Delhi High Court today sought Centre's response on a plea moved by healthcare major Reckitt Benckiser challenging the state licensing authority's order directing the company's Indian joint venture firm to surrender its licence for manufacturing Benzocaine dosed condoms.
Delhi High Court today sought Centre’s response on a plea moved by healthcare major Reckitt Benckiser challenging the state licensing authority’s order directing the company’s Indian joint venture firm to surrender its licence for manufacturing Benzocaine dosed condoms.
Justice Manmohan asked the government’s lawyer to take instructions on the issues raised in the petition and listed it for hearing on May 23.
Senior advocate Nidhesh Gupta, appearing for Reckitt, said that its joint venture – TTK Protective Devices Ltd – was issued a licence for manufacture of the condoms in 2001 by the state authority which has been delegated power to do so.
Gupta also said that when Reckitt had applied for import licence in 2015, the central government had granted the licence and had not treated the product as a new drug.
However, 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.
As per the petition, also filed by TTK, the state authority wrote to the company in February to surrender its manufacturing licence.
Gupta said that the government has taken the decision to cancel TTK’s licence to manufacture without issuing it a show cause notice and added that the company has not yet surrendered its licence.
Reckitt has sought setting aside of the communications of January and February saying no show cause notice was issued prior to asking for surrender of the licence.
Gupta argued that the drug 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.
The lawyer for the Centre contended that even a small change in the amount of Benzocaine being used would convert the product into a new drug.