|
Karnataka pharma industry concerned over absence of licensing authority in state DC dept
|
|
Nandita Vijay, Bengaluru
December 29 , 2022
|
|
|
The pharmaceutical industry in Karnataka is concerned over the absence of a licensing authority in the state drugs control department as pending approvals affect exports and revenues. Besides, with the new Covid spread in China and its impact on India and the rest of the world, the industry sees the need to ensure adequate stock of medicines to face any healthcare emergency situation.
In this regard, the industry has called for immediate appointment of a licensing authority in the State drugs control department. Absence of a licensing authority has resulted in undue delay to manufacturing activities.
It was on November 23, 2021 that the state government appointed Deepak Gaikwad, deputy drugs controller, regional office, Belgaum, drugs control department as ‘Licensing Authority’. He worked out of the Bengaluru head office of the Karnataka drugs control department. Now Gaikwad superannuated on November 30, 2022. From December 1, 2022 till date, there is no licensing authority for the pharma industry in Karnataka.
As on today, nearly 500 applications are pending on the online Seva Sindhu portal of the Karnataka government in addition to offline applications for additional products licenses and GMP (good manufacturing practices) Certifications for Exports.
A big cause for concern is the unpredictable Covid spread where the Karnataka government has announced measures to prevent the ferocious spread of the BF.7 Covid variant scare like what is happening in China. Here, the industry said that during the first and second wave of Covid, Karnataka pharma chipped in its supplies of medicines and medical devices which was administered and deployed respectively in patient care.
Now in the wake of another threat of the Covid and with people diagnosed of the virus, the government needs to appoint a licensing authority immediately. All these drugs are supplied via tenders which the government calls for and this is a cumbersome and time consuming process requiring certificates from licensing authority. Therefore, the state government needs to immediately appoint a licensing authority to ensure adequate drug supplies. Also shortage of critical drugs in Covid care will only lead to unwarranted complications for patients and pressure on the pharma industry in Karnataka, sources in Karnataka pharma industry pointed out.
In this regard, the industry communicated to the Karnataka government on the non-existence of a licensing authority which is causing considerable challenges for the pharma industry with regard to licenses and certificates. As a consequence, business, especially exports is suffering.
We therefore request you to kindly address the lacunae on priority basis. This is also on the best interest of the Karnataka pharma industry, they added in his communication to the state government.
The state has 425 manufacturing units. Companies from here contribute 10 per cent to the country’s exports. At least 10 major brands are manufactured by Karnataka pharma companies which is a clear indication of the dependability on quality and timeline deliveries. Therefore a licensing authority is mandated to approve drugs in a time-bound manner, stated the industry.
|
|
|
|
|
|
|
|
TOPICS
|
That foods might provide therapeutic benefits is clearly not a new concept. ...
|
|
|
|
|