News Analysis India

Tag: Serum Institute of India

  • SII writes to PMO to allow manufacturing, stockpiling of non-COVID vaccines during trial

    By PTI
    NEW DELHI: The world’s largest vaccine manufacturer by volume, Serum Institute of India, has written to the Prime Minister’s Office proposing reforms in the existing drug regulatory system, including allowing manufacturing and stockpiling of non-COVID vaccines while undergoing clinical trial.

    In the letter, Prakash Kumar Singh, the Director of Government and Regulatory Affairs at the Pune-based Serum Institute of India (SII) referred to the Health Ministry’s May 18, 2020, gazette notification, saying it allowed manufacturing and stockpiling of COVID-19 vaccine under clinical trial for marketing authorization for sale or distribution.

    “Because of this rule, it became possible for us to manufacture and stockpile the COVID-19 vaccine during the clinical trial and we could make the vaccine available in such a short span of time to protect millions of lives,” he said in the letter dated March 2.

    By the end of 2020, SII has already produced around 50 million dosages of the Oxford-AstraZeneca COVID-19 vaccine ‘Covishield’, even while it awaited the Drugs Controller General of India’s (DCGI) nod for emergency use of its vaccine in the country.

    It got the nod in early January this year.

    “In view of the successful result of this provision for COVID-19 vaccine, this provision should also be implemented for non-COVID-19 vaccines,” Singh said.

    In the letter to the PMO, he also sought permission to use the remaining quantities of batches of COVID and non-COVID vaccines for commercial purpose which have been used in a clinical trial.

    In this context, he said the Health Ministry had issued draft rules dated April 12, 2018, to allow the remaining quantities of batches of vaccines which have been used in a clinical trial for commercial use after the grant of permission in Form 46 (now it is Form CT-23) and manufacturing licence in Form 28D.

    “However, this draft rule has not been implemented till now. This draft rule should be implemented shortly to avoid wastage of life-saving vaccines,” Singh pointed out.

    Singh also sought implementation of recommendations of a high-powered inter-ministerial committee for reforming the Drug Regulatory Systems in India.

    The letter stated that on the directions of Prime Minister Narendra Modi, a high-powered inter-ministerial committee for reforming the Drug Regulatory Systems in India was constituted on May 11 last year under the chairmanship of then officer on special duty Rajesh Bhushan, who is presently the union health secretary.

    “A series of meetings of this committee was held starting May 2020. Recommendations of this inter-ministerial committee should be implemented immediately in line with the ease of doing business” he said.

    Singh’s letter highlighted a few other points also related to regulatory reforms and said, “We are putting forward the following points with relation to necessary regulatory reforms in the existing Drug Regulatory system for your kind reference and intervention, which will take the vaccine industry of our country to new heights in the world.”

    Singh also lauded the prime minister’s vision mentioning, “It is a matter of great pride for all of us that because of our Hon’ble Prime Minister’s vision about the regulatory reforms, the vaccine industry of our country is growing very fast and under his global leadership, our country has proved that we are the world leader in vaccine sector.”

  • ‘Provide vaccine to citizens first before exporting it’: HC raps Centre

    By Express News Service
    NEW DELHI:  Questioning the Centre over strictly controlling the class of persons who can be vaccinated against Covid-19, the Delhi High Court on Thursday asked it to explain the rationale behind the present system in which those above the age of 60 years or with comorbidities can receive the jabs.

    The high court felt the two institutes Pune-based Serum Institute of India and Hyderabad-based Bharat Biotech which manufacture the vaccines Covishield and Covaxin, respectively, have more production capacity but their full potential is not being exploited.

    “We are not utilising it fully. We are either donating or selling it to foreign countries and are not vaccinating our own people. So there has to be that sense of responsibility and urgency,” a bench of Justices Vipin Sanghi and Rekha Palli said.

    The high court directed the two institutes to file separate affidavits on their capacity to manufacture the vaccines on per day/week/ month basis and also how much unused capacity is lying and whether the two firms can scale up the production.

    “The Centre shall explain the rationale behind keeping strict control over class of persons who can be vaccinated as noticed in our last order. Under the present system, persons above 60 years of age and between 45 to 60 years with co-morbidities can receive the vaccine. An affidavit to be filed by the Centre disclosing the rationale for such classification,” it said.

    “Union of India (UoI) shall file an affidavit disclosing the capacity to transport the vaccines while maintaining the whole chain particularly to the NCT of Delhi. The Union of India shall also indicate the extent to which it is presently being used,” the high court said.

    “The UoI shall explain the rationale behind keeping strict control over class of persons who can be vaccinated as noticed in our last order. Under the present system, persons above 60 years of age and between 45 to 60 years with co-morbidities can receive vaccination.”

    “An affidavit to be filed by the UoI disclosing the rationale for such classification,” it said.

    It also asked the Delhi government to carry out inspection of medical facilities available in court complexes here and to report if COVID-19 vaccination centres could be set up there and also the short comings in facilities.

    The high court asked all the authorities to file their affidavits by March 9 and listed the matter for further hearing on March 10.

    The high court was hearing a PIL initiated by it to examine the demand of Bar Council of Delhi (BCD) to declare all people associated with the judicial functioning, including judges, court staff and lawyers as “frontline workers” so that they could receive COVID-19 vaccination on priority and without limitations of their age or physical condition.

    It also asked the Delhi High Court Bar Association and BCD to disclose the strength of members registered with them to get an idea of number of people to be vaccinated in the judicial system in the national capital.

    During the hearing, the counsel for Bharat Biotech sought to know the target audience for vaccination and whether the ambit was entire judiciary.

    Additional Solicitor General Chetan Sharma and advocate Anil Soni, representing the Centre, informed the court that selection of class of people for vaccination was a policy decision which was taken by an expert body.

    Sharma informed the high court that a similar petition is pending before the Supreme Court and will come up for hearing on Monday.

    To this, the bench said the issue here is to find out if the whole judicial system, including judges, lawyers and court staff, can be prioritised without age and co-morbidities limitation.

    On Wednesday, the high court had taken suo motu cognisance and initiated on its own a public interest litigation on the basis of a communication received from the BCD.

    It had said there is a clear pattern emerging that the number of COVID-19 positive cases increases with greater intermingling and congregation of people.

    It had said premises and court rooms of the high court, which is scheduled to resume physical functioning from March 15, and some of the district courts are air-conditioned and with increased footfall, there is likelihood of the rate of infection amongst those who attend the courts spiking, once the full-fledged physical functioning of courts in Delhi resumes.

    It had noted that in the first round, frontline workers, particularly of the medical community were covered, and others such as the police force have already been covered.

    The court had referred to a communication sent to the chief justice by BCD Chairman Ramesh Gupta requesting that appropriate directions be issued to the concerned authorities to make available necessary infrastructure in court premises, particularly in dispensaries for vaccinating the members of the judicial system by treating them as frontline workers.

    The bench had said that the need of the hour is to vaccinate the masses, in view of the raging pandemic, on a war footing so as to secure the life and health of all those who step out of their homes to attend to their avocations and professions.

    It had added that since the cases listed on any given day are mostly different from those listed on the previous or the next day, the litigants are also different and this peculiarity exposes the judges, court staff and the lawyers to the risk of contracting the disease.

    The bench had observed that the comorbidities enlisted by the government to accommodate people of 45 to 60 years age are serious conditions from which the judges, staff and advocates may or may not be suffering with but this does not mean that the risk of their contracting the disease and suffering serious health issues, including fatality, does not exist.

    (With PTI Inputs)

  • Unhappy with price cap in private hospitals, Covid-19 vaccine makers ‘could be subsidised’

    Express News Service
    NEW DELHI: After COVID-19 vaccine makers showed displeasure at the capping of vaccine cost at Rs 250 in private hospitals, The New Indian Express has learnt that the government is likely to give subsidies for the same. The amount and details of the subsidy, however, are yet to be worked out.

    This comes at a time when the country is getting ready for a widened COVID-19 immunisation drive from Monday.

    As per the agreed terms finalised on Saturday, the immunisation drives covers people above the age of 60 and those above 45 with comorbidities from March 1.

    ​While Rs 150 will go to the vaccine companies, hospitals will get Rs 100 for every jab administered. At government health facilities, the coronavirus vaccine will be given to beneficiaries free of cost.

    Sources in the Serum Institute of India (SII) and the Bharat Biotech said they had “agreed to the terms but are not happy with it.”

    ​ALSO READ | Nearly 91 centers to go live in Telangana for COVID-19 vaccine rollout for senior citizens

    “The government is procuring the vaccines first and for every shot administered, hospitals have to pay Rs 150 to the National Health Authority upfront,” said a source in one of the vaccine manufactuing companies.

    He added that the government had fixed a “difficult price” despite the risk that the market “may not respond to a very cheap and inexpensive vaccine as it could be needlessly viewed as inferior.”

    “Also this low price has been imposed without any competition here, for example, there are not many Covid-19 vaccines to choose from,” he rued but added that the companies have been assured that they will be subsidised but how is not clear yet.

    The government had earlier procured Covishield from the SII at the cost of Rs 200 per dose and Covaxin from Bharat Biotech at the cost of Rs 295 per dose for the first phase of vaccination drive which covered only healthcare and frontline workers. 

    ALSO READ | COVID-19 vaccine to cost Rs 250 per dose in private hospitals, only Covishield to be available

    Meanwhile, a senior official in the ministry said that the price gap that the companies are facing now could be made up from the fund of Rs 35,000 crore that the Centre has allocated for Covid-19 vaccine this year.

    Neither SII nor Bharat Biotech made any comments publicly on the vaccine pricing but they got a shot in the arm with Kiran Mazumdar-Shaw, executive chairperson, Biocon who strongly criticised the price cap fixed by the Union government on Sunday.

    Vaccine companies feel betrayed by the low-price cap which is “too low to sustain,” she said.

    “Covid vaccine jab capped at Rs 250 at Private Hospitals: Government – understand vaccine cos (companies) feel betrayed as price is too low to sustain,” she wrote on Twitter. Shaw further referred to the World Health Organization’s price cap of $ 3 per dose. 

    “If WHO has agreed to $3 per dose, why beat them down to $2? We’re crushing instead of incentivising the vaccine industry,” she further wrote.

  • SII CEO Adar Poonawalla asks countries, governments to ‘be patient’ over COVID vaccine supplies

    By ANI
    NEW DELHI: Pune-based Serum Institute of India CEO Adar Poonawalla requested the countries to ‘be patient’ as they await the Covishield supplies, adding that SII is trying to maintain a balance between the needs of India and the world.

    “Dear countries and governments, as you await COVISHIELD supplies, I humbly request you to please be patient, Serum Institute of India has been directed to prioritise the huge needs of India and along with that balance the needs of the rest of the world. We are trying our best,” Poonawalla said.

    SII has been asked to prioritise India’s vaccine needs and balance it out with the supplies to the rest of the world who are procuring COVID vaccine doses from India.

    ALSO READ: Notices issued on plea saying Covishield unsafe

    India on Wednesday announced a gift of 2 lakh doses of Covid-19 vaccines for UN peacekeepers.

    Earlier, he said that SII makes 70 to 80 million doses every month and the planning is underway for distribution to India and foreign countries.

    Poonawalla said many countries have been writing to India and the Prime Minister’s Office (PMO) for vaccines to be supplied from Serum Institute to their countries and they are trying to make everyone happy.

    ALSO READ: Now, you can choose between Covaxin, Covishield in Tamil Nadu

    “We are trying to keep everyone happy. We have to take care of our population and nation as well. We are trying to supply the vaccine to Africa, South America. So we are doing a little bit everywhere. So we will try to keep everyone happy,” he had said.

    According to the Ministry of Health and Family Welfare (MoHFW), the cumulative number of COVID-19 vaccine doses administered to healthcare and frontline workers crossed over 1.08 crore so far in the country.

    The countrywide vaccination drive was rolled out on January 16, 2021. The vaccination of the frontline workers started on February 2.

  • Government places orders for 1.45 crore doses of COVID-19 vaccines

    By PTI
    NEW DELHI: The government has placed orders for 1 crore additional doses of Covishield from Serum Institute of India and 45 lakh more doses of Covaxin from Bharat Biotech, officials of the two vaccine makers said on Tuesday.

    India’s COVID-19 vaccination drive was launched by Prime Minister Narendra Modi on January 16. Serum Institute has received another order from the government for 10 million doses of Covishield, a company official said in response to a query.

    The government had earlier placed a purchase order with Serum Institute of India (SII) for 1.1 crore doses of AstraZeneca-Oxford COVID-19 vaccine, Covishield. When asked, a Bharat Biotech spokesperson said, “The company has received a letter of comfort from the Government of India to supply another 4.5 million (or 45 lakh) doses.”

    The spokesperson also added that Bharat Biotech will also be exporting its COVID-19 vaccine, Covaxin, to Brazil and the United Arab Emirates. The company is also likely to export the vaccine to the Philippines and other South Asian countries, the spokesperson said.

    The government had earlier placed an order for 55 lakh doses of Covaxin from Bharat Biotech.

  • Government places second purchase order with SII for one crore doses of Covishield

    By PTI
    NEW DELHI: The Centre on Wednesday placed a second purchase order with the Serum Institute of India for the supply of one crore doses of Oxford-AstraZeneca COVID-19 vaccine ‘Covishield’, each costing Rs 210, including GST, sources said.

    The HLL Lifecare Limited, a public sector undertaking, on behalf of the Union health ministry issued the supply order in the name of Prakash Kumar Singh, Director, Government and Regulatory Affairs at Serum Institute of India (SII), Pune.

    The government had on January 11 placed an order for 1.1 crore doses of Covishield at a cost of Rs 231 crore, which has now risen to Rs 441 crore with the second order placed on Wednesday, a source said.

    The government had on January 11 also committed to buy from the Serum Institute 4.5 crore doses of the vaccine, in addition to the first order of 1.1 crore doses.

    India has approved two COVID-19 vaccines–Covishield manufactured by SII and indigenously developed Covaxin of Bharat Biotech–for restricted emergency use in the country.

  • Relief for SII as court rejects trademark-violation plea over ‘Covishield’ 

    By PTI
    PUNE: A local court has rejected an application seeking injunction against the use of `Covishield’ as brandname by the vaccine-maker Serum Institute of India (SII), the company said on Saturday.

    SII is producing a coronavirus vaccine named Covishield, co-developed by the University of Oxford and British-Swedish company AstraZeneca.

    The Indian government has purchased 11 million doses of Covishield vaccine.

    While the court order was not available immediately, the lawyer of Cutis-Biotech, which had filed the suit, said it would file an appeal in the high court.

    On January 4, Cutis-Biotech, a pharmacertical firm, filed a suit in the civil court claiming it was a prior user of the brandname Covishield, and sought to restrain SII from using the name.

    SII had told the court that the two companies operate in different product categories and there is no scope for confusion over the trademark.

    “Court has rejected the application,” said SII’s lawyer Hitesh Jain.

    Advocate Aditya Soni, lawyer of Cutis-Biotech, said the order copy was not yet available, but operative order was read out in the court.

    “We will file an appeal against the order in the high court,” he said.

  • Inside the world’s biggest vaccine factory, India’s Serum Institute

    By AFP
    PUNE: The tiny clinking vials supervised by silent PPE-wearing technicians belie the excitement inside the world’s largest vaccine manufacturer, the Serum Institute of India, a major player in the fight against coronavirus.

    The firm, founded in 1966 in the western city of Pune, is producing millions of doses of the Covishield vaccine, developed by AstraZeneca and Oxford University, for India and much of the developing world.

    Unlike the rival Pfizer-BioNTech vaccine, Covishield can be stored and transported using standard refrigeration. 

    It is also significantly cheaper than the vaccines developed by Pfizer or the US firm Moderna, making it better suited for countries with poorer populations and rusty infrastructure.

    Even before the pandemic, the Indian firm was a world leader in vaccines, producing 1.5 billion doses a year and inoculating two out of three children in 170 countries against diseases such as polio, mumps, meningitis and measles.

    Its journey kicked off on a stud farm, where the firm’s owners, the Poonawalla family, began breeding horses in 1946, before a conversation with a vet sparked the realisation that anti-toxin serum extracted from the animals could be used to make vaccines.

    The Serum Institute soon became a market leader thanks to its cheap and effective drugs, which were eagerly sought after by price-conscious governments and consumers, prompting the company to expand at a dizzying rate.

    Adar Poonawalla, its 40-year-old CEO, has spent nearly a billion dollars in recent years enlarging and improving the sprawling Pune campus.

    As a result, when the coronavirus pandemic began to sweep across the world, the company, which recorded annual revenues of over $800 million in 2019-20 and is debt-free, was in pole position to reap the rewards.

    ‘Used to pressure’

    The palm-fringed Pune campus, whose grounds boast horse-shaped topiaries in a playful nod to the firm’s origins, is home to several buildings where vaccines are manufactured and scrutinised for quality before being deposited into sterilised vials and stored for delivery.

    From Brazil to South Africa, there is no shortage of customers, with governments clamouring to buy Covishield.

    With Poonawalla vowing to reserve 50 percent of Covishield stocks for the Indian market, New Delhi, which intends to immunise 300 million people by July, is engaging in a bout of vaccine diplomacy, planning to supply 20 million doses to its South Asian neighbours.

    The Serum Institute also plans to supply 200 million doses to Covax, a World Health Organization-backed effort to procure and distribute inoculations to poor countries. 

    If all this sounds overwhelming, the firm’s bosses are not worried.

    “We are used to these kinds of pressures because even in the past there were situations when we were required to step up the production to meet individual countries’ requirements,” Suresh Jadhav, Serum Institute’s executive director, told AFP.

    Even a deadly fire at an under-construction building this week failed to dent confidence, with Poonawalla promptly tweeting that “there would be no loss of #COVISHIELD production due to multiple production buildings that I had kept in reserve to deal with such contingencies”.

    The pandemic has transformed Poonawalla’s public profile, from a jet-setting billionaire known for his expensive taste in cars and fine art to a pharma-tycoon applauded for his willingness to take risks and his commitment to affordable vaccines.

    Unsurprisingly, the father-of-two has not held back from taking so-called anti-vaxxers to task, including berating US rapper Kanye West for spreading conspiracy theories.

    “Though we enjoy your music very much @KanyeWest, your views on #vaccines come across as irresponsible and borderline dangerous, considering the influence you have today and may have in the future; vaccines save lives,” Poonawalla tweeted in July.

  • Court order in ‘Covishield’ trademark lawsuit likely on January 30

    By PTI
    PUNE: A Pune court hearing a suit filed by a pharmaceutical firm over the brand name ‘Covishield’, used by the Serum Institute of India (SII) for its COVID-19 vaccine, is likely to deliver its order in the case on January 30.

    Cutis-Biotech had filed the suit in the civil court on January 4, seeking to restrain the SII from using the trademark Covishield or any other similar names for its COVID-19 vaccine and claimed the pharma firm is a prior user of the brand name.

    On Tuesday, the SII had filed its response to the lawsuit, stating that both the firms operate in different product categories and there is no scope for confusion over the trademark.

    Advocate S K Jain, representing the SII, said he argued in the court on Friday that Cutis-Biotech had filed another application before the trademark registry for a vaccine in the name of Covishield in December 2020.

    “However, SII applied for the trademark in June 2020. Thus, SII becomes the prior and first user of the trademark Covishield,” said Jain, adding that he also presented some material which showed that the work of printing the material having the name of Covishield had begun in March last year itself.

    “In such a scenario, SII becomes the first user of the trademark,” Jain said.

    Jain said the case filed by the plaintiff should be dismissed as it had cheated the court by not revealing all the information related to the second application of December last year before the trademark registry for a vaccine under the name Covishield.

    Advocate Aditya Soni, representing Cutis-Biotech, countered the SII lawyer’s argument about product distinction, and said it was not necessary that the products should be identical and it was sufficient if the goods are similar, he said.

    Soni said he had cited some judgements to counter the SII’s lawyer’s point that the plaintiff firm did not reveal the details about their December 2020 application.

    “It is irrelevant to attach the documents (related to the application made by Cutis-Biotech to trademark registry for a vaccine under the name Covishield) to the present case,” Soni said.

    After hearing both sides, Additional Sessions Judge A V Rotte kept the hearing on January 30 when the order is expected to be delivered in the case.

  • Three Maharashtra government agencies launch probe in Serum Institute blaze

    By PTI
    PUNE: Top officials from fire wings of three Maharashtra government agencies on Friday launched a probe to ascertain the cause of the blaze that killed five workers at Serum Institute of India’s premises here.

    Heads of fire departments of the Pune Municipal Corporation (PMC), Pune Metropolitan Region Development Authority (PMRDA) and Maharashtra Industrial Development Corporation (MIDC) are part of the joint probe team.

    Five contractual labourers had died in the fire which broke out in a five-storeyed under-construction building in the Serum Institute of India’s Manjari premises on Thursday. The fire damaged the top two floors of the building located in ‘SEZ 3’ area of the premises of the vaccine major.

    Devendra Potphode, Chief Fire Officer, PMRDA, said officials from the planning and development authority, PMC, and MIDC have come together to ascertain the cause of the fire in the building. DCP (Zone-V) Namrata Patil said that police have registered an accidental death and burning incident case with the Hadapsar police station.

    “As we are seeing today, theentire floor (4th and 5th) has been damaged. We are trying to ascertain the cause of thefire as well as how the fire spread. Several types of equipmentwere damaged in the blaze. On the basis of findings from all the agencies, a conclusion will be reached on a how the fire started,” said Potphode

    The PMRDA officer declined to speculate on possible causes of the fire at this juncture. MIDC Chief Fire Officer Santosh Warrick also said it is difficult to comment on the cause right now. “We have started the probe. Our scope of investigation is to check how the fire broke out,” said Prashant Ranpise, PMC’s fire department head.

    Another official said that a team of forensic experts reached the spot and conducting their probe. The Manjari facility is where Covishield, the SII vaccine against COVID-19, which is being used in the nationwide inoculation drive against the infection, is made.

    The building where fire broke out is one km from the Covishield vaccine manufacturing unit.