New Delhi : Delhi High Court put on hold the orders of the Centre and state licensing authority directing Reckitt Benckiser’s Indian joint venture company to surrender its licence for manufacture and sale of Benzocaine dosed condoms.
Justice Manmohan said the orders “shall not be given effect to” till central government decides the joint venture (JV) company’s representation to not cancel its licence.
It directed the JV, TTK Protective Devices Ltd, to file its representation within two weeks and also ordered it to maintain a “log and accounts” of the number of such condoms manufactured and sold by it.
With these directions, the court disposed of the plea filed by Reckitt and TTK against the Centre’s and the state authority’s orders.
Senior advocate Nidhesh Gupta, appearing for Reckitt, contended that 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 told the court that if the company approaches it with a representation, a decision would be taken in eight weeks.
He also said there is no mention of Benzocaine in the licence granted by the Centre to Reckitt in February last year to import the product.
To this, Gupta said that in the application for import licence, Benzocaine was mentioned along with name of the product.
As per the petition, TTK was issued a licence for manufacture of the condoms in 2001 by the state authority which has been delegated power to do so.
It had also said that when Reckitt had applied for import licence in 2015, the central government had granted licence and had not treated the product as a new drug.
In January this year the Centre wrote to the state
authority that the product falls under the category of a new drug requiring permission of the Drugs Controller General of India (DCGI) which TTK does not have and thus, the licence for manufacture ought to be cancelled, the petition had said.
It had also said that in view of the January 2016 letter of the Centre, the state authority wrote to the company in February this year to surrender its manufacturing licence.
The company had contended that the government has taken the decision to cancel TTK’s licence to manufacture without issuing it a show cause notice and said that the company has not yet surrendered its licence.
It had argued that the condom was being manufactured in India for last 15 years and over 300 million boxes have been sold and thus, it cannot be termed as a new drug.