After smooth going for 15 years in India’s sex products market, Durex condoms have run into regulatory friction over an additive that is said to facilitate more pleasurable intercourse.
Reckitt Benckiser and its Indian partner TTK Protective, manufacturer of Durex and Kohinoor condoms, have approached the Delhi high court after the country’s drug regulator asked the joint venture to seek a separate licence for its benzocaine-laced condoms – Durex Extended Pleasure and Kohinoor Xtra Time.
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.
The makers have argued they disclosed the use of benzocaine while acquiring their manufacturing licence in 2001 and have already sold 300 million pieces in the Indian market. Senior advocate Nidhesh Gupta informed justice Manmohan’s bench that the regulator wrote to Tamil Nadu’s drugs controller in January, saying the state agency could not have granted the licence to the joint venture that has set up manufacturing units in Puducherry. A month later, the state regulator ordered the companies to surrender their licence.
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). “It is also used as a local anaesthetic to reduce pain or discomfort caused by minor skin irritation, sore throat, sunburn and many other sources of minor pain,” he argued.
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. Gupta said benzocaine-dosed condoms were introduced decades ago and marketed in a large number of countries, including India. Therefore, a new licence was uncalled for, he said.
The lawyer said the government could not take away his client’s right on a “whimsical decision” and the order issued should be set aside. Justice Manmohan has sought a government response to the petition and given it time till May 23 to respond.