DCGI suspends permission for eye drops claiming to replace reading glasses; Firm to challenge order
New Delhi: The Drugs Controller General of India (DCGI) has suspended the permission granted to manufacture and sell Entod Pharmaceuticals’ eye drops, PresVu. The company had claimed that the eye drops could help individuals with presbyopia, an age-related vision condition, eliminate their dependency on reading glasses.
"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 CDSCO to manufacture and market, the regulator has suspended their permission till further order. The unauthorised promotion in press and over social media had raised doubt on its unsafe use by patients and safety concerns for the public. The promotion raised concern about its use like OTC drugs, whereas it is approved as a prescription only drug," the Union Ministry of Health and Family Welfare said in a statement, as reported by ANI.
The drug regulator also highlighted that the company had failed to respond to the queries and tried to justify the claims for the product for which no approval was granted.
Nikkhil Masurkar, Chief Executive Officer of Entod Pharmaceuticals, mentioned in a statement that the company has not made any unethical or false presentation of facts about PresVu eye drops. He added that all the facts disclosed to the media are strictly on the basis of recent DCGI approval and clinical trials. The company noted that they will challenge the order in court.
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Maharashtra sets up state vaccination task force to strengthen immunisation programme
Mumbai (PTI): The Maharashtra government has set up a State Vaccination Task Force to strengthen the regular immunisation programme and review the progress of related campaigns, a health department official said on Monday.
The State Vaccination Task Force will comprise at least 29 members and will be headed by the administrative head of the health department, he informed.
The government has also constituted separate district-level and municipal vaccination task forces to improve implementation and address challenges at the grassroots level, he said.
Municipal task forces, chaired by respective civic commissioners, have been constituted in view of the vast urban population in Maharashtra and the role of civic bodies in implementing different health programmes.
The district-level task forces will function under the chairmanship of collectors.
"Complete immunisation of children at the appropriate age is an extremely simple, cost-effective and highly effective measure to reduce child mortality and the prevalence of diseases among kids. Immunisation is a powerful tool for reducing illness in children," maintained the official.
To ensure full vaccination of all children, the state government implements various campaigns from time to time as per the central government guidelines, he pointed out.
"Active participation and cooperation of other relevant government departments are essential (in making these campaigns successful)," according to the official.
The state-level body will review the regular immunisation programme, associated campaigns and vaccine-preventable diseases in detail. It will also conduct focused assessments of high-risk districts and municipal corporations, including vacancies at district, municipal and sub-district levels, availability of cold chain equipment, resource gaps and training requirements, he noted.
The state task force will review allocation and utilisation of funds for immunisation and ensure timely action by officers concerned based on reports from district and municipal task forces and state-level monitoring mechanisms, the official said.
It will also ensure active coordination and participation of other government departments in immunisation drives, while district and municipal task forces will carry out similar functions at their respective levels, the official added.
