The first oral anti-viral Covid pill, Molnupiravir, which was approved for the emergency use in India on Tuesday, will be tested on additional 13,000 patients to assess the safety of the drug, and companies will have to submit a report on the updated details of the clinical trial to the government, News18 has learnt.
Thirteen Indian pharmaceutical companies, including Torrent, Cipla, Sun Pharma, Dr. Reddy’s, Natco, Mylan, Hetero, Optimus will be manufacturing Molnupiravir, which is being developed by US-based biotechnology company Ridgeback Biotherapeutics in collaboration with US Pharma giant Merck.
The Drug Controller General of India (DCGI) – the apex authority clearing new drugs and vaccines for use in the country – has asked the pharma companies to follow 13 conditions.
According to the document, accessed by News18, on “condition of permission” issued and signed by the DCGI, VG Somani, the companies will conduct a post marketing surveillance (PMS) study on the first 1,000 patients to assess the safety of the pill. It means all 13 companies will generate additional data on 13,000 patients.
“The updated details of the clinical trial should be submitted within three months,” the document said. The evolving data of patients who are given the drug will be shared with the companies for conducting the study.
The companies will also have to submit reports about every three months to the government on the effects and side-effects of the drug observed. The DCGI office will communicate the exact interval soon, the companies have been told.
The document signed by Somani read, “All reported serious unexpected adverse reactions related to the drug shall be intimated to the Central Licensing Authority and regulatory action resulting from their review shall be complied with.”
The companies will also generate and submit the stability data on the drug to decide the expiry date of the product. “If long-term stability data submitted do not cover the proposed shelf-life of the product, the stability study shall be continued to firmly establish the shelf-life and the complete stability data shall be submitted,” it said.
Packaging Details Part of Conditions for Approval
The companies need to ensure that the label on the container of the drug and the packaging should have: “WARNING: To be sold by retail only under prescription of medical specialists”.
“This warning will be in a box with a red background,” the document describes. The conditions bar manufacturers from making any claim except those mentioned in the document.
It directs companies that all the specimens of the cartons, labels or packaging inserts for marketing of the drug will be approved by the government prior to the launch.
Who Can Be Prescribed Molnupiravir?
The DCGI has recommended a dose of 800 milligramme, twice daily for five days, the document shows.
Molnupiravir is not authorised for use in patients less than 18 years of age, it clarifies.
Its treatment should not be initiated in those patients who require immediate hospitalisation due to Covid-19. However, if it was initiated before hospitalisation due to Covid-19, it may be continued. Also, it is not allowed to be used for more than five consecutive days.
The DGCI bars the drug being used to prevent Covid-19 besides banning it for pregnant women.
Even females of childbearing potential have been advised to use a reliable method of contraception correctly and consistently for the duration of treatment and for four days after the last dose of Molnupiravir.
“Males of reproductive potential who are sexually active with females of child bearing potential should use a reliable method of contraception correctly and consistently during treatment and for at least three months after the last dose,” the document said.
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