Drug Claims and Presbyopia
• The Drugs And Magic Remedies (Objectionable Advertisements) Act was enacted to curb unsubstantiated claims in medicine.
• Controversy over eye drops prescribed for presbyopia led to the suspension of a pharma company’s permission to manufacture and market the product.
• The company, ENTOD Pharmaceuticals, argued that the drug’s approval was based on a valid controlled clinical trial that demonstrated efficacy and safety in 234 patients.
• Despite protestations, the company posted a message on X tagging Prime Minister Narendra Modi, claiming that PresVu is the first DCGI-approved proprietary prescription eye drops to eliminate the need for reading glasses.
• The main ingredient in the drops, pilocarpine, works by causing pupils to constrict, creating a pinhole effect, enabling better vision for presbyopes.
• The intervention by the CDSCO is an attempt to reinforce the Drugs and Magic Remedies Act.
• The government’s duty is to set standards based on scientific data and rein in unsubstantiated claims about drugs.