Karnataka drugs control is now all set to conduct a stringent inspection of its pharmaceutical manufacturing plants that are engaged in exports. The move follows the recent slew of new guidelines issued by the global regulatory authorities.
The Drugs Controller General of India (DCGI) too has taken on the onus to issue written confirmation (WC) certificate well ahead of the stipulated deadline of July 1, 2013 in line with the requirements of the European Union Directives which is intended prevent falsified medicinal products from entering the EU from other countries.
“In lieu of these developments, we have taken a decision that if the enforcement team consisting of 109 officers carry out inspections, it will assure the manufacturers and the state regulator that all guidelines have been adhered to. Although the state is so far known for its impeccable quality control practices, yet there is need for constant monitoring, Dr BR Jagashetty, drugs controller, government of Karnataka told Pharmabiz.
In the first week of June 2013, the department would be engaged in inspections spanning from raw materials sourcing to production, packaging and distribution covering warehousing too. This would help the pharma company and the regulatory authority to double check if at every stage the right practices are in place, he added.
“The inspections could be either carried out by our state drugs control inspectors along with the CDSCO officials who are in Karnataka or may also be undertaken independently by the state enforcement teams only.
In mid 2012, the department began issue of new and renewal manufacturing licenses which has created an environment of transparency and efficiency. “Therefore now we wish to make sure that there are no slip-ups in regulatory adherences,” said Dr Jagashetty.
Further, the state government has also recently sanctioned 77 posts to drugs control dept to strengthen enforcement activities These include 50 inspectors, 21 assistant drug controller, five deputy drugs controllers and one system analyst. This takes the total number of enforcement officials from the existing 109 (62 drug inspectors, 39 assistant drugs controllers & eight deputy drugs controllers) increases to 185 (112 DI, 60 ADC, 14DDC & 01 system analyst).
The drugs control department has a Five Year growth strategy 2012-2017 with a prime focus on quality of drugs in the market, said Dr Jagashetty.
Of the 236 pharma companies in Karnataka which are all Schedule M compliant, 70 units export to global markets. The facilities include US FDA, UK MHRA, EMA, TGA Australia and MCC South Africa audited units. Leading exporters include Strides Arcolab, Biocon Limited, Medriech, Micro Labs, Bal Pharma, Shilpa Medicare, RL Fine Chem, Srushti Pharmaceuticals and Embiotic, among others.
The state drugs control department is known for its regular surprise inspections of both production units and the pharmacy trade outlets. There are three drug test labs at Bengaluru, Hubli and Bellary. Efforts are on to commission mobile test labs for its five regional offices at Bengaluru, Mysore, Hubli, Bellary and Gulbarga and set-up a Biological drug lab.