State drug licensing authorities from across the country expressed strong discontent over the latest notification issued by the drug controller general of India (DCGI), which clarifies that companies can market and use brand name of their products even though they will be granted licence only in their generic name. Authorities fear that such a set up will lead to a chaotic situation which will hinder the smooth functioning of the regulatory agencies in monitoring and enforcing the rules and provisions as required under the law.

Regulators strongly believe that allowing the manufacturers to sell medicines in the brand name without licence may spur a trend that will give rise to incidence of malafide practices within the industry. This  they fear will not only stunt the growth of the industry but also will impact its reputation as well.

Since no manufacturers would like to forfeit their already established brand name, industry seems to have accepted the clarification albeit fears, as they will be allowed to market their products in the brand names. However regulators strongly maintain that such a practice may lead to a dangerous trend wherein wrongdoers can take up the brand name that are already established to sell malafide drugs that are not of standard quality (NSQ).

A highly placed source from government said, “Since, we will be required to grant license only in the generic name, we will not be having any data on brand names making it difficult for us to track the activities of the manufacturers selling drugs in the brand names. Thus making it difficult for us to monitor and enforce the provisions in the Act properly. Moreover, such a situation can create a safe haven for offenders who may manufacture and sell drugs by mimicking brand names leading to sale of sub standard and NSQ drugs in the market risking patients life.”

Having said so, the regulators pointed out that rather than taking a middle ground the centre should take a strong stand on its decision. Taking into account the regulatory perspective to ensure successful monitoring and enforcement of the provisions, state licensing authorities want the centre to either completely withdraw the said directive which is at the centre of the debate, or make it mandatory to sell drugs only in the generic names.

The source stressed, “They should send a strong message to the industry stating that they can not sell their product under their brand names since there is no licence granted for it to avoid complications. We fail to understand the CDSCO's reasoning behind bringing this directive. If they had no issues with manufacturers selling their products in brand name, then why propagate this directive under section 33 (P).in the first place. And if they really wanted to ensure the availability of affordable generic drugs to all, then what is the point behind granting them license only in generic name while letting them market it in the brand name.”