The small scale pharma units in the country have sought Prime Minister Dr Manmohan Singh's intervention to scrap Drugs Controller General of India's (DCGI) proposal to make bar coding mandatory for all medicines which is being implemented to check spurious (fake) drugs in the country. “It is obvious that use of bar codes is not going to benefit the common man as the DCGI proposal will only help increase the prices of medicines”, they argue.
Terming the DCGI proposal a ‘fake solution to a fake problem,’ the small scale industry said that the bar codes are used by manufacturers to prevent counterfeits and they have no role in ensuring quality of the products. Even a poor quality or fake item can have a bar code, they said.
The small scale industry argues that an owner of a brand name must register it with the Trade Mark authority to prevent use by others. But 90 per cent trade names of medicines in India are not registered. Even large manufacturers have not registered many of their top selling brands. Hence the use of bar codes will serve no purpose unless it is made mandatory to register all trade names. But, DCGI is neither concerned nor empowered to insist on the registration of brand names. It is also the government’s policy to proactively encourage the use of cheaper drugs under generic names where brand names are not used and therefore bar codes have no utility.
Opposing the DCGI proposal tooth and nail, secretary general of SME Pharma Industries Confederation (SPIC) Jagdeep Singh said, “the bar code technology is not fool proof. It is possible for counterfeits to copy, create and use bar codes. If ATM cards can be duplicated, so can bar codes. Spurious drugs can also have bar codes.”
Expressing the unviability of the bar coding system, the small units say that strips of many drugs are so small (such as Zentel 30mm x 30mm) that even legally mandatory information on ingredients, schedule with warning, batch number, price, name and address of manufacturer can not be accommodated. It is impossible to include a bar code in the available space even if it were to serve any useful purpose. Moreover strips are cut into pieces and sold. The bar code can not appear on such cut strips. There is no way bar code can be provided on a tiny ampoule of tetanus toxoid (15mm x 15mm). A bar code on the carton or container is meaningless because its contents can be replaced and in any case consumers do not have access to it.
Besides, customers, on their own, can not use bar codes to identify genuine from counterfeits. Moreover, the problem in India is certainly not of counterfeit medicines. According to a survey done by the DCGI in 2009, around 24,136 samples were lifted and only 11 were found to be counterfeits. Hence, such an action on counterfeits has no justification, the small scale industry feels.