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Indian pharma cos welcome patent waivers on COVID vaccines, says tech transfer needed to scale up

NEW DELHI, May 6: The Indian pharma industry welcomed the decision by the US government to support the temporary waiver of Trade-Related Aspects of Intellectual Property Rights (TRIPS) on Covid-19 vaccines.

The industry said along with patent waivers, it is important to push for more licensing and tech transfer arrangements to expand production of COVID-19 vaccines.

The European Union (EU) too on Thursday said it is willing to discuss a proposal to waive intellectual property rights for COVID-19 vaccines.

"This is positive development, equitable distribution of vaccines around the world is very important to end the pandemic," said Sudarshan Jain, Secretary General of Indian Pharmaceutical Alliance (IPA).

IPA represents large domestic pharmaceutical companies.

Jain cautioned that while temporary patent waivers will help to get the best out of manufacturing capabilities available around the world, only patent waivers may not be sufficient.

"We also need the technology to make it, patent waivers along with technology transfer would boost vaccine manufacturing," Jain added.

AstraZeneca-Serum Institute of India, Johnson & Johnson - Biological E, RDIF-Dr Reddy’s are some of the examples of collaboration between innovators and Indian vaccine makers.

Experts say India has a considerable knowledge base on vaccine platforms such as whole virion vaccines (inactivated or live virus), viral vectors and recombinant proteins. Here the patent waiver may not be of much help.

"The patent waiver may be useful for mRNA vaccines, the technology that is something new for Indian developers.

There are certain things that are not able to do now with mRNA vaccines will be possible," said Dr KV Balasubramaniam, a vaccine industry veteran and life science industry consultant.

Balasubramaniam says companies like Pune-based Gennova Biopharmaceuticals that's developing messenger RNA (mRNA) COVID-19 vaccine may possibly benefit by patent waivers.

But Balasubramaniam warns that things won't be that easy as patent holders try to fence their vaccine manufacturing know-how by broad patent claims.

"For Indian companies to understand the specifics, break the barrier of knowledge, experiment - it would take 2-3 years," Balasubramaniam

Dr Sanjay Singh, CEO of Gennova Biopharmaceuticals hasn't responded to calls and messages.

"We still don't know the broad contours, but if the waiver is extended to manufacturing of adjuvants (the component that boost vaccine efficacy), some of the other key raw ingredients like certain enzymes, reagents, would definitely help," the executive said.

PhRMA, which represents America's leading innovative biopharmaceutical research companies, opposed the US government decision to support patent waivers for COVID-19 vaccines.

"(The) decision will sow confusion between public and private partners, further weaken already strained supply chains and foster the proliferation of counterfeit vaccines," PhRMA said.

PhRMA companies are devoted to discovering and developing medicines that enable patients to live longer, healthier and more productive lives. Since 2000, PhRMA member companies have invested nearly 1 trillion in the search for new treatments and cures, including an estimated USD83 billion in 2019 alone.

75 lakh people lose jobs in April as lockdowns sprout; unemployment at a 4-month high: CMIE chief

NEW DELHI, May 4: The second wave of COVID-19 and the resultant localised lockdowns have impacted over 75 lakh jobs, taking the unemployment rate to a four-month high of 8 per cent, the Centre for Monitoring Indian Economy (CMIE) said on May 3.

The situation on the employment front is expected to continue to remain challenging going forward as well, CMIE's managing director and chief executive Mahesh Vyas said.

“In the month of April, compared to March, we have lost 75 lakh jobs. That is what has caused the jump in the unemployment rate,” he said.

The national unemployment rate touched 7.97 percent as per the centre's proprietary data, with urban areas witnessing higher stress at 9.78 per cent and rural joblessness at 7.13 percent.

The national unemployment rate had stood at 6.50 per cent in March, and the number on both rural and urban front was lower.

The second wave of the COVID-19 pandemic has led to a slew of pockets going under lockdown-like situation with only essential activities being allowed, which result in a chill in a bulk of economic activities and a resultant impact on jobs.

“I do not know about the peaking of the COVID wave, but I can see stress on the employment front,” Vyas said.

What is likely to happen is that unemployment can remain at high levels, he said, adding that the labour force participation rate can also fall. “In worst situation, both can happen,” Vyas added.

