New Delhi: TheDrug 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.