Aug 14,2024
The Karnataka drugs control department, which ranks third in the country for total implementation of the Drugs and Cosmetics Act & Rules behind Maharashtra and Gujarat, aims to attain the top spot, Karnataka Drugs Controller in-charge Dr Umesh Shantharaj said.
“Our state has been in the third position for a while and now my vision is to move up the ladder and take the top slot. The need of the hour is to raise the bar in enforcement of drug regulations and ensure high quality standards of medicines. There is no reason why Karnataka should lag behind in drug enforcement. We need to become No. 1,” he added.
The biggest responsibility of a regulator is to ensure the safety, efficacy and high quality of the medicines reach the patients at a cost fixed by the National Pricing Control Authority (NPPA), he stated.
Taking charge on August 1, Dr Umesh told Pharmabiz that he is entrusted to oversee all the functions of the state drugs control department spanning from enforcement, drug testing laboratory, Board of Control for Examination Authority. Reaching the top spot in the country for regulation adherence will indeed be challenging but a worthwhile endeavour to elevate Karnataka’s performance.
Revised Schedule M on par with WHO-GMP is critical for this industry which is recognised as the Pharmacy of World. The task on hand is to inspect the large manufacturing units for which the deadline was July 5, 2024 to ensure that they are compliant and ensure total adherence by MSMEs for which the last date is December 27, 2024, he said.
Then there is an impending shortfall of drug inspectors (DIs) as their recruitment decision is with the Supreme Court. DIs are the heart of the drugs control department. Yet with a handful of enforcement officers, our team is carrying out the required surprise checks for not-standard quality (NSQ) drugs and raising flags on violations to the D&C Act which is commendable. Current shortfall of DIs are 5 as against the total sanctioned posts of 112. In fact, there were 11 inspectors and six were promoted as assistant drugs controllers. We are in talks with health minister Dinesh Gundu Rao to look into this. Once the required DIs are inducted, our department will go full throttle in inspections across the 31 districts, he said.
There is a visible lack of investments in pharmaceuticals and as the drugs controller in-charge, meetings will be held with the industry to ascertain reasons for not being able to attract global big ticket investments. It is of prime importance for our department as the state regulatory authority to be with the industry as only working together will enable us to help Karnataka pharma sector progress, Dr Umesh said.
Every effort to interact with the government on industry issues are on. The 2022 move to form a committee for the Pharma Park will be re-ignited as this file is pending with the government and therefore the process is easier. Karnataka also needs a NIPER at Bengaluru which is justified as the state already home to 388 pharmacy colleges with an impressive line-up of the related industries.
Also we will ensure that no MSMEs will shut down as the drugs control department will extend the much-needed guidance to implement the revised Schedule M, he said.
On a concluding note, Dr. Umesh said that manufacturers are cooperative with the state regulatory authority. This is the only state where the adherence is total making us in top three in the country because the industry is responsible not to deviate regulations to keep their image intact.
Source: Pharmabiz