Warns of cancellation of licences in case of violation
Irfan Tramboo
Srinagar, Nov 26: The Drug and Food Control Organization (DFCO) in a bid to prevent the illicit use and sale of Habit-Forming Drugs (HFD), has issued several directives to be followed by the pharmaceutical companies particularly the operators of the medical shops.
In this regard, it has been stated that to check, prevent and stop the illicit use of HFDs, the department is committed to zero tolerance towards the unregulated sale of such drugs which has been seen happening over the counter for the last some time.
The HFDs, the DFCO said, include Tapentadol, Diazepam, Clonazepam, Phenobarbital, and allied preparations in any generic or branded generic or branded form, single ingredient or Fixed Dose Combinations.
“The pharma trade fraternity has been impressed upon to strictly follow the guidelines which will go a long way in achieving what the department is intending to,” the officials said.
Under the directives which have been issued, it has been stated that the prescription must not be dispensed more than once unless the prescriber has stated thereon that it may be dispensed more than once.
Those who provide the medicines on the prescription have been directed to record the name and quantity of medicine supplied as well as the name and address of the patient including the prescription date and name. They also have to see to it that the name and address of the prescriber is clearly mentioned on the prescription.
As per the guidelines, all records and registers must be maintained as per the mandate of the Drugs & Cosmetics Act, 1940 & Rules and such records should be made available for inspection.
While the Chemists have been directed to install HD CCTV, and Computerized Billing Systems in their respective establishments, it has also been noted that the records of Schedule H, H1 and X drugs shall be preserved by the licensee for a period of two years.
Further, the chemists have also been directed not to dispense medication if the prescription is incomplete, has or does not bear alteration(s) signatures of the prescriber who has to be a registered practitioner.
It has also been made clear that the medicines must not be provided on the production of the prescription when there are reasons to believe that the prescription has not been issued by a valid prescriber, while it has also been noted that the personal information of the end user and prescriber must not be disclosed.
The officials said that the department has decided to adopt a zero-tolerance approach to counter the unregulated sale of Habit-Forming Drugs in the larger interest of a drug-free society in J&K.
Further, it has been warned that in case any pharma trader indulges in wilful omission or breach concerning the purchase, or sale of Habit-Forming Drugs, the drug sale licenses of such dealers will be cancelled immediately.
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