TEAM HERALD
teamherald@herald-goa.com
PANJIM: In an attempt to reduce its misuse, the government has notified a new genre of scheduled drugs – Sch H1- that specifies 46 drugs as well as their formulations have to be compulsorily sold against proper prescription.
But more importantly, all details of sale, the prescriber’s name and address as well as the name of the patient have to be maintained in a separate register and records to be kept for three years, which can be inspected at anytime. It will come into force from March 2014.
This however, does not apply for ophthalmic and local formulations. The notification by the Union ministry of health and family welfare says that when draft rules to amend the drugs and cosmetics rules 1945 were published, they were done without consulting the drugs technical advisory board.
This procedure is as required by Sections 12 and 33 of the Drugs and Cosmetics Act 1949. These rules were then put out in March 20, 2012 inviting objections and suggestions from those likely to be affected.
After the drugs technical advisory board has been consulted in the matter and objections and suggestions received were considered by the Central Government and according to Sections 12 and 33 of the Act and after consultation with the drugs technical committee the rules were framed. The amendment has substituted the word Schedule H by words Schedule H and schedule H1.
“In the supply of drugs specified in schedule H1 shall be recorded in a separate register at the time of the supply giving the name and address of the prescriber, the name of the patient the name of the drug and the quantity supplied and such records shall be maintained for three years and open for inspection,” says the notification by Joint Secretary Arun K Panda.
It also says that if the drug contains a drug substance specified in schedule H1 the drug formulation shall be labeled with the symbol Rx which shall be in red and conspicuously displayed on the left top corner of the label and shall also be labeled with the following words in a box with a red border.
The state has seen the misuse of many drugs and over the counter sell of scheduled drugs continues.
In genuine cases, this does not construe so much of a problem, but many times these drugs are misused.
As far back as 2011 Herald had written on how easy it was to purchase sleeping pills over the counter –‘call it as easy as buying a candy.’
Even today it is still not difficult with pharmacies still not observing the provisions of Drugs and Cosmetics Rules 1945. This new notification seeks to curb this, but implementation will prove to be a challenge.
In 2011, Herald’s investigation had found that one could casually buy hundreds of sleeping tablets by procuring small quantities of pills from each pharmacy.
