Bookings for select destinations in USA, Canada, UK and Europe under Phase3 of Vande Bharat Mission open

Indore, Aug 3: In a bizarre development, the Indore Bench of the Madhya Pradesh High Court has granted bail to an accused in a sexual harassment case on the condition that he will request the victim to tie a ‘rakhi’ on him with a promise to protect her “to the best of his ability for all times to come”.

Justice Rohit Arya on July 30 also ordered the man to pay Rs 11,000 to the complainant as a “customary ritual usually offered by brothers to sisters” on Raksha Bandhan and seek her blessings while visiting her with his wife and a box of sweets. “The applicant shall also tender Rs 5,000 to the son of the complainant for purchase of clothes and sweets,” the order said.

The court directed the accused to take photographs and receipts of payment made to the victim and her son, which should be filed through his lawyer for placing on record of the case before the Registry.

The victim, a resident of Ujjain district, had alleged that her neighbour, Vikram Bagri, entered her house and sexually harassed her on April 20. The police registered a case under Sections 452 (House-trespass after preparation for hurt, assault or wrongful restraint), 354 (A) (Sexual harassment and punishment for sexual harassment), 354 (Assault or criminal force to woman with intent to outrage her modesty), 323 (Punishment for voluntarily causing hurt) and 506 (Punishment for criminal intimidation) of the Indian Penal Code.

The order said the man, in jail for more than two months, was released on bail, on furnishing a personal bond of Rs 50,000 with “one solvent surety in the like amount to the satisfaction of the trial court, on the condition that he shall remain present before the court concerned during trial,” and comply with conditions under Section 437 (3) of CrPC, along with other conditions.

The Drugs Controller General of India (DCGI) has given nod to the Serum Institute of India (SII) for conducting phase 2 and 3 human clinical trials of the Oxford University developed Covid-19 vaccine candidate in the country.

Government officials said that the approval for conducting phase 2 and 3 clinical trials by the SII was granted by DCGI Dr V G Somani late Sunday night after a thorough evaluation based on the recommendations of the Subject Expert Committee (SEC) on Covid-19.

"The firm has to submit safety data, evaluated by the Data Safety Monitoring Board (DSMB), to the CDSCO before proceeding to phase 3 clinical trials," a senior official said.

"As per the study design, each subject will be administered two doses four weeks apart (first dose on day one and second dose on day 29) following which the safety and immunogenicity will be assessed at predefined intervals," the official said.

As a rapid regulatory response, the expert panel at the Central Drugs Standard Control Organisation (CDSCO) on Friday, after a detailed deliberation and considering the data generated on the vaccine candidate in phase 1 and 2 of the Oxford University trial, had recommended granting permission for phase 2 and 3 clinical trials of the potential vaccine, 'Covishield', on healthy adults in India,  the officials said.

Currently, phase 2 and 3 clinical trials of the Oxford vaccine candidate is going on in the United Kingdom, phase 3 clinical trial in Brazil and phase 1 and 2 clinical trials in South Africa.

The officials said that the SII had submitted a revised proposal on Wednesday after the SEC on July 28, following deliberation over its application, had asked it to revise its protocol for the phase 2 and 3 clinical trials besides seeking some additional information.

The panel had also recommended that the clinical trial sites which have been proposed for the study be distributed across India.

According to the revised proposal by the SII, 1,600 people aged above 18 years will participate in the trials across 17 selected sites, including AIIMS-Delhi, B J Medical College in Pune, Rajendra Memorial Research Institute of Medical Sciences (RMRIMS) in Patna, Post Graduate Institute of Medical Education and Research in Chandigarh, AIIMS-Jodhpur, Nehru Hospital in Gorakhpur, Andhra Medical College in Visakhapatnam and JSS Academy of Higher Education and Research in Mysore.

"According to the application, it would conduct an observer-blind, randomised controlled study to determine the safety and immunogenicity of 'Covishield' on healthy Indian adults," the official said.

The SII, which has partnered with AstraZeneca, for manufacturing the Oxford vaccine candidate for Covid-19 had submitted its first application to the DCGI on July 25 seeking permission for conducting the phase 2 and 3 trials of the potential vaccine. 

Initial results of the first two-phases of trials of the vaccine conducted in five trial sites in the UK showed that it has an acceptable safety profile and homologous boosting increased antibody response, sources had said.

To introduce the vaccine, SII, the world's largest vaccine maker by number of doses produced and sold, has signed an agreement to manufacture the potential vaccine developed by the Jenner Institute (Oxford University) in collaboration with British-Swedish pharma company AstraZeneca.