Karnataka Drugs Control department has sent in a proposal to the State government and Directorate of Health and Family welfare for the allocation of around Rs 15 crore to set up two more Regional Drug Test Labs. With this, the state will have a total of three testing labs.
The State drugs control department wants the labs to be located at Hubli and Bellary. Right now the Drug Test Lab in Bangalore located within the premises of the State drugs control department. There is a huge workload and only around 2,300 tests are being carried out annually, Dr. BR Jagashetty, drugs controller, government of Karnataka told Pharmabiz.
"We need to ensure that there is no circulation of spurious and not-of-standard quality drugs. The only way will be to increase the number of labs. There is also lot of pharmaceutical manufacturing activity going on in the northern districts of the State. Samples are passed down to Bangalore and there is a huge work load. We need to provide time bound and accurate results," pointed out the Karnataka drugs controller.
The facility at Hubli and Bellary will require any where between Rs 10-15 crore investment for the infrastructure and the latest equipment besides a team of qualified personnel. The new labs will give a major boost to the drug test initiatives, he added.
The state drugs controller is confident of getting the approval for the drug test labs for which he gives a maximum estimated time for commission by early 2010.
Going hand in hand with the drug test lab proposal is the also the need for an additional Government pharmacy college at Hubli in north Karnataka which can help the rural students have access to affordable and quality pharmacy education. Right now there are only private colleges in the region.
The department which has a total staff strength of 510 has around 200 vacancies resulting out of hiring stoppage. The drugs controller has asked for another 300 additional personnel. Recommendations are also made for outsourcing the staff.
The drugs controller has also formed a vigilance squad representing four officials which include 2 inspectors and one assistant drugs controller and one deputy drugs controller to study the activities in the manufacturing facilities at Maharashtra, Gujarat and Andhra Pradesh. The team will assess the modalities adopted by these states to weed out the presence of spurious drug production and circulation. A report on this will be submitted by the Squad in July-August to the drugs controller.
Further, there are also efforts to train the officers in the cadre of the assistant drugs controller and one inspector in the pharma industry. This will enable the officers to comprehend the various steps carried out during production and the kind of adherence to quality practices. It will also help to speed up the inspection processes as there are several practical difficulties during an audit. Five officers have also been sent for the NIPER training programme.
The department has also proposed for an allocation of Rs 10 crore for the computerization of the entire department. The project will be taken over by the State e-governance department. Computerization will offer provide the status online status of manufacturing licenses. The trade licensing will be taken on after this. There is a serious need for transparency and accountability and hence the computerization is a must for our operations, added Dr. Jagashetty.