Following a recent order by the Allahabad High Court on the computerisation of drug distribution system up to retail level, the Drug Controller of India (DCGI) has set up a committee under Malai Mitra, deputy drugs controller. The committee will conduct countrywide surveys to get the industry's view and suggestions on how to implement the computerisation of drug distribution system upto retail stage across the nation.
This move is expected to bring a check on the entry of counterfeit drugs into the market spoiling the reputation of the country and genuine manufacturer-exporters of pharmaceutical products.
Keeping in view the serious implications of spurious drugs on public health as well as the losses to genuine drug manufacturers, the Allahabad High Court recently heard a petition stressing on the need for computerisation of drug distribution system up to retail level. It has given directions to the drugs regulator to device and place in operation a system for distribution of drugs across the Country based on computerisation from manufacturing to retail levels so to have a check on spurious and adulterated drugs. The Court has desired that the system be formulated in consultation with NIC and association of the manufacturers.
Court’s view was that genuine and bonafide manufactures will be interested in a system which checks the proliferation of spurious or sub-standard drugs by unreliable and un-monitored producers.
Taking a cue from it, the DCGI set up a committee to involve all the stake holders and conduct a survey .The committee consists of H G Koshia, Commissioner, Gujarat Food & Drugs Control Administration, (FDCA), Salim Velji, director, Goa, Foods and Drugs Control Administration, Dr Jagshetty, Karnataka Drugs Controller, M Bhaskaran, Tamil Nadu Drugs Controller and this committee will be convened by Malai Mitra.
The focus of the committee will be to gauge the situation in the country with regard to counterfeit drugs and get a clear picture of it so that required steps can be taken in favour of implementation of computerisation of drug distribution system up to retail stage.
H G Koshia, commissioner, Gujarat FDCA informed that this system is basically for the consumers so that they can track the medicines they buy. He informed, “We want to make such a website through which the consumers can log in and get the legitimate source from where the drugs originated. This website will have a database from all the manufacturers who will have to put all the information about their drugs on the website.” He added that the committee shall work in a transparent manner along with the industry after consultation with various manufacturing organisation etc where people from NGO, local welfare associations shall be involved.
Many associations have responded positively towards the DCGI's decision to set up a committee and have extended full support to it. According to T S Jaishankar, chairman, Confederation of Indian Pharmaceutical Industry (CIPI), “Our association is committed to lend it support to any such system which is finalised after due deliberations with the stake holders.” He expressed that a concept paper may be finalised having complete details of the scheme and the same be placed in public domain inviting suggestions and comments of the stake holders, if deemed fit by the regulatory authority and approved by the Court.
Jaishankar informed that majority of CIPI member units are computerised and are using some kind of software for on-line maintaining of their production, inventory and distribution records and the present system can be made compatible to the extended system where C&F agents, distributors, stockist and retailers will be required to computerise their operations. However he pointed out that the success of the scheme is dependent on the computerisation at the retail level.
He suggested that the system so introduced will be efficient and cost effective and can be introduced or implemented in phased manner in specified regions and also for specified products having high turn over in such ranking, also that it must have legislative backing to be mandatory as a voluntary scheme may not succeed.