An avoidable confusion has been created amongst the state drug licensing authorities by the office of the Union health ministry in October last by issuing an order to grant or renew product licenses only in generic names. Most of the SLAs subsequently stopped issuing licenses in brand names even for the purpose of exports. The Central directive is strongly objected by the pharma manufacturers and exporters as it is ambiguous and it can affect their operations. Hitherto, the state licensing authorities at the time of granting a manufacturing license for drug formulations, the trade name is also endorsed along with generic name of the product. This practice had given some kind of legitimacy to market the product under the brand name. This has been going on for several decades although the practice had led to unrestricted growth of similar sounding and confusing brands in the market place. And the health ministry had felt it necessary to curb this practice as it has been leading to prescription and dispensing errors. Now, the health ministry’s directive is intended to correct this but is riddled with some administrative issues with no clarity on matters like combination drugs and the fate of brands for which licenses are already issued by various state authorities.
In the wake of objections from the leading exporters and Pharmexcil, the health ministry issued two clarifications to SLAs last month. The one clarification said that granting or renewing of drug licenses in generic names will not be applicable to the exporters. The other clarification said that companies can market and use brand name of their products in the domestic market although they may be granted license only in generic names. Despite the first clarification, SLAs are not issuing licenses in brand names for exports citing that there is no written directive from the ministry. Same is the case with the licenses for domestic marketing of products. Both SLAs and drug units are waiting for the written communication from the ministry. SLAs think that allowing the manufacturers to sell medicines in brand names without authorization may lead to incidences of unethical practices in the industry. It is possible that the unscruplous elements in the industry can use the established brand names and sell substandard or even fake drugs using those names. This should not happen. Therefore, it is important that the ministry should maintain the status quo until it is clear about how the generic licensing policy can be effectively implemented. It is certainly a tough job to introduce marketing of drugs only in generic names overnight in India and needs meticulous planning and cooperation from all the SLAs. And above all the medical practitioners should also be ready to prescribe the medicines in generic names.