Tag: Pfizer India

Exclusive: Pfizer says transparency improving in India’s drug regulatory process

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

Listen to the Article (6 Minutes)

Pfizer India on Thursday (October 19) said the regulatory landscape for drug approval in India is becoming more transparent and systematised, while also highlighting the increased speed with which pharmaceutical companies can introduce new drugs to the Indian market.

Speaking at the PWC Pharma and Healthcare CEO Dialogues, Meenakshi Nevatia, the country president and managing director of Pfizer India, said, “A lot has changed in the positive direction in India. First, is about how quickly we are able to now bring drugs into the country and make new launches.”

She said this acceleration in the drug launch process aligns with India’s growing global connectivity, where both doctors and patients have access to information about the latest developments in the medical field worldwide.

Also Read: Glenmark Pharma shares gain on becoming first to launch Triple-drug FDC for Type 2 Diabetes

Further, Nevatia said the regulatory landscape for drug approval in India is becoming more transparent and systematised, “The regulatory process to bring drugs into the country is also getting much more transparent and systematised in a sense.”

The Central Drugs Standard Control Organization (CDSCO) is actively exploring electronic submission processes, which will streamline and digitise the vast amount of data required for product approval, she pointed out.

This digital transformation is set to enhance the efficiency and transparency of bringing pharmaceutical products to the Indian market, Nevatia added.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

3 Mins Read

Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Drug maker Pfizer recalls four products from Indian market

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

Listen to the Article (6 Minutes)

Drug maker Pfizer India said on Thursday that the company has decided to initiate a voluntary recall of four products, namely Magnex, Magnex Forte, Zosyn, and Magnamycin after it observed an out-of-specification during a routine environmental monitoring of its manufacturing block.

The drugs were manufactured by Astral SteriTech Private Ltd. Astral manufactures Magnex (1gm, 2gm), Magnex Forte (1.5gm, 3gm), Zosyn (4.5gm) and Magnamycin (250mg, 1gm, 2gm) for Pfizer, the company said in an exchange filing.

“The company was informed by its contract manufacturer in India, Astral SteriTech Private Ltd, that it has observed an out-of-specification during a routine environmental monitoring of its manufacturing block,” Pfizer said.

Also Read: India’s largest lender is country’s second-most profitable company after Reliance Industries

The company said it places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process.

While this issue is presently being investigated, out of an abundance of caution, Pfizer has decided to voluntarily recall from the market, all batches of these products, the company stated.

Pfizer said it’s taking all necessary steps to resolve the situation. The voluntary recall is likely to have an impact on the revenue and profitability of the company. The said products recorded a sale of Rs 139 crore for the year ended on March 31, 2023.

Also Read: Swiggy’s food delivery business turns profitable in 9 years since its inception

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

3 Mins Read

Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Pradip Shah appointed Pfizer India chairman

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

Listen to the Article (6 Minutes)

Pfizer India on Monday appointed Pradip Shah as the chairman of its board following the resignation of R A Shah on February 3. Announcing the appointment, S Sridhar, the managing director of the company, said with Pradip Shah’s elevation as the chairman, the firm will work closely with him on matters of strategic importance.

He had earlier been contributing the board for many years as a financial expert. He also thanked the outgoing chairman R A Shah.

Also Read | IndiGo appoints Co-founder Rahul Bhatia as Managing Director

Pradip Shah is the ex-managing director and a founding member of Crisil. Prior to founding Crisil, he assisted in founding HDFC in 1977. He has also served as a consultant to USAID, the World Bank, and the Asian Development Bank. He is a director with several reputed companies and also a member of various prestigious committees/commissions.

He is currently the chairman of IndAsia Fund Advisors. He holds an MBA from the Harvard Business School and is a chartered accountant and a cost accountant.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

3 Mins Read

Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Pfizer Q3 net profit up 1.56% at Rs 141 crore

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

Listen to the Article (6 Minutes)

Drug firm Pfizer on Friday reported a 1.56 per cent rise in its net profit to Rs 141.24 crore for the quarter ended December 31, 2020. The company had posted a net profit of Rs 139.06 crore for the corresponding period of the previous fiscal, Pfizer said in a filing to BSE.

Revenue from operations of the company stood at Rs 593.49 crore for the quarter under consideration. It was Rs 538.18 crore for the same period a year ago, it added. Shares of Pfizer closed at Rs 4,516.60 per scrip on BSE, up 0.37 per cent from their previous close.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

3 Mins Read

Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

SEC to consider emergency use authorisation request of Serum, Bharat Biotech on January 1

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

Listen to the Article (6 Minutes)

The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) is considering EUA requests from Serum Institute of India (SII) and Bharat Biotech’s application for COVID-19 vaccines when it will reconvene on January 1, 2010, reported CNN-News18.

Coming to Pfizer India, the company will make a presentation before SEC of CDSCO for approval of its COVID-19 vaccine. An emergency use authorisation (EUA) is short of a full approval.

This comes in after SEC on COVID-19 deliberated and analysed the additional data and information submitted by SII and Bharat Biotech yesterday. “The Subject Expert Committee (SEC) in the CDSCO met today in the afternoon to consider the emergency use authorisation (EUA) request of Pfizer, Serum Institute of India (SII) and Bharat Biotech Pvt. Ltd,” the health ministry said in a statement.

“Further time was requested on behalf of Pfizer. The additional data and information presented by SII and Bharat Biotech Pvt. Ltd was perused and analysed by the SEC. The analysis of the additional data and information is going on. The SEC will convene again on January 1, 2021,” it said.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Wednesday approved the COVID-19 vaccine developed by scientists at Oxford University and produced by AstraZeneca for human use. The Pune-based Serum Institute of India (SII), the world’s largest vaccine manufacturer, has entered into a tie-up AstraZeneca to manufacture ‘Covishield’.

While considering SII’s application, the SEC on December 9 had recommended that the firm should submit updated safety data of phase 2 and 3 clinical trials in the country, immunogenicity data from the clinical trial in the UK and India, along with the outcome of the assessment of the UK MHRA for grant of EUA.

As for Bharat Biotech, after detailed deliberation, the committee had recommended that the firm should present the safety and efficacy data from the ongoing phase 3 clinical trial in the country for further consideration.

SII had applied to the Drugs Controller General of India (DCGI) for emergency use authorisation for Covishield on December 6 while Bharat Biotech had sought a similar nod for its its indigenously developed Covaxin on December 7. Pfizer had applied for a similar approval for its vaccine on December 4.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

3 Mins Read

Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Pfizer seeks emergency use authorisation for its COVID-19 vaccine in India

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

Listen to the Article (6 Minutes)

Pfizer India has become the first pharmaceutical firm to seek from the Drugs Controller General of India (DCGI) an emergency use authorisation for its COVID-19 vaccine in the country after its parent company secured such clearance in the UK and Bahrain.

The firm, in its application submitted to the drug regulator, has sought permission to import the vaccine for sale and distribution in the country, besides waiver of clinical trials on Indian population in accordance with the special provisions under the New Drugs and Clinical Trials Rules, 2019, official sources said.

“Pfizer India has submitted an application on December 4 to the DCGI seeking emergency use authorization (EUA) for its COVID-19 vaccine in India,” a source said.

“The firm has submitted the EUA application in Form CT-18 for grant of permission to import and market Pfizer-BioNTech’s COVID-19 mRNA vaccine BNT162b2 in the country,” the source said, citing the application.

The UK on Wednesday became the first country to approve the Pfizer/BioNTech vaccine against COVID-19, with the UK regulator Medicines and Healthcare products Regulatory Agency (MHRA) granting a temporary authorisation for its emergency use.

The British regulator said the jab, which claims to offer up to 95 percent protection against COVID-19, is safe for roll-out.

Bahrain on Friday also announced that it has granted a EUA for the two-dose vaccine made by Pfizer and its German partner BioNTech. The pharma company has already applied to the US FDA seeking EUA for the vaccine.

The extremely low temperature of minus 70 degrees Celsius required for storing the vaccine poses a big challenge for its delivery in a country like India, especially in its smaller towns and rural areas where maintaining such cold chain facilities would be very difficult, top government officials have said.

When contacted, Pfizer said it remains committed to engaging with the Government of India and explore opportunities to make this vaccine available for use in the country.

“During this pandemic phase, Pfizer will supply this vaccine only through government contracts based on agreements with respective government authorities and following regulatory authorisation or approval,” the global pharma major said in a statement.

Five vaccines are in advanced phases of clinical trials in India with the Serum Institute of India conducting the phase-3 trial of the Oxford-Astrazeneca COVID-19 vaccine, while the indigenously developed vaccine by Bharat Biotech in collaboration with ICMR has already started the phase-3 clinical trial.

Drug firm Zydus Cadila has received the approval from the DCGI to start the phase-3 clinical trials of the indigenously-developed anti-coronavirus vaccine.

Dr Reddy’s Laboratories and the Russian Direct Investment Fund (RDIF) have announced that they commenced adaptive phase 2 and 3 clinical trials for COVID-19 vaccine Sputnik V in India, Also, Biological E. Ltd has started early phase 1 and 2 human trials of its COVID-19 vaccine candidate.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

3 Mins Read

Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow