DRAP launches provisional database of medicines
Body warns that the database cannot be used for legal purposes, invites manufacturers to point out flaws
ISLAMABAD:
The apex drug regulator, after completing a process of digitally listing all registered products, has launched a web portal where people can access the database of medicines in the country.
According to the Drug Regulatory Authority of Pakistan (Drap), their Pharmaceutical Evaluation and Registration Division had created a provisional database after starting a computerisation process for the 40-year-old manual drug registration record earlier this year.
A spokesperson for Drap said that the public, healthcare officials, can use the database, available on Drap’s website (www.dra.gov.pk), to check the registration number, proprietary or brand, generics with composition, the name of manufacturer or importer.
The official, however, warned that since the computerisation process was being undertaken for the first time, the records were being continuously verified and scrutinised. Hence, the authority clarified that the information on the site cannot be used for any legal reference. Moreover, Drap invited manufacturers to review information about their products.
The official explained that under the Drug Act 1976, pharmaceutical companies which manufacture, import or export medicines, should register their product with the government before making it available to the market.
Fighting counterfeits: DRAP launches barcodes for drugs
The Drug Registration Board (DRB), after the product completes the registration process laid down in the licencing, registering and advertising (LRA) rules 1976, registers the drugs.
“Online access to this database will strengthen the regulatory system and monitoring in order to eradicate unregistered, substandard, spurious, falsified and counterfeit drug products from the country,” he said.
Apart from the database, the official said that they had introduced a WHO-CTD format for drug registration dossiers, 2-D barcodes on labels, mandatory GMP certified source of raw materials, the establishment of pharmaco-vigilance system would help provide quality drugs in the market and allow patients to spot fake or spurious drugs.
“These steps have put few culprits [involved in the manufacture of spurious drugs] in trouble and they are trying to malign the officials of Drap and the ministry of health through baseless complaints and thus to divert public and agencies attention from their misdeeds.”
Published in The Express Tribune, December 30th, 2017.
The apex drug regulator, after completing a process of digitally listing all registered products, has launched a web portal where people can access the database of medicines in the country.
According to the Drug Regulatory Authority of Pakistan (Drap), their Pharmaceutical Evaluation and Registration Division had created a provisional database after starting a computerisation process for the 40-year-old manual drug registration record earlier this year.
A spokesperson for Drap said that the public, healthcare officials, can use the database, available on Drap’s website (www.dra.gov.pk), to check the registration number, proprietary or brand, generics with composition, the name of manufacturer or importer.
The official, however, warned that since the computerisation process was being undertaken for the first time, the records were being continuously verified and scrutinised. Hence, the authority clarified that the information on the site cannot be used for any legal reference. Moreover, Drap invited manufacturers to review information about their products.
The official explained that under the Drug Act 1976, pharmaceutical companies which manufacture, import or export medicines, should register their product with the government before making it available to the market.
Fighting counterfeits: DRAP launches barcodes for drugs
The Drug Registration Board (DRB), after the product completes the registration process laid down in the licencing, registering and advertising (LRA) rules 1976, registers the drugs.
“Online access to this database will strengthen the regulatory system and monitoring in order to eradicate unregistered, substandard, spurious, falsified and counterfeit drug products from the country,” he said.
Apart from the database, the official said that they had introduced a WHO-CTD format for drug registration dossiers, 2-D barcodes on labels, mandatory GMP certified source of raw materials, the establishment of pharmaco-vigilance system would help provide quality drugs in the market and allow patients to spot fake or spurious drugs.
“These steps have put few culprits [involved in the manufacture of spurious drugs] in trouble and they are trying to malign the officials of Drap and the ministry of health through baseless complaints and thus to divert public and agencies attention from their misdeeds.”
Published in The Express Tribune, December 30th, 2017.