Delhi high court stayed a government order that abruptly halted production of condoms laced with benzocaine, providing some respite to the manufacturers of Durex Extended Pleasure and Kohinoor Xtra Time condoms.
The central regulator had asked Reckitt Benckiser and its Indian partner TTK Protective to apply for separate license because their condoms were benzocaine laced. The manufacturers termed the order as whimsical because their first application made 15 years ago declared use of the additive, which is said to facilitate more pleasurable intercourse.
Justice Manmohan on Monday said the order asking the companies to surrender their license for the two products will not be acted upon. The manufacturers were directed to make a representation to the regulator that will decide it in eight weeks.
Benzocaine is a local anaesthetic and pain-reliever. It works by temporarily numbing the area to which it is applied. Benzocaine cream or solution inside the condom de-sensitises the male sexual organ to help delay ejaculation and prolong erection during intercourse. Though a condom is not a drug in law, the manufacturer requires a licence under it.
Senior advocate Nidhesh Gupta, appearing for Reckitt, contended there were 51 products in the Indian market which contain Benzocaine in varying amounts and which have been granted licence for manufacture by state licensing authorities.
The Centre’s lawyer said there is no mention of Benzocaine in the licence the regulator cleared to Reckitt February last to import the product.
To this, Gupta said that in the application for import licence, Benzocaine was mentioned along with name of the product.
The makers have argued they disclosed the use of benzocaine while acquiring their manufacturing licence in 2001 and have already sold 300 million units in the Indian market. But the regulator issued the notice on the ground that benzocaine is a new drug used in the condom for which new license is required.
Gupta said benzocaine is not a new drug. Its application has increased and it is used as a topical drug (applied on the surface of the skin or exposed area).
Additionally, the chemical has wide and varied application in the medical field and there are a large number of products such as cough drops, after-shave lotions and baby teething products, he said.