DCGI Suspends Manufacture, Marketing Permission Of Pilocarpine Ophthalmic Solution

The National Eye Institute reported that presbyopia is a refractive error that makes it hard for middle-aged and older adults to see things up close. The drug regulator said the company made claims for the drug product for which it had not obtained approval from the Central Licensing Authority, thereby violating provisions under the New Drugs and Clinical Trial Rules, 2019.

New Delhi: The Drug Controller General of India (DCGI) on Wednesday suspended manufacture and market permission of M/s Entod Pharmaceuticals Ltd after the company was found involved in unauthorised promotion of its product.

“Taking serious note of the unauthorised promotion of the product, PresVu (1.25% Pilocarpine w/v) by M/s Entod Pharmaceuticals Ltd, after getting permission from Central Drugs Standard Control Organisation (CDSCO) to manufacture and market, the regulator has suspended their permission till further order,” a note from the Health Ministry said.

It said that the unauthorised promotion in press and over social media had raised doubt on its unsafe use by patients and safety concern for the public. “The promotion had raised concern about its use like OTC drugs whereas it is approved as a prescription only drug,” the DCGI said.

The CDSCO is India’s national regulatory body for cosmetics, pharmaceuticals and medical devices while the DCGI is the head of department of the CDSCO, responsible for approval of licences of specified categories of drugs such as blood and blood products, IV fluids, vaccines, and sera.

The directorate had earlier issued permission on August 20 for manufacture and marketing of Pilocarpine Ophthalmic Solution USP 1.25% w/v for the treatment of Presbyopia adults.

Presbyopia is the loss of the eyes' ability to focus on nearby objects.

Earlier, the DCGI issued show cause notice to the Maharashtra based M/s Entod Pharmaceuticals Ltd over its various claims made in the press.

An order issued by DCGI Rajeev Singh Raghuvanshi said, “You (M/s Entod Pharmaceuticals Ltd) are informed that the Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25% w/v is approved for the treatment of Presbyopia in adults and is not approved such claim that PresVu can provide an advanced alternative that augment near vision within 15 minutes.”

The DCGI said that the company 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 for the said drug product. You have violated the condition number (vi) of the permission number MF/SND/24/000092 dated August 20 issued to you for manufacture and marketing of Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25% w/v under the provisions of the New Drugs and Clinical Trials Rules, 2019,” the DCGI said while issuing order suspending manufacture and market permission to M/s Entod Pharmaceuticals Ltd.

Read More