India’s apex drug regulatory authority has suspended the manufacturing and marketing approvals it had granted to Entod Pharmaceuticals, a Mumbai-based firm, after the company claimed that it had developed “the first eye drop(s) in India to reduce the need for reading glasses”.

In a letter sent to Entod on Wednesday, the Central Drugs Standard Control Organisation (CDSCO) said that it was suspending its approval for the pilocarpine hydrochloride ophthalmic solution under concerns that claims made by the company could mislead the public.

Entod on Wednesday announced that it would challenge the decision in court.

The CDSCO action follows a complaint sent to the regulatory authority by K.V. Babu, an ophthalmologist in Kannur, Kerala, on September 6 that Entod had posted on X on the product, claiming that it is the first India-approved “proprietary Rx eye drops to eliminate reading glasses”.

Babu cited the post by Entod on its official X handle on September 4.

“Many ophthalmologists were concerned about such a claim and its potential for misuse by the public,” Babu told The Telegraph.

“Pilocarpine hydrochloride has been in use for decades to treat certain eye disorders, but this new formulation has a temporary effect of constricting the iris which can make reading easier in some people. But this is a short-lasting effect and not a replacement for reading glasses,” Babu said.

The CDSCO has told Entod that the eye drops formulation had “not been approved for any such claim that it is designed to reduce the need for reading glasses” or the claim that it can provide an advanced alternative that augments near vision within 15 minutes”.

The permission for manufacturing and marketing the product is suspended “in public interest”, the CDSCO said in its note to the firm.

The company said it strongly opposes the action against Entod, a member of the medium and small enterprises sector which is purely research driven and is seeking to introduce new therapeutic options in India.

Entod said the CDSCO had approved the product on the basis of a clinical trial in 234 patients which demonstrated the safety and efficacy of the formulation in people with presbyopia, a condition marked by the gradual loss
of eyes’ ability to focus on nearby objects.

“Such eye drops with the same active ingredient and same concentration has been approved by the US Food and Drug Administration and marketed in the US for the last three years without any serious complications,” the company said.

Entod said its decision to fight the suspension order in court “will not only allow innovative medicines to be available in India, but will
also encourage other pharmaceutical entrepreneurs and companies in the MSME sector to continue the research drive in India without facing similar obstacles”.