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FDA rejects emergency use authorization for Bharat Biotech’s Covaxin jab

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FDA rejects emergency use authorization for Bharat Biotech’s Covaxin jab

This is a consequence of the US FDA asking the company to launch an additional trial so that the company can file for a Biologics Licence Application (BLA), which is a full approval. “The FDA provided feedback to Ocugen regarding the Master File the Company had previously submitted and recommended that Ocugen pursue a BLA submission instead of an EUA application for its vaccine candidate and requested additional information and data,” said a statement from Ocugen to NYSE. Adding that the company is in discussions with the FDA on the additional documents required to clear its application. “While this will extend our timelines, we are committed to bringing Covaxin to the US,” said Shankar Musuniri, chief executive of Ocugen.

This development comes at a time when Bharat Biotech is under criticism in India for not sharing data from its phase 3 clinical trials almost six months after the company’s vaccine was included in India’s immunization programme.

The company has been betting on being able to launch its vaccine in regulated markets as it looks to gain validation at a time where authorization of a covid vaccine from WHO or a regulator such as USFDA or the European Union is needed to cross borders. At present, several countries do not recognize the Bharat Biotech vaccine, and those who have received two doses of the vaccine are considered “unvaccinated” in some countries.

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Haryana

After record haul, illegal MTP kit supplier’s house raided in Haryana’s Karnal

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After record haul, illegal MTP kit supplier’s house raided in Haryana’s Karnal

A joint team of the health department, FDA, and Haryana State Narcotics Control Bureau (HSNBC) raided Ravinder Kumar’s house in Karnal, Haryana, after seized 5,805 medical termination of pregnancy (MTP) kits. The largest-ever haul of these kits was found in Haryana, where the sex ratio at birth is among the worst in the country. CCTV footage showed Kumar.

Kaithal-based medical representative Vikas Bansal was arrested and booked after the recovery. Haryana state drug controller Manmohan Taneja said that during interrogation, Bansal and his family members fleeing with large boxes. A search is on for the absconding supplier after CCTV footage showed him and his family members fleeing with large boxes admitted that he.

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Procured the kits from Ravinder Kumar in Karnal. When the joint team, including drug control officers of Kaithal and Karnal, an HSNCB sub-inspector, and the Kunjpura senior medical officer, reached Ravinder Kumar’s house at Shiv Colony in Karnal in the evening, they found it locked. Ravinder was untraceable and his mobile phone was switched off, a member raiding.

As of April 30, 2025, the country has seen a surge in the number of people seeking abortion kits, with the largest-ever haul of over 5,000 kits in Haryana. The state government has revamped the National Security Advisory Board after the Pahalgam terror attack and his family members fleeing with large boxes. A search is on for the absconding supplier CCTV.

A team of Indian authorities seized large quantities of unaccounted homoeopathic and footage showed him and his family members fleeing with large boxes. allopathic drugs from Ravinder Kumar’s brother Yashvinder. CCTV footage showed Kumar fleeing the premises with large boxes. The drugs included 1,000 tablets of Vigueur, 258 tablets of TrustPostpil pills.

Footage showed him and his family members fleeing with large boxes.of Unwanted-72, 216 Manforce 100, and German-made Calcium Phosphorica homeopathic medicine. The team also seized 5,805 MTP kits worth ₹25 lakh, with 60 taken for sampling. The drugs contained to all Medical experts warn that misuse of MTP kits, especially without prescription or supervision.

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The Haryana Drug Control Department and Karnal Police conducted a joint raid on can lead to severe complications Mifepristone and Misoprostol tablets, which are used for terminating pregnancies. Tuesday at the house of a 38-year-old man identified as Ramesh Kumar, located in Sector 7 of Karnal. According to officials, Kumar is believed to be a major distributor of unlicensed MTP kits across northern India, with connections extending to Delhi, Punjab, and Uttar Pradesh.

Record Seizure Prompted Probe

The raid follows last week’s record haul of over 3,000 MTP kits from a warehouse in Panipat, marking one of the largest illegal pharmaceutical seizures in the state’s history. Investigations revealed that many of the confiscated kits were unregistered, expired, or counterfeit, posing severe health risks to women seeking abortions Ramesh Kumar’s name surfaced during.

Raid Yields More Stock and Evidence

At the Karnal residence, officials recovered over 500 MTP kits, several stamped prescription pads from different clinics, fake invoices, and a laptop containing what appears to be a customer and distribution database Interrogation of individuals arrested during the Panipat operation. His role appears to be central in the distribution chain,” said Rajeev Deputy.

Drug Control Officer Neha Sharma confirmed that many of the recovered kits were illegally imported and had been relabeled with new expiry dates. “Some of the labels didn’t match regulatory codes, and none of the kits had proper documentation. This indicates organized manipulation,” she stated Superintendent of Police (DSP), Karnal. “This is not just a case.

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