NEW DELHI: India’s drug regulator has suspended manufacturing and marketing permission of Mumbai-based ETOD Pharmaceuticals, which had claimed that their new eye drop could help people reduce dependency on reading glasses for those suffering from presbyopia, an age-related vision condition.The Central Drugs Standard Control Organisation (CDSCO) had earlier granted the pharma company approval to manufacture and market their eye drop, PresVu, which the company said offers an advanced alternative that augments near vision within 15 minutes.Taking serious note of the unauthorised promotion of the product, the CDSCO said that their permission to manufacture and market has been suspended till further notice.This daily was the first to report that the Drug Controller General of India (DCGI), Dr Rajeev Singh Raghuvanshi, had sought an explanation from the company for its claims that raised doubts.In a tersely written notice dated September 10, the DCGI said, “The unauthorised promotion in the 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 (over the counter) drugs whereas it is approved as a prescription-only drug.”In a rebuttal, the company’s CEO, Nikkhil K Masurkar, said, “We at ENTOD Pharmaceuticals at this moment declare that we have not made any unethical or false presentation of facts to the media or public when it comes to Presvu Eye Drops. All facts disclosed to the media were strictly based on the recent DCGI approval for treatment of presbyopia in adults and the results of the phase 3 clinical trial conducted by us in India.”
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