs and
Cosmetics (D&C) Rules. It has also been observed that cough syrups
are also sold in the absence of pharmacist.
The Central
government through a notification dated November 14, 1985 had declared
the list of narcotic drugs and preparations to be considered to be
manufactured drugs. At Serial Number 35 codeine is stated. This entry
has exemption for preparations compounded with one or more other
ingredients and containing not more than 100 mg of the drug per dosage
unit and with a concentration of not more than 2.5 per cent in undivided
preparation.
Besides this, it also stipulates as being
established in therapeutic practice as another criteria for its
exemption as manufactured narcotic drug.
Hence, these
preparations are also as per Rule 97(c) not to be labeled with suffix
NRx (narcotic drugs) but rather to be labeled as Rx (Schedule H) as per
Rule 96(b) of Drugs and Cosmetics Act, 1940 and Rules thereunder.
Schedule
H and H1 implies that it contains a substance specified in Schedule H
and H1 with the symbol Rx. The symbol need to be conspicuously displayed
on the top left corner with the warning that it has to be sold in
retail on the prescription of a registered medical practitioner only.
Schedule
X contains a substance specified in Schedule X to be labeled as XRx
which shall be in red conspicuously displayed on the top left corner of
the label with the words saying to be sold in retail on the prescription
of a registered medical practitioner only.
|
|
|
|
|
|
|
|
TOPICS
|
That foods might provide therapeutic benefits is clearly not a new concept. ...
|
|
|
|
|