Karnataka drugs control dept seizes 6 not of standard quality drugs from pharmacy outlets
Karnataka drugs control department has raided a few chemist outlets in the state and seized six not of standard quality drugs. The inspections were carried out over two days in March end and the test reports have been dispatched from the drug test labs recently. These drugs were tested at random during a surprise inspection carried out by the department’s team of inspectors
Of the six drugs, five are manufactured out of Karnataka and only one drug is produced at Malur district in the state by Medopharm.
All drugs which are not of standard quality were tested at its three labs in Bengaluru, Hubli and Bellary.. These drugs are flavoured dispersible A moxicillin Trihydrate manufactured by Minopharm Laboratories at Pernamitta in Andhra Pradesh, Powering by Eifil Pharma in HPSIDC in Baddi, Crispa A Tablets manufactured by Kare Labs in Verna Industrial Area Goa, Enflocin manufactured by B&T Pharmaceuticals, Animal Healthcare, Hyderabad, Medomo manufactured by Medopharm in Malur district in Karnataka and Rabinem DSR by Lifevision Healthcare, in Solan district in Himachal Pradesh.
Raghurama Bhandary, drugs controller said,” we have issued the notices to these companies and they will need to now look into these products”.
The department has also alerted all government and private hospitals, besides nursing homes and clinics not to prescribe these drugs and stock them at the pharmacies. The general public have also been cautioned not to purchase these drugs over-the-counter.
“These inspections are part of the standard checks. It is critical to make sure that products are of good quality,” said the Karnataka drugs controller.
The department has adopted the electronic dispatch mode to ensure speedy transmission of reports. It has opted to disburse the information via small message service (SMS) as it enables informing not just the pharmacy retailers and wholesalers besides the manufacturer on the status of the drug contents.
According to the Parliamentary Standing committee on health and family welfare, a drug can be categorised 'not of standard quality' for a variety of both major and minor technical reasons such as not stating the name of the pharmacopoeia correctly, problem with quality of bonding agent, colouring agent, dissolution time, etc. However, there are other more serious cases, where the active ingredient is significantly less in quantity that can harm patients. Therefore, the Committee too has called on to address this issue as it is seen to require rigorous checks during the procurement of active pharmaceutical ingredients (APIs) and excipients by in-house quality control departments of manufacturers or handle the issue of disintegration during transportation or storage at distribution/retail levels.