DCGI suspends license of eye-drop maker Entod Pharma, firm to challenge order

New Delhi: The Indian drug regulatory agency has suspended the license of making and marketing of an eye-drop by a Mumbai-based company following the firm’s misleading claims to the media about the medicine’s potential.

While the approval was granted for a specific eye disorder, the company said the drop could “reduce the need for reading glasses” and “augment near vision within 15 minutes” among many such claims, triggering the regulatory action.

Considering public interest, the Central Drug Standards Control Organisation wrote to the firm suspending its license to manufacture and sell Pilocarpine Hydrochloride ophthalmic solution till further orders in view of such claims.

The manufacturer, Entod Pharmaceuticals, however, said it would challenge the suspension order in a court of law because it did not make any unethical or false presentation of facts to the media.

According to the CDSCO, the company, which was selling the drug under the brand name of PresVu, made several astounding claims. They are – 'the first eye drop in India to reduce the need for reading glasses'; 'a non-invasive option to enhance near vision without the need for reading glass'; and 'an eye drop to augment near vision within 15 minutes'.

The CDSCO stated that the drug was licensed only for the treatment of presbyopia (an eye condition that makes it harder for people to see objects up close as they age) in adults and nothing else.

The regulator sent a notice to the company earlier this month seeking responses, but the replies were found inadequate.

“After a perusal of your reply, it is clear that you had tried to justify the claims for the product for which no approval was granted. It is clear that you have not obtained any prior approval from the central licensing authority to make such claims,” Rajeev Singh Raghuvanshi, the Drugs Controller General of India wrote in the suspension letter.

In a press statement, the company said the suspension order from the DCGI made no reference to any specific violation of the Drugs and Cosmetics Act and the objections were on the basis of the content of the press release, which described the benefits in “more verbose terms than the exact wording of the approved indication.”