Last week, the Union health ministry issued a directive to the health departments of all states and Union Territories instructing them to grant or renew licenses for manufacture or sale of drugs only in generic names. The state licensing authorities at the time of granting a product licence for drug formulations, the trade name as submitted by the manufacturer, is also endorsed along with generic name of the product. This practice thus gives legitimacy to market the drug under the brand or the trade name to the manufacturer. Now, effective implementation of the new order may enable patients to purchase low priced drugs in one therapeutic category with the advice of the pharmacists. Currently physicians prescribe company specific brands leaving no option to the patients or to the pharmacists to go for cheaper product in a therapeutic group. The intention of health ministry is to bring an end to the growing unethical practices in the pharmaceutical industry and trade. Brand promotion amongst the pharma companies is rampant today and doctors are being regularly bribed for the purpose. One of the main reasons for the high cost of medicine today is the increasing cost of brand promotion by the companies. Printing only the chemical or the generic name of the drug on the label makes it difficult to the companies to promote their products as they are doing now.
The Central directive is being strongly objected to by the pharma manufacturers as they think it is confusing and can therefore affect their operations. It is possible that some industry associations may think of challenging the order. No doubt, the directive is ridden with some administrative issues and there is no clarity on matters like the fate of brands for which licenses are already issued by various state authorities. Nearly a lakh of drug brands are already in circulation in the country and a majority of them are combination drugs. To recall all of them from the market and reissue licences in generic names is next to impossible. It will be extremely difficult to identify a drug combination by generic name as the chemical names are usually lengthy and confusing. A serious problem that can arise in the new environment is at the time of prescribing drugs by the doctors. Most of the physicians are not familiar with generic names of the drugs and errors can occur while prescribing drugs in chemical names. As most medical shops are managed by unqualified sales persons in the country, there could also be dispensing errors while handling prescriptions in generic names. It seems that these administrative issues have not been considered by the health ministry before issuing such an important directive.