He, however, said that the situation right now is not as dire as the one witnessed in the first lockdown, when the unemployment rate had touched up to 24 per cent levels.

The country is reporting around 4 lakh new infections a day and over 3,000 deaths. In an address to the nation last month, Prime Minister Narendra Modi had advised states to look at lockdowns as a last resort, because of its impact on economic activity.

Reserve Bank of India imposes Rs 3 crore penalty on ICICI Bank over rule violations

NEW DELHI, May 3: The Reserve Bank of India (RBI) on May 3 imposed a monetary penalty of Rs 3 crore on ICICI Bank for certain rule violations.

The penalty has been imposed for contravention of certain directions issued by the RBI on ‘Prudential Norms for Classification, Valuation and Operation of Investment Portfolio by Banks’, the central bank said in a release.

"This penalty has been imposed in exercise of powers vested in RBI under the provisions of section 47 A (1) (c) read with section 46 (4) (i) of the Banking Regulation Act, 1949 (the Act)," the RBI said.

This action is based on the deficiencies in regulatory compliance and is not intended to pronounce upon the validity of any transaction or agreement entered into by the bank with its customers, the RBI said.

Explaining the action, the RBI said an examination revealed contravention of the aforesaid directions issued by the apex bank.

In furtherance to the same, a notice was issued to the bank advising it to show cause as to why penalty should not be imposed on it for failure to comply with the directions issued by the RBI.

After considering the bank’s reply to the notice, oral submissions made in the personal hearing and examination of additional submissions made by it, the RBI came to the conclusion that the aforesaid charge of non-compliance with RBI directions was substantiated and warranted imposition of monetary penalty, the central bank said.

In an update to stock exchanges, ICICI Bank said the penalty has been imposed for shifting certain investments from HTM (held to maturity) category to AFS (available for sale) category in May 2017.

The bank had transferred two separate categories of securities on two different dates from HTM to AFS in April and May of 2017, which it believed was permissible as per Master Circular on Prudential Norms for Classification, Valuation and Operation of Investment Portfolio by Banks' dated July 1, 2015, the bank said in the exchange note.

"The RBI has held that the shifting of securities the second time in May 2017 without explicit permission was in contravention of RBI directions," ICICI Bank said.

GST revenue hits all-time high of Rs 1.41 lakh crore in April

NEW DELHI, May 1: The gross GST revenue collected in the month of April is at a record high of Rs. 1,41,384 crore of which CGST is Rs. 27,837 crore, SGST is Rs. 35,621, IGST is ₹68,481 crore (including Rs. 29,599 crore collected on import of goods) and Cess is Rs. 9,445 crore (including Rs. 981 crore collected on import of goods).

"Despite the second wave of COVID-19 pandemic affecting several parts of the country, Indian businesses have once again shown remarkable resilience by not only complying with the return filing requirements but also paying their GST dues in a timely manner during the month," according to a statement by Ministry of Finance.

The GST revenues during April 2021 are the highest since the introduction of GST even surpassing collections in the last month (March’2021). In line with the trend of recovery in the GST revenues over past six months, the revenues for the month of April 2021 are 14% higher than the GST revenues in the last month of March’2021. During the month, the revenues from domestic transaction (including import of services) are 21% higher than the revenues from these sources during the last month.

GST revenues have not only crossed the Rs. 1 lakh crore mark during successively for the last seven months but have also shown a steady increase. These are clear indicators of sustained economic recovery during this period. Closer monitoring against fake-billing, deep data analytics using data from multiple sources including GST, Income-tax and Customs IT systems and effective tax administration have also contributed to the steady increase in tax revenue. Quarterly return and monthly payment scheme has been successfully implemented bringing relief to the small taxpayers as they now file only one return every three months. Providing IT support to taxpayers in the form of pre-filled GSTR 2A and 3B returns and ramped up System capacity have also eased the return filing process.

During this month the government has settled Rs. 29,185 crore to CGST and Rs. 22,756 crore to SGST from IGST as regular settlement. The total revenue of Centre and the States after regular and ad-hoc settlements in the month of April’ 2021 is Rs. 57,022 crore for CGST and Rs. 58,377 crore for the SGST.

 

 

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