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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. 

Mumbai, Jul 30: Counterfeiting incidents have increased 24 per cent in the country in 2019 over the previous year, creating an over Rs 1 lakh crore hole in the economy, according to a report.

The report also said counterfeiters are having a free run due to the pandemic-driven disruptions to organised supply chains and the resultant spike in consumer demand.

According to the report by ASPA, a self-regulated industry body of anti-counterfeiting and traceability solutions providers, counterfeiting has risen steadily in the last few years, and exploiting the pandemic as a cover for their activities.

Between February and April 2020, over 150 incidents of counterfeiting cases were reported, mostly about fake PPE kits, sanitisers and masks taking advantage of the high demand for these products, it noted.

"There was a 24 per cent increase in counterfeiting in 2019 over 2018, leading to the loss of more than Rs 1 lakh crore to the overall economy," said Nakul Pasricha, president of Authentication Solution Providers Association.

The association works with global authorities like the International Hologram Manufacturers Association, Counterfeit Intelligence Bureau of the Interpol, and domestic industry lobbies like Ficci, he said.

Counterfeiting is a universal issue and is 3.3 per cent of global trade, according to the OECD data, impacting social and economic development across the world.

The report lists the currency, FMCG, alcohol, pharma, documents, agriculture, infrastructure, automotive, tobacco, lifestyle and apparel, as the 10 sectors impacted most by counterfeiting.

Among these, currency, alcohol and FMCG continue to be the top three sectors with the highest counterfeiting in the last two years. The FMCG sector is most vulnerable, as counterfeit incidents rose 63 per cent between 2018 (79) and 2019 when the reported cases jumped to 129.

Within the states, the fakers have a free run in Uttar Pradesh, Bihar, Rajasthan, Madhya Pradesh, Bengal, Punjab, Jharkhand, Delhi, Gujarat, and Uttarakhand, calling for urgent actions to frame anti-counterfeiting policy measures.

According to the report, UP continues to be on top followed by Bihar, Rajasthan, and together these three states represent almost 45 per cent of all counterfeiting reported in the last two years.

What is more alarming is that counterfeiting is not limited to high-end luxury items today, as common everyday items as fake cumin seeds, mustard cooking oil, ghee, hair oils, soaps, baby care vaccines and medicines are aplenty in the markets.

"There is an urgent need for building and nurturing authentication ecosystems in the country with the active involvement and active participation of all stakeholders," said Pasricha.