Kerala Drug Control Department has decided to insist on mandatory registration of all drug products of companies outside Kerala before they start marketing them in the state.
The move is to ensure the quality and to have a comprehensive database of the drugs available in the Kerala market, as at present the state DCA lacks much information on the 23, 000 odd drugs sold in the state. The rule is likely to be implemented within three months time, as a team of officials led by an assistant drug controller is in the process of compiling the feedback from companies.
According to M P George, the assistant drug controller in charge of the project, the DCA has instructed more than 100 leading pharmaceutical companies to produce attested copies of their manufacturing license and details of the product with technical information of each of the drugs marketed in the state. About 50 companies have responded so far. The DCA hopes to complete this process within another two-three months time. Sources indicated the department was likely to strictly implement the rule once the drug controller promulgates the notification on mandatory registration.
Once the data is fully available, the DCA would circulate the details to the enforcement officials for reference. At present, manufacturers of general hospital items and government hospital suppliers have been exempted from the mandatory registration, as it would further compound the laborious data compilation process. However, the department was likely to mandate the rule applicable for these sectors also at a later stage, said sources.
They said lack of enough manpower with the state DCA caused to delay implementing the proposal, mooted a year ago. However, a group of committed officials decided to go ahead with the process.
As per the move, if any company, say for example, Ranbaxy, is marketing a product in the state manufactured by its contract manufacturer, it is binding on Ranbaxy to produce the manufacturing license before the DCA. With this multinationals that manufacture numerous contract-manufactured products, would have to pool a lot of information and manpower for producing the documents before DCA, noted the sources.
The sources noted that out of the 23, 000 odd drugs available in the state, only 2300 drugs have manufacturers in the state. The state makes only about 10 per cent of the medicines consumed in the state, despite the presence of 50 odd active allopathic drug manufacturers. The state has a market of over Rs 700 crore annual drug sales.