The Karnataka drugs control department is now empowered by the state government to handle 15 services under the Sakala Act. The legislation introduced in 2011 and amended in 2014 so long mandated only 5 services related to grant and renewal of pharmacy trade among others. Now with 15 services coming under its ambit, the drugs control department needs to ensure that under the scheme every person has the right to obtain related services in accordance with this Act within the stipulated time specified in the Schedule M, failing which the concerned officers will be questioned and taken to task.
The 15 services that require time-bound implementation are issue of WHO certificate, market standing certificate, GMP certificate as per Schedule M, No conviction certificate, production capacity certificate, validity license certificate, essentiality certificate, neutral code number, issue of manufacturing and marketing certificate, quality and capacity certificate, performance certificate, installation and registration/products certificate, Certificate of Pharmaceutical Products (COPP) and Good Laboratory Practices.
The Act has called for designated officers to carry out the services within a stipulated timeline of 7 working days. In the case of issue of performance certificate it is 10 working days and for COPP it is 20 working days. If the assistance to issue any of the certificates is not adhered to then the pharma and the biotech industry could now approach a competent officer from the department of health and family welfare to get the same fulfilled within a duration of 15 days. If this fails too, then the industry could move to the appellate authority which needs to provide the approval within 15 days.
The move by the state government to specify timelines will now bolster efficiency and transparency. It indicates accountability which is the hallmark of smooth functioning of our department, Karnataka drugs controller Bhagoji T Khanapure told Pharmabiz.
“Our dedicated technical cell which used to handle a few services is now in sync to adhere to the 15 Sakala services from March 1, 2018. Earlier the timing of this cell was 3 pm to 5pm. Now it is changed to 11 am to 1 pm. The objective is to ensure acceptance and rejection of the industry’s submission could be communicated on the same day”, he added.
Moreover, the industry is not held up with unnecessary delays for want of certificates to export or market its drugs within the country. The prompt services have given the much-needed confidence to the department’s capability as far as approvals are concerned. Going forward such competence of the department to deliver services in a time-bound manner will in turn empower the pharma and biotech industry to make certain effective delivery times. Eventually this is accelerates economic growth of the state and country, said drugs controller Khanapure